Qaraaty et al.

DARU Journal of Pharmaceutical Sciences 2014, 22:45

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RESEARCH ARTICLE Open Access

Effect of myrtle fruit syrup on abnormal

uterine bleeding: a randomized double-blind,
placebo-controlled pilot study
Marzieh Qaraaty1, Seyed Hamid Kamali2*, Fataneh Hashem Dabaghian3, Nafiseh Zafarghandi4*,
Roshanak Mokaberinejad5, Masumeh Mobli6, Gholamreza Amin6, Mohsen Naseri1, Mohammad Kamalinejad7,
Mohsen Amin8, Azizeh Ghaseminejad9, Seyedeh jihan HosseiniKhabiri10 and Daryush Talei11

Abstract
Background: Myrtle (Myrtus communis L.) has been used in the Iranian Traditional Medicine as a treatment for
abnormal uterine bleeding-menometrorrhagia. The main aim of this study is to evaluate the effect of myrtle fruit
syrup on abnormal uterine bleeding-menometrorrhagia.
Methods: A randomized, double-blind, placebo-controlled pilot study was conducted on 30 women suffering
from abnormal uterine bleeding-menometrorrhagia. Treatment comprised of giving 15 ml oral myrtle syrup daily
(5 ml three times a day) for 7 days starting from the onset of bleeding. The myrtle syrup along with placebo was
repeated for 3 consecutive menstrual periods. Menstrual duration and number of used pads were recorded by the
Pictorial Blood loss Assessment Chart at the end of each menstrual period. The quality of life was also evaluated
using the menorrhagia questionnaire.
Results: The mean number of bleeding days significantly declined from 10.6 ± 2.7 days to 8.2 ± 1.9 days after
3 months treatment with the syrup (p = 0.01) and consequently the participants in the intervention group used
fewer pads after 3 months (16.4 ± 10.7) compared with the number of pads used at the beginning of the treatment
(22.7 ± 12.0, p = 0.01). Bleeding days and number of pads used by the participants in the placebo group did not
change significantly. Also significant changes of quality of life scores were observed in the intervention group after
3 months compared to the baseline.
Conclusion: Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia.
Keywords: Abnormal uterine bleeding-menometrorrhagia, Effrat-e-tams, Iranian traditional medicine, Myrtus
communis L, Myrtle, Myrtaceae

Introduction families and health services [4]. Different types of AUB in-
Abnormal uterine bleeding (AUB) is one of the main rea- clude a range of dysfunctional conditions affecting regu-
sons of visiting gynecologists [1]. AUB affects up to one- larity, frequency, duration or volume of menstrual flow
third of sexually active women [2] and the overall preva- [5,6]. Menorrhagia or hypermenorrhea is defined as men-
lence of this abnormality is 11%-13%, reaching 24% at the strual blood loss of more than 80 ml per cycle or longer
age of 36–40 [3]. AUB has a considerable high morbidity than 7 days or both of them [7], while polymenorrhea is
rate among women of childbearing age and imposes major defined as having menstruations about every 21 days and
medical, social and financial burdens on women, their occasionally at even shorter intervals causing irregular
ovulation. Metrorrhagia is uterine bleeding at irregular in-
* Correspondence: kamaliseyyedhamid@yahoo.com; nafis_zafar@ymail.com tervals, particularly between the expected menstrual pe-
2
Department of Traditional Medicine, Faculty of Traditional Medicine, Shahid
Beheshti University of Medical Sciences, Tehran, Iran riods [8]. Abnormal uterine bleeding-Menometrorrhagia
4
Department of Gynecology and Obstetrics, Faculty of Medical Sciences, (AUB-MM) is defined as prolonged and excessive uterine
Shahed University, Tehran, Iran bleeding in irregular intervals [9]. The most common
Full list of author information is available at the end of the article

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Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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causes of AUB may be pregnancy, genital tract diseases, were selected according to the defined inclusion criteria:
certain medical conditions such as thyroid dysfunctions 20 to 55 years old, married women, not disposed toward
and hypothalamic suppressions including stress, weight hormone therapy, not pregnant, not lactating, normal
loss, excessive exercise, and even coagulopathies [1,10]. gynecological observations, normal pap smear, endo-
AUB treatment includes administration of non-steroidal metrial thickness less than 12 mm, menstrual period
anti-inflammatory drugs (NSAIDs), antifibrinolytics such more than 7 days in duration and/or less than 21 days
as tranexamic acid, cyclic oral progestins, oral contra- from the start of one period until the start of the next
ceptives and levonorgestrel-releasing intra-uterine sys- menstrual period and/or clot excretion, use of more than
tem [1,5,11]. Hormone therapies have many side effects 10 sanitary product items in a cycle. Sexually active
[12] and the common complication of tranexamic acid women were required to use a suitable non-hormonal
is gastrointestinal disturbances [13]. AUB involves two- birth control. Initially, 92 patients were interviewed from
thirds of all hysterectomies leading to several complica- which, 35 patients were recruited and randomized in two
tions [14,15]. groups of placebo and extract treatment. 30 participants
Iranian Traditional Medicine (ITM) practitioners such completed the study, 15 in each group (Figure 1). Two
as Ibn Sina (Avicenna, 980–1037 A.D) believed that the participants in the placebo group discontinued their ther-
normal menstruation is a good sign of healthy status of a apy because of increasing bleeding during first cycle. One
woman which results in chastity and modesty [16-18]. In subject in the intervention group did not use the syrup
ITM literature, AUB is described under the title of “Effrat- completely and two persons discontinued the study be-
e-Tams” or “Kasrat-e-Tams” [7,18]. Menometrorrhagia is cause of personal reasons.
more compatible with Effrat-e-Tams in ITM [17-20]. Women were excluded from the study if they had a
Based on ITM literature, particularly Avicenna’s book history of significant medical problems (coagulopathies,
(Al-Qanun fit-teb or Canon of medicine, 1025 A.D), diabetes mellitus, chronic inflammatory disease, thyroid
myrtle is known as “mourd” or “aass” and dysfunctions); had a history of endometrial abnormalities
its fruit that called Habbol- aass, is one of the effective (such as hyperplasia), cervical carcinoma, uterine or ovary
medicinal herbs for decreasing the menstrual bleeding malignancy; sub-mucosal or intramural fibroids more than
[18]. Myrtle is a fragrant evergreen shrub belonging to 5 cm; needed surgery and emergency procedure because
myrtaceae family, growing wild in Iran [21,22] and the of increasing bleeding during the study. All of the subjects
Mediterranean area. The fruits have sweet-spicy tastes were free to withdraw at any time during the course of
that are very astringent [23]. Myrtle has been used as anti- study.
viral, antifungal, antiseptic and antioxidant agent [24,25]. Participants were not permitted to use mefenamic acid,
Myrtle berries extract has ulcer-protective properties [26] tranexamic acid, any hormonal therapy, herbal medicine
and anti-inflammatory effects [27]. The essential oils ob- and medicinal herb during the study. Use of acetamino-
tained from leaves, flowers and fruits have been used in phen, oral iron therapy and analgesic opioids was permit-
flavor and fragrance industries [28]. Its biological effect in ted throughout the study.
menstrual disturbances has been described in ITM which All participants signed a written informed consent be-
may be novel in modern medicine [18]. fore recruiting in the study. The Ethics Committee of
There is a lack of detailed trials on the effects of myrtle Shahed University approved the protocol (approval num-
syrup on menstruation. The main objective of the present ber: 41/138342). In addition, the trial was registered in the
study was to investigate the effects of myrtle syrup on redu- Iranian Registry of Clinical Trials under the number IRCT
cing AUB-MM in a pilot placebo-controlled clinical trial. 201109077511 N1.

Plant material
Materials and methods Myrtle dried berries were collected from Manjil on road
Study design and target group to Gilan (North of Iran) in 2011 and its identity was au-
In this randomized, double-blinded, placebo-controlled thenticated by Professor Gholamreza Amin. A voucher
pilot study, 30 patients were randomly assigned into two specimen of the plant has been deposited in Herbarium
groups of placebo (n = 15) and myrtle treatment (n = 15). Tehran University of Medical Sciences, Faculty of Phar-
Participants were treated with either 15 ml of myrtle fruit macy under the voucher No 6632-TEH.
syrup or placebo, 3 times a day for seven days starting
from the onset of bleeding. The treatment was performed Preparation of syrup and placebo
for 3 consecutive menstrual periods. Randomization of Traditional decoction was prepared as described in
equal number of subjects to placebo or treated group “Qarabadin” (Ghayeni, Qarabadin-e-Salehi, 1765 AD;
was achieved using a simple random allocation strategy, Aghili, Qarabadin-e-Kabir, 1781 AD) [29,30] texts be-
using block randomization method. The participants longing to ITM pharmaceutical discipline. 63 g of the
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Figure 1 Study flow chart.

pulverized samples of myrtle fruits were macerated for This treatment was repeated for three consecutive men-
24 hours with 200 ml of distilled water, filtered and boiled struation cycle.
for 15 min. 108 g sucrose was added to the extract in The myrtle syrup and placebo were identical in the
order to prepare the syrup. The medication was supplied same physical form, packaging and labeling and divided
in bottles of 120 ml, containing either drug or placebo. to groups 1 and 2. Physician prescribed syrups to the pa-
Placebo was prepared based on pharmacopoeia simple tients according to the label numbers. Physician and
syrup formula including approved color additives and presenter of the myrtle syrup or placebo were blind for
looked the same as the myrtle syrup. the contents. The pharmacist was the only person who
Myrtle syrup is standardized based on total phenols was aware of the numbers assigned to the myrtle syrup
(Folin-Ciocalteau method) and gallic acid (Rhodanine or placebo.
assay) content. Each 5 ml of syrup contains 0.05 ±
0.03 g dry residue and 41 mg total phenols as gallic Bleeding measurements
acid equivalents. All the participants were evaluated based on a complete
The participants were given either 5 ml of prepared medical history and gynecological examination. Menstrual
syrup or placebo three times a day, 30 minute after each blood loss was assessed with Pictorial Blood loss Assess-
meal for seven days starting from the onset of bleeding. ment Chart (PBAC). The quality of life was evaluated with
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menorrhagia questionnaire (MQ-Iranian Version) [31,32] Table 1 Baseline characteristics of study subjects
before treatment and at the end of the study. Certain Parameter Intervention Placebo group P value
blood test including complete blood count (CBC), pro- group
thrombin time (PT), partial thromboplastin time (PTT), Age 41.33 ± 7.228 41.13 ± 6.978 0.5
follicle-stimulating hormone (FSH), luteinizing hormone BMI 28.86 ± 4.68 31.99 ± 6.29 0.2
(LH) and thyroid stimulating hormone (TSH) were done MQ score 47.8 ± 15.7 41.2 ± 15.3 0.2
before the study. PT and PTT were done to exclude bleed-
Duration of 53.93 ± 61.46 72.33 ± 69.92 0.3
ing disorders. TSH, FSH and LH were done to exclude abnormality (month)
thyroid dysfunction and hypothalamic pituitary dysfunc-
tion, respectively. CBC was performed to determine
hemoglobin (Hb) and hematocrit (Hct). Trans-vaginal Effects of myrtle fruit syrup on duration and intensity of
ultra sonography was also performed to find out if the bleeding
subject had any pelvic pathological disorders and to de- The average number of bleeding days and number of
termine the endometrial thickness. Cervical cytology pads used during the study are summarized on Table 2.
(Pap smear) was done to rule out other abnormalities. There was not statistically significant difference between
Menstrual blood loss and menstrual duration were mea- the groups in terms of bleeding days and number of
sured using PBAC chart during three consecutive treat- pads at the beginning of the study.
ment cycles and was compared with the ones at the The number of bleeding days and consequently number
beginning of the treatment (baseline). The participants of pads used by the participants significantly decreased in
were requested to report the details of their menstrual the intervention group after 3 months (P = 0.01), while
cycle i.e., the start date, duration of menstruation, the changes of these variables were not significant in the pla-
number of sanitary pads used (considered as the intensity cebo group.
of bleeding) and any adverse effects. The information was Significant changes of MQ score was observed in the
recorded at the beginning of the treatment and at the end intervention group after 3 months compared to the base-
of each menstrual cycle. The PBAC chart had a sensitivity line (P = 0.02).
of 80% and specificity of 88% in diagnosing menorrhagia
(as defined in the alkaline hematin method) [33]. Discussion
To the best of our knowledge, the present study is the
Statistical analysis first randomized placebo-controlled trial on the effects
The primary outcome measures included the duration of of myrtle fruit in women with AUB-MM. The results of
menstrual period, number of pads used during menstru- this study showed that myrtle syrup had notable advan-
ation. The MQ score and the side effects were the sec- tages over placebo in women with AUB-MM. Also, the
ondary outcome measures. quality of life was significantly improved in the interven-
Normal probability plot was used to test for normality tion group with minor side effects.
of data in GraphPad Prism version 5. The data points During luteal phase in menstrual cycle, some inflam-
appeared linear on the plot and the data were considered matory processes lead to tissue edema in endometrium
as normal distribution. Repeated-measures ANOVA func- and continue with excessive menstrual bleeding (EMB).
tion in the program GraphPad Prism version 5 was used Unusual secretion of local pro-inflammatory cytokines
to test for differences of primary outcomes within the responsible in the vascular tone has been observed [2,4].
groups. Repeated-measures ANOVA compares the means In these women, endometrium synthesizes much more
of more than two matched groups in a longitudinal prostaglandin E2 (PGE2) than it does with vasocon-
study in which change over time is assessed. Student’s t- strictor PGF2α. A noticeable increased PGE2/PGF2α ratio
test was used to compare the MQ scores before and happens during luteal phase in women with menstrual
after the treatment. blood loss (>90 ml). Endometrial synthesis of PGs and
signaling in women with profuse menstruation is greater
Results than women with normal menstrual bleeding [4]. These
Baseline characteristics inflammatory molecules can be targeted to treat the dis-
The baseline characteristics of the subjects are described turbances in women suffering from AUB.
on Table 1. There were no statistically significant differ- Myrtle berries aqueous extract contains phenolic-like
ences in baseline characteristics between the groups. tannins (galllic acid derivatives), anthocyanins and flavo-
Hence, the groups were homogenous with respect to age, noids [34]. Tannin-containing medications have been used
level of education and investigations. Age of the patients traditionally as styptics [35]. Anti-inflammatory activities
ranged from 20 to 55 years with the mean age 41.2 ± of anthocyanins have been proven in some studies [36].
6.9 years. Some studies have demonstrated that flavonoids can
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Table 2 The effect of myrtle fruit syrup in bleeding at baseline and post treatment
Variable Group Title Mean(±SD) Mean difference (±SE) 95% CI* P values**
compared with baseline
Menstrual duration (day) Intervention (n = 15) Baseline 10.6(2.7)
st
After 1 cycle 8.8(2.3) 1.7(0.6) −0.3− 3.8 0.08
After 2nd cycle 8.9(3.8) 1.6(0.9) −1.3− 4.7 0.08
rd
After 3 cycle 8.2(1.9) 2.3(0.6) 0.3− 4.3 0.01
Placebo (n = 15) Baseline 9.8(3.5)
After 1st cycle 8.8(3.2) 1(0.5) −0.7− 2.7 0.6
After 2nd cycle 8.7(2.6) 1.1(0.6) −0.8− 3.1 0.5
rd
After 3 cycle 8.6(3.2) 1.2(0.4) −0.08− 2.6 0.5
Number of pads used Intervention (n = 15) Baseline 22.7(12)
After 1st cycle 20(14) 2.6(1.6) −2.4−−7.7 0.5
After 2nd cycle 21.4(17.9) 1.3(2.7) −7.1− 9.7 0.8
After 3rd cycle 16.4(10.7) 6.3(1.5) 1.6− 11 0.01
Placebo (n = 15) Baseline 15.4(9.8)
After 1st cycle 13.9(7.2) 1.5(1.7) −3.7− 6.8 0.6
After 2nd cycle 11.6(7.8) 3.8(1.5) −0.7− 8.4 01
rd
After 3 cycle 15(8.7) 0.4(2) −5.9− 6.7 0.9
MQ score Intervention (n = 15) Baseline 47.8(15.7)
After 3 months 39.4(16.7) 8.4(3.7) 0.4-16.4 0.02
Placebo (n = 15) Baseline 41.2(15.3)
After 3 months 39.2(14.5) 2(2.03) −2.3- 6.4 0.7
*One-way analysis of variance (ANOVA) was used to compare the groups before and after each treatment with either placebo or extract. There was statistically
significant difference between groups before and after three rounds of treatment with myrtle syrup, while the difference between groups before and after
placebo treatment was not statistically significant.
**P values <0.05 are significant.

inhibit inflammatory mediators [37]. According to a pre- were not followed up after finishing the study and the
liminary study, micronized flavonoids suppressed endo- long-lasting effects are not clear to us.
metrial prostaglandins and were safe and effective in AUB
[38]. Another phytochemical compound in myrtle that
Conclusion
suppresses prostaglandin E2 formation efficiently is myrtu-
The outcomes of this study showed that myrtle syrup is
commulon [39]. Therefore, the presence of the effective
an effective drug as a short-term treatment of AUB-
anti-inflammatory components in the myrtle extract can
MM. Women in the test group experienced significant
render the myrtle syrup a potential source to reduce
reductions of bleeding duration, as well as a significant
prostaglandin secretion and to cure AUB subsequently.
decline of the intensity of bleeding while placebo did not
Further mechanistic studies are suggested to prove the
affect the variables significantly. The quality of life im-
anti-inflammatory effects of the components in the
proved among the subjects in the syrup-treated group.
myrtle extract.
Based on the current novel results, a therapeutic role of
This study had some potential limitations which are
myrtle syrup is suggested for women with AUB-MM,
usually part of the nature of human studies. Firstly, ITM
which is accessible and cost-effective therapy. Larger
has two groups of principal variables: one is part of
and longer randomized trials are being planned in our
human nature, mezaj (temperament), racial/ethnic, sex,
research group to confirm the long-term effects of myr-
age, season, zone, profession [40], and the second factor
tle on bleeding reduction in AUB-MM.
is the composition of the herbal preparations which may
vary based on the geographical habitat of the plant, the
Abbreviations
climate, and the time of reaping [41]. These factors have AUB-MM: Abnormal uterine bleeding-menometrorrhagia; CBC: Complete
not been considered in our study. blood count; EMB: Excessive menstrual bleeding; FSH: Follicle- stimulating
In the present study, the subjects received syrup only hormone; Hb: Hemoglobin; Hct: Hematocrit; HMB: Heavy menstrual bleeding;
ITM: Iranian traditional medicine; LH: Luteinizing hormone; MQ: Menorrhagia
for three cycles; therefore we cannot comment on any questionnaire; PG: Prostaglandin; PT: Prothrombin time; PTT: Partial
long-term efficacy of myrtle syrup. Also, the subjects thomboplastin time; TSH: Thyroid stimulating hormone.
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doi:10.1186/2008-2231-22-45
Cite this article as: Qaraaty et al.: Effect of myrtle fruit syrup on
abnormal uterine bleeding: a randomized double-blind, placebo-
controlled pilot study. DARU Journal of Pharmaceutical Sciences 2014 22:45.

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