THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

Volume 16, Number 2, 2010, pp. 193–198

ª Mary Ann Liebert, Inc.
DOI: 10.1089=acm.2008.0600

Unexplained Infertility Treated with Acupuncture

and Herbal Medicine in Korea

Jongbae J. Park, K.M.D., Ph.D.,1,2 Myungja Kang, K.M.D., Ph.D.,3 Sangseop Shin, M.D.,3
Eunmi Choi, K.M.D., Ph.D.,3 Sukyung Kwon, K.M.D.,3 Hyosun Wee, K.M.D.,3
Bonghyun Nam, Ph.D.,4 and Ted J. Kaptchuk, D.M.D.2

Abstract

Aim: We aim to determine the safety and effectiveness of a standard therapeutic package of Korean medicine for
the treatment of unexplained infertility in a cross-section of women who sought treatment at an integrative
hospital in Seoul, Korea.
Background: Infertility affects more than 1.2 million women in the United States alone. Treatment options for
infertility vary, yet the barriers of invasiveness, cost, and access inhibit treatment use for many women.
Alternative medical approaches exist for this indication, and sustain certain popularity. Therefore, we system-
atically studied a standard therapeutic package of Korean medicine to treat unexplained infertility in women.
Methods: Female participants included in this observational study met inclusion criteria before receiving a set of
treatments including herbal medicine, acupuncture, and moxibustion. A study physician screened each patient
in accordance with inclusion criteria, provided study information, and after the patients consented, performed
the baseline assessment. Assessments included age, the history of assisted reproductive technology, and dura-
tion of infertility. The key outcome measure included the number who achieved pregnancy and any neo-natal
morbidity and mortality at follow-up stage for those who got pregnant. Any other adverse events including
aggravation of existing symptoms, and the number of dropouts, were recorded. Treatments were supposed to be
completed after 6 menstrual cycles between February 2005 and April 2006.
Results: One hundred and four (104) women with unexplained infertility were included in this observational
study. Participant mean age was 32 years (SD: 2.7), with a range between 26 and 41 years. The median duration
of infertility after diagnosis was 33.5 weeks (interquartile range: 20.8–50.3). In total, 41 participants (39.4%) had
undergone a mean number of 1.4 (SD: 2.2) assisted reproductive technology treatments prior to joining the
study. The number of patients remaining in or achieving pregnancy throughout the 6-month study period was
23 (14 pregnancies), 22.1%. Six (6) participants (4.8%) reported minor adverse events including rash in the face
(n ¼ 1), diarrhea (n ¼ 2), dizziness (n ¼ 1), and heartburn (n ¼ 2). Of the 14 pregnancies, there were 10 normal
births, and 4 miscarriages; otherwise, no neonatal morbidity=mortality occurred. According to per protocol
analysis, 14 pregnancies out of 23 total were achieved by those who remained for the entire six menstruation
cycle treatments, yielding a pregnancy rate of 60.9%.
Conclusions: The standard therapeutic package for unexplained infertility in women studied here is safe for
infants and the treated women, when administered by licensed professionals. While it remains challenging to
have the target population complete a 6-month treatment course, during which most patients have to pay out of
pocket, the extent of successfully achieved pregnancy in those who received full treatment provides meaningful
outcomes, warranting further attention. A future study that includes subsidized treatment costs, encouraging the
appropriate compliance rate, is warranted.

1
Asian Medicine & Acupuncture Research, Department of Physical Medicine & Rehabilitation, University of North Carolina at Chapel
Hill, NC.
2
Division for Research and Education for Complementary & Integrative Medical Therapies, Harvard Medical School, Osher Research
Center, Boston, MA.
3
Conmaul Hospital, Seoul, Republic of Korea.
4
Korea Food & Drug Administration, National Institute of Toxicological Research Biostatistics Division, Seoul, Republic of Korea.

193
194 PARK ET AL.

Introduction provided to treat specifically ‘‘unexplained female infer-

tility.’’ Herein we describe the participation, outcomes, and

O f the approximately 62 million American women

of reproductive age in 2002, 1.2 million (2%), had an
infertility-related medical appointment within the previous
any adverse events related to this integrative care package.
This population either has few established conventional
treatment options, or has experienced a substantial number
year, and 10% had an infertility-related medical visit at some of failures from the prior use of conventional treatments.
point in the past.1 This common and frustrating medical
condition can take a significant emotional and physical toll on Methods
women and their partners. The burden of infertility includes
This study evaluates the outcome of 104 women who re-
the frequent psychopathologic consequences of anxiety, de-
ceived treatment using a standard therapeutic package for
pression, crisis within the relationship, divorce, and lack of
unexplained infertility at Conmaul Hospital in Seoul, Korea.
self-reliance.2,3 Because of such negative consequences, it is
All participants were treated for six menstrual cycles be-
desirable to find cost-effective and successful therapies for
tween February 2005 and April 2006. The women received
infertility.
treatment with a standard therapeutic package of Korean
Typical Western treatments for infertility include medica-
Herbal Medicine, acupuncture, and moxibustion for their
tion (hormone stimulation), surgical correction of anatomical
unexplained infertility. Treatment was cumulative and not
defects, or artificial insemination. For couples who do not
contingent upon use of the standard therapeutic package in
benefit from these treatments, the remaining options include
consecutive months. Those study participants who missed
gamete intrafallopian transfer, intracytoplasmic sperm injec-
three consecutive monthly treatments were contacted by a
tion, in vitro fertilization, and zygote intrafallopian transfer.
physician to determine the reason for discontinuation.
Although all of these therapies can be successful, they are
Inclusion criteria for study participation included all of the
often expensive, invasive, and time consuming. With the in-
following: unexplained infertility confirmed with laparos-
troduction and integration of Eastern medicine into Western
copy and ultrasonography, regular menstrual cycle of 25–35
practices, there has been an increase in the acceptance and use
days, no infertility factor in their male partner, clear com-
of complementary practices in dealing with infertility.4,5 The
munication skills with hospital researchers, and normal hor-
anxiety and depression that are often associated with infer-
monal test result range. If all of the inclusion criteria were
tility has made alternative and combination therapies a real-
verified within the 12 months prior to initiation of participa-
istic and beneficial option for those faced with varied types of
tion, women were included. Women were excluded from the
infertility. Any noninvasive, non-time-consuming, and cost-
study when the inclusion criteria were not met, or if hormone
effective manner of alternative therapies can also be viewed as
supplementation (including clomiphene citrate13), in vitro
a patient benefit. The now common use of acupuncture has
fertilization or intrauterine insemination treatments were
proven effective for endocrine stimulatory and regulatory
undertaken during the 6-month study period. Those women
interventions.6
with minimal=mild endometriosis were included in the study,
While conventional treatment options are well established,
as were women over the age of 35 (age typically classified as
there have been few systematic reviews of CAM approaches
the cutoff for high-risk pregnancies to develop).
for the treatment of infertility.7 Several studies have reported
the use of acupuncture as a treatment for various gynecologic
Standard therapeutic package intervention
conditions,8 while others have reported case studies on the
use of Traditional Chinese Medicine (including herbs and A study physician screened each patient in accordance
acupuncture) for treating infertility.9,10 While the proponents with inclusion criteria, provided study information, and after
of these therapies value their safety, minimally invasive ap- obtaining consent, completed a baseline assessment. After
proaches, and minimal side-effects, there have not been screening, women were subjected to the standard therapeutic
thorough reviews or studies to assess the effectiveness of package for unexplained infertility for up to six menstruation
traditional approaches for treating infertility. Bridging the cycles and ceased treatment when conception was confirmed
gap in knowledge and practice between Western and Eastern with ultrasonography. This package included (1) water-
medicine as well as looking at how medicine is practiced in extracted decoction (120 mL) of herbal prescription pre-
under studied medical systems11 are important issues in the pared through individual diagnosis given three times a day
fertility field. 30 minutes after meals; (2) a pack of Song Keum Dan taken
In South Korea, where the traditional system of medicine with warm water 30 minutes before meals 3 times daily. This
has evolved into an integrative approach, a significant pop- herbal medicine pill, referred to in Dong-Yi-Bo-Gam, an en-
ulation of infertile patients seeks health services from clinics cyclopedia-style Korean medical text published in 1659, con-
and hospitals of Korean medicine. Medicine in Korea, while tains 214 mg of dried powder of Paeonia moutan, Angelica
it has evolved with influence from and exchange with Tra- tenuissima, Panax ginseng, Angelica sinensis, Poria cocos, Angel-
ditional Chinese Medicine, has developed and sustained ica dahurica, Cinnamomum cassia, Marsdenia longipes, Cnidium
various unique aspects. This is the rationale to use the term, officinale, Corydalis ternata, Paeonia albifloria, and Atractylodes
Korean medicine. The Conmaul Hospital (Seoul, Korea) is japonica; and 107 mg of dried powder of Glycyrrhiza glabra and
well known as an infertility specialty clinic, where an inte- Achyranthes japonica per each pack; (3) moxibustion on um-
grated service between Medical Doctor (M.D.) and Korean bilicus (CV8) done once daily except during the menstrual
Medicine Doctor (K.M.D.)12 is provided. The scope of its cycle; and (4) herb acupuncture (injection of extracted solution
service includes diagnosis and treatment packages including of dried Cervi Parvum Cornu and Hominis Placenta onto acu-
herbs, moxibustion, and acupuncture. This study is a pro- puncture points, at each point 0.3 mL containing 0.06 mg of
spective observational study of the integrative care package the two herbs) on mainly CV4, BL19, and BL22. All women
INFERTILITY TREATMENT IN KOREA 195

who achieved pregnancy during the observational period Six (6) participants (5.8%) reported minor adverse events
were followed up until birth. including rash in the face (n ¼ 1), diarrhea (n ¼ 2), dizziness
(n ¼ 1), and heartburn (n ¼ 2). All of the symptoms were
mild, and eased after patients stopped taking the specific
Outcome measures
herbal medicine; no hospitalization was required. Figure 2
The baseline data included age, the history of assisted shows reasons stated for individual dropouts. The most
reproductive technology, and duration of infertility. The key frequently cited reason was ‘‘personal reasons,’’ which may
outcome measure was the number of participants achieving be a polite way of expressing difficulty or unwillingness to
pregnancy. Patients were also asked to inform the study afford this treatment ($500=month).
physician whether they complied with the standard thera- Regarding the success rate for achievement of pregnancy,
peutic package, and whether they have attempted to con- 14 of 23 patients remained in the study for six menstrual
ceive, and to report the aggravation of any existing cycles achieving a pregnancy rate of 60.9%. This success rate
symptoms. Also, the number of dropouts and adverse events must be considered in light of the high dropout rate for
in the patient population were recorded. participants in this study.
The study protocol included the collection of details on
menstruation period and related symptoms including length
Discussion
of menstrual cycle, the color of menstrual blood on the second
or third day of menstruation using the Munsell color system, The use of acupuncture, moxibustion, and herbal medicine
the amount of menstrual blood per day of significant bleeding has deep roots in women’s health in Korea. In this study, we
during the total menstrual period, the number of pads used, attempted to record the results of such practices pertaining to
and the existence of blood clots observed with the naked eye unexplained female infertility. The use of the standard ther-
(score 0 if no clot, 1 with the diameter <1 cm, and 2 with the apeutic package used in this study is safe and minimally, if at
diameter
1 cm). A visual analogue scale of menstrual pain, all, risky. The absence of teratogenic or reported neonatal
breast pain, and breast swelling was also asked. All of the morbidity and mortality solidifies the place of such treatment
above data were to be used as indicators of reproductive packages alongside other established medical, natural, and
health status in the patient base, including infertility and self-administered (drug) infertility interventions. The ad-
ovulation. However, these data were not analyzed due to the herent group of women achieved a successful pregnancy
lack of compliance on the part of patients. outcome at a rate of 60.9%. Upon assuring appropriate com-
The assessment forms for each participant were given a pliance rates (through insurance support, availability of ser-
unique identifier number and kept in a locked filing cabinet. vices, positive outcomes reported in the literature, etc.), a
All data analysis was done offsite at Harvard Medical School, promising outcome can be anticipated. Meanwhile, the pa-
Boston, and was securely maintained. The study IDs for each tients’ full comprehension regarding scope of treatment and
participant were maintained such that participant anonymity willingness to comply with it when entering into the course of
was never compromised. Approval for this primary study treatment seems crucial, as the high number of dropouts in the
was obtained from the Institutional Review Board at Con- early study stages adversely affected the overall study.
maul Hospital, and the data analysis of the de-identified data The outcomes that were obtained in the group that com-
was approved by the Harvard Medical School Institutional pleted the study as well as those that dropped out are sig-
Review Board. After the completion of data analysis and the nificant. Although the success for achieving pregnancy is
drafting of the manuscript, the Principal Investigator ( J.P.) downplayed by the number of dropouts in the study, if more
moved to the University of North Carolina at Chapel Hill and than 22.1% of the initial subject group had followed through
finalized the manuscript. until the end, the outcomes might have provided a strong
call for the implementation of noninvasive Eastern medical
practices to be more than an adjuvant therapy for infertility.
Results
Although completion rates for observational studies on in-
One hundred and four (104) women with unexplained fertility may range as high as 90% in studies that involve a
infertility were included in this observational study. Their stipend,14 it is our understanding that our completion rate of
mean age was 32 years old (SD: 2.7), ranging between 26 and 22.1% in an observational study (which should be markedly
41. The median duration of infertility after diagnosis was less than any designed cohort or case–control study) that
33.5 weeks (interquartile range: 20.8–50.3). In total, 41 par- asked for a capitation payment from the subjects was ac-
ticipants (39.4%) had undergone a mean number of 1.4 (SD: ceptable. In contrast to studies where treatments were pro-
2.2) assisted reproductive technology treatment attempts vided free of charge, in this observational study participants
prior to joining the study. had to pay for their individual treatment. The personal rea-
The flow of the study is shown in Figure 1. The number of sons for dropping out could also include unreported illness,
patients remaining in or achieving pregnancy throughout the emotional or psychologic burden, and loss of interest, which
entire study period of 6 months was 23 (14 pregnancies), or the investigators regret we did not classify in detail. The
22.1%. Slightly more than half (n ¼ 55) dropped out before movement of patients out of the area as well as the desire
reporting their third menstruation cycle. The trend of dropout to seek other treatment options, and administrative issues
was high in the early stage and gradually decreased. Out of 14 in contacting participants accounted for the remainder of
pregnancies, there were 10 normal births, 4 miscarriages, and patients who did not complete the treatment course.
no stillbirth. Otherwise, there was no neonatal morbidity= It is important to understand the complex array of effects
mortality. Total monthly cost for the treatment package was that play into the seeking out of and adherence to treatment
about $500. in regard to fertility. In the realm of unexplained in fertility,
196 PARK ET AL.

Admission (n=104)

1st Menstruation (n=104)

Dropout (n=33)

2nd Menstruation (n=67) Pregnancy (n=4)

Attempt to conceive (n=64)

Missing attempt (n=1) Dropout (n=22)

3rd Menstruation (n=41) Pregnancy (n=4)

Attempt to conceive (n=40)

Missing attempt (n=1) Dropout (n=16)

4th Menstruation (n=23) Pregnancy (n=2)

Attempt to conceive (n=23)

Dropout (n=6)

5th Menstruation (n=15) Pregnancy (n=2)

Attempt to conceive (n=15) Dropout (n=4)

6th Menstruation (n=9) Pregnancy (n=2)

Remaining & Non pregnant (n=9)

Total Pregnancy
(n=14)

Normal birth (n=10); miscarriage (n=4); still birth (n=0)

FIG. 1. Flow of an outcome study of an infertility clinic of Korean Medicine for unexplained women’s infertility.

especially where patients have no pointed abnormality with personal reasons not get in the way of adherence for those
hormone levels, or physical impediments that have been women who completed treatment? Is this group older and
diagnosed, the emotional and psychologic toll is overarch- therefore more prone to follow through without regard to
ing. To achieve success and completion with the standard time constraints or economic detriment? Is this group more
package of care in this difficult situation is promising. One inclined to participate in this traditional and noninvasive
interesting point to interpret in future study results will be to type of care in other aspects of their lives? Or simply, does
look at the demographic composition of women who did this group live closer or have substantial economic means to
complete the treatment. As such a large percentage of achieve the final outcome of visiting for a combined six
dropouts stated that ‘‘personal reasons’’ were the impetus for menstrual periods? In addition, are women in this group
lack of completion, it brings forth the question, why did more desperate for conception than the others?
INFERTILITY TREATMENT IN KOREA 197

Reasons for stopping treatment

Unknown
Other Tx

Reasons
Personal reason
Moving away
Lost contact
AE
0 10 20 30 40 50 60
Frequencies
FIG. 2. Reasons for dropouts from an outcome study of an infertility clinic of Korean Medicine for unexplained women’s
infertility. Tx, treatment; AE, adverse events.

As we look at previous studies of traditional care for in- Upon completion of this study, the limitations of an ob-
fertility, there is insufficient literature looking at Korean servational study in the Conmaul Hospital were typified by
medical practices and their influence on infertility. Much of the relatively low adherence rate of participants. At the same
the current literature on traditional medicine and infertility time, the success rate of the standard therapeutic package for
deals with male infertility, includes the use of medical pro- treatment of unexplained infertility was strengthened. Over-
cedures in conjunction to Eastern medicine,7 or comes from all, whether or not pregnancy was achieved, and whether or
Indian or Chinese researchers who use similar but decisively not participants finished treatment, or infertility persisted, the
different methods from those of this study. These alterna- multiple psychologic and physiologic problems associated
tives include the use of numerous similar yet different herbs, with unexplained infertility were studied and provided a
but exclude the use of acupuncture and herbal pills. There- baseline for future research on this meaningful complemen-
fore, research in this area is to an extent novel and in its own tary subject field.
right a worthwhile endeavor. In summary, this study is a starting point for future re-
The use of traditional Korean medicine has become very search. Although a large percentage dropped out of the study
appealing to patients as a primary or adjuvant therapeutic tool. for myriad nonspecified reasons, the treatment for infertility
The mixed results reported by many researchers in regard to was beneficial in the small cohort who utilized it as pre-
fertility-related outcomes can be explained by the standardi- scribed. Therefore, future research into the mechanisms of
zation of treatments and therefore lack of personalized care action for individual treatment components, the cost effective-
plans.15,16 While further discussion of the individual treatments ness of the treatment versus conventional infertility methods,
included in the package is beyond the scope of this study, there and the overall success rate in a double-blind placebo-
may certainly be a benefit to this method of treatment. controlled study, could act to solidify this treatment method
This observational study into unexplained infertility as a positive option for women with unexplained infertility.
treatment would further benefit from work done in the fol-
lowing aspects: (1) investigating the outcomes of consecu- Acknowledgments
tive treatment in contrast to a cumulative treatment over a
number of months on the success of pregnancy and other Jongbae Park and Bonghyun Nam acknowledge the grant
symptoms of menstruation; (2) studying detailed categories provided to the Harvard Medical School by the Myung
of reasons for the discontinuation of treatments, including Kyung Medical Foundation (account number #520-45578-
cost and confidence in the treatment; (3) carrying out mat- 225011). Ted J. Kaptchuk was supported by NIH-NCCAM
ched comparative studies on women with unexplained in- grant #K24 AT004095. In addition, the assistance of Stephen
fertility who did not use the standard therapeutic package Flaherty in manuscript preparation is sincerely appreciated.
from Conmaul Hospital versus women who did (introduc-
tion of a specific control); (4) investigating outcomes of the Disclosure Statement
standard care package for this unexplained infertility in re-
No competing financial interests exist.
gard to general health and wellness. What other benefits or
detriments can be associated with the package, as most
herbal therapeutic packages have extensive effects; (5) look- References
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