Dysmenorrhea Study Fitoki

Chinese Herbal Medicine
for the treatment of Dysmenorrhea:

a Community-based Qualitative Study
Research project submitted in partial fulfilment of the degree of
MSc in CHINESE HERBAL MEDICINE
Validated by UNIVERSITY OF EAST LONDON
Cindy Méndez Pendavis

MSc in Traditional Chinese Herbal Medicine
Supervisor: Dr Chris Low
October, 2011
Chinese Herbal Medicine for the treatment of Primary Dysmenorrhea | Cindy Méndez Pendavis
MSc in Chinese Herbal Medicine validated by The University of East London | October, 2011
ACKNOWLEDGEMENTS
I would like to thank a number of people and institutions who have supported me during
this course and have made this research possible. I am grateful to Birinder Tember for
his continued support in undertaking these studies, to the other academic staff for their
dedication and motivation, especially to Chris Low for his guidance, to Sandra for her
hospitality and warm support, to my collegues Dardané, Nico and Carles for their
encouragement, substitutions and treatments, to Luo Shan Shan for her inspiration, to
Fitoki for the financing of the treatments, to Susan for her help and to my parents and
sister for their constant and unconditional support. I’m deeply indebted to Alberto
Pertusa for generously sharing his knowledge throughout the process and I’m
particularly grateful to Thomas, my partner on this journey, for his support, love,
understanding and encouragement.
2
GENERAL INDEX
ACKNOWLEDGEMENTS 3
LIST OF TABLES 7
LIST OF CHARTS 9
GLOSSARY OF ABBREVIATIONS 10
0. ABSTRACT 11
SECTION 1 – INTRODUCTION 13
1. INTRODUCTION 13
1.1 Background and context 13
1.2 Research question 14
1.3 Summary of the research 15
1.4 Hypothesis and variables 16
1.5 Relevance of the study 16
1.6 Aims and objectives of the research 16
1.7 Summary 17
SECTION 2 – LITERATURE REVIEW 18
2. LITERATURE REVIEW 19
2.1 Introduction 19
2.1.1 PD according to CM 19
2.1.2 PD according to TCM 21
2.1.2.1 Differentiation of disharmony patterns 21
2.1.2.2 Treatments for PD with Traditional Chinese pharmacopoeia 26
2.2 Literature review of articles and studies 30
2.2.1 Introduction 30
2.2.2 Methodology - search strategy 30
2.2.3 Evaluation of papers 32
2.2.3.1 Description of studies 32
2.2.3.2 Research question and hypothesis 33
2.2.3.3 Design 34
2.2.3.4 Data collection technique 36
2.2.3.5 Participants 38
2.2.3.6 Analysis 42
2.2.3.7 Findings 43
2.2.3.8 Implications for practice 44
2.2.4 Cochrane systematic review 44
2.2.5 Conclusions 45
SECTION 3 – FIELD WORK 46
3. METHODOLOGY FOR THE FIELD WORK 47
3.1 Introduction 47
3.2 Design of the research 47
3.2.1 Recruitment of participants 47
3.2.2 Design 49
3.3 Data collection and analysis 52
3.3.1 Material 52
3.3.1.1 Menstrual pain assessment questionnaire used in the study 53
3.3.1.2a Review of questionnaire bibliography 57
3.3.1.2b Selection of the best available measuring instrument
for pain assessment in PD for the current study 59
3
3.3.1.3 Adaptation of the questionnaire to the necessities of the study 61

3.3.2 Procedure (application of the questionnaire) questionnaire for
assessment of menstrual pain in PD in TCM 62
3.3.3 Revision of the questionnaire used and proposal of a revised
questionnaire for assessment of menstrual pain in PD in TCM 62
3.4 Scope and limitations 63
4. RESULTS 64
4.1 Introduction 64
4.2 Data analysis 65
4.2.1 Demographic profiles 65
4.2.2 General Heath behaviours and characteristics 66
4.2.3 Menstrual history 66
4.2.4 Disharmony patterns of the participants 68
4.2.5 Evolution of menstrual pain 68
4.2.6 Evolution of premenstrual pain 70
4.2.7 Evolution of the number of days with pain 72
4.2.8 Evolution of the number of days of analgesia use 73
4.2.9 Evolution of the number of days of abandonment of activities 74
4.2.10 Variations in menstruation and blood characteristics 75
4.2 Findings 77
4.3 Summary 77
5. DISCUSSION AND CONCLUSIONS 78
5.1 Discussion 78
5.2 Conclusions and implications 79
5.3 Recommendations for further research 80
5.4 Summary 80
REFERENCES 81
BIBLIOGRAPHY 87
APPENDICES 103
APPENDIX I – Poster advertisement 104
APPENDIX II – Social network announcement 105
APPENDIX III – Article in Web pages 106
APPENDIX IV – Telephone script for preliminary assessment of candidates 108
APPENDIX V – Preliminary assessment of candidates questionnaire 109
APPENDIX VI – Composition of the formula used in the study 110
APPENDIX VII- Traditional composition of Xiao Yan San 112
APPENDIX VIII – Laboratory quality certificates 116
APPENDIX IX – Precepts of the law "Law 29/2006, of the 26th of July" of
guarantees and rational use of medicaments and health care products 118
APPENDIX X – Informed consent 122
APPENDIX XI – Organic Law on Data Protection 125
APPENDIX XII – Initial menstrual pain questionnaire 126
APPENDIX XIII – Daily menstrual pain questionnaire 128
APPENDIX XIV – Final menstrual pain questionnaire 136
APPENDIX XV – Adverse effects report 138
APPENDIX XVI – Medication report 139
APPENDIX XVII - Reliability and validity of a questionnaire 140
APPENDIX XVIII– Larroy menstrual pain questionnaire 142
APPENDIX XIXa – Proposal for initial assessment of menstrual pain in PD
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in TCM questionnaire 145

APPENDIX XIXb – Proposal for daily assessment of menstrual pain in PD
APPENDIX XIXc – Proposal for final assessment of menstrual pain in PD
APPENDIX XX – Tongues and radial pulses of the participants at the
beginning and at the end of the study 158
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LIST OF TABLES
Table 2.1 Evidence of the role of PG in the etiopathogenesis of PD 20

Table 2.2 Current factorisation of the symptoms of dysmenorrhea 20
Table 2.3 Conventional therapeutic approaches for the treatment of PD 21
Table 2.4 Differentiations of disharmony patterns for dysmenorrhea according
to traditional TCM texts 23
Table 2.5 Comparative table of the differentiations of disharmony patterns for
dysmenorrhea according to traditional TCM texts 24
Table 2.6 Differentiation of disharmony patterns applied to this study 26
Table 2.7 Formulas for treatment of PD used in the traditional TCM texts 27
Table 2.8 Comparison between the most widely used formulas for treatment
of PD in the traditional TCM texts 29
Table 2.9 Formulas used to treat PD in this study 30
Table 2.10 Treatment methods and Country of the studies reviewed 33
Table 2.11 Interventions of the studies reviewed 35
Table 2.12 Design of the studies reviewed 36
Table 2.13 Data collection methods of the studies reviewed 38
Table 2.14 Inclusion criteria and subjects of the studies reviewed 40
Table 2.15 Summary of ethical concerns of the studies reviewed 42
Table 3.1 Gantt diagram 47
Table 3.2 Formulas to used depending on disharmony pattern 50
Table 3.3 Stages of questionnaire validation 51
Table 4.2.1 Demographic characteristics of the participants 65
Table 4.2.2 General health behaviours and characteristics of the participants 66
Table 4.2.3 Menstrual characteristics of the participants 67
Table 4.2.4 Disharmony patterns manifested by the participants 68
Table 4.2.5 Results of the Student's t-test for the evolution of the peak
menstrual pain 69
Table 4.2.6 Results of the Wilcoxon test for the evolution of the peak
menstrual pain 69
Table 4.2.7 Representation of the data in bloxpot of the initial and final
comparisons for the evolution of the peak menstrual pain 69
Table 4.2.8 Representation of the initial and final peak menstrual pain
comparisons per participant 69
Table 4.2.9 Results of the Student's t-test for the evolution of the average
menstrual pain 70
Table 4.2.10 Results of the Wilcoxon test for the evolution of the average
menstrual pain 70
comparisons for the evolution of the average menstrual pain 70
Table 4.2.12 Results of the Student's t-test for the evolution of the level
of premenstrual pain 71
Table 4.2.13 Results of the Wilcoxon test for the evolution of the level
Table 4.2.14 Representation of the data in bloxpot of the initial and final level
Table 4.2.15 Results of the Student's t-test for the evolution of the number of
premenstrual symptoms 72
6
Table 4.2.16 Results of the Wilcoxon test for the evolution of the number of
premenstrual symptoms 72
Table 4.2.17 Representation of the data in bloxpot of the initial and final number
of premenstrual symptoms 72
Table 4.2.18 Results of the Student's t-test for the evolution of the number
of painful days 73
Table 4.2.19 Results of the Wilcoxon test for the evolution of the number
of painful days 73
number of painful days 73
of painful days of analgesia use 74
of painful days of analgesia use 74
number of days of analgesia use 74
of painful days of abandonment of activities 75
of painful days of abandonment of activities 75
number of days of abandonment of activities 75
Table 4.2.27 Evolution of the characteristics of menstrual bleeding 77
Table VI Composition of the formula used in the study 112
7
LIST OF CHARTS
Chart 1.1 Summary of the research 15

Chart 3.1 Study design 50
Chart 3.2 Factors that determine the validity of a questionnaire 142
Chart 3.3 Process of creation of the questionnaires for the study 54
Chart 3.4 Stages of adaptation of a questionnaire 55
Chart VII.1 Xiao Yao San Hierarchy composition 116
8
GLOSSARY OF ABBREVIATIONS
ANCP: A Newly Compiled Practical English-Chinese Library of Traditional Chinese

Medicine (Zuo 2003)
CHM: Chinese herbal medicine
CM: Conventional medicine
DRF: Daily rating form
DSRS: Daily symptom rating scale
E2: Estradiol
FSH: follicle-stimulating hormone
Ha: Experimental hypothesis
H1: Working or research hypothesis
H0: Null hypothesis
HPOA: hypothalamus–pituitary–ovary axis
ICC: Intraclass correlation coefficient
IUD: intrauterine device
Kid: Kidney
LH: luteinizing hormone
Liv: Liver
MDQ: The menstrual distress questionnaire
MSQ: The menstrual symptom questionnaire
NRS: Numerical rating scale
NSAIDs: Nonsteroidal anti-inflammatory drugs
OMS: Organización Mundial de la Salud
PD: Primary dysmenorrhea
PG: Prostaglandins
PRL: Prolactin
SD: Systematic desensibilization
SPSS: Statistical package for the social sciences
TCM: Traditional Chinese Medicine
TENS: Transcutaneous electrical nerve stimulation
VAS: Visual analogue pain scale
WHO: World Health Organization
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0. ABSTRACT
Background
Dysmenorrhea is a common condition suffered by between 52% and 90% of women
and can be severe enough to cause absence from work in about 2% of women. Primary
dysmenorrhea (PD) refers to severe pain with no identifiable pelvic pathology that can
account for painful menstruation. Evidence of efficacy supports use of pharmacological
agents such as NSAIDs, or the use of oral contraceptives to alleviate menstrual pain.
However, despite this wide range of treatments, pain relief may be inadequate for some
women, or side effects may not be well tolerated and given that conventional treatment
for primary dysmenorrhoea has a failure rate of 20% to 25%, Chinese Herbal Medicine
(CHM) may be a suitable alternative.
Methodology
A prospective, uncontrolled naturalistic study was carried out in which 10 participants
received treatment with a modified Traditional Chinese Herbal formula Xiao Yao Wan
during three menstrual periods. Participants were followed for four menstrual cycles;
the first one was without treatment and was considered as a baseline.
Modified questionnaires for the assessment of menstrual pain were used for data
collection in different phases of the study: a retrospective questionnaire at the beginning
of the study, a daily questionnaire during 4 menstrual periods, to be filled out on the
days with menstruation, and a final questionnaire.
Results and conclusions

This study assesses the efficacy of treatment of menstrual pain with modified Xiao Yao
Wan with a sample of 10 women. For assessing the evolution of menstrual pain, of
premenstrual pain, the number of days with pain, the number of days of use of analgesia
and the number of days of abandonment of activities due to pain the SPSS programme
was used to apply the Student's t-test for related samples. As well, since the study
sample number is small, in order to confirm the results the Wilcoxon test was also used,
which makes no assumption as to the normal distribution of the frequency of the
variables.
The analysis of the study data shows improvement in all menstrual characteristics, with
some of these being statistically significant and others not.
The analysis of the results partially confirms the working hypothesis, showing that Xiao
Yao Wan is significantly effective (p≤0.05) for treatment of maximum menstrual pain
and reduces the number of days with pain and the number of days of use of analgesia in
primary dysmenorrhea.
The results of the study seem to show the effectiveness of treatment of menstrual and
premenstrual discomfort in PD with the modified Xiao Yao Wan formula, especially
when the predominant disharmony patterns are Qi stagnation, Qi/Xue vacuity and/or el
Xue stasis. The study seems to show these as the main TCM disharmony patterns
causing dysmenorrhea. There also seems to be a relationship between the characteristics
of the menstrual bleeding and the intensity and duration of both menstrual and
premenstrual pain.
Keywords
Primary dysmenorrhea, Dysmenorrhoea, Menstrual Pain, Painful menstruation,
Tradicitonal Chinese Herbal Medicine, Tradicitonal Chinese Medicine
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SECTION 1 – INTRODUCTION
1. INTRODUCTION 13
1.1 Background and context 13
1.2 Research question 14
1.3 Summary of the research 15
1.4 Hypothesis and variables 16
1.5 Relevance of the study 16
1.6 Aims and objectives of the research 16
1.7 Summary 17
11
1. INTRODUCTION
1.1 Background and context
Dysmenorrhea is a common condition suffered by between 52% and 90% of women

(Weissman et al., 2004) and can be severe enough to cause absence from work in about
2% of women. (Weissman et al., 2004). Primary dysmenorrhea (PD) refers to severe
pain with no identifiable pelvic pathology that can account for painful menstruation
(Howard, 2000) (Smith et al., 2010)
A study conducted in the Autonomous Community of Madrid, Spain (Larroy C, et al.,

2001) showed that 61.9% of women suffer menstrual pain, said percentage
decreasing with age. The study concluded that pain severity depends on age, as well as
on the number of children and there was high and significant correlation between pain
severity and frequency. 80.7% of women in the sample women reported the location of
the pain in the abdominal region, 45% in the lumbar region, 38.9% in the breasts and
7.5% in the thighs. (Larroy C, et al., 2001).
Dysmenorrhea represents a significant health problem on both a personal and public

level, being a common complaint in both adolescent and adult women. In the United
States, work absenteeism due to dysmenorrhea is estimated at 600 million work hours
per year, and the economic consequences are estimated at 2 billion dollars per year
(Howard, 2000).
There are three conventional approaches to the management of primary

dysmenorrhea: pharmacological, nonpharmacological and surgical. Conventional
treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives,
danazol, gonadotropin-releasing hormone agonists, medroxyprogesterone acetate,
presacral neurectomy, uterosacral neurectomy and trascutaneous electrical nerve
stimulation (Howard, 2000).
Evidence of efficacy supports use of pharmacological agents such as NSAIDs (Wong et

al., 2009), or the use of oral contraceptives (Sundell et al., 1990) to alleviate menstrual
pain. However, despite this wide range of treatments, pain relief may be inadequate for
some women, or side effects may not be well tolerated. Given that conventional
treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be
12
contraindicated or not tolerated by some women (Xiaoshu Zhu et al., 2010), Chinese
Herbal Medicine (CHM) may be a suitable alternative.
Traditional Chinese Medicine (TCM) throughout its history has treated dysmenorrhea
from its own perspective. It is believed that the first reference to dysmenorrhea in a
TCM text dates back to the Han Dynasty (25-220) (Maciocia, 1998), and is found in
the classic text Jin Gui Yao Lue Fang Lun (Synopsis of prescriptions of the Golden
chamber) (Zhang, 1987).
Now, Zuo et al. (Zuo Yanfu et al., 2006) consider that dysmenorrhea is usually caused
by emotional factors, invasion of six exogenous pathogenic factors and Qi and Blood
Stagnation; or by retention of Blood in the Uterus due to Liver Depression and Qi
Stagnation resulting from emotional upsets; or by Cold-dampness attacking the Lower
Energizer and lodging in the Uterus due to walking in water during menstruation or
sitting on damp ground; or by constitutional Qi and blood vacuity, or depletion of Qi
and Blood due to serious disease and prolonged illness; or by congenital defect or
impairment of the Liver and Kidney, consumption of Blood and malnutrition of the
Uterus due to multiparity and excessive sexual activity.
Cochrane recently published a review (Xiaoshu Zhu et al., 2010) where they found
promising evidence for the use of CHM in reducing menstrual pain in the treatment of
primary dysmenorrhea, compared to both conventional medication such as NSAIDs and
the oral contraceptive pill and acupuncture and heat compression. All available
measures of effectiveness confirmed the overall superiority of CHM to placebo, no
treatment, NSAIDs, OCPs, acupuncture and heat compression. No significant adverse
effects were identified in the review. However, the small number and the low quality of
included studies did not allow any definite conclusion for their use in clinical practice
1.2 Research question
Can primary dysmenorrhea be effectively treated with modified CHM Xiao Yao San
(Xiao Yao Wan)?
13
1.3 Summary of the research
This research attempts to assess treatment of menstrual pain of PD with CHM. For this
purpose the issues that came up were dealt with from four different perspectives; three
theoretical and one practical:
• Theoretical perspective on PD in Conventional Medicine (CM): as defined by

CM texts on PD, its etiopathogenesis and therapeutic approach
• Theoretical perspective on PD in TCM: how TCM texts on PD are considered, its

etiology and therapeutic approach
• Recent research studies: looking at which research studies have been carried out
recently in this area and the conclusions that can be drawn.
The information obtained from this literature review was used to define the study design
used:
• Practical application: a prospective, uncontrolled naturalistic study carried out in

Barcelona between May and September of 2011, in which 14 participants received
treatment with Chinese herbs based on the traditional formula Xiao Yao Wan during
three menstrual periods.
The data obtained from these three approaches were analysed in order to resolve issues
within the research.
THEORETICAL THEORETICAL
PERSPECTIVE PERSPECTIVE
OF CM OF TCM
FIELD
STUDY
LITERATURE REVIEW OF
CURRENT SCIENTIFIC
STUDIES
Chart 1.1 Summary of the research
14
1.4 Hypothesis and variables
1.4.1 Hypothesis
Working hypothesis: Xiao Yao Wan is significantly effective (p≤0.05) for treatment of
menstrual pain in primary dysmenorrhea
Null Hypothesis: Xiao Yao Wan is not significantly effective (p>0.05) for treatment of
menstrual pain in primary dysmenorrhea
1.4.2 Variables
Dependent variable: menstrual pain
Independent variable: Xiao Yan Wan
1.5 Relevance of the study
This study:
• Will assess the efficacy of treatment of menstrual pain in PD with Xiao Yan
Wan in women that live in Barcelona
• Will offer an alternative treatment for menstrual pain in PD without adverse
effects
• Will serve as a base for future research in CHM for treatment of PD
• Will provide knowledge about PD from the perspective of TCM
• Will help promote knowledge of TCM and CHM in Spain
• Will promote the use of TCM and CHM in Spain
1.6 Aims and objectives of the research
• Aims
o To determine the effectiveness of Xiao Yao Wan in the treatment of pain

in primary dysmenorrhea.
o To create a questionnaire tailored to TCM for assessing menstrual pain
• Objectives
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o To determine a differentiation of TCM disharmony patterns in PD

o To review the main pain assessment questionnaires and to assess the
possibility of adapting one of them to the specific needs of TCM
o Create a questionnaire tailored to TCM for assessing menstrual
pain
o To determine an adequate formula for treatment of menstrual pain in PD
for each disharmony pattern
o To determine evolution of the colour of menstrual blood in function of
the degree of pain
o To determine the relation between the degree of pain and the presence of
clots in menstrual blood
o To determine the relation between the degree of efficacy of the formula
de Xiao Yao Wan and the diagnosis of other disharmony patterns,
different to Qi/Xue stagnation
o To determine the relation the degree of efficacy of the formula Xiao Yao
Wan and pain onset
1.7 Summary
This research attempts to assess the efficacy of the CHM formula Xiao Yao Wan for
treatment of menstrual pain in PD.
16
SECTION 2 – LITERATURE REVIEW
2. LITERATURE REVIEW 19
2.1 Introduction 19
2.1.1 PD according to CM 19
2.1.2 PD according to TCM 21
2.1.2.1 Differentiation of disharmony patterns 21
2.1.2.2 Treatments for PD with Traditional Chinese pharmacopoeia 26
2.2 Literature review of articles and studies 30
2.2.1 Introduction 30
2.2.2 Methodology - search strategy 30
2.2.3 Evaluation of papers 32
2.2.3.1 Description of studies 32
2.2.3.2 Research question and hypothesis 33
2.2.3.3 Design 34
2.2.3.4 Data collection technique 36
2.2.3.5 Participants 38
2.2.3.6 Analysis 42
2.2.3.7 Findings 43
2.2.3.8 Implications for practice 44
2.2.4 Cochrane systematic review 44
2.2.5 Conclusions 45
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2. LITERATURE REVIEW
2.1 Introduction
2.1.1 PD according to CM
Dysmenorrhea, uterine pain associated with menstrual cycles (Proctor & Cynthia
Farquhar, 2006), is one of the most common gynecological disorders and is suffered
from by between 52% and 90% of all women of reproductive age (Weissman et al.,
2004).
Normally dysmenorrhea is classified into two types, primary and secondary.

Primary dysmenorrhea is the pain associated to ovulation cycles, without demonstrable
lesions that affect the reproductive organs. Secondary dysmenorrhea is the pain
associated with ovulatory cycles caused by a demonstrable pathology (Beers et al.,
1999). Secondary dysmenorrhea is frequently caused by endometriosis, myomas,
adenomyosis, pelvic inflammatory disease or the use of the intrauterine device, among
others. (Proctor & Cynthia Farquhar, 2006)
PD usually has its onset near the menarche, normally after 6 to 12 months. Typically the
pain lasts between 8 and 72 hours, is associated with the start of the menstrual period,
although can begin before, (Martínez & López, 2004), and usually disappears as
menstruation tapers off. (Michelle L Proctor and Cynthia M Farquhar, 2006)
Over the years different theories have been brought forward on the etiopathogenesis of
PD, some of which are now obsolete, for example such as the allergic theory (Palacios,
2000). In spite of the numerous studies carried out the cause is not clear, although in
general it is considered that PD is caused by the excessive production of
prostaglandins (PG) as a consequence of the decreased levels of ovarian hormones that
precede the menstrual period (Palacios, 2000). The PG provoke an excessive uterine
contractility, which reduces the blood supply to the uterine blood vessels and causes
ischemic pain (Dmitrovic et al., 2003; Proctor & Cynthia Farquhar, 2006).
Table 2.1 is a summary of available evidence on the possible role of PG in the

etiopathogenesis of PD (Palacios, 2000):
18
• The dysmenorrhoeic symptoms can be reproduced by the administration of PG

• There are higher levels of PG in the menstrual flow of dysmenorrhoeic women
• There is higher plasma concentration of PG metabolites in dysmenorrhoeic
women
• In anovulatory cycles the concentrations of PG are barely 20% of those in
ovulatory cycles
• Pharmacological inhibitors of PG are effective in treatment of PD
Table 2.1 Evidence of the role of PG in the etiopathogenesis of PD
The main clinical manifestation of PD is spasmodic pain at the midline of the inferior
hemiabdomen, frequently accompanied by nausea, diarrhoea, vomiting, headache and
syncope, among others (R. P. Smith, 2004).
Table 2.2 shows current factorisation of dysmenorrhea [(Stephenson et al., 1983) named
in (Larroy C et al., 2001)]:
Menstrual pain Spasms and contractions of the uterine and vaginal muscles.
Localised in the abdomen and inner thighs.
Negative premenstrual Irritability, dysphoric feelings, fatigue, loss of appetite.

psychological states
Premenstrual fluid Abdominal pain, inflammation, edema.

retention
Premenstrual general Dull and diffuse pain, localised in the back (lower back and
malaise neck) and headache.
Menstrual back pain Tensional pain in the lumbar region - is a continuation of the
abdominal pain.
Gastric disorders Constipation or diarrhoea, dizziness, nausea and vomiting.
Table 2.2 Current factorisation of the symptoms of dysmenorrhea
The diagnosis of PD is usually made by: (Howard, 2000; Prieto, 2007)
19
• Anamnesis, investigating the characteristics of the pain and verifying their

cyclical nature.
• Gynecological exploration to rule out pelvic pathology
• Rectal examination
There are three conventional approaches to the management of primary

dysmenorrhea: pharmacological, non-pharmacological and surgical. Conventional
treatments include non-steroidal anti-inflammatory drugs (NSAIDs), oral contraceptives,
danazol, gonadotherpin-releasing hormone agonists, medroxyprogesterone acetate,
presacral neurectomy, uterosacral neurectomy and transcutaneous electrical nerve
stimulation (Howard, 2000), local application of heat (R. P. Smith, 2004) and
psychological treatment (Palacios, 2000) (see table 2.3). Interestingly some
conventional medicine books include acupuncture as treatment for pelvic pain (Howard,
2000).
CONVENTIONAL THERAPY APPROACHES

FOR THE TREATMENT OF PD
PHARMACOLOGICAL Nonsteroidal anti-inflammatory drugs (NSAIDs), oral
contraceptives, danazol, gonadotherpin-releasing hormone agonists,
medroxyprogesterone
NON Local application of heat (R. P. Smith, 2004), Trascutaneous

PHARMACOLOGICAL electrical nerve stimulation (TENS)1
SURGICAL Presacral neurectomy, uterosacral neurectomy
OTHERS Psychological treatment (Palacios, 2000)

Table 2.3 Conventional therapeutic approaches for the treatment of PD
2.1.2 PD according to TCM
2.1.2.1 Differentiation of disharmony patterns
It is frequent that when consulting the differentiation of disharmony patterns of a

pathology or of a symptom TCM texts that we detect differences between different
1
Nerve Stimulation: “(Treatment for chronic pain that consists of a) phenomenon of depolarisation of the
nervous system, produced by passing an electric current in such a way that the effect can either be
stimulation (facilitation) or inhibition, at the same time local or distal.” (Villoria, 2007)
20
authors. To determine a differentiation of disharmony patterns of dysmenorrhea for

application to this study several TCM gynecological texts were consulted. Following is
a table with the summary of the different differentiations of disharmony patterns from
Maciocia (1998), Flaws (1997), Zuo (2003) [A Newly Compiled Practical English-
Chinese Library of Traditional Chinese Medicine encyclopaedia de Shanghai (ANCP)],
Riley (2003) and Peilin (2002).
21
WORK DIFFERENTIATION OF DISHARMONY PATTERNS

MACIOCIA Qi stagnation
Xue stasis
Cold stagnation
Heat- dampness
Liver Qi stagnation that is converted into Fire
Qi/Xue vacuity
Yang and Xue vacuity
Liv/Kid vacuity
ANCP Qi stagnation and Xue stasis
Cold- dampness that freezes and stagnates
Qi/Xue vacuity
Liv/Kid vacuity
FLAWS Qi stagnation and Xue stasis
Cold- dampness that freezes and stagnates
Stasis de heat- dampness
Liver Qi stagnation that is converted into Fire
Qi/Xue vacuity
Cold internal due to vacuity in the uterus
Liv/Kid vacuity
Heat due to vacuity
RILEY Qi stagnation and Xue stasis
Internal Cold due to vacuity
Cold and dampness that freeze
Heat- dampness that descends
Qi/Xue vacuity
Liv/Kid vacuity
PEILIN Qi stagnation
Xue stasis
Accumulation of Cold- dampness
Descent of Heat- dampness
Qi/Xue vacuity
Liv/Kid Yin vacuity
Kid Yang vacuity
Table 2.4 Differentiations of disharmony patterns for dysmenorrhea according to traditional TCM
texts
As often occurs, differences between the classifications were detected. In order to

determine a differentiation of disharmony patterns for this study, a comparative study of
these differentiations of disharmony patterns was carried out. It was found that:
• All of the authors consider Qi stagnation to be a disharmony pattern that

causes dysmenorrhea. Maciocia and Flaws also take Qi stagnation that is
22
converted into Fire into consideration. Maciocia and Peilin also consider
Xue stasis.
• All of the authors consider the accumulation of Cold-dampness as a
cause of dysmenorrhea, except Maciocia who only considers Cold
• All of the authors, except ANCP, consider Yang vacuity as a cause of
dysmenorrhea. Maciocia also considers that this is usually accompanied
by Xue vacuity
• All of the authors, except ANCP, contemplate Heat- dampness as a
cause of dysmenorrhea
• All of the authors contemplate Qi/Xue vacuity as a cause of
dysmenorrhea
• All of the authors consider Liver/Kidney (Liv/Kid) vacuity as a cause of
dysmenorrhea. Peilin also specifies Liv/Kid Yin vacuity, and Flaws adds
Heat due to vacuity.
MACIOCIA ANCP FLAWS RILEY PEILIN

(Maciocia, (Zuo, 2003) (Flaws, 1997) (Riley, 2003) (Peilin, 2002)
1998)
Qi stagnation x x
x x x
Xue stasis x x
Qi stagnation
that is converted x x
into Fire
Accumulation of
x
Cold
Accumulation of
x x x x
Cold- dampness
Yang vacuity x (with Xue
x x x
vacuity)
Heat- dampness x x x x
Qi/Xue vacuity x x x x x
Liv/Kid vacuity x x x x x (Yin)
Heat due to
x
vacuity
Table 2.5 Comparative table of the differentiations of disharmony patterns for dysmenorrhea
according to traditional TCM texts
23
On the basis of the comparative study the following differentiation of disharmony

patterns for the study were determined:
• Qi stagnation: Qi stagnation was included because all of the authors

consider this disharmony pattern as a cause of dysmenorrhea
• Xue stasis: in spite of only being considered by Maciocia and Peilin all
the texts contemplate the possible presence of dark blood or with dark
clots. Probably the texts that do not consider Xue stasis as a specific
cause is because Qi and Xue are interdependent, they circulate together
and Qi stagnation implies, to a certain extent, Xue stasis and vice versa.
This would explain that many of the formulas that treat Qi stagnation in
dysmenorrhea include one or several of the substances that mobilise Xue.
This disharmony pattern was specifically included as it is not infrequent
to find many women with dark and often thick menstrual blood, often
thick, even sometimes described as ‘thick chocolate’ or ‘with the
appearance of faeces’.
• Cold- dampness: all of the authors consider Cold as a cause of
dysmenorrhea, and all except Maciocia also contemplate Cold- dampness.
It was decided to include the Cold- dampness disharmony pattern
because the majority include it and because Cold facilitates the
accumulation of dampness as it blocks the circulation and obstructs the
metabolism of liquids.
• Yang vacuity: Yang vacuity was included as the majority of authors,
except ANCP, consider it a cause of dysmenorrhea.
• Heat- dampness: was included was included as the majority of authors,
except ANCP, consider it a cause of dysmenorrhea.
• Qi/Xue vacuity: the disharmony pattern Qi/Xue vacuity was included
because all of the authors consider it a cause of dysmenorrhea
• Liv/Kid Yin vacuity: In spite of the fact that only Flaws specified
Liv/Kid vacuity as well as Yin vacuity, it was decided to include the
Liv/Kid Yin vacuity disharmony pattern as the only vacuity that Liv and
Kid have in common is Yin.
24
These are the main disharmony patterns contemplated for this study. Fire was also
added as a possible disharmony pattern added to Qi stagnation, and Heat as a possible
disharmony pattern added to Liv/Kid Yin vacuity.
DISHARMONY PATTERNS
Qi stagnation + Fire
Xue stasis
Cold- dampness
Yang vacuity
Heat- dampness
Qi/Xue vacuity
Liv/Kid Yin vacuity + Heat

Table 2.6 Differentiation of disharmony patterns applied to this study
2.1.2.2 Treatments for PD with Traditional Chinese pharmacopoeia
Historically there are a multitude of formulas of traditional Chinese pharmacopoeia for

treatment of PD. In order to determine the formulas to use in this study a literature
search was carried out and, as with the differentiation of disharmony patterns,
treatments specified by the following authors were compared: Maciocia (1998), Flaws
(1997), ANCP (Zuo, (2003), Riley (2003) and Peilin (2002).
Following is a table summarising the treatments indicated in the texts mentioned:
25
WORK DIFFERENTIATION OF FORMULA/S

DISHARMONY PATTERNS
MACIOCIA Qi stagnation Xiao Yao San
Xue stasis Tao Hong Si Wu Tang
Ge Xia Zhu Yu Tang
Tao Hong Yin
Nei Yi Fang
Hua Yu Ding Tong Tang
Cold stagnation Wen Jing Tang
Ai Fu Nuan Gong Wan
Wen Qi Hua Shi Tang
Wen Shen Fu Yang Tang
Heat- dampness Qing Re Tiao Xue Tang
Er Miao San
Liver Qi stagnation that is converted Xuan Yu Tong Jing Tang
into Fire Dan Zhi Xiao Yao San
Qi/Xue vacuity Sheng Yu Tang
Ba Zhen Yi Mu Tang
Shi Quan Da Bu Tang
Yang and Xue vacuity Dang Gui Jian Zhong Tang
Yi Shen Tong Jing Tang
Yu Shen Hua Yu Tang
Liv/Kid vacuity Tiao Gan Tang
Gui Shao Di Huang Tang
ANCP Qi stagnation and Xue stasis Xuefu Zhuyu Tang
Cold- dampness that freezes and Shaofu Zhuyu Tang
stagnates
Qi/Xue vacuity Bazhen Tang
Liv/Kid vacuity Tiaogan Tang
FLAWS Qi stagnation and Xue stasis Ge Xia Zhu Yu Tang
Xue Fu Zhu Yu Tang
Qing Re Tiao Xue Tang
Jia Wei Wu Yao Tang
Ba Wu Tang
Tao Hong Si Wu Tang Jia Wei
Tong Jing Fang
Shen Hua Tang Jia Wei
Tiao Jing Yin
Jia Jian Chai Hu Shu Gan Tang
Jia Jian Xiao Yao San
Cold- dampness that freezes and Shao Fu Zhu Yu Tang
stagnates Wu Zhu Yu Tang
Wen Jing Tang
Gui Zhi Fu Ling Wan
San Jie Fang
Dang Gui Si Ni Tang Jia Wei
Chu Tong San
26
Table 2.7 Formulas for treatment of PD used in the traditional TCM texts
In this case more differences were found than in the comparison between the
differentiations of disharmony patterns. The number of times a formula was repeated by
different authors in the selection of formulas in function of the disharmony pattern was
used as criteria.
The following formulas are those that were repeated the most for each disharmony
pattern:
• For Qi stagnation: Xiao Yao San (3) Xue Fu Zhu Yu Tang (2)
• For Xue stasis: Tao Hong Si Wu Tang (3) Ge Xia Zhu Yu Tang (2) Xue Fu
Zhu Yu Tang (2)
• For Cold- dampness: Wen Jing Tang (2), Shao Fu Zhu Yu Tang (2)
• For Yang vacuity: Tong Jing Tang (2)
• For Heat- dampness: Er Miao San (2)
• For Qi/Xue vacuity: Shi Quan Da Bu Tang (3), Ba Zhen (Yi Mu) Tang (3)
• For Liv/Kid Yin vacuity: Tiao Gan Tang (4)
27
Maciocia ANCP Flaws Peilin Most repeated

formulas
(nº repetitions)
Qi stagnation Xiao Yao San Xuefu Jia Jian Xiao Yao Xiao Yao Xiao Yao San (3)
Zhuyu Tang San, San Xue Fu Zhu Yu
Ge Xia Zhu Yu Tang, Tang (2)
Xue Fu Zhu Yu Tang,
Qing Re Tiao Xue
Tang,
Jia Wei Wu Yao Tang
Ba Wu Tang,
Tao Hong Si Wu Tang
Jia Wei,
Tong Jing Fang,
Shen Hua Tang Jia
Wei,
Tiao Jing Yin,
Jia Jian Chai Hu Shu
Gan Tang
+ Fire Xuan Yu Tong Xuan Yu Tong Jing
Jing Tang, Tang
Dan Zhi Xiao
Yao San
Xue stasis Tao Hong Si Xuefu Ge Xia Zhu Yu Tang, Tao Hong Si Tao Hong Si Wu
Wu Tang, Zhuyu Tang Xue Fu Zhu Yu Tang, Wu Tang and Tang (3)
Ge Xia Zhu Yu Tao Hong Si Wu Shi Xiao San Ge Xia Zhu Yu
Tang, Tang Jia Wei, Tang (2)
Tao Hong Yin, Qing Re Tiao Xue Xue Fu Zhu Yu
Nei Yi Fang, Tang, Tang (2)
Hua Yu Ding Jia Wei Wu Yao Tang,
Tong Tang, Ba Wu Tang,
Tong Jing Fang,
Shen Hua Tang Jia
Wei,
Tiao Jing Yin,
Jia Jian Chai Hu Shu
Gan Tang,
Jia Jian Xiao Yao San
Cold- dampness Wen Jing Shaofu Shao Fu Zhu Yu Cang Fu Dao Wen Jing Tang
Tang, Zhuyu Tang, Tan Tang (2)
Ai Fu Nuan Tang Wen Jing Tang, Shao Fu Zhu Yu
Gong Wan, Wu Zhu Yu Tang, Tang (2)
Wen Qi Hua Gui Zhi Fu Ling Wan,
Shi Tang, San Jie Fang,
Wen Shen Fu Dang Gui Si Ni Tang
Yang Tang Jia Wei,
Chu Tong San
Yang vacuity Dang Gui Jian Shaofu Wen Shen Fu Yang Ba Wei Wan Tong Jing Tang
Zhong Tang, Zhuyu Tang Tang, with Wen (2)
Yi Shen Tong Tong Jing San Hao Jing Tang,
Jing Tang, Fang, You Gui Wan
Yu Shen Hua Tong Jing Shen Fang
Yu Tang
Heat- dampness Qing Re Tiao Xiao Yao San He Wan Long Dan Xie Er Miao San (2)
Xue Tang, Jia Jin, Gan Tang,
28
Table 2.8 Comparison between the most widely used formulas for treatment of PD in the
traditional TCM texts
Therefore the following formulas were those chosen for use in this study:
DISHARMONY PATTERN FORMULA/S
Qi stagnation Xiao Yao San
+ Fire Dan Zhi Xiao Yao San
Cold- dampness Wen Jing Tang or Shao Fu Zhu Yu Tang
Yang vacuity Tong Jing Tang
Heat- dampness Er Miao San
Qi/Xue vacuity Shi Quan Da Bu Wan or Ba Zhen Yi Mu

Tang
Liv/Kid Yin vacuity Tiao Gan Tang
+ Heat Jia Wei Tiao Gan Tang
Table 2.9 Formulas used to treat PD in this study
2.2 Literature review of articles and studies
2.2.1 Introduction
Throughout the history of TCM many forms of CHM have been used for the treatment
of menstrual pain. In recent years there have been several studies to verify the
effectiveness of these traditional treatments. A literature review of the most relevant
TCM current studies in the treatment of menstrual pain with CHM was done to clarify
the current status of research in this field.
2.2.2 Methodology - search strategy
The databases used were:

• Medline
• Cochrane Library Plus
29
• Informa Healthcare
• JSTOR
• Google Scholars [http://scholar.google.es/]
• ScienceDirect – SciVErse
• SpringerLink
• EBSCOhost
• SCIRUS
• WILEY Online Library
• World Scientific
The search keywords used were:

• Traditional Chinese Medicine
• Traditional Chinese Herbal Medicine
• Dysmenorrhea
• Dysmenorrhoea
• Menstrual Pain
• Painful menstruation
The selection of studies was based on the following criteria:
• Types of studies: This review included RCTs and systematic reviews
• Types of participants: Studies with primary dysmenorrhea participants

were included. Studies with secondary dysmenorrhea participants or
participants with dysmenorrhea caused by use of an intra-uterine device
were excluded
• Types of intervention: Studies that used CHM were included
• Types of targets: Studies that aimed relieve menstrual pain and

discomfort associated with primary dysmenorrhea were included
Finally 6 RCTs and a systematic review were found consistent with the detailed criteria.
Non-inclusion of articles in Chinese and the omission of searches on Chinese databases

should be considered as a limitation of this review.
30
2.2.3 Evaluation of papers
2.2.3.1 Description of studies
Six RCTs and a systematic review were selected. The systematic review will be
discussed later in point 2.2.4. The studies selected were:
Cheng, J.-F. et al., 2008. ‘A traditional Chinese herbal medicine used to

treat dysmenorrhoea among Taiwanese women’. Journal of Clinical
Nursing,17(19), pp.2588-2595. Available at:
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2702.2008.02382.x/full
[Accessed October 31, 2010].
Geng, S.S. et al., 2010. ‘Effect of Wujijing Oral Liquid on menstrual

disturbance of women’. Journal of Ethnopharmacology, 128(3), pp.649-
653. Available at: http://www.sciencedirect.com/science/article/B6T8D-
4Y34V41-6/2/3f282428b22d5608536e540ede488c6c.
Jang, J.-B. et al., 2009. ‘Therapeutic effects of Chiljehyangbuhwan on

primary dysmenorrhea: A randomized, double blind, placebo-controlled
study.’ Complementary Therapies in Medicine, 17(3), pp.123-130.
Available at: http://www.sciencedirect.com/science/article/B6WCS-
4TKXD61-1/2/e05378c907e4ea8ce99211d7087575f3.
Kennedy, S. et al., 2006. ‘Randomized controlled trial assessing a

traditional Chinese medicine remedy in the treatment of primary
dysmenorrhea’. Fertility and Sterility, 86(3), pp.762-764. Available at:
http://www.fertstert.org/article/S0015-0282(06)00957-5/abstract
[Accessed October 31, 2010].
Tseng, Y.-F., Chen, C.-H. & Yang, Y.-H., 2005. ‘Rose Tea for Relief of
Primary Dysmenorrhea in Adolescents: A Randomized Controlled Trial in
Taiwan’. Journal of Midwifery & Women’s Health, 50(5), pp.e51-e57.
Available at: http://www.sciencedirect.com/science/article/B6W6R-
4H2F7JB-1C/2/8f9a7b0cb082c32cb4588e51f80b2914.
31
Yeh, L.L.L. et al., 2007. ‘A Randomised Placebo-Controlled Trial of a

Traditional Chinese Herbal Formula in the Treatment of Primary
Dysmenorrhoea’. PLoS ONE, 2(8), p.e719. Available at:
http://dx.doi.org/10.1371/journal.pone.0000719 [Accessed October 31,
2010].
All selected studies evaluated the effectiveness of treatment of primary dysmenorrhea

with one or more TCM remedy. One of them was developed in continental China in
Nanjing, 3 in Taiwan, one in Korea and one in Netherlands.
In the studies of Cheng et al. and Yeh et al., Si Wu Tang formula was used, Tseng et al.
used Rose tea, Geng et al. used Wujijing, Jang et al. used Chiljehyangbuhwan and
Kennedy et al. used a TCM formula consisting of three ingredients (Angelica sinensis
root, Paeonia lactiflora root and Corydalis yanhusuo rhizome).
Study Treatment methods Country

Si Wu Tang China (Taiwan)
(Yeh et al., 2007) Si Wu Tang China (Taiwan)
(Tseng, C.-H. Chen & Rose tea. China (Taiwan)
Yang, 2005)
(Geng et al., 2010) Wujijing China (Nanjing)
(Jang et al., 2009) Chiljehyangbuhwan Korea
(Kennedy et al., 2006) TCM formula consisting of three Netherlands in
collaboration with
ingredients (Angelica Sinensis root,
The University of
Paeonia lactiflora root and Corydalis Oxford
yanhusuo rhizome)
Table 2.10 Treatment methods and Country of the studies reviewed
2.2.3.2 Research question and hypothesis
The studies did not specify the working hypothesis or the null hypothesis, but specified
the objectives.
The purposes of the Cheng et al. study were twofold. Firstly, to ascertain the relative
effectiveness of the alternative drug, Si-Wu-Tang, for dysmenorrhoea treatment and
32
secondly to compare two different timings for consumption of SWT in relation to

menstrual pain.
The Yeh et al. study assessed the effectiveness and safety of Si Wu Tang for primary
dysmenorrhoea and evaluated the compliance and feasibility for a future trial.
The purpose of the Tseng et al. study was to investigate the effects of drinking rose tea
for alleviating the pain and psycho-physiological distress experienced by adolescents
with primary dysmenorrhea in Taiwan.
The Geng et al. study attempted to evaluate the clinical efficacy and mechanism of
action of Wujijing Oral Liquid for menstrual disturbance.
The Jang et al. study was conducted to investigate the efficacy and safety of an oriental
herbal medicine native to Korea, Chiljehyangbuhwan, in treating primary dysmenorrhea.
The Kenedy et al. study assessed the safety and efficacy of a TCM formula as treatment
for primary dysmenorrhea; however it showed no statistically significant results over
placebo.
2.2.3.3 Design
All studies were controlled and randomized. Participants in studies control group in the
Yeh et al., Geng et al., Jang et al. and Kennedy et al. studies received a placebo with a
similar appearance to the treatment, however those of the Cheng et al. study received
the same treatment as the experimental group but on different days of the menstrual
period, and in the Yeh et al. study the control group received no intervention, which
could cause serious bias.
33
Study Intervention
(Cheng, Lu, Two cycles of treatment during which the experimental group (n = 24) was provided
with Si Wu Tang for seven consecutive days commencing at the completion of
Su, Chiang
menstruation, while the comparison group (n = 25) was provided with Si Wu Tang
& R.-Y. on the first day of menstrual bleeding for seven consecutive days
Wang,
2008)
(Yeh et al., Three cycles of treatment during which the experimental group (n = 37) was
provided with Si Wu Tang for five days from the onset of bleeding or pain, while the
2007)
comparison group (n = 39) was provided with placebo during the same period
(Tseng, C.- Six cycles of treatment during which the experimental group (n=70) was treated with
rose tea from 1 week before their menstrual period to the fifth menstrual day, for 12
H. Chen &
days every month. The participants drank 2 teacups of rose tea. Participants in the
Yang, control group (n=60) did not receive any intervention
2005)
(Geng et Two menstrual cycles during which the experimental group received Wujijing 10mL
twice daily (n = 28) and the control group received an identical-looking placebo (n =
al., 2010)
25) from the 1st day after onset of menstrual flow until 1 day after onset of
menstrual flow of the third cycle.
(Jang et al., One menstrual cycle during which the experimental group received
Chiljehyangbuhwan (n = 24) and the control group received a placebo (n = 17),
2009)
starting at the conclusion of one menstrual period and ending al the conclusion of the
next. Each group was further split into smaller subsets (indication, non-indication
and unspecified group, according to Korean Oriental medical diagnosis.
(Kennedy Three cycles of treatment (plus two observation cycles, one before and one after)
during which the participants took three tablets twice per day for 7 days,
et al., 2006)
commencing 2 days before the anticipated start of menstruation during three cycles.
The intervention group (n = 17) received a TCM formula consisting of three
ingredients (Angelica Sinensis root, Paeonia lactiflora root and Corydalis yanhusuo
rhizome) and the control group (n = 19) received placebo tablets, indistinguishable
in appearance.
Table 2.11 Interventions of the studies reviewed
The treatment period of the studies varied between 1 and 6 cycles, and only Cheng et al.,
Yeh et al. and Kennedy et al. carried out a follow up after the end of the treatment
period.
Geng et al. Jang et al. applied daily treatment during the intervention period, whereas
the other studies only applied treatment during certain days of each cycle, which could
affect the results, since the pharmacological effect of pharmacopoeial formulas is
usually cumulative (Kennedy et al. 2006). In addition, treatments carried out throughout
34
the cycle may be less symptomatic and have a deeper effect in treatment of the
disharmony pattern.
With the exception of Cheng et al. and Tseng et al., the studies used double blinding and
appropriate randomization, increasing thereby their reliability.
Study (Cheng, Lu, (Yeh et al., (Tseng, C.- (Geng et al., (Jang et al., (Kennedy et
Su, Chiang 2007) H. Chen & 2010) 2009) al., 2006)
& R.-Y. Yang, 2005)
Wang, 2008)
Randomisation Not specified Computer- Unclear Computer- Random Computer-
generated randomisatio generated number table generated
randomizatio n randomizatio randomizatio
n list n list n list
Blinding No Double-blind No Double-blind Double-blind Double-blind
Length of 2 cycles 3 cycles 6 cycles 2 cycles 1 cycle 3 cycles
intervention
Follow-up 2 cycles 2 cycles 0 cycles 0 cycle 0 cycle 1 cycle
Table 2.12 Design of the studies reviewed
Cheng et al. and Tseng et al. did not use a placebo for treatment of the control group,
which gives less validity to their results. In the studies using placebo in the control
group, those that found significant differences in the level of pain between the
experimental and control group at the end of the study were those that applied the
treatment throughout the study period - Geng et al. and Jang et al. On the other
hand those that applied the treatment only on certain days of the menstrual cycle during
the study period, Yeh et al. and Kennedy et al., found no significant differences.
Generally the studies with the most appropriate methodological designs were Geng et al.
and Jang et al., although they did not monitor the evolution of menstrual pain after the
study. Jang et al. was the only study that used TCM differentiation of disharmony
patterns for choice of treatment.
2.2.3.4 Data collection technique
The data collection techniques were similar in Cheng et al., Yeh et al., Jang et al. and
Kennedy et al. who used the Visual Analogue Scale (VAS) for pain assessment, along
35
with other additional parameters such as duration of pain or intake of NSAIDs. Tseng et
al. used specific questionnaires (Short-form McGill Pain Questionnaire and The Short
form of the Menstrual Distress Questionnaire) as well as scales for the assessment of
stress. Geng et al. used a non specific questionnaire about the intensity of the primary
symptoms of menstruation (menstrual blood loss) and menstruation-related symptoms
(dysmenorrhea, breast pain, dizziness, fatigue, insomnia) from 0 (none) to 3 (severe),
and an assessment of sex hormone profiles included the levels of follicle-stimulating
hormone (FSH), luteinizing hormone (LH), prolactin (PRL), estradiol (E2),
progesterone (PG) and testosterone.
As discussed below, the VAS is generally considered the most suitable, since its validity
and reliability has been widely studied (M. S. Serrano - Atero, 2002). We will also see
later that the Menstrual Distress Questionnaire used by Tseng et al. is one of the most
criticised, mainly because it is retrospective (Norvell et al.,1987) (Terry et al., 2008).
The questionnaire reliability, as well as its validity, are questioned because the factors
originally considered by Moos (the author of the questionnaire) as constituents of
premenstrual syndrome, have not been later verified (Norvell et al. 1987) (Terry et al.
2008).
In general, all of the studies used appropriate data collection techniques, except Tseng et
al. which used questionnaires that currently are of questionable validity and reliability.
36
Study Data collection methods

(Cheng, Lu, Su, 1. Visual analogue scale
Chiang & R.-Y. 2. Duration of the pain
Wang, 2008) 3. Frequency of use of NSAIDs
(Yeh et al., 1.Visual analogue scale
2007) 2. Four-point pain scale
3. Confounders:
Data regarding the type and frequency of the intake of all drugs and the use of other
remedies as possible confounders was collected along with the VAS pain intensity in
an electronic diary.
4. Adverse reactions or events
(Tseng, C.-H. 1. Short-form McGill Pain Questionnaire
Chen & Yang, 2. The Menstrual Distress Questionnaire Short Form
2005) 3. Visual Analogue Scales for Anxiety
4. Perceived Stress Scale
5. The Psycho-physiological Life Adaptation Scale
(Geng et al., 1. Questionnaire (non specific) on primary symptoms of menstruation (menstrual blood
2010) loss) and menstruation-related symptoms (dysmenorrhea, breast pain, dizziness, fatigue,
insomnia) from 0 (none) to 3 (severe)
2. Assessment of sex hormone profiles
(Jang et al., 1. Visual analogue scale
2009) 2. Verbal Rating Scale
3. Multidimensional Verbal Rating Scale
(Kennedy et al., 1. Visual analogue scale
2. Duration of dysmenorrhea
2006)
3. The amount of rescue medication used
4. Global assessment of treatment
Table 2.13 Data collection methods of the studies reviewed
2.2.3.5 Participants
The studies included between 41 and 130 participants with the sum total of 393
participants in all studies.
Yeh et al. and Kennedy et al. used age, duration of the cycles, and absence of associated
gynecological pathology as inclusion criteria. Yeh et al. also specified the required
number of painful cycles in recent months, however for Kennedy et al. inclusion criteria
included menstrual cycles that 'usually' required and obtained relief from analgesia
and/or participants whose daily functioning was significantly impaired, which may have
caused significant bias.
Cheng et al. and Jang et al. used less specific inclusion criteria limiting it only to age
and secondary dysmenorrhea.
37
Tseng et al. and Geng et al. did not specify the inclusion criteria, which could lead to
possible bias, in addition to affecting the reliability of the study.
Cheng et al. and Tseng et al. limited the age range of participants which means that the
results are not applicable to the general (El Centro Nacional de la Medicina
Complementaria y Alternativa, s.f.).
38
Study Subjects Inclusion criteria

(Cheng, Lu, 49 Women between 20 and 30 years of age and who, reportedly,
Su, Chiang &
R.-Y. Wang, had suffered from dysmenorrhoea for a period of more than one year.
2008)
(Yeh et al., 76 Women 18 years or older, with cycles lasting 21 to 35 days, with the
2007) actual menstrual periods lasting three to seven days, and that
experienced at least 4 consecutive painful periods in the six months
prior to the study, with pain starting one day before or on the day of
onset of bleeding.
The women were not taking oral contraceptive pills and agreed to
refrain from sexual activity during the study due to any possible
confounding effect on pain and/or early withdrawal due to pregnancy,
and they had no prior severe gastrointestinal, gynaecological or
autoimmune diseases, or gynaecological surgery, including pregnancy
(Tseng, C.-H. 130 Not specified (nursing students)

Chen &
Yang, 2005)
(Geng et al., 53 Not specified
2010)
Exclusion criteria: Patients with any prior diagnosis of cardiovascular
disease, digestive system diseases, tuberculosis, tumors, hypersensitivity
and diseases of the nervous system were excluded. Patients with
adenomyosis, endometriosis, or gynaecologic cancer were also
excluded.
(Jang et al., 41 Women over 14 and under 45 years of age and more than 2-3 years past
2009) menarche
Cyclic, periodic manifestations of dysmenorrhea symptoms
No underlying conditions leading to secondary dysmenorrhea
Not related to conditions causing pelvic pain outside the uterus
Not related to drug interactions (contraceptives, hormonal drugs,
analgesics, etc.)
(Kennedy et 44 Women between 18 and 45 years of age, with menstrual cycles
al., 2006) occurring every 21 to 42 days and with dysmenorrhea, who usually
required and obtained relief from analgesia and/or whose daily
functioning was significantly impaired
Exclusion criteria:
-known to have pathology associated with dysmenorrhea
-concurrent use of any other TCM, alternative therapy or herbal remedy
for dysmenorrhea
-likely to take analgesics, sedatives or muscle relaxants within the 48
hours before menstruation
-use of mood-altering medication
-not willing to use reliable contraception if sexually active
Total 393
Table 2.14 Inclusion criteria and subjects of the studies reviewed
All of the studies were approved by an ethics committee, and all, except Jang et al. and
Kennedy et al., obtained a signed informed consent from the participants or their parents,
39
a necessary aspect designed to ensure protection for participants (National Center for
Complementary and Alternative Medicine, nd) (Zaslawski, 2010).
Only Jang et al., Yeh et al. and Geng et al. conducted an evaluation of adverse-effects.
These three studies and Kennedy et al. performed ultrasound, haematological and
biochemical screening tests to evaluate the safety of interventions used.
In the Yeh et al. study no blood chemistry levels changed, except for an increase in
heavy metals at the end of treatment. This slight increase occurred not only in the FAD
group but also in the placebo group.
In the Geng et al. study 1 patient from the intervention group reported adverse. There
were no reports of severe adverse reactions. Level of hepatic and renal function and
hemogram parameters were without change.
In the Jang et al. study adverse reactions were recorded on observation charts, and 8
participants in the intervention group reported various forms of discomfort, but none of
the subjects chose to leave the trial for these reasons. The 2 subjects who eventually
chose to discontinue were all from the placebo group.
40
Study (Cheng, (Yeh et al., 2007) (Tseng, (Geng et al., (Jang et al., 2009) (Kennedy et
Lu, Su, C.-H. 2010) al., 2006)
Chiang & Chen &
R.-Y. Yang,
Wang, 2005)
2008)
Ethical China Human Ethics Research Department of Kyung Hee University
approval Medical Committee of Ethical Obstetrics and University Korean of Oxford
University, National Health Committ Gynecology of Oriental Medicine and The
Taiwan Research ee of the Nanjing Hospital Netherlands
Institutes of participat General Institutional by TNO
Taiwan ing Hospital Review Board of Quality of
institutio firstly Clinical Trials Life
n
Evaluation Not Possible adverse Not At each visit, Adverse reactions Evaluation
of adverse specified reactions to TCM specified patients were were recorded on of adverse
effects and were annotated. asked whether observation charts effects not
safety there were any specified.
adverse effects Safety was
Safety was or not. assessed by using Safety was
assessed by using standard assessed by
standard Safety was haematological using
haematological assessed by and biochemical standard
and biochemical using standard tests haematologi
tests haematologica and pelvic cal and
and pelvic l and ultrasound. biochemical
ultrasound. biochemical tests.
tests.
Informed Yes Yes Yes Yes Not specified Not
consent specified
Table 2.15 Summary of ethical concerns of the studies reviewed
2.2.3.6 Analysis
Cheng et al. used the SAS program (for Windows) although the study did not specify
the kind of statistical test used to analyze the results. The results indicated that the
decrease of menstrual pain levels and the duration of pain between the experimental
group and the comparison group was not significant. However, the decrease in
menstrual pain over the five menstrual cycles within the experimental group and within
the comparison group was significant.
Yeh et al. used the SAS program and t-test for statistical testing. They found that at the
end of the treatment, both overall-pain and peak-pain decreased in the intervention
group and increased in the placebo group; however, the difference between the two
groups was not statistically significant.
41
Tseng et al. also used the SAS program and applied Dunn’s method. The results showed
that the experimental group, in comparison with the control group, perceived less
menstrual pain, distress, and anxiety and showed greater psycho-physiological well-
being over time, at 1, 3, and 6 months after the interventions.
The Geng et al. study does not specify a statistical program but mentioned that the chi-
square tests and the Student´s t-test were used to compare clinical and demographic data
between the intervention and control groups. Comparisons were made with t-test and
Wilcoxon test before and after intervention in each group. They found that the score for
pain and related symptoms of the menstruation decreased significantly among patients
treated with the Wujijing. Comparing the Wujijing group and the placebo group, the
levels of P and T differed significantly after treatment.
Jang et al. used the SPSS statistical program and t-test. They found that in the non-
indication group there were no significant differences in VAS, VRS, and MVRS scores
and score changes before and after medication between the placebo group and the
Chiljehyangbuhwan group. In the indication group there were significant differences in
the changes in VAS and MVRS scores between the placebo group and the
Chiljehyangbuhwan group.
Kennedy et al. used the SAS program for data analysis, although did not specify the
statistical test used. They found that there were no significant differences in any of the
measures of efficacy between the TCM formula and the placebo. However, after cycle 3,
53% of women in the TCM group reported less pain than usual compared with the 26%
in the placebo group.
2.2.3.7 Findings
Cheng et al. found that the Si Wu Tang formula can be integrated as an alternative
therapy within Western medicine.
Yeh et al. concluded that the finding of statistically significant pain-reducing effect in
the first follow-up cycle was unexpected and warrants further study, and a larger,
similar trial among primary dysmenorrheic young women with a longer treatment phase
42
and multiple batched study products could determine the definitive efficacy of this
historically documented formula.
Tseng et al. concluded that the findings suggest that drinking rose tea is a safe, readily
available and simple treatment for dysmenorrhea, which female adolescents may take to
suit their individual needs.
Geng et al. concluded that the Wujijing oral liquid could improve menstrual disorder
and is generally safe and well tolerated. The possible mechanism could be associated
with its effects on strengthening the kidney and regulating the hypothalamus–pituitary–
ovary axis (HPOA).
Jang et al. concluded that the results suggest that Chiljehyangbuhwan is effective and
safe in treating primary dysmenorrhea when prescribed appropriately under Korean
Oriental medical diagnosis.
Kennedy et al. concluded that, although not statistically significant, there could be an
indication of a cumulative effect over time, but that the study was inadequately powered
to reject or confirm this possibility completely.
2.2.3.8 Implications for practice
The analysis of the clinical studies discussed allows the deduction that the application of
treatment throughout the menstrual cycle may be more effective in treating pain than
treatment during only a fraction of the menstrual cycle.
2.2.4 Cochrane systematic review
Cochrane recently published a review (Xiaoshu Zhu et al., 2010). Thirty-nine

randomised controlled trials involving a total of 3475 women were included in the
review. They included any randomised controlled trials involving Chinese herbal
medicine versus placebo, no treatment, conventional therapy, heat compression, another
type of Chinese herbal medicine, acupuncture or massage. Exclusion criteria were
identifiable pelvic pathology and dysmenorrhoea resulting from the use of an intra-
uterine contraceptive device.
43
They found promising evidence for the use of CHM in reducing menstrual pain in the
treatment of primary dysmenorrhea, compared to both conventional medication such as
NSAIDs and the oral contraceptive pill and acupuncture and heat compression. All
available measures of effectiveness confirmed the overall superiority of CHM to
placebo, no treatment, NSAIDs, OCPs, acupuncture and heat compression. No
significant adverse effects were identified in the review. However, the small number
and the low quality of included studies did not allow any definite conclusion for their
use in clinical practice
2.2.5 Conclusions
According to the findings of the discussed studies, we can conclude that:
• The application of a continuous treatment during the study instead of applying it for
just a few days during the menstrual cycle may be more effective in treatment of
menstrual pain, possibly due to a cumulative effect.
• Treatments may be more effective when prescribed according to a TCM diagnosis and
differentiation of disharmony patterns
• Pharmacopoeia treatments applied under the right conditions appear to be safe and
could be integrated as alternative treatments to CM
• Further trials with more robust methodology are necessary to reach more definitive
conclusions
44
SECTION 3 – FIELD WORK
3. METHODOLOGY FOR THE FIELD WORK 47

3.1 Introduction 47
3.2 Design of the research 47
3.2.1 Recruitment of participants 47
3.2.2 Design 49
3.3 Data collection and analysis 52
3.3.1 Material 52
3.3.1.1 Menstrual pain assessment questionnaire used in the study 53
3.3.1.2a Review of questionnaire bibliography 57
3.3.1.2b Selection of the best available measuring instrument
for pain assessment in PD for the current study 59
3.3.1.3 Adaptation of the questionnaire to the necessities of the study 61
3.3.2 Procedure (application of the questionnaire) questionnaire for
assessment of menstrual pain in PD in TCM 62
3.3.3 Revision of the questionnaire used and proposal of a revised
questionnaire for assessment of menstrual pain in PD in TCM 62
3.4 Scope and limitations 63
4. RESULTS 64
4.1 Introduction 64
4.2 Data analysis 65
4.2.1 Demographic profiles 65
4.2.2 General Heath behaviours and characteristics 66
4.2.3 Menstrual history 66
4.2.4 Disharmony patterns of the participants 68
4.2.5 Evolution of menstrual pain 68
4.2.6 Evolution of premenstrual pain 70
4.2.7 Evolution of the number of days with pain 72
4.2.8 Evolution of the number of days of analgesia use 73
4.2.9 Evolution of the number of days of abandonment of activities 74
4.2.10 Variations in menstruation and blood characteristics 75
4.2 Findings 77
4.3 Summary 77
5. DISCUSSION AND CONCLUSIONS 78
5.1 Discussion 78
5.2 Conclusions and implications 79
5.3 Recommendations for further research 79
5.4 Summary 80
45
3. METHODOLOGY FOR THE FIELD WORK
3.1 Introduction
A prospective, uncontrolled naturalistic study was carried out in Barcelona between

May and September of 2011, in which 14 participants received treatment with chinese
herbs based on the traditional formula Xiao Yao San during three menstrual periods.
The mean age of the participants was (6,6), with a range of 22 to 42 years.
The timeline of the study is specified in the following table:

April May June July August September
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
Recruitment
Data collection
Literature search
Analysis of literature
Writing of literature review
Writing of introduction
Writing of methods
Data analysis
Writing of results and discussion
Submission of project
Table 3.1 Gantt diagram
3.2 Design of the research
3.2.1 Recruitment of participants
10 women of reproductive age and over the age of 18 participated in the study. The
inclusion and exclusion criteria that were established were the following:
• Inclusion criteria:
• menstrual cycles between 21 and 35 days
• menstruations with between 3 and 7 days duration
46
• women that experienced pain unrelated to secondary dysmenorrhea

during a minimum of 4 consecutive periods in the 6 months prior to
study
• not pregnant
• who did not take oral contraceptives and who were in agreement to use
non-hormonal contraceptive methods during the study
• and in the case of taking oral contraceptives, that these had been taken
for a minimum of 6 months and with the understanding that they should
continue to be taken throughout the entire duration of the study.
• Exclusion criteria
• that the women included in the study were not using an intrauterine
device (IUD)
• had not been diagnosed with any serious illness
• were not receiving other TCM treatment.
The study was publicised by posters in natural health centres and therapies schools in
Barcelona (see Appendix I– Poster), and through announcements in social networks and
Web pages (see Appendix II– Announcements in social networks and Appendix III–
article in Web pages).
56 candidates who responded to these advertisements were interviewed by telephone

to evaluate their suitability for the study. To standardise the interviews a telephone
script and a questionnaire were used (see Appendix IV– Telephone script for
preliminary assessment of candidates and Appendix V– Questionnaire for preliminary
assessment of candidates).
Of the 56 candidates, 19 did not comply with the inclusion criteria, it was not possible
to contact 9 by telephone, 3 responded that they would have to think about it and 25
decided to participate in the study. 5 of the latter did not attend the initial interview and
gave no explanation as to why they had decided to not participate.
Of the 19 candidates that did not meet the requirements, 4 were receiving TCM
treatment, 1 was underage, 3 did not meet the requirements regarding cycle or duration
of the menstrual period, 7 suffered from secondary dysmenorrhea, 1 did not meet
47
requirements regarding pain, 1 was trying to get pregnant and was not prepared to use
contraceptive methods, 1 did not meet the requirements regarding oral contraceptives
and 1 was excluded because of living far away from the centres where the interviews
would be carried out and on her informing that she was not going to be able to travel to
any of them.
20 participants were included in the study, 6 of whom abandoned for personal reasons
or were excluded because they did not follow the treatment adequately (they did not
collect the different formulas on time) and 4 of them was not included in the results as
the study would finalise outside the deadline of this work. Therefore the study sample
size was 10 participants.
3.2.2 Design
A prospective, uncontrolled naturalistic study was carried out in which participants

received treatment with a traditional Chinese herb formula during three menstrual
periods.
The study obtained prior approval from the Ethics Committee of the University of East
London (www.uel.ac.uk)
The initial design of the study contemplated carrying out a randomized controlled trial
but this was not possible due to the time constraints of the deadline for this work. In
order to carry out a trial with these characteristics in Spain approval from a Spanish
ethics committee is necessary and this takes from six months to a year to process. For
this reason it was decided to carry out an uncontrolled naturalistic study, respecting the
diagnostical bases of TCM.
48
RECRUITMENT Interview, selection criteria, informed consent
First visit, prescription of Chinese herbal

1 retrospective
formulation
questionnaire, an interview
and tongue photo
Self-administered questionnaires during 1st

menstrual period. Participants begin to take
Chinese herbal medicine following the end of
the 1st menstrual period
MONITORING
1 prospective questionnaire
Self-administered questionnaires during 2nd,

3rd and 4th menstrual periods
3 prospective questionnaires
End-of study visit interview
ANALYSIS
1 retrospective questionnaire,
Analysis of results an interview and a tongue
photo
Chart 3.1 Study design
The World Health Organisation (WHO), in its initiative to develop standardisation of

evidence based Traditional Chinese Medicine (Chang, 2004) recommends the
application of TCM diagnostic criteria. The initial design of the study contemplated
personalised choice for the formulation of remedies with traditional Chinese herbs
based on the differentiation of disharmony patterns of dysmenorrhea as determined in
sectionx2.1.2:
49
DISHARMONY FORMULA/S
PATTERN
Qi stagnation Xiao Yao San
+ fire Dan Zhi Xiao Yao San
Cold-Humidity Wen Jing Tang or Shao Fu Zhu Yu Tang
Yang vacuity Tong Jing Tang
Heat-Humidity Er Miao San
Qi/Xue vacuity Shi Quan Da Bu Wan or Ba Zhen Yi Mu Tang
Liv/Kid Yin vacuity Tiao Gan Tang
+ heat Jia Wei Tiao Gan Tang
Table 3.2 – Formulas used depending on disharmony pattern
The design of the study was modified as, when carrying out the initial interviews and
determining the diagnosis according to TCM, it was found that all of the participants
presented signs and symptoms that coincided with Qi stagnation. For this reason it was
decided to prescribe modified Xiao Yao Wan for all cases (See Appendix VI–
Composition of the formula used in the study and Appendix VII- Traditional
composition of Xiao Yan San) and in this way simplify the final analysis of the study
results.
The herbal based formulas used in the study were formulas commercialised by Fitoki
(www.fitoki.com). The Fitoki formulas are registered in the European Union and have
obtained the necessary health records required by the Spanish Ministry of Health and by
the provincial government for their production, commercialisation and distribution as
alimentary supplements (see Appendix VIII– Laboratory quality control certificates).
Spanish legislation only permits TCM therapists to prescribe registered products and not
personalised formulas and this was another reason for using registered products for the
study (see Appendix IX- Precepts of the law "Law 29/2006, of the 26th of July" of
guarantees and rational use of medicaments and health care products)
50
3.3 Data collection and analysis
3.3.1 Material
All participants signed an informed consent (see Appendix X– Informed consent) and
a document under the Organic Law on data protection in Spain (see Appendix XI–
Organic Law on Data Protection).
Modified questionnaires for the assessment of menstrual pain were used for data
collection (Larroy, C et al.,2001) in different phases of the study:
• A retrospective questionnaire at the beginning of the study (see Appendix XII –

initial menstrual pain questionnaire)
• A daily questionnaire during 4 menstrual periods to be filled out on the days
with menstruation (see Appendix XIII– daily menstrual pain questionnaire)
• A final questionnaire (see Appendix XIV– final menstrual pain questionnaire)
At the first interview participants were individually informed about the study details and
the process, intervention and informed consent were all explained. The participants also
received instructions on how to fill out the questionnaires and were free to ask any
questions and comment on any doubts that they might have.
The participants were informed that in the case of presenting any unpleasant symptoms
that they believed to be related to taking the herbal formula that they could consult
someone using the telephone number or email given in the informed consent, as well as
being able to consult their doctor if considered necessary. A form was provided for
making note of any possible adverse effects from the medication (see Appendix XV–
Adverse effects report) where the contact telephone number and email where once again
specified.
The participants were informed that they were allowed to take pain killers during the
study and they were shown where to annotate this on the daily menstrual pain
questionnaire. They should indicate any other medication in the report of medication
taken (see Appendix XVI– Medication Report)
51
3.3.1.1 Menstrual pain assessment questionnaire used in the study
There are several different questionnaires for the assessment of pain and specifically
menstrual pain. The most commonly used questionnaires for assessment of menstrual
pain are:
• The Menstrual Distress Questionnaire (MDQ) (Moos, 1968)

• The Menstrual Symptom Questionnaire (MSQ) (Chesney & Tasto, 1975)
• Daily Symptom Rating Scale (DSRS) (Taylor, 1979)
• Daily Rating Form (DRF) (J Endicott et al., 1986)
• The end of day questionnaire (Choi & Salmon, 1995)
• Menstrual pain questionnaire (Larroy, C et al., 2001)
Sometimes generic pain assessment scales are used, the most important of which are:
(Ferreira-Valente et al., 2011) (M. S. Serrano - Atero, 2002) (Price et al.,1983)
• Numerical rating scales (NRS)
• Visual analogue pain scale (VAS)
The factors that determine whether a questionnaire is adequate for use are its
reliability and its validity. Martín Arribas defines these parameters in the following way:
(Martín Arribas, M.C., 2004) us it is explained in Appendix XVII.
Summing up, Martín Arribas (Martín Arribas, M.C., 2004) highlights the following
points to clarify what is meant by validity and reliability:
1. What is validated is not the test but the test scores and therefore the question we
try to answer is: Are the scores of this test valid for use?
2. Validity cannot be summed up in a single indicator or numerical index, the same
as with reliability (reliability coefficient, Cronbach's alpha, etc.)
3. Validation is a continuous and dynamic process and
4. The theory plays an important role as a guide both for the development of a
test and its validation process.
52
This last point in particular explains and justifies the need to have a questionnaire for
assessment of menstrual pain that is specific to TCM as the very theory of TCM takes
into consideration some quite different parameters to those considered in CM.
As there was no pre-existing questionnaire for assessment of menstrual pain specific to

TCM, the first step was to draw one up for this study. The process of creation of the
questionnaires for the study was the following:
• Selection of a valid questionnaire, adaptable to the necessities of TCM

• Adaptation of the questionnaire to the necessities of the study
• Application of the questionnaire to the study.
Selection of a valid Adaptation of Application of

questionnaire that is the the
adaptable to the questionnaire to questionnaire to
necessities of TCM the necessities the study
of the study
Chart 3.3- Process of creation of the questionnaires for the study
The stages of validation of a questionnaire are: (Morales & Zárate, 2004)
• Selection of the best available instrument for measuring the phenomenon being
studied
• Translation into Spanish and afterwards translation back to the original language.
• Pilot test: to assess the points of the questionnaire, their usefulness as well as the
format
• Assessment of reliability
• Assessment of validity
• Assessment of the sensitivity to change: it is necessary that the questionnaire be
sensitive to even slight clinical variations. To assess the sensitivity to change
requires application of the same questionnaire to the same subject on repeated
occasions, for example before and after treatment. Some authors have proposed
indexes for measuring sensitivity to change, such as the ratio obtained from the
division of the average intraindividual score changes, after an effective treatment,
by the variability between stable subjects. This index can help in calculating the
53
sample size necessary for the study of measuring instruments [(DeVellis, 2003)
mentioned in (Morales & Zárate, 2004)].
• Revision depending on the previous steps and new application of the instrument.
VALIDATION STAGES OF A QUESTIONNAIRE
Selection of the best available measuring instrument

for the phenomenon under study
Translation into Spanish and afterwards translation

back to the original language.
Pilot test
Assessment of reliability
Assessment of validity
Assessment of sensitivity to change
Revision and new application
Chart 3.4 Stages of adaptation of a questionnaire
Based on the necessary stages for validation of a questionnaire, as defined by Morales

& Zárate, the process of creation of an assessment of menstrual pain questionnaire for
the current study was determined.
In the following table are shown the actions taken in each of the stages:
54
VALIDATION STAGES OF A STAGES FOLLOWED IN THE STUDY

QUESTIONNAIRE
(Morales & Zárate, 2004)
Selection of the best available Selection of the Larroy menstrual pain questionnaire
measuring instrument for the
phenomenon under study
Translation into Spanish and Not applicable
afterwards translation back to the
original language.
Pilot test: to assess the points of In spite of it being advisable to carry out a pilot to test to try
the questionnaire, their out usage, refine technical aspects and improve and correct
usefulness as well as the format any deficiencies that might be found (Morales & Zárate
2004), given the limitations of resources and time this was
not done and the questionnaire was applied directly to the
study. It should be noted that the variations to the original
questionnaire are minimal, to be exact 8 questions were
added, 2 were excluded, 1 was modified and the 20
remaining questions were maintained. Details of the changes
made will be given below. (Section 3.2.1.3)
Assessment of reliability Larroy & cols. Carrying out of the relevant assessments for
the validation of the original questionnaire:
Assessment of validity
(Larroy, C et al. 2001) “The discriminative value of the
Assessment of sensitivity to elements in the questionnaire were put to the test with a
change Crombach test and the differences in mean point scores for
the items, finding that all the relevant elements (items) were
able to differentiate between people with and without
disorders (i.e. dysmenorrhea) with a level of confidence of
99%.”
In the current study no assessment of the reliability or
validity of the adapted questionnaire was made because of
limitations of resources and time. In future researchs it
would be recommendable to carry out these steps.
Revision depending on the After application of the questionnaire some slight changes to
previous steps and new some of the questions were proposed. Details of these will be
application of the instrument given below. (Section 3.2.1.5)
Table 3.4 Stages of questionnaire validation
Finally therefore, the process of creation of the assessment of menstrual pain

questionnaire used in the study was the following:
• Bibliographical review and selection of the best measuring instrument available

for measuring pain in PD for the current study (see page 57)
• Adaptation of the questionnaire to the necessities of the study (see page 61)
• Application of the questionnaire to the study (see page 62)
55
• Revision of the questionnaire used and proposal for a revised questionnaire for
assessment of menstrual pain in PD in TCM (see page 62)
3.3.1.2a Review of questionnaire bibliography
As has already been mentioned there are several menstrual pain questionnaires, the
main ones of which are commented on below.
The Menstrual Distress Questionnaire (MDQ) (Moos 1968)
A retrospective questionnaire consisting of 47 items measured on a scale of 6 points,

ranging from not experiencing symptoms through to experiencing incapacitating
symptoms. Here the participants are asked to assess their premenstrual, menstrual and
inter-menstrual symptoms, allowing comparisons to be made between the luteal phase
and the follicular phase. Different variations of the questionnaire have been created,
some of which are prospective (A. Haywood et al., 2002).
There is no outline of advice specified for interpretation of the data and levels of
suffering. Tests of reliability and validity have not been carried out (A. Haywood et al.,
2002).
The MDQ is the most widely used questionnaire but is also one of the most criticised,
with doubts as to both its reliability and its validity. Furthermore the factors that Moos
originally considered constitute premenstrual syndrome have been questioned as they
have not been subsequently verified. Along the same lines numerous studies consider it
invalid because of being retrospective (Norvell et al., 1987) (Terry et al., 2008),
although some studies consider that it can provide valuable information. (Hawes & Oei,
1992) (Ross et al., 2003)
The Menstrual Symptom Questionnaire (MSQ) (Chesney and Tasto 1975)
A prospective questionnaire consisting of 25 items measured on a scale of 5 points,

ranging from experiencing no symptoms to experiencing symptoms always. (Buela-
Casal, Caballo & Sierra, 1996)
Chesney and Tasto developed the MSQ based on Dalton's theory that differentiates
between two types of dysmenorrhea, spasmodic and congestive, caused by opposite
56
hormonal alterations and which therefore cannot be encountered in the same woman.
There are studies that suggest that this theory is incorrect and propose modifications to
the questionnaire. (Wildman & White, 1986), (Cox, 1977) and (Webster et al., 1979)
concluded that Dalton's theory is not correct as menstrual pain depends on more than 2
factors and that premenstrual and menstrual pain can occur in the same woman.
(Cox, 1977) carried out a study that reproduced Chesney and Tasto's study and
concluded that:
(a) the MSQ does not have significant test-retest reliability

(b) the dimension of congestive - spasmodic symptoms of the MSQ is not dichotomous
and that
(c) the MSQ does not predict the effectiveness of systematic desensibilization. (SD)2
(Cox, 1977)
Daily Symptom Rating Scale (DSRS) (Taylor 1979)

ranging from not experiencing any symptoms through to experiencing severe symptoms.
Each form registers 5 weeks of symptoms. (A. Haywood et al. 2002)
There is no outline of advice specified for interpretation of the data and levels of
suffering. Reliability and validity are considered adequate. (A. Haywood et al., 2002)
(Taylor, 1979)
Daily Rating Form (DRF) (Endicott et al. 1986)

ranging from experiencing no symptoms to experiencing extreme symptoms. Each form
registers data from 5 days before the menstrual period until 5 days after menstruation.
(A. Haywood et al. 2002)
2
Systematic desensibilization (SD): “SD is a technique for reducing anxiety that is more
complex than the relaxation procedures that are also included in it. It is recommended in those
cases where a phobic component or intense fear are an important part of the expression of pain.
Its creator was J. Wolpe. It consists of progressively presenting the subject with a series of
previously hierarchised aversive stimuli while he/she remains in a relaxed state. It attempts to
find the incompatibility between different psychological states (tension vs. relaxation) in order
to eliminate the cause of the fear or flight/avoidance mechanism. (Villoria, 2007)
57
In spite of not assessing the reliability of the questionnaire during the study, this
questionnaire has been widely used in different population types. Validity tests were not
done. (A. Haywood et al. 2002)
The end of day questionnaire (Choi and Salmon 1995)

ranging from not experiencing symptoms to experiencing severe / intolerable symptoms.
There is evidence of the internal consistency of this questionnaire; however its validity
is seriously questioned. (A. Haywood et al. 2002)
Menstrual pain questionnaire (Larroy, C et al. 2001)
The reliability and consistency were determined with a Crombach test and through the
different scoring methods for the items. It was found that all the relevant items were
able to differentiate between subjects with or without disorders to a level of confidence
of 99%. (Larroy, C et al. 2001)
The questionnaire collects information on different aspects of primary dysmenorrhea

and is useful both in prevalence studies and clinical studies. (Larroy C, et al., 2001)
Others
Other questionnaires can be found however those that only assess the premenstrual
period were rejected for this study.
3.3.1.2b Selection of the best available measuring instrument for pain assessment
in PD for the current study
The Moos (1968) MDQ was ruled out mainly because it is a retrospective questionnaire
(Norvell et al., 1987) (Terry et al., 2008) as well as because of the doubts as to its
reliability and validity. (A. Haywood et al., 2002) (Hawes & Oei, 1992)
The Chesney and Tasto (1975) MSQ was ruled out because of the multiple evidence
found that indicates that the questionnaire is based on an incorrect theory and therefore
should be modified. (Webster et al., 1979) (Cox, 1977) (Wildman & White, 1986)
(Buela-Casal, Caballo & Sierra, 1996)
58
The Choi and Salmon (1995) end of day questionnaire was ruled out because of
evidence found as to its possible lack of validity. (A. Haywood et al., 2002)
The Endicott et al. (1986) DRF was ruled out because in spite of being widely used no
validity tests have been done. (A. Haywood et al., 2002)
The two remaining questionnaires were those considered for use in the study. In spite of
the reliability and validity of the DSRS, Taylor (1979), being considered adequate (A.
Haywood, P.Slade & H.King, 2002) (Taylor, 1979), the Larroy questionnaire was the
one finally selected. One of the main reasons for selecting this questionnaire was that it
was created in the same country, which minimises the cultural / regional differences in
interpretation of the questions in such a way as to guarantee that in the application of
the questionnaire the validity and reliability of the initial interview and inquiry would be
maintained. (Morales & Zárate 2004).
The Larroy questionnaire contains “sociodemographic data (age, profession, education);

factors that may influence menstrual pain (number of children, number of years since
menarche); characteristics of menstrual pain (intensity and localisation of the pain,
number of painful menstruations, moment of pain onset); request for professional help
because of menstrual pain; symptoms associated with menstrual pain; strategies used for
pain relief (taking medication and rest); and other symptoms and disorders” (Larroy, C,
Meseguer, C & Crespo, 2001) which allows multidimensional assessment of
dysmenorrhea (M. S. Serrano - Atero, 2002). This is interesting given that the different
physiopathological changes may be accompanied by other changes such as in behaviour
and mood states. (Uriel Halbreich & Jean Endicott, 1985)
The questionnaire also includes a daily / monthly chart (see Appendix XVIII – Larroy
menstrual pain questionnaire) which facilitates differentiation between dysmenorrhea
and premenstrual syndrome by determining the days on which associated symptoms
appear.
The Larroy (Larroy, C and al. 2001) version was used, that uses the NRS for pain
assessment instead of the version that uses VAS. Both are the most widely used and are
considered the most adequate (M. S. Serrano and Atero 2002) (Ferreira-Valente et al.,
2011). The validity and reliability of both has been demonstrated, however the NRS is
slightly more sensitive (Ferreira-Valente et al., 2011). Furthermore the NRS has the
59
advantage of defining equal intervals amongst the different levels (M. S. Serrano -
Atero, 2002). Even Larroy, in another study, concluded (Larroy, C, 2002) that the use of
the NRS is simpler and more convenient.
In spite of the endorsement by numerous studies of the use of the VAS considering it a
simple, solid, sensitive and reproducible instrument (Price et al. 1983) (Rosier et al.,
2002), a study carried out by (Yarnitsky et al., 1996) presents the VAS as a useful
instrument that reflects the differences in individual response to treatment and placebo,
but one that has a low test re-test reliability in determined circumstances such as pain
from application of heat.
3.3.1.3 Adaptation of the questionnaire to the necessities of the study
The Larroy questionnaire adapts well to the necessities of the study and it was
completed with sections for assessment of aspects of menstruation considered important
in TCM.
The structure of the questionnaire was maintained along with the majority of the
questions. Only the following modifications where made:
• Question 6: was not included as this was a prerequisite for participation in the
study
• Question 21: was simplified, reducing the number of answer possibilities from 6
to 3
• Question 23: the daily / monthly chart was not included in order to simplify the
process for the participants, thus minimising the number of dropouts. Also the
study did not intend to evaluate in detail the premenstrual symptoms but only
menstrual and premenstrual pain and premenstrual so it was considered that the
inclusion of the chart would not provide relevant data and instead could be
uncomfortable for the participants to fill it out.
• Questions 4 and 5 were added to determine the date of the last visit to the
gynaecologist and if the participant had been diagnosed with any pathology
• Question 6 was added to find out whether participants had been pregnant at any
time
60
• Questions 11, 16, 17, 18 and 19 were added to the questionnaire. These relate to
the colour of menstrual blood, the quantity of blood, the possible presents of
clots and whether pain is alleviated with the application of heat or not, as this
data is relevant and decisive for diagnosis in TCM (Flaws 1997) (Maciocia
1998).
3.3.2 Procedure (application of the questionnaire)
A personalised interview was carried out with each of the participants where the study
process was explained. In this first interview the participants filled out a retrospective
menstrual pain questionnaire (see Appendix XII– initial menstrual pain questionnaire), a
tongue photograph was taken and radial pulse were taken. They were given four
questionnaires (see Appendix XIII– daily menstrual pain questionnaire) to fill out over
the following four menstruations and they were given instructions on how to fill out the
forms.
The first questionnaire was filled out without receiving the pharmacopoeial
treatment. The pharmacopoeial treatment was begun on the first day after the first
menstruation and during three menstrual cycles. During these 3 cycles the participants
filled out the daily questionnaire during menstruation.
At the end of the fourth cycle a final interview was carried out, where the participants
filled out a retrospective questionnaire (see Appendix XIV– final menstrual pain
questionnaire) and a second tongue photograph was taken and the characteristics of the
radial pulse were annotated.
The data was treated statistically with the Statistical Package for the Social Sciences
(SPSS).
3.3.3 Revision of the questionnaire used and proposal of a revised questionnaire

for assessment of menstrual pain in PD in TCM
After the application of the questionnaire to the 10 participants the following limitations
in the initial menstrual pain questionnaire were detected:
61
• The questions were not numbered and subsequent numbering was done
in order to facilitate results analysis
• Various participants found it difficult to remember their last
gynecological visit (question 4) so the addition of different answer
possibilities could simplify response
• Question 6 (‘Have you ever been pregnant?’) could be more useful if it
were substituted by ‘How many times have you been pregnant?’
Likewise, in the daily questionnaire, the question ‘Have you taken medication for pain?’
is not specific enough. The question should permit specifying the number of pain killers
and dosage.
Lastly, in all of the questionnaires (initial, final and daily), the section for assessment of
premenstrual symptoms should not limit responses to a maximum of two days prior to
menstruation. It would be more convenient to leave space for the participant to indicate
how many days before menstruation their symptoms begin, as in many cases symptoms
may begin a week, or even up to two weeks, before the menstrual period.
In spite of this, by carrying out a prior interview and completing the questionnaire along
with the participants on an individual basis, the deficiencies that could be derived from
the questionnaire were minimised.
In Appendix XIX (XIXa, XIXb and XIXc) a proposal for revised questionnaires is
presented for assessment of menstrual pain in PD in TCM for future studies.
3.4 Scope and limitations
The design of the study should be considered as a limitation due to the lack of a control
group and because of the small sample size.
Other factors detected throughout the study could also be considered limitations, these
being the lack of control over the administration of treatments, the lack of control over
the number and weight of analgesic tablets taken as well as a more thorough
determination of the number of days participants suffered from premenstrual syndrome.
62
The questionnaire used would seem to be adequate for the study objectives but needs to
be correctly validated. In the light of the lack of validation it was decided to consult
with Cristina Larroy for her opinion on the modifications made to the original
questionnaire elaborated by her and her team, and at the same time request more
detailed evidence on the validity of the original questionnaire. Dr. Larroy kindly
collaborated indicating that the modifications made for the adaptation of the
questionnaire to TCM seemed to her to be “very appropriate” and added that “many of
these questions where included in a personalised self-report that the women in our study
filled out along with the menstrual pain questionnaire (MPQ)”.
Regarding the validation of the original questionnaire she commented that “the MPQ
arose from a previous questionnaire drawn up ad hoc for a pilot study carried out in
1987, based on items in the MSQ and other questionnaires with which there were
significant correlations; the instrument became more refined and its validity and
reliability were proven in a couple of studies, but I can't give you the data because the
process was not published and I don't remember them”.
In spite of the fact that the contributions of Dr. Larroy do not validate the questionnaire
used for this study, they do however reinforce the idea that this could be an adequate
questionnaire and it would be interesting to validate it in future investigations.
4. RESULTS
4.1 Introduction
This study assesses the efficacy of treatment of menstrual pain with modified Xiao Yao
Wan with a sample of 10 women. For assessing the evolution of menstrual pain, of
premenstrual pain, the number of days with pain, the number of days of use of analgesia
and the number of days of abandonment of activities due to pain the SPSS programme
was used to apply the Student's t-test for related samples. As well, since the study
sample number is small, in order to confirm the results the Wilcoxon test was also used,
which makes no assumption as to the normal distribution of the frequency of the
variables.
63
4.2 Data Analysis
4.2.1 Demographic profiles
The demographic characteristics of the participants (n=10) are summarised in the table
4.2.1:
Variable n=10
Age
Average (SD) 30.9 (6.6)
Range 22 - 42
Family situation
Single 4
Married or de facto 6
Separated/divorced 0
Ever pregnant
Yes 2
No 8
Nationality
Spanish 8
French 1
Croatian 1
Level of education
Tertiary 7
Secondary 3
Primary 0
Without studies 0
Work activity
Professional 5
Semi-professional 1
Non professional 3
Unemployed 1
Table 4.2.1 Demographic characteristics of the participants
The average age of the participants was 30.9 (6.6), eight of them were of Spans
nationality, one was French and one was Croatian. Six were married, or living with a
partner and four were single. Eight of the participants had never been pregnant; two of
them had been and had had one child each.
Seven of the participants had university level education and three had secondary school
education. At the time of the study five of them were professionally employed, one in a
semi-professional job, three non-professionals and one was unemployed.
64
4.2.2 General Heath behaviour and characteristics
Eight of the participants were of normal weight (CMI3 between 18.5 and 24.9) and two
were obese (CMI between 30 and 39.9). Seven were smokers, six consumed alcohol
regularly and one also took drugs. Half of them normally did regular exercise.
One of the participants had been taking oral contraceptives for 7 years and continued
taking them during the study.
The table 4.2.2 summarises the general health behaviours and characteristics:
Variable n=10
CMI classification
Slim 0
Normal 8
Overweight 0
Obese 2
Smoker
Yes 7
No 3
Does physical exercise
Yes 5
No 5
Alcohol consumption
Yes 6
No 4
Drug consumption
Yes 1
No 9
Takes oral contraceptives
Yes 1
No 9
Table 4.2.2 General health behaviours and characteristics of the participants
4.2.3 Menstrual history
The average age of menarche was 13.5 (2.2), between a minimum age of 10 years and
maximum of 17 years. The average number of years suffering pain was 15.7 (7.3), with
the average number of years with menstruation 17.4 (6.7). Nine of the participants had
normal cycle duration according to TCM parameters (Maciocia, 1998), between 26 and
32 days, however one of the participants had a longer cycle of between 32 and 35 days.
Eight of the participants had menstrual periods of normal duration, between 4 and 6
3
CMI = weight (kg) / height2 (m) (Beers, Berkow & Merck, 1999)
65
days, according to the parameters of TCM (Maciocia, 1998), one had short periods of 3
days and one had long periods of 7 days.
Nine of the participants felt relief from pain with the application of heat, one did not
know whether the heat alleviated her pain or not.
The maximum pain suffered by the participants was 8.3 (0.82) on average, with a range
of between 7 and 10 points. Nine of the participants had suffered pain in the last 6
months, the tenth participant in 4 or 5 of the last 6 cycles. The participants on average
suffered pain in 11.5 (1.1) months per year, and took analgesic medication on an
average of 9 (3.5) cycles per year.
Nine of the participants suffered from Premenstrual syndrome (PMS) and had to
abandon normal activities on average 1.4 (1.1) days each menstruation, with a range of
between 0 and 3.
The table 4.2.3 shows a summary of the data presented on the menstrual characteristics
of the participants:
Variable n=10
Menarche
Average (SD) 13.5 (2.2)
Range 10 - 17
Years of pain
Average (SD) 15.7 (7.3)
Range 3 - 29
Years of menstruation
Average (SD) 17.4 (6.7)
Range 8 - 29
Normal duration of menstruation
3 days 1
4 - 6 days 8
7 days 1
Normal duration of the menstrual cycle
21 - 26 days 0
Painful26menstruations
- 32 days per year 9
Average (SD)
32 - 35 days 11.5 1(1.1)
Range
Alleviated with application of heat 9 - 12
PainfulYes
months in the last 6 months 9
6Doesn’t know 91
Maximum 4 or pain
5 1
Average (SD)
Menstruations per year that require the use of 8.3 (0.82)
analgesics
Average
Range (SD) 97 (3.5)
- 10
66
Range 2 - 12
Premenstrual syndrome (PMS)
Yes 9
No 1
Days of abandonment of activities due to menstrual pain
Average (SD) 1.4 (1.1)
Range 0–3
Table 4.2.3 Menstrual characteristics of the participants
4.2.4 Disharmony patterns of the participants
All of the participants manifested signs and symptoms of Qi stagnation, nine also
manifested Qi/Xue vacuity and six manifested Xue stasis, these were the predominant
disharmony patterns. Secondarily there was Fire in three cases, Cold-dampness in three
cases, Liv/Kid Yin vacuity in three cases and Yang vacuity in two cases. No cases of
Heat-dampness or of Heat due to vacuity were detected. In the table 4.2.4 the
disharmony patterns manifested by the participants are summarised:
DISHARMONY
10JN01 18A02 11M01 18A03 13A01 25M01 16M01 20M01 10M01 20A01 Total
PATTERNS
Qi stagnation √ √ √ √ √ √ √ √ √ √ 10
+ Fire √ √ √ 3
Xue stasis √ √ √ √ √ √ 6
Cold-dampness √ √ √ 3
Yang vacuity √ √ 2
Heat-dampness 0
Qi/Xue vacuity √ √ √ √ √ √ √ √ √ 9
Liv/Kid Yin
vacuity √ √ √ 3
+ Heat 0
Table 4.2.4 Disharmony patterns manifested by the participants
4.2.5 Evolution of menstrual pain
The menstrual pain maximum at the beginning of the study was 7.8 (1.4) and at the end
was 4.2 (2.5), the difference is statistically significant (t=4.07; p<0.05)
In the tables 4.2.5 and 4.2.6 the results of the Student's t-test and the Wilcoxon test can
be seen.
67
Related samples test

Related differences
95% Confidence interval
Typical Typical for the difference Sig.
Mean deviation. mean error Lower Upper t gl (bilateral)
Par 1 InMaxP_1 - InMaxP_4 3.60000 2.79682 .88443 1.59927 5.60073 4.070 9 .003
Table 4.2.5 Results of the Student's t-test for the evolution of the peak menstrual pain
Contrast statisticsb
InMaxP_4 - Intensity of MAXIMUM pain of cycle 1
Z -2.558a
Asymptotic sig. (bilateral) .011
a. Based on the positive ranges.
b. Test of ranges with Wilcoxon sign
Table 4.2.6 Results of the Wilcoxon test for the evolution of the peak menstrual pain
In the chart 4.2.7 the representation of the data in bloxpot of the initial and final
comparisons can be seen and in the chart 4.2.8 the representation of the initial and final
comparisons per participant can be seen:
Table 4.2.7 Representation of the data in bloxpot of the initial and final comparisons for the
evolution of the peak menstrual pain
10
Nivel de dolor
6 Dolor máximo Ciclo 1
4 Dolor máximo Ciclo 4
0
1 2 3 4 5 6 7 8 9 10
Participantes
Comparativa de dolor máximo Ciclo 1/Ciclo 4
Table 4.2.8 Representation of the initial and final peak menstrual pain comparisons per participant
68
The menstrual pain average at the beginning of the study was 5.6 (1.3) and at the end
was 3.7 (2.1), the difference is not statistically significant (t=1.994; p≮0.05)
In tables 4.2.9 and 4.2.10 the results of the Student's t-test and the Wilcoxon test can be
seen.
Related differences
Par Level of 2.3500 3.72715 1.17863 -.31624 5.01624 1.994 9 .077
1 premenstrual Pain 0
Cycle 1 -
LevelPMPain_4
Table 4.2.9 Results of the Student's t-test for the evolution of the average menstrual pain
LevelPain_4 - Range of Level of pain Cycle 1
Z -1.886a
Table 4.2.10 Results of the Wilcoxon test for the evolution of the average menstrual pain
comparisons can be seen:
Table 4.2.11 Representation of the data in bloxpot of the initial and final comparisons for the
evolution of the average menstrual pain
4.2.6 Evolution of premenstrual pain
The level of premenstrual pain at the beginning of the study was 3.2 (3.0) and at the end
was 0.8 (1.4), the difference is not statistically significant (t=2.0; p≮0.05)
69
In tables 4.2.12 and 4.2.13 the results of the Student's t-test and the Wilcoxon test can
be seen.
Related differences
Typical 95% Confidence interval Sig.
Typical mean for the difference (bilater
Mean deviation. error Lower Upper t gl al)
Par Level of 2.3500 3.72715 1.17863 -.31624 5.01624 1.994 9 .077
1 premenstrual Pain 0
Cycle 1 -
LevelPMPain_4
Table 4.2.12 Results of the Student's t-test for the evolution of the level of premenstrual pain
LevelPMPain_4 - Level of premenstrual Pain Cycle 1

Z -1.778a
Asymptotic sig. .075
(bilateral)
Table 4.2.13 Results of the Wilcoxon test for the evolution of the level of premenstrual pain
Table 4.2.14 Representation of the data in bloxpot of the initial and final level of premenstrual pain
The number of premenstrual symptoms at the beginning of the study was 4.2 (1.9) and
at the end was 2.2 (1.9), the difference is statistically significant (t=2.4; p<0.05)
In the tables 4.2.15 and 4.2.16 the results of the Student's t-test and the Wilcoxon test
can be seen.
70

Related differences
Par Number of 2.000 2.582 .816 .153 3.847 2.449 9 .037
1 premenstrual
symptoms Cycle 1 -
PMSymptoms_4
Table 4.2.15 Results of the Student's t-test for the evolution of the number of premenstrual
symptoms
PMSymptoms_4 - Number of premenstrual symptoms Cycle 1

Z -2.032a
(bilateral)
Table 4.2.16 Results of the Wilcoxon test for the evolution of the number of premenstrual
symptoms
Table 4.2.17 Representation of the data in bloxpot of the initial and final number of premenstrual
symptoms
4.2.7 Evolution of the number of days with pain
The number of days of menstrual pain at the beginning of the study was 3.1 (1.3) and at
the end was 2.0 (1.1), the difference is statistically significant (t=2.7; p<0.05)
In the tables 4.2.18 and 4.2.19 the results of the Student's t-test and the Wilcoxon test
can be seen.
71

Related differences
95% Confidence
interval for the
Typical Typical difference Sig.
Par Days of pain Cycle 1.100 1.287 .407 .180 2.020 2.703 9 .024
1 1 - Pain days_4
Table 4.2.18 Results of the Student's t-test for the evolution of the number of painful days
Pain days_4 - Days of pain Cycle 1

Z -2.041a

Table 4.2.19 Results of the Wilcoxon test for the evolution of the number of painful days
Table 4.2.20 Representation of the data in bloxpot of the initial and final number of painful days
4.2.8 Evolution of the number of days of analgesia use.
The number of days of use of analgesia at the beginning of the study was 3.1 (1.3) and
at the end was 2.0 (1.1), the difference is statistically significant (t=2.7; p<0.05)
be seen.
72

Related differences
95% Confidence
interval for the
Typical Typical difference Sig.
Par Days of analgesia 1.100 1.197 .379 .244 1.956 2.905 9 .017
1 Cycle 1 -
AnalgDays_4
Table 4.2.21 Results of the Student's t-test for the evolution of the number of painful days of
analgesia use
AnalgDays_4 - Days of analgesia Cycle 1

Z -2.209a
Table 4.2.22 Results of the Wilcoxon test for the evolution of the number of painful days of
analgesia use
Table 4.2.23 Representation of the data in bloxpot of the initial and final number of days of
analgesia use
4.2.9 Evolution of the number of days of abandonment of activities
The number of days of abandonment of normal activities due to pain at the beginning of
the study was 1.4 (1.1) and at the end was 0.6 (1.1), the difference is not statistically
significant (t=2.2; p≮0.05)
73
be seen.

Related differences
Par Days need to .800 1.135 .359 -.012 1.612 2.228 9 .053
1 abandon activities
Cycle 1 -
AbanAct_4
Table 4.2.24 Results of the Student's t-test for the evolution of the number of painful days of
abandonment of activities
AbanAct_4 - Days need to abandon activities Cycle 1

Z -1.930a
(bilateral)
Table 4.2.25 Results of the Wilcoxon test for the evolution of the number of painful days of
Table 4.2.26 Representation of the data in bloxpot of the initial and final number of days of
4.2.10 Variations in menstruation and blood characteristics
For the analysis of the study results the characteristics of menstrual bleeding were also
considered. In the table 4.2.27 a summary of the evolution of these characteristics from
the beginning (Cycle 1) to the end (Cycle 2) can be seen.
TCM considers normal characteristics of menstruation (Maciocia, 1998) to be:
74
• Colour: bright red

• Quantity: one sanitary napkin or tampon every 3 hours
• Consistency: fluid
• No clots
To simplify the interpretation of the assessment of this data the number of improved and
worsened characteristics for each participant was calculated. We can use the case of one
participant as an example:
• The participant with code 10JN01 began the study with normal coloured
menstrual blood (bright red) with no change at the end of the study. The
quantity of menstrual blood was scant both at the beginning and end of the
study, and therefore there was neither improvement nor worsening. At the
beginning of the study the consistency of the blood was thick and at the
end it was fluid, showing improvement in this aspect. At the beginning of
the study there were red, medium sized clots and at the end there were no
clots, this also being an improvement. If she had had small red clots this
would also have been considered an improvement, however if at the end
the clots were medium but dark this would have been considered a
worsening.
The results were three participants with improvement in three characteristics, four
participants with improvement in two characteristics, three participants with
improvement in one characteristic and there were no participants that did not experience
some kind of improvement.
Only two participants suffered worsening of any of the characteristics
It should be noted that nine of the participants had improvement in the quality or
presence of clots.
75
10JN01 18A02 11M01 18A03 13A01 25M01 16M01 20M01 10M01 20A01
Bright Bright Pale- Bright Bright Bright Bright Bright Pale,
COLOUR CYCLE 1 red red dark red red red red red red Pale
MENSTR Bright Pale-red- Red- Bright Bright Bright Bright Bright Bright
CYCLE 4 red dark dark red red red red Pale red red
QUANTITY CYCLE 1 Scant Abundant Scant Abundant Normal Normal Abundant Normal Scant Abundant
CYCLE 4 Scant Normal Scant Normal Normal Normal Scant Scant Normal Abundant
With With
CONSISTENCY CYCLE 1 Thick Fluid Fluid clots Fluid Fluid Thick clots Fluid Thick
CYCLE 4 Fluid Fluid Fluid Fluid Fluid Fluid Thick Fluid Fluid Fluid
Red,
CYCLE 1 Red, Dark, Dark, Red, Red, Dark, Dark, Dark, dark,
med med small large small med large large small Red, med
CLOTS Red, Dark, Dark, Dark, Pale, Red, Red,
CYCLE 4
No small small Red, med No small med small small small
Changes in clots √ √ = √ √ √ √ √ √ √
nº improved √√ √√ √ √√√ √ √ √√ √√ √√√ √√√
nº worse ↓ ↓↓
Table 4.2.27 Evolution of the characteristics of menstrual bleeding
4.3 Findings
The analysis of the data shows that the predominant disharmony patterns in the
participants were Qi stagnation (10), Qi/Xue vacuity (9) and Xue stasis (6).
The statistical analysis of the data shows that the improvement in the menstrual pain
maximum, in the number of premenstrual symptoms, in the number of days with
menstrual pain and in the number of days with use of analgesia are statistically
significant. There was an improvement in the menstrual pain average, premenstrual pain
and the number of days of abandonment of activities but these were not statistically
significant.
As far as the analysis of the menstrual blood characteristics went, all participants
experienced improvement, especially in the presence and characteristics of clots (9 out
of 10).
Therefore the results obtained from the data analysis partially confirm the
working hypothesis: Xiao Yao Wan is significantly effective (p≤0.05) for treatment of
menstrual pain in primary dysmenorrhea (Xiao Yao Wan is significantly effective
76
(p≤0.05) for treatment of maximum menstrual pain and reduces the number of days
with pain in primary dysmenorrhea).
The results also partially confirm the null hypothesis: Xiao Yao Wan is not
significantly effective (p>0.05) for treatment of menstrual pain in primary
dysmenorrhea (Xiao Yao Wan reduces average menstrual pain in primary dysmenorrhea,
but is not significantly effective (p>0.05)).
4.4 Summary
The analysis of the data of the study shows improvement in all menstrual characteristics,
with some of these being statistically significant and others not.
The analysis of the results partially confirms the working hypothesis, showing that Xiao
Yao Wan is significantly effective (p≤0.05) for treatment of maximum menstrual pain
and reduces the number of days with pain in primary dysmenorrhea.
5. DISCUSSION AND CONCLUSIONS
5.1 Discussion
The results of the study seem to indicate that the modified Xiao Yao Wan formula is
effective for treatment of menstrual and premenstrual pain and discomfort, although the
sample is small and therefore further research is necessary.
All of the participants had improvement in one or more of the aspects investigated,
but it is interesting to look closely at the two cases where less improvement of
menstrual pain was noted.
The first case that stands out is that of a participant who suffered a two point increase
in maximum pain. In cycle 1 (without treatment) she had 4 days of continuous pain
with a pain maximum of 6 and a pain average of 3.75. In cycle 4 she had a day with a
pain intensity of 10. In the interview it was detected that this pain in the last cycle was
felt during approximately 1 hour at night having not felt pain at any other moment
during that entire menstrual period. It would seem then that the pain improvement was
important however this is not reflected accurately in the data analysis. In spite of this
it should also be noted that this participant experienced the greatest worsening of
77
menstrual bleeding characteristics, beginning with blood bright red and ending with
pale blood, beginning with normal quantity and ending with scant bleeding.
The analysis of the second case provided different data and conclusions. This
participant had an improvement in pain levels, but less than that of the rest of the
participants. In cycle 1 she had 3 days of pain, with an average intensity of 8.3 and a
maximum intensity of 10. In cycle 4 she had 4 days of pain (1 more) with an average
intensity of 5.5 (lower) and a maximum intensity of 8 (also lower). Therefore this case
presented slight improvement. Although this participant presented signs and
symptoms of Qi stagnation and Qi/Xue vacuity (for which Xiao Yao Wan is indicated)
she also presented important signs and symptoms of both Yin and Yang Kidney
vacuity, and it would seem that the noteworthy presence of Kidney vacuity may be
one of the reasons that the reduction of pain and discomfort was less than in the rest of
the cases.
5.2 Conclusions and implications
• The modified Xiao Yao Wan formula seems to be effective for menstrual
pain, reducing significantly (p<0.05) the number of days with pain, the
menstrual pain maximum, the taking of analgesics and premenstrual
discomfort.
• Modified Xiao Yao Wan seems to modify the characteristics of menstrual

bleeding, bringing them closer to the ideal according to TCM
• Menstrual pain and discomfort seem to be related to the characteristics of

menstrual bleeding as TCM affirms
• The most frequent disharmony patterns that cause dysmenorrhea seem to be

Qi stagnation, Qi/Xue vacuity and Xue stasis
• Modified Xiao Yao Wan seems to be most effective for treating menstrual
pain and discomfort when the predominant disharmony patterns are Qi
stagnation, Qi/Xue vacuity and Xue stasis
78
• Modified Xiao Yao Wan seems to be most effective for treating menstrual
pain and discomfort when there is premenstrual discomfort
• Modified Xiao Yao Wan may well be a safe and effective alternative to
treatment of menstrual pain de with CM
5.3 Recommendations for future research
Further work is required to assess the contributions of CHM for treatment of

dysmenorrhea using scientific methods. The RCT's are the most recognised studies in
terms of the range of scientific evidence and therefore it is recommendable to carry out
studies using this design. Currently there is a tendency to question the ethics of the use
of placebo as a control technique (Zaslawski, 2010) and therefore it is necessary to go
deeper into this aspect in order to guarantee maximum respect for human rights.
For future research it would be recommendable to begin the process validating the
proposed questionnaire from this study or another questionnaire that responds to the
needs and characteristics of TCM.
It would also be recommendable to add a post-treatment follow up phase to the study in

order to assess the perdurability of the effects of the treatment.
It would be recommendable to carry out studies with treatments during the entire
menstrual cycle and not limited to some specific days of the cycle.
Finally, would be recommendable to establish a method of control over the

administration of the treatment and the taking of analgesics.
5.4 Summary
The results of the study seem to show the effectiveness of treatment of menstrual and
premenstrual discomfort in PD with the modified Xiao Yao Wan formula, especially
when the predominant disharmony patterns are Qi stagnation, Qi/Xue vacuity and/or el
Xue stasis. The study seems to show these as the main TCM disharmony patterns
causing dysmenorrhea. There also seems to be a relationship between the characteristics
of the menstrual bleeding and the intensity and duration of both menstrual and
premenstrual pain.
79
Further work is required to evaluate the contributions of CHM for dysmenorrhea using
scientific methods.
80
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APPENDICES
103
APPENDIX I – Poster advertisement
¿DO YOU HAVE PAINFUL PERIODS?

Participa en un estudio sobre la efectividad del tratamiento del dolor menstrual
Cindy Méndez Pendavis, terapeuta

licenciada en Medicina Tradicional China,
está realizando un estudio sobre el dolor
menstrual con el apoyo de ISMET y Centre
Equilibrium.
El estudio titulado “Estudio naturalístico

sobre la efectividad de la Farmacopea
China para el tratamiento de la
dismenorrea primaria” tiene como objetivo evaluar la eficacia de diferentes fórmulas
chinas de plantas para el tratamiento del dolor menstrual.
Si tienes entre 18 y 50 años y estás padeciendo dolor durante el período, o conoces

a alguien que pueda estar interesada en obtener más información o en participar
en el estudio, por favor ponte en contacto con Cindy Méndez en el 93 000 53 23 o
escríbele a dismenorrea@centreequilibrium.com.
Más información en el artículo ¿Tienes dolor menstrual? en la web de Centre

Equlibrium.
104
APPENDIX II – Social network announcement
¿Do you have painful periods? or ¿Do you know someone with painful periods?
Receive FREE treatment of Chinese herbs taking part of a trial I’m conducting with The
University of East London. For more information please contact me or read the
following article:
http://centreequilibrium.com/2011/03/%C2%BFtienes-dolor-menstrual/
105
APPENDIX III – Article in Web pages
¿Tienes dolor menstrual?
Participa en un estudio sobre la efectividad del tratamiento del

dolor menstrual con farmacopea china
La dismenorrea primaria es la presencia de

dolor severo relacionado con la menstruación
en ausencia de patología pélvica que lo justifique
(Howard 2000) (Smith et al. 2010).
Entre el 52 y el 90% de las mujeres padecen
dismenorrea (Weissman et al. 2004) y es una
causa de absentismo laboral y escolar
frecuente. En Estados Unidos se estima que se
pierden 600 millones de horas de trabajo al año
por esta causa, suponiendo aproximadamente 2
millones de dólares por año. (Howard 2000)
En la Comunidad Autónoma de Madrid se llevó a cabo un estudio para recoger datos fiables y
válidos sobre la incidencia de la dismenorrea funcional (Larroy, C et al. 2001). Los resultados
sugieren que el 61,9% de las mujeres sufren dolor menstrual y que la intensidad del dolor
depende de la edad, así como del número de niños. La correlación entre la intensidad del dolor y
la frecuencia de dolor fue alta y significativa. El dolor se reportó principalmente en la región
abdominal, seguido del dolor lumbar, el dolor mamario y por último, dolor en los muslos.
(Larroy, C et al. 2001)
Enfoques de tratamiento
Hay tres enfoques convencionales para la gestión de la dismenorrea primaria: farmacológico, no
farmacológico y quirúrgico. El tratamiento convencional incluye medicamentos
antiinflamatorios no esteroideos (AINEs), los anticonceptivos orales, danazol, agonistas de la
hormona liberadora de gonadotropina, el acetato de medroxiprogesterona, neurectomía presacra,
neurectomía uterosacra y la estimulación nerviosa eléctrica transcutánea (Howard 2000). Es
interesante destacar la inclusión de la acupuntura en algunos libros de medicina convencional
como tratamiento para el dolor pélvico (Howard 2000).
Existen estudios que evidencian la eficacia del uso de agentes farmacológicos como los AINEs
(Wong et al. 2009), o como los anticonceptivos orales (Sundell et al. 1990) para aliviar el dolor
menstrual, sin embargo, el tratamiento convencional para la dismenorrea primaria tiene
una tasa de fracaso del 20% al 25% y puede estar contraindicado o no tolerado por
algunas mujeres (Xiaoshu Zhu et al. 2010). La Medicina Herbal China puede ser una
alternativa adecuada para todas aquellas mujeres que no puedan o no quieran tratarse con
tratamientos convencionales.
La Biblioteca Cochrane (una colección de bases de datos sobre ensayos clínicos controlados en
medicina y otra áreas de la salud) publicó una revisión reciente. En ella se detectaron evidencias
que avalan el uso del tratamiento con Farmacopea Tradicional China en comparación con
el placebo, con tratamientos de Medicina Convencional como los AINEs y la píldora
anticonceptiva oral, con la ausencia de tratamiento, o en comparación con otros tratamientos
como la acupuntura, o la aplicación de calor. Así mismo no se observaron efectos adversos
significativos. (Zhu X 2007). Sin embargo, los autores de la revisión también concluyeron que
los resultados están limitados por la escasez de estudios y por la baja calidad metodológica de
los mismos, lo que no permite ninguna conclusión definitiva. (Xiaoshu Zhu et al. 2010)
106
Un nuevo estudio en marcha

Cindy Méndez Pendavis, terapeuta Licenciada en Medicina Tradicional China, está realizando
un estudio sobre el dolor menstrual, en Barcelona, con el apoyo de ISMET y Centre
Equilibrium. El estudio titulado “Estudio naturalístico sobre la efectividad de la Fitoterapia
China para el tratamiento de la dismenorrea primaria” tiene como objetivo evaluar la eficacia de
diferentes fórmulas chinas de plantas para el tratamiento del dolor menstrual, así como validar
la importancia de la diferenciación de síndromes en el tratamiento con farmacopea.
Para este estudio se están reclutando participantes mujeres en edad reproductiva, con ciclos
menstruales entre 21 y 35 días, de entre 3 y 7 días de duración, que hayan experimentado dolor
en 4 períodos consecutivos en los últimos 6 meses no relacionado con dismenorrea secundaria,
que no están embarazas, que están de acuerdo en tomar medidas anticonceptivas no hormonales
durante el estudio, y que en caso de tomar anticonceptivos orales, hayan estado tomándolos
durante como mínimo los últimos 6 meses y que están de acuerdo en seguir tomándolos durante
la duración del estudio. Las mujeres incluidas en el estudio no deben estar utilizando dispositivo
intrauterino (DIU), no deben haber sido diagnosticadas de una enfermedad grave y no deben
estar recibiendo tratamiento de Medicina Tradicional China.
Las participantes recibirán como tratamiento una formulación tradicional de hierbas chinas
durante tres períodos menstruales que será elegida de manera personalizada con base en la causa
del dolor según la Medicina Tradicional China. Las formulaciones a base de hierbas que se
utilizarán en este estudio son fórmulas comercializadas por Fitoki (www.fitoki.com) que se
recetarán sin coste económico para las participantes.
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Collaboration & C. L. Wong, eds. Cochrane Database of Systematic Reviews. Chichester, UK:
John Wiley & Sons, Ltd. Available at: http://www2.cochrane.org/reviews/en/ab002120.html
Xiaoshu Zhu et al., 2010. Chinese herbal medicine for primary dysmenorrhoea. Available at:
http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD005288/frame.html
Zhu X, P.M., 2007. Chinese herbal medicine for primary dysmenorrhoea. Cochrane Database
Syst Rev.
107
APPENDIX IV – Telephone script for preliminary assessment of candidates
Buenas tardes, quería hablar con ----
Mi nombre es Cindy y me pongo en contacto contigo por una solicitud que nos has hecho para participar
en un estudio sobre dolor menstrual.
El estudio que estamos realizando investiga la efectividad de la farmacopea china en el tratamiento del
dolor menstrual.
A continuación voy a hacerte unas preguntas para evaluar si cumples con los requisitos para participar en
el estudio. Toda la información que me proporciones será tratada de modo absolutamente confidencial, y
en caso de no cumplir con los requisitos la destruiremos. ¿Estás de acuerdo con que te haga las preguntas?
Respuestas:
• Este es un requisito indispensable para participar en el estudio, por lo que no podemos incluirte.
De todas maneras te agradecemos tu interés, y en cualquier caso tienes mi contacto por si algún
día necesitas realizarme cualquier consulta. Muchas gracias y hasta pronto
• Felicidades, cumples con lo requisitos para participar en el estudio. A continuación voy a

explicarte los siguientes pasos. El estudio tendrá una duración de 4 meses. Durante el estudio
realizaremos dos entrevistas presenciales, una al inicio y otra al final. Tendremos una tercera
entrevista 2 o 3 semanas después de iniciar la toma de las plantas que podrá ser presencial o
telefónica.
¿Cuándo tuviste la última menstruación y para cuando esperas la siguiente?

Ahora concertaremos la primera entrevista, en ella te explicaré el proceso con
más detalle, e iniciaremos a rellenar los impresos para el estudio. En la
entrevista evaluaremos el dolor que has tenido en las últimas menstruaciones, y
te daré unos impresos para que rellenes cuando tengas la siguiente
menstruación, y a partir del último día podrás empezar a tomar las plantas.
Bien ---, nos vemos entonces el --- de abril, ¿puedes apuntar la dirección? Calle
XXX, XX
Metro
L1 (Espanya, Rocafort)
L3 (Espanya, Poble Sec)
Ferrocarriles Catalanes
Espanya
Autobuses
13-38-50-52-53-55-57-65-91-141
Muchas gracias por participar en el estudio, nos vemos el –---
108
APPENDIX V – Preliminary assessment of candidates questionnaire
I will ask you some questions to assess whether you are eligible to participate in this study. All
information you provide will be treated confidentiality, and if they do not meet the requirements
will be destroyed.
Do you agree to answer my questions?
Name __________________________________________________________
Email address _________________________________________________
Teléfono__________________________________________________________
Have you age of majority? Yes No ok

Requirement: Yes
Age: ___
How long is your menstrual cycle normally? ___ ok
Requirement: between 21 and 35 days long
How long is your menstrual period normally? ___ ok
Requirement: between 3 and 7 days long
In the past 6 months, how many periods have been painful? __ ok
Requirement: who have experienced pain in 4 consecutive periods in the last 6 months
Did you visit a gynaecologist for this reason? Yes No
Have you been diagnosed with any gynecological condition? Yes No
Requirement: Not associated with secondary dysmenorrhea
Which? ______________________________________________________ ok
Are you pregnant? Yes No ok
Requirement: No
Do you use intrauterine device (IUD)? Yes No ok
Requirement: No
Do you use hormonal contraceptives? Yes No
Requirement: If taking oral contraceptives, have been taking them for at least the last 6 months
and agree to continue taking them for the duration of the study.
How long? ___
Requirement: more than 6 months
You agree to keep using this method of contraception as long as
duration of the study? Yes No ok
Requirement: Yes
Do you agree to use non-hormonal contraceptive measures during the time
duration of the study? Yes No ok
Requirement: Yes
Have you been diagnosed with any illness? Yes No
Which? ______________________________________________________
Do you take any medication or do any treatment? ¿Which?
_______________________________________
Requirement: Must not have been diagnosed with a serious illness ok
Are you following any TCM treatment? Yes No ok
Requirement: No
The candidate meets the Requirements? Yes No
109
APPENDIX VI – Composition of the formula used in the study
NOMBRE EN PIN YIN NOMBRE FARMACEÚTICO Dosis diaria CP (Polvo concentrado)*

F019 - XIAO YAO WAN
CHAI HU Radix Bupleurum 395,46
DANG GUI Radix Angelica sinensis 602,64
BAI SHAO YAO Radix Paeoniae alba 451,98
BAI ZHU Radix Atractylodis macrocephalae 602,64
FU LING Sclerotium Poria cocos 602,64
GAN CAO Radix et Rizoma Glycyrrhizae uralensis 113,04
CHEN PI Pericarpium Citri reticulatae 395,46
CHUAN XIONG Rizoma Ligustici wallichi 602,64
TOTAL XIAO YAO WAN 3766,5
V010 REGULAR LA MENSTRUACIÓN (REGULATE THE PERIOD)
YU JIN Radix Curcumae 627,78
CHUANG XIONG Rizoma Ligustici wallichi 627,78
ZE LAN Herba Lycopi 627,78
JI XUE TENG Caulis Spatholobus 627,78
TOTAL REGULAR 2511,12
MENSTRUACIÓN
TOTAL DIARIO 6277,62
Table VI.1 Composition of the formula used in the study | Photo © Carles Garay, Jordi Sales
*Extraction ratio CP: Fresh Herb 5:1
110
CHAI HU DANG GUI BAI SHAO BAI ZHU FU LING GAN CAO
Radix Bupleuri Radix Angelica YAO Rizoma Sclerotium Poria Radix et Rizoma
柴胡 sinensis Radix Paeoniae Atractylodis cocos Glycyrhizae
当归 alba macrocephalae 茯苓 uralensis
白芍藥白术甘草
Liberate Biao Nourish the Nourishes the Activates Qi Removes Damp Tonify Spleen Qi
Removes heat Blood Blood Strengthens the Strengthens the Tonify and
Unlock the Liver Activate Nourishes Liver Spleen Spleen Hydrates Lung
Qi theBlood Yin Removes Damp Calms the Shen Eliminates Phleg
Elevate Yang Qi Calm pain Regulates the Activates the m
Harmonize Shao Moisten the Liver metabolism of Stop coughing
Yang intestines Relieves pain liquids Relieves spasms
Subdue Liver Contains sweatin Relieves pain
Yang g Eliminates Heat
Calms the fetus and Toxins
Moderate and
harmonize
and formulas
CHEN PI CHUAN YU JIN ZE LAN JI XUE TENG

Pericarpium XIONG Radix Herba Lycopi Caulis
Citri reticulatae Rizoma Ligustici Curcumae 泽兰 Spatholobus
陈皮 wallichi 郁金鸡血藤
川芎
Regulates Activate Activate Blood Activate Blood Nourish the

the Spleen and Blood and Qi Eliminates Blood Eliminate Blood Blood
Lung Qi Eliminate stasis stasis Activate Blood
Eliminate Dampn wind Mobilize the Qi Stimulate diuresis Relax the tendons
ess and Phlegm Analgesic Relieve pain Reduce edema Unlock the
Cool the Blood meridians
Eliminate Heat
Remove
Heart Damp
Stimulate bile
secretion
and treate
jaundice
Table VI.2 Functions of materias in the formula used in the study | Photo © Carles Garay, Jordi Sales
111
APPENDIX VII- Traditional composition of Xiao Yan San
XIAO YAO SAN

Rambling Powder
(xiāo yáo sǎn)
逍遙散
Source: Tai Ping Hui Min He Ji Ju Fang (太平惠民和劑局方, Formulary of the Tai Ping Era). Imperial
Department of Medicine (1085).
The formula book, “He Ji Ju Fang" was edited by the office of "He Ji Ju" of the Song Dynasty (960-
1279). He Ji Ju was an official agency that oversaw the management and business of herbs and herbal
formulae during that time. Later, during the year of Shaoxing ( A.D. 1136－1141) of later Southern Song,
the name of the agency was changed to "Tai Ping Hui Min Ju,太平惠民局" meaning "office of peaceful
benefiting the people". Thereafter the book has been known as "Tai Ping Hui Min He Ji Ju Fang". Fang
means formulae. Now, there are ten volumes in existence, and there are three volumes of appendices on
general instruction. There are 788 formulae listed in the book.4
Formula
Pin Yin Name Pharmaceutic Name g. * %**

CHAI HU Radix Bupleuri 9,00 14,50
DANG GUI Radix Angelicae Sinensis 9,00 14,50
BAI SHAO YAO Radix Paeoniae Lactiflorae 9,00 14,50
BAI ZHU Rhizoma Atractylodis Macrocephalae 9,00 14,50
FU LING Sclerotium Poriae Cocos 9,00 14,50
ZHI GAN CAO Radix Glycyrrhizae Uralensis (honey fried) 6,00 9,00
WEI SHENG JIANG Rhizoma Zingiberis Officinalis Recens (roasted) 6,00 14,50
BO HE Herba Menthae Haplocalycis 3,00 4,00
60 100
* Grams (Bensky, Barolet 1990:147)
** Percentages (Marié 1991:456)
Analysis of Formula
CHIEF HERB
CHAI HU (Radix Bupleuri): Bitter | Slightly cold | Channels: Liver, Gall Bladder, Pericardium,
Triple Heather
DEPUTIES
DANG GUI (Radix Angelicae Sinensis): Sweet, pungent | Warm | Channels: Liver, Heart,
Spleen
BAI SHAO YAO (Radix Paeoniae Lactiflorae): Bitter, sour | Slightly cold | Channels: liver,
Spleen
ASSISTANTS
BAI ZHU (Rhizoma Atractylodis Macrocephalae): Bitter, sweet | Warm | Channels: Spleen,
stomach
FU LING (Sclerotium Poriae Cocos): Sweet, bland | Mild | Channels: Heart, spleen, kidney
4
Joe Hing Kwok Chu. Tai Ping Hui Min He Ji Ju Fang [Internet]. Accessed 2011-09-23.
Available at http://alternativehealing.org/tai_ping_hui_min_he_ji_ju_fang.htm
112
ZHI GAN CAO (Radix Glycyrrhizae Uralensis honey fried): Sweet | Mild | Heart, lung, spleen,
stomach
ENVOYS
SHENG JIANG (Rhizoma Zingiberis Officinalis Recens roasted): Pungent | Warm | Lung,
spleen, stomach
BO HE (Herba Menthae Haplocalycis): Pungent | Cool | Lung, liver
Preparation and dosis

The original formula is powdered, but this formula could be prepared in two ways:
in decoction and powder. For the decoction, boil the ingredients in 1 liter of water and
let reduce to 40 cl. Bo He should be added at the end of the decoction. The 40cl should
be taken in one day in 3 times.
For preparing powder herbs are picked, they are ground until they are just dust, and 6-
9g are taken with warm water 3 times a day.
Acciones
• Smooth the liver
• Tonify Spleen
• Nourish Blood
• Armoniza Hígado y Bazo
Indications
- Oppression of Liver Qi and deficiency of Blood
- Disharmony between Liver and Spleen due to excessive control of Liver over
Spleen
Symptoms5
- Amenorrea
- Anemia
- Bitter taste
- Bloating
- Chronic hepatitis
- Digestive disorders
- Dizziness
- Dysmenorrhea
- Fatigue
- Fibrocystic breast
- Functional sterility
- Gastritis
- Headache
- Hiccup
- Irregular menstruation
- Leukorrhea
- Menorrhagia
5
Xiao Yao San [Internet] Accessed 2011-09-26. Available at
http://www.tcmassistant.com/search/index.asp?stype=f1
113
- Pain of the hypochondrium

- Peptic ulcer
- Poor appetite
- Premenstrual síndrome
- Dry mouth
- Dry throat
- Hypoglycemia
- Nervous breakdown
- Pleurisy
- Poor vision
- Retinitis
- Slight, chronic fever
- Pale-red tongue
- Weak-Wiry pulse (Ruo Xian); Wiry-Empty pulse (Xian Xu)
114
CHIEF HERB
Chai Hu harmonizes and relieves liver constraint
DEPUTIES
Chai Hu and Bai Shao Yao nourish the blood and soften edginess that results from liver
constraint
ASSISTANTS
Bai Zhu and Fu Ling strengthen the spleen and tus its transforming and transporting functions.
Zhi Gan Cao tonifies the spleen and combined with Bai Shao Yao moderates the spasmodic
abdominal pain.
ENVOYS
Bo He and Sheng Jiang harmonize and control Qi and prevent rebellious Qi. Therefore Bo He
helps Chai Hu to relieve liver constraint.
Figure VII.1 Xiao Yao San Hierarchy composition | Photo © Carles Garay, Jordi Sales
115
APPENDIX VIII – Laboratory quality certificates
116
117
APPENDIX IX – Precepts of the law "Law 29/2006, of the 26th of July" of

guarantees and rational use of medicaments and health care products
Artículo 51. Medicamentos de plantas medicinales.
1. Las plantas y sus mezclas, así como los preparados obtenidos de plantas en forma de
extractos, liofilizados, destilados, tinturas, cocimientos o cualquier otra preparación
galénica que se presente con utilidad terapéutica, diagnóstica o preventiva seguirán el
régimen de las fórmulas magistrales, preparados oficinales o medicamentos
industriales, según proceda y con las especificidades que reglamentariamente se
establezcan.
2. El Ministerio de Sanidad y Consumo establecerá una lista de plantas cuya venta al

público estará restringida o prohibida por razón de su toxicidad.
3. Podrán venderse libremente al público las plantas tradicionalmente

consideradas como medicinales y que se ofrezcan sin referencia a propiedades
terapéuticas, diagnósticas o preventivas, quedando prohibida su venta ambulante.
En primer lugar tenemos que la legislación estatal regula los medicamentos

homeopático como medicamentos legales y autorizados para su fabricación y consumo
humano. Asimismo también están permitidas las plantas medicinales incluso su venta
libre al público. En este sentido los productos propios de la homeopatía y plantas
tradicionalmente consideradas como medicinales tienen su permisión legal. Cosa
diferente es su dispensación.
El Artículo 19. de la citada ley respecto de las Condiciones de prescripción y

dispensación de medicamentos, que al respecto previene que :
1. En la autorización del medicamento, la Agencia Española de Medicamentos y

Productos Sanitarios determinará sus condiciones de prescripción clasificándolo, según
corresponda, en las siguientes categorías:
Medicamento sujeto a prescripción médica.
Medicamento no sujeto a prescripción médica.
118
2. Estarán en todo caso sujetos a prescripción médica los medicamentos que se

encuentren en alguno de los siguientes supuestos:
Puedan presentar un peligro, directa o indirectamente, incluso en condiciones

normales de uso, si se utilizan sin control médico.
Se utilicen frecuentemente, y de forma muy considerable, en condiciones

anormales de utilización, y ello pueda suponer, directa o indirectamente, un
peligro para la salud.
Contengan sustancias o preparados a base de dichas sustancias, cuya actividad y/o

reacciones adversas sea necesario estudiar más detalladamente.
Se administren por vía parenteral, salvo casos excepcionales, por prescripción médica.
3. La Agencia Española de Medicamentos y Productos Sanitarios podrá establecer, en

los medicamentos que sólo pueden dispensarse bajo prescripción médica, las siguientes
subcategorías:
a. Medicamentos de dispensación bajo prescripción médica renovable o no

renovable.
b. Medicamentos sujetos a prescripción médica especial.
c. Medicamentos de dispensación bajo prescripción médica restringida, de

utilización reservada a determinados medios especializados.
Reglamentariamente se establecerán los criterios para su aplicación.
La Agencia Española de Medicamentos y Productos Sanitarios podrá calificar

como medicamentos no sujetos a prescripción médica aquéllos que vayan
destinados a procesos o condiciones que no necesiten un diagnóstico preciso y
cuyos datos de evaluación toxicológica, clínica o de su utilización y vía de
administración no exijan prescripción médica, de modo que dichos medicamentos
puedan ser utilizados para autocuidado de la salud, mediante su dispensación en la
oficina de farmacia por un farmacéutico, que informará, aconsejará e instruirá
sobre su correcta utilización.
119
5. Los prospectos y el etiquetado de los medicamentos que no requieran prescripción

médica contendrán aquellas advertencias que convengan a su naturaleza y, en especial,
las orientadas a prevenir su uso indebido.
6. El Ministerio de Sanidad y Consumo establecerá los requisitos mínimos,

características y plazo de validez de las recetas médicas y prescripciones hospitalarias,
así como los requisitos especiales para la prescripción y dispensación de los
medicamentos de sustancias psicoactivas y otros que por su naturaleza lo requieran o
para tratamientos peculiares.
7. La dispensación de medicamentos se ajustará a las condiciones de prescripción

establecidas.
En este sentido lo medicamentos homeopáticos son medicamentos cuya dispensa no

precisa, de acuerdo con las autoridades sanitarias de receta médica, lo que supone de
acuerdo con el precepto estudiado que, por parte del estado pueden ser adquiridas por
cualquier ciudadano en una farmacia, y repetimos por cualquier ciudadano. Lo que el
homeópata realiza es una recomendación sobre un medicamento homeopático concreto,
medicamento que el paciente debe adquirir en una farmacia, dicho medicamento nunca
será dispensado por el homeópata. Sin embargo el farmacéutico podrá entregar dicho
medicamento sin receta médica y ello porque de acuerdo con la norma estudiada dicho
medicamento no se encuentra se encuentren en ninguno de los siguientes supuestos:
Puedan presentar un peligro, directa o indirectamente, incluso en condiciones

normales de uso, si se utilizan sin control médico.
Se utilicen frecuentemente, y de forma muy considerable, en condiciones

anormales de utilización, y ello pueda suponer, directa o indirectamente, un
peligro para la salud.
Contengan sustancias o preparados a base de dichas sustancias, cuya actividad y/o

reacciones adversas sea necesario estudiar más detalladamente.
Y porque dicho medicamento homeopático va destinados a procesos o condiciones

que no necesitan un diagnóstico preciso y cuyos datos de evaluación toxicológica,
clínica o de su utilización y vía de administración no exigen prescripción médica,
120
de modo que dichos medicamentos pueden ser utilizados para autocuidado de la

salud, mediante su dispensación en la oficina de farmacia por un farmacéutico, que
informará, aconsejará e instruirá sobre su correcta utilización.
En definitiva, sin someternos a grandes interpretaciones retóricas, sino con una sencilla
lectura de las normas estudiadas las conclusiones a las que llegamos son las siguientes:
1. Lo medicamentos homeopáticos están regulados por el Estado así como las

plantas medicinales, por tanto son medicamentos que deben reunir una serie de
requisitos y autorizaciones para su venta en farmacias.
2. La dispensa de dichos medicamentos es sin receta médica de acuerdo con la ley

estatal existente al respecto, por lo que cualquier ciudadano puede comprarlo sin
la receta ni recomendación de un profesional sanitario.
La consideración estatal de tales medicamentos, por tanto, es que van destinados a

procesos o condiciones que no necesitan un diagnóstico preciso y cuyos datos de
evaluación toxicológica, clínica o de su utilización y vía de administración no
exigen prescripción médica, de modo que dichos medicamentos pueden ser
utilizados para autocuidado de la salud, mediante su dispensación en la oficina de
farmacia por un farmacéutico, que informarán, aconsejará e instruirá sobre su
correcta utilización. Por tanto, un práctico en terapias naturales dedicado a la
homeopatía puede, por la legislación existente a fecha de hoy recomendar un
medicamento homeopático a un ciudadano, pues este medicamento puede ser adquirido
por el ciudadano sin esta previa recomendación, ya que el farmacéutico se lo deberá
dispensar tanto en un caso como en otro, porque la legislación estatal permite dicha
dispensa sin receta médica, esto es, sin la intervención de un profesional sanitario
Sin más rodeos, llegar a otras conclusiones y hacer juegos semánticos supone alejarse
de la legislación estatal vigente al respecto y estudiada, pues es clara y ninguna duda
ofrece al respecto de los medicamentos homeopáticos.
121
APPENDIX X – Informed consent
Title of study: Effectiveness of Chinese herbal medicine for the treatment of primary
dysmenorrhea: a naturalistic study
Principal investigator: Cindy Méndez Pendavis
My name is Cindy Méndez Pendavis and you are invited to participate in a research clinical
trial as part of an MSc course awarded by the University of East London, UK.
The purpose of this study is to investigate the efficacy of Chinese herbal medicine in the
treatment of primary dysmenorrhea, that is, pain during menstrual period. I would like to
invite you to join this research study.
Procedures
This study will recruit women in reproductive age, with menstrual cycles between 21 to
35 days, menstrual periods of 3 to 7 days, which have experienced pain in 4 consecutive
periods in the last 6 months not related to secondary dysmenorrhea and who are not
pregnant and agree to take non-hormonal contraceptive measures during the study.
Women included in the study, should not be using intrauterine contraceptive device. In
order to participate, you should not have been diagnosed with a severe disease that may
interfere with the symptoms or with the treatment and you should not be currently
receiving treatment with Traditional Chinese Medicine. Participants will take an herbal
formulation during three periods. This formulation may be changed after one or two
periods if the clinician deems it clinically appropriate. The herbal formulations that will be
used in this study are commercialised by Fitoki (www.fitoki.com). In some of the visits the
study a photo of the tongue will be taken and the radial pulse will be assessed.
Possible risks or benefits

The herbal formulations used in this study have been used in numerous previous studies
and are commercialised in Spain for their consumption in an over the counter basis. No
significant side effects have been reported for any of the formulations that will be used in
this study. However, some women may experience mild gastrointestinal problems such as
discomfort, pain, nausea or vomiting. If you experience any of these or any other symptom,
whether or not it is suspected to be associated with the herbal prescription, please contact
the researcher Cindy Méndez Pendavis on 647430072 or by email on
cindymendez@centreequilibrium.com or contact your doctor for advice. Any symptoms
should disappear soon after discontinuing the herbs.
As a participant in this study, there is no direct financial compensation associated with

participating in this study. However, all the clinical visits will be free of cost for you and the
Chinese herbal formulations will be provided for free during the duration of the study.
Right of refusal to participate and withdrawal
You are free to choose to participate in the study. You may refuse to participate without
any loss of benefit that you are otherwise entitled to. You may also withdraw any time from
the study without any adverse effect on management.
122
Confidentiality
The information provided by you will remain confidential. Nobody except Cindy Méndez
and her assistant will have access to it. Your name and identity will not be disclosed at any
time. However the data may be published in a journal or elsewhere without giving your
name or disclosing your identity.
123
AUTHORIZATION
I have read and understand this consent form, and I volunteer to participate in this research
study. I understand that I will receive a copy of this form. I voluntarily choose to participate,
but I understand that my consent does not take away any legal rights in the case of
negligence or other legal fault of anyone who is involved in this study. I further understand
that nothing in this consent form is intended to replace any applicable laws.
I understand that I will receive a copy of this form. I voluntarily choose to participate, but I
understand that my consent is not a pound of any legal rights in case of fault or negligence
of any other legal entity that is involved in this study. I further understand that nothing in
this consent form is intended to replace applicable laws.
Participant’s Name (Printed or Typed):

Date:
Principal Investigator’s Signature: Cindy Méndez Pendavis

Date:
124
APPENDIX XI – Organic Law on Data Protection
Pursuant to the provisions of Law 15/1999 of December 13, Protection of Personal Data
(PPD) and its implementing regulations, we inform you that your personal data will be
included in a file named "Participants dysmenorrhea study " owned by Centre Equilibrium -
Sun Si Miao SLL Barcelona in order to maintain the professional relationship with you, and
only send information related to the study entitled 'A naturalistic study on the effectiveness
of traditional Chinese Pharmacopoeia for the treatment of Primary dysmenorrhea '. You can
exercise at any time the right of access, rectification, cancellation and opposition of your
personal information, please contact: Centre Equilibrium - Sun Si Miao Barcelona, SLL, c /
Castillejos 343, entlo 3 ª, 08025 Barcelona or in the following email address:
centreequilibrium@centreequilibrium.com
According: (Name and national identity number)
Date and signature:
125
APPENDIX XII – Initial menstrual pain questionnaire
Thank you for completing this questionnaire. The information provided by you will remain
confidential. Nobody except Cindy Méndez and her assistant will have access to it. Your name
and identity will not be disclosed at any time. However, the data may be published in a
scientific journal and elsewhere without giving your name or disclosing your identity.
Your collaboration will be very helpful for this study about pain during menstruation.
1. Age:
2. Job:
3. Level of studies:
No studies Primary school Secondary school University
4. When was your last visit to the gynaecologist?
5. Were you diagnosed with any disease?
6. Have you ever been pregnant? No Yes
7. How many children do you have? _____
8. For how many years have you have had your period (approx.)? ______
9. Score in the following scale the intensity of the pain in the last period (circle one)
0 1 2 3 4 5 6 7 8 9 10
No pain Intense pain
10. Score in the following scale the mean intensity of the pain in your periods (circle one)
0 1 2 3 4 5 6 7 8 9 10
11. Can the pain be relieved with local application of heat? No Yes
12. How many of your periods have been painful during the last 12 months?
0 1 2 3 4 5 6 7 8 9 10 11 12
13. For how many years have you been having painful periods? __________
14. Have you ever visited a gynaecologist for menstrual pain? No Yes
15. During menstruation, the pain is located in (mark an X in the correct alternatives):
Belly Lower back Thighs (internal side)
Tension in breasts Other places (specify) __________________________
16. What is the colour of your menstrual blood today?
Pale Vivid red Dark
(Pink, red, lilac) (Brown, blackish, purple)
17. How much do you normally bleed?
Scant Normal Abundant
(1 sanitary towel/tampon every 6h or more) (1 st/t every 3h) (1 st/t every 1h or less or having to
change it during the night)
126
18. How is your menstrual blood?

Fluid Thick With clots
19. If you had clots, how were they?
Pale Red Dark
Small Medium size Large

(like lentils or rice grains) (like chickpeas) (like a date)
20. Before or during menstruation, do you have any of these symptoms? (Mark with X)
Bad temper Sadness
Swollen belly Swollen, painful breasts
Intestinal problems (e.g. diarrhoea, dizziness, vomiting . . .)
Other (specify) __________________________________________________________
21. Pain or menstrual cramps usually begin:
Two days before menstruation One day before menstruation
On the same day of menstruation
Sometimes the day before and sometimes the same day
22. Do you take medication for pain relief?
No Yes what? :
23. How many periods (in the last year)?
0 1 2 3 4 5 6 7 8 9 10 11 12
24. Are you relieved by the medication?
No relief Slightly relieved Fairly relieved Very relieved
25. How many periods (in the last 12 months) did medication succeed in relieving your pain?
0 1 2 3 4 5 6 7 8 9 10 11 12
26. Do you need to stop what you are doing because of the pain? No Yes
27. How many periods (in one year) do you need to stop what you are doing because of pain? (Circle
one)
0 1 2 3 4 5 6 7 8 9 10 11 12
28. How long do you abandon what you are doing? (Mark with X)
Less than one hour One to 6 hours Whole day
29. When you are not menstruating, do you suffer from any of these? (Mark all that are present)
Cold hands or feet Headache High blood pressure
Low back pain Neck pain Stomach or abdomen pain
Allergy Changes in your cardiac rhythm
We’ve finished. Thank you very much for your cooperation. Remember, your data is
anonymous and will be treated confidentially.
127
APPENDIX XIII – Daily menstrual pain questionnaire
Thank you for completing this questionnaire. The information provided by you will remain confidential.
Nobody except Cindy Méndez and her assistant will have access to it. Your name and identity will not be
disclosed at any time. However, the data may be published in a scientific journal and elsewhere without
giving your name or disclosing your identity.
PREMENSTRUAL PERIOD
Did you feel pain in the days before the menstruation? Yes No
Please score the intensity of pain in the days before the menstruation.
0 1 2 3 4 5 6 7 8 9 10
Can the pain be relieved with local application of heat? Yes No
Please score the intensity of pain according to location.
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
Inner side of the thighs
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
Other - please explain:
0 1 2 3 4 5 6 7 8 9 10
Please circle the symptoms you had in the days previous to menstruation
Bad temper Low mood Swollen belly Tension in breasts
Intestinal problems (diarrhoea, dizziness, vomiting …) Headache
Swollen legs/arms Dizziness Other (specify)
128
DAY 1 of menstruation
Please circle your answers for every one of the questions below
What was the colour of your menstrual blood today?

Pale Vivid red Dark
How much did you bleed today?

How was your menstrual blood today?
If you had clots, how were they?

Pale Red Dark

Has your period been painful today? Yes No
Please circle the number that best reflects the intensity of the pain:
0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10

Please circle the symptoms you have had today
Intestinal problems (diarrhoea, nausea, vomit…) Headache
Swollen legs/arms Dizziness Other (please specify)
Did you have the need to stop your activities? Yes No
If so, for how long?

Less than 1 hour Between 1 - 6 hours Whole day
Has you take medication for pain relief today? Yes No

Have you relieved by the medication?
129

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



130

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



131

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



132

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



133

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



134

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10



135
APPENDIX XIV – Final menstrual pain questionnaire
Score the characteristics of your menstruation after the treatment
0 1 2 3 4 5 6 7 8 9 10
Pale Vivid red Dark
Pale Red Dark

Bad temper Sadness
Other (specify) __________________________________________________________
136

No Yes what? :
137
APPENDIX XV – Adverse effects report
No significant side effects have been reported for the formulas used in this study.
However, exceptionally, some people may experience gastrointestinal discomfort
including nausea, diarrhea or vomiting. If you feel any discomfort suspected to be
associated with taking the formulas, please contact Cindy Mendez phone 647430072 or
email cindymendez@centreequilibrium.com Any symptoms will reduce or eliminating
disappear stopping the oral taking of the formula. Also, thank you for register on the
following schedule the day when you experience some discomfort that you suspect may
be associated with taking formulas.
MONTH
DAY:
Disconfort:
MONTH
DAY:
Disconfort:
MONTH
DAY:
Disconfort:
MONTH
DAY:
Disconfort:
138
APPENDIX XVI – Medication report
Thank you for register in the following calendar the day you take any medication during
the study, this is important data to analyze the results.
MONTH
DAY:
Type of medication:
MONTH
DAY:
Type of medication:
MONTH
DAY:
Type of medication:
MONTH
DAY:
Type of medication:
MONTH
DAY:
Type of medication:
139
APPENDIX XVII - Reliability and validity of a questionnaire
The factors that determine whether a questionnaire is adequate for use are its
reliability and its validity. Martín Arribas defines these parameters in the following way:
(Martín Arribas, M.C., 2004).
Reliability: is the degree of precision of the measuring instrument. The reliability of a

measuring instrument is assessed through the consistency, temporal stability and
interobserver agreement:
o Consistency: the degree by which the different questions in the

questionnaire relate to each other. There are different statistical methods
used to determine this, the most widely used being Cronbach's Alpha
Coefficient (which uses a scale between 0 and 1). It is usually considered
that there is acceptable internal consistency when the score is greater
than 0.7
o Temporal stability or test-retest reliability: concordance of the

responses and results obtained in a test when the same sample group is
assessed by the same assessor in two different situations. This is
normally measured with the intra-class correlation coefficient (ICC) and
a correlation of 70% indicates that the measuring instrument has
acceptable temporal stability.
o Interobserver reliability: This can be analysed using the correlation

percentage and the Kappa index and represents the degree of consistency
obtained when the same sample group is assessed in the same conditions
but by two different assessors, or at different times.
• Validity is the degree to which a measuring instrument serves the purpose for
which is was built, so that it really measures what it is intended to measure.
Different types of validity can be described, however, in reality it is a unitary
process which allows correct interpretation of point scores obtained from tests
and to correlate them with the variable of that which is being measured.
140
o Content validity: Refers to whether the questionnaire and therefore the

chosen items in it are indicators of that which is to be measured. This is
qualitative assessment done by researchers and experts who must judge
the capacity of the questionnaire to assess all the dimensions that need to
be measured.
o Construct validity: Construct validity is the degree to which the results

obtained from the questionnaire may be considered and used as a true
measure of the phenomenon being measured. This can be calculated by
different methods but the most frequent are factor analysis and the multi-
risk - multi-method model.
o Criterion validity: Relation between the score of each subject with a

Gold Standard that guarantees to measure that which it is intended to
measure. Reference indicators are not always available, so often, in
practice, measuring instruments that have been supported by other
studies or research and can offer guarantees for measuring what needs to
be measured are used. Depending on the type of variables Pearson's
correlation coefficient may be used for quantitative variables and
calculation of sensitivity and specificity for qualitative variables.
Factors that determine the validity as to whether a questionnaire is
RELIABILITY VALIDITY
1. Consistency 1. of the content

2. Temporal stability 2. of the construct
3. Interobserver reliability 3. of the criteria
Figure 3.2 Factors that determine the validity of a questionnaire
141
APPENDIX XVIII– Larroy menstrual pain questionnaire
confidential. Your name and identity will not be disclosed at any time. Your collaboration will
be very helpful to carry out an epidemiological study on menstrual pain that is conducting the
School of Psychology at the Universidad Complutense. Please answer all questions as quickly
and accurately as possible. DO NOT HESITATE TO ASK IF IN DOUBT.
DO NOT FILL IN THE QUESTIONNAIRE IF YOU. USE ANY TYPE OF ORAL

CONTRACEPTIVES OR IUD OR IF YOU HAVE BEEN DIAGNOSED WITH A
GYNECOLOGICAL DISORDER.
1. Age:
2. Job:
3. Number of children:
No studies ❍ Primary school ❍ Secondary school ❍ University ❍
5. For how many years have you have had your period (approx.)?
6. Is your menstruation painful? ❍ N o ❍ Yes
0 1 2 3 4 5 6 7 8 9 10
8. Mark with an X on the next line which has been the intensity of pain in the last period
0 1 2 3 4 5 6 7 8 9 10
10. For how many years have you been having painful periods? (aprox.)
11. For how many years have you been having painful periods? ❍No ❍ Yes
142
Belly ❍ Lower back ❍ Thighs (internal side) ❍

Tension in breasts ❍ Other places (specify) _________________
Bad temper ❍ Sadness ❍ Swollen belly ❍
Swollen, painful breasts ❍ Intestinal problems ❍ (e.g. diarrhoea, dizziness, vomiting . . .)
Other (specify) _____________________

Two days before menstruation ❍ One day before menstruation ❍
On the same day of menstruation ❍
Sometimes the day before and sometimes the same day ❍
15. Do you take medication for pain relief??

❍No ❍ Yes what? :

0 1 2 3 4 5 6 7 8 9 10 11 12

No relief ❍ Slightly relieved ❍ Fairly relieved ❍ Very relieved ❍
18. How many periods (in one year) are you relieved by the medication?
0 1 2 3 4 5 6 7 8 9 10 11 12
19. Do you need to stop what you are doing because of the pain? ❍No ❍ Yes
20. How many periods (in one year) do you need to stop what you are doing because of pain? (Circle one)
0 1 2 3 4 5 6 7 8 9 10 11 12
Less than half an hour ❍ Between half an hour and one hour ❍
Between one hour and three ❍ Between three hours and six ❍
Between six hours and one day ❍ More than a day ❍
Allergy ❍ Headache ❍ High blood pressure ❍
Low back pain ❍ Stomach or abdomen pain ❍ Neck pain ❍
Cold hands or feet ❍
Changes in your cardiac rhythm ❍
143
23. The table below shows the days of a month. Please indicate with an Me in the table on which day your
last period started (if you do not remember exactly, indicate the approximate date) and the days it lasted.
Please also appeared on what days you suffer symptoms, each symptom using the symbol below:
Mood changes = M Belly swelling = B

Chest Swelling = C Irritability = I
Depression = D Headache = H
Gastric disorders = G
For example, if your period started on day 13, marked Me in the box that corresponds to that day, and the
following (as well as duration of the period) in the first row, if you had breast swelling and the day before
day of menstruation, will mark a signal in the tables for 12 and 13 in the rows corresponding to the
symbol P, if in addition, since two days before to two days after the onset of menstruation suffered
headaches, will a sign on the tables for the 11, 12, 13, 14 and 15 in the row for the symbol C.
Now, please answer the following table appeared on what days of menstruation and the symptoms (if
sustained) during the last month (if not remember the exact date, indicate the approximate dates). Write a
sign in the row for the appropriate symbol.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
M
Me
We have finished done. Thank you very much for your cooperation. Remember, your data is anonymous
and treated confidentially.
144
APPENDIX XIXa – Proposal for initial assessment of menstrual pain in PD in

TCM questionnaire
PLEASE DO NOT FILL THE QUESTIONNAIRE IF YOU HAVE BEEN DIAGNOSED

WITH A GYCOLOGICAL DISOREDE
Participant code:
1. Age:
2. Job:
No studies Primary school Secondary school University
4. When was your last visit to the gynaecologist?
6 months or less Between 6 months and 1 year
Between 1 and 2 years More than 2 years
5. How many times have you been pregnant? _____
6. How many children do you have? _____
7. For how many years have you have had your period (approx.)? ______
0 1 2 3 4 5 6 7 8 9 10
9. Score in the following scale the mean intensity of the pain in your periods (circle one)
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10 11 12
12. For how many years have you been having painful periods? __________
13. Have you ever visited a gynaecologist for menstrual pain? No Yes
145
Pale Vivid red Dark

Pale Red Dark

Bad temper Sadness
Other (specify) __________________________________________________________
No Yes what? :
0 1 2 3 4 5 6 7 8 9 10 11 12

24. How many periods (in the last 12 months) did medication succeed in relieving your pain?
0 1 2 3 4 5 6 7 8 9 10 11 12
26. How many periods (in one year) do you need to stop what you are doing because of pain? (Circle
one)
0 1 2 3 4 5 6 7 8 9 10 11 12
146

147
APPENDIX XIXb – Proposal for daily assessment of menstrual pain in PD in

TCM questionnaire
Thank you for completing this questionnaire. The information provided by you will remain confidential.
Nobody except Cindy Méndez and her assistant will have access to it. Your name and identity will not be
disclosed at any time. However, the data may be published in a scientific journal and elsewhere without
giving your name or disclosing your identity.
PREMENSTRUAL PERIOD
1. Did you feel pain in the days before the menstruation? Yes No
2. If yes, please score the intensity of pain in the days before the menstruation.
0 1 2 3 4 5 6 7 8 9 10
3. How many days before the onset of menstruation did you feel pain? _____
4. Please score the intensity of pain according to location.
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
5. Please circle the symptoms you had in the days previous to menstruation
Intestinal problems (diarrhoea, dizziness, vomiting …) Headache
Swollen legs/arms Dizziness
Other (specify)__________________________________________________________________
148
1. What was the colour of your menstrual blood today?

Pale Vivid red Dark
2. How much did you bleed today?

3. How was your menstrual blood today?

Pale Red Dark

5. Has your period been painful today? Yes No
6. If yes, please circle the number that best reflects the intensity of the pain:
0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
8. Please circle the symptoms you have had today

Other (please specify)______________________________________________________
9. Did you have the need to stop your activities? Yes No
10. If so, for how long?

11. Has you take medication for pain relief today? Yes No
What medication? _________ How many tablets? ______________ How many grams? ___________
12. Have you relieved by the medication?
149

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


150

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


151

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


152

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


153

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


154

Pale Vivid red Dark


Pale Red Dark

0 1 2 3 4 5 6 7 8 9 10
Abdomen
0 1 2 3 4 5 6 7 8 9 10
Lower back
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10
Tension in breasts
0 1 2 3 4 5 6 7 8 9 10
0 1 2 3 4 5 6 7 8 9 10


155
APPENDIX XIXc – Proposal for final assessment of menstrual pain in PD in TCM

questionnaire
Score the characteristics of your menstruation after the treatment

0 1 2 3 4 5 6 7 8 9 10
Pale Vivid red Dark
Pale Red Dark

Bad temper Sadness
Other (specify) __________________________________________________________
No Yes what? :
156

157
APPENDIX XX – Tongues and radial pulses of the participants at the beginning

and at the end of the study
ED-10JN01 First interview
Tongue Swollen, red, red edges, studded top, red spots on roots, small crack in the
tip, thick dry and cracked in the center
Radial Little thin and taut, fast
Pulse
ED-10JN01 Final interview
Tongue Red, swollen, thick at root, and bristling red tip, red edges
Radial Deep, fast, slippery
Pulse
158
ED-10M01 First interview

Tongue Swollen, red spots on root, edges red, yellow root layer, strawberry tongue
Radial Tense and strongest in the Middle Heater
Pulse
ED-10M01 Final interview
Tongue Swollen, red edges, red dots across the tongue, thick yellow seborrheic in
root
Radial Deep on the Right , soft and slightly slippery, slightly tense and tender on
Pulse the Left
159
Tongue Pale purple, red edges, teeth marks, swollen, cleft to the tip
Radial Tight, thin and fast

Pulse
Tongue Pale-purple, pale edges, teeth marks, swollen edges and anterior
portion
Radial Pulse Thin and slightly tense
160
ED-13A01 First interview
Tongue Swollen, teeth marks, slightly purple, moist, thick at root with red spots
Radial Pulse Deep, fast, slippery
ED-13A01 Final interview
Tongue Red spots on root, swollen, yellowish thick, teeth marks

Radial Pulse Deep, fast, slippery
161
Tongue Red, red spots on root, thick in root, deep central fissure, swollen,
teeth marks, red edges
Radial Deep, weak, rapid, weak in left Kidney

Pulse
Tongue Red, red spots on root, thick in root, deep central fissure
Radial Deep, soft

Pulse
162
Tongue Red, slightly purple, teeth marks, red edges, depression in tip
Radial Weak, deep, short (no Chi barrier )

Pulse
Tongue Normal color, teeth marks and depression in anterior portion

Radial Weak, short (no barrier Chi)
Pulse
163
Tongue Normal color, low layer in middle and Upper Heater, swollen, teeth marks,
cracks in the center, bristling red tip, root layer with red dots
Radial Thin and weak
Pulse
Tongue Normal color, root layer with red dots, trembling, teeth marks
Radial Thin and tight
Pulse
164
Tongue Red, peeling in Middle and Upper Heater, swollen, puffy edges, root
and center cracks
Radial Pulse Slightly thin, tense
Tongue Normal color, swollen edges and toe, red spots on root, horizontal
fissures, normal layer
Radial Fast, tight and thin in Chi barrier
Pulse
165
Tongue Normal color, borders and anterior portion more swollen, red spots on
edges, tip and anterior
Radial Fine and tight, weaker in the left
Pulse
Tongue Normal color, borders and anterior portion more swollen, red spots on
edges, tip and anterior
Radial Fine and tight, weaker on the left

Pulse
166
Tongue Slightly pale purple, red edges and tip (especially tip), teeth marks, red
spots on root
Radial Soft on the Left and fast, tense, deep on the right
Pulse
Tongue Pink, thin white layer, thicker in the right, slight teeth marks
Radial Fine, slightly faster, rough on the left

Pulse
167
168

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What is the research project about?

What is the research project about?

What are the aims and objectives of the research?

What are the aims and objectives of the research?

Chinese Herbal Medicine

for the treatment of Dysmenorrhea:

Cindy Méndez Pendavis

Supervisor: Dr Chris Low

3.3.1.3 Adaptation of the questionnaire to the necessities of the study 61

in TCM questionnaire 145

Table 2.1 Evidence of the role of PG in the etiopathogenesis of PD 20

Chart 1.1 Summary of the research 15

ANCP: A Newly Compiled Practical English-Chinese Library of Traditional Chinese

Results and conclusions

1.1 Background and context

Dysmenorrhea is a common condition suffered by between 52% and 90% of women

A study conducted in the Autonomous Community of Madrid, Spain (Larroy C, et al.,

Dysmenorrhea represents a significant health problem on both a personal and public

There are three conventional approaches to the management of primary

Evidence of efficacy supports use of pharmacological agents such as NSAIDs (Wong et

1.2 Research question

1.3 Summary of the research

• Theoretical perspective on PD in Conventional Medicine (CM): as defined by

• Theoretical perspective on PD in TCM: how TCM texts on PD are considered, its

• Practical application: a prospective, uncontrolled naturalistic study carried out in

Chart 1.1 Summary of the research

1.4 Hypothesis and variables

Dependent variable: menstrual pain

Independent variable: Xiao Yan Wan

1.5 Relevance of the study

1.6 Aims and objectives of the research

o To determine the effectiveness of Xiao Yao Wan in the treatment of pain

o To determine a differentiation of TCM disharmony patterns in PD

SECTION 2 – LITERATURE REVIEW

Normally dysmenorrhea is classified into two types, primary and secondary.

Table 2.1 is a summary of available evidence on the possible role of PG in the

• The dysmenorrhoeic symptoms can be reproduced by the administration of PG

Table 2.1 Evidence of the role of PG in the etiopathogenesis of PD

Negative premenstrual Irritability, dysphoric feelings, fatigue, loss of appetite.

Premenstrual fluid Abdominal pain, inflammation, edema.

Gastric disorders Constipation or diarrhoea, dizziness, nausea and vomiting.

Table 2.2 Current factorisation of the symptoms of dysmenorrhea

The diagnosis of PD is usually made by: (Howard, 2000; Prieto, 2007)

• Anamnesis, investigating the characteristics of the pain and verifying their

There are three conventional approaches to the management of primary

CONVENTIONAL THERAPY APPROACHES

NON Local application of heat (R. P. Smith, 2004), Trascutaneous

SURGICAL Presacral neurectomy, uterosacral neurectomy

OTHERS Psychological treatment (Palacios, 2000)

2.1.2 PD according to TCM

2.1.2.1 Differentiation of disharmony patterns

It is frequent that when consulting the differentiation of disharmony patterns of a

authors. To determine a differentiation of disharmony patterns of dysmenorrhea for

WORK DIFFERENTIATION OF DISHARMONY PATTERNS

As often occurs, differences between the classifications were detected. In order to

• All of the authors consider Qi stagnation to be a disharmony pattern that

MACIOCIA ANCP FLAWS RILEY PEILIN

On the basis of the comparative study the following differentiation of disharmony

• Qi stagnation: Qi stagnation was included because all of the authors

Liv/Kid Yin vacuity + Heat