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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

Volume 19, Number 9, 2013, pp. 740–745


ª Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2012.0429

Effectiveness of Abdominal Acupuncture for Patients


with Obesity-Type Polycystic Ovary Syndrome:
A Randomized Controlled Trial

Yan-Hua Zheng, MM, Xin-Hua Wang, MD, Mao-Hua Lai, MD, Hong Yao, MM,
Hua Liu, MM, and Hong-Xia Ma, MD

Abstract

Objective: To assess the effectiveness of abdominal acupuncture at the endocrine and metabolic level in patients
with obesity-type polycystic ovary syndrome (PCOS).
Methods: Eighty-six women from the First Affiliated Hospital of Guangzhou Medical College with a diagnosis of
PCOS (body–mass index [BMI] ‡ 25 kg/m2) were randomly assigned to receive 6 months of abdominal acu-
puncture (once a day) or oral metformin (250 mg three times daily in the first week, followed by 500 mg three
times daily thereafter). BMI, waist-to-hip ratio (WHR), ovarian volume, menstrual frequency, homeostasis model
assessment for insulin resistance (HOMA-IR), and Ferriman–Gallwey score were measured at the beginning of
the study and after 6 months of treatment. Luteotrophic hormone (LH), testosterone, follicle-stimulating hor-
mone (FSH), fasting blood glucose, 2-hour Postprandial blood glucose, fasting insulin, 2-hour postprandial
blood insulin, total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density
lipoprotein cholesterol (HDL-C) were also assessed.
Results: According to the results at baseline and 6 months, BMI, WHR, Ferriman–Gallwey score, ovarian volume,
luteotrophic hormone, ratio of luteotrophic hormone to follicle-stimulating hormone, testosterone, LDL-C, triglyc-
erides, total cholesterol, fasting blood glucose, 2-hour postprandial blood glucose, fasting insulin, 2-hour post-
prandial blood insulin, and HOMA-IR were reduced significantly in the two groups ( p < 0.05). Menstrual frequency
and HDL-C ( p < 0.05) increased significantly in both groups; follicle-stimulating hormone also increased in both
groups, but the change was not significant ( p > 0.05). The acupuncture group showed considerable advantages over
the metformin group in terms of reduced BMI and WHR and increases in menstrual frequency ( p < 0.05).
Conclusion: Abdominal acupuncture and metformin improved the endocrine and metabolic function of patients
with obesity-type PCOS. Abdominal acupuncture may be more effective in improving menstrual frequency,
BMI, and WHR, with few adverse effects.

Introduction duction is considered important in treatment of menstruation


disorders. Lifestyle modification, focusing predominantly on

P olycystic ovary syndrome (PCOS) is a complex endo-


crine and metabolic disorder associated with ovulatory
dysfunction, hyperandrogenism, abdominal obesity, and insu-
diet and physical exercise, is first-line therapy for metabolic
complications in overweight and obese women with PCOS.
However, a controlled diet and aerobic exercise over a
lin resistance that affects 4%–12% women of reproductive age.1 long time span may be hard to maintain. Thus, patients with
Obesity and abdominal adiposity may play a critical role in PCOS are commonly treated with metformin, an oral insulin-
generating and maintaining PCOS; 50% of women with PCOS sensitizing agent.4 This drug reduces blood glucose con-
have been reported as overweight or obese.2 Recent studies centrations and improves insulin sensitivity in the liver and
have shown that weight loss is associated with beneficial effects the peripheral tissues, thereby inhibiting hepatic glucose
on hormones, metabolism, and clinical features; weight loss of production and increasing glucose uptake and use in mus-
5%–10% could restore menstrual function, lead to increased cle.5 Metformin normalizes several measures in women
glucose tolerance, and improve body composition.3 Given the with PCOS.6 Reduction of androgen levels, with an approx-
high prevalence of obesity in women with PCOS, weight re- imately 25%–50% decrease in testosterone, has been well

First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China.

740
EFFICACY OF ABDOMINAL ACUPUNCTURE FOR OBESE PCOS PATIENTS 741

documented, and a recent study showed that metformin ad- PCOS. To ensure equal proportions of age and body–mass
ministered for up to 6 months reduced hirsutism in PCOS.7 In index (BMI) in each study group, female patients who met
addition, other studies have revealed that metformin may the inclusion criteria were randomly allocated in a 1:1 ratio to
increase the number of menstrual cycles in women with an abdominal acupuncture or a metformin group. Stratifi-
PCOS.8 Thus, in women without evidence of renal or hepatic cation by age and BMI ensured equal proportions of those
disease, metformin appears effective in reducing the negative variables across groups. Computer-generated randomization
effects of PCOS on reproductive and metabolic health. within each stratum was conducted by using permuted
Traditional Chinese Medicine (TCM) is a label that covers a blocks of two; randomization was concealed until interven-
broad range of traditional medicine practices throughout Asia. tions were assigned. The study was conducted in accordance
Acupuncture is an important component of TCM. There are with the principles of the Declaration of Helsinki and was
more than 300 acupoints along the meridians that are described approved by the ethics committee of the First Affiliated
as a system for transporting energy and as a fundamental cir- Hospital of Guangzhou Medical College, Guangzhou, China.
culatory system for all tissues in the body. The meridians are not The trial is registered at the Chinese Clinical Trial Registry
nerves and are not visible in anatomy; however, manual or with identifier no. ChiCTR-TRC-12002003.
electrical acupuncture activates the afferent nerve fibers.9
Acupuncture is considered a relatively safe treatment. The Participants
incidence of adverse effects is substantially lower than that of
Participants were recruited from an outpatient gynecology
many drugs or other accepted procedures for the same
department, and the study took place at the First Affiliated
conditions. Compared with many conventional medical
Hospital of Guangzhou Medical College from January 2006
treatments, the rate of serious adverse effects of acupuncture
to May 2009. PCOS was defined according to modified
has been reported as 3 per 1 million treatments.10 Because
Rotterdam criteria: ultrasonography-verified PCOS ( ‡ 12
adverse effects and serious adverse reactions are obstacles to
follicles 2–9 mm and/or ovarian volume ‡ 10 mL in one or
current therapies for ovulation induction in women with
both ovaries) with oligomenorrhea/amenorrhea or clinical
PCOS, alternatives are required. Acupuncture has been re-
signs of hyperandrogenism (hirsutism or acne).15 A BMI ‡ 25
ported to be a suitable alternative or complement to phar-
kg/m2 was used to define obesity.16 Hirsutism was defined
macologic induction of ovulation in women with PCOS; this
as a Ferriman–Gallwey score of ‡ 8.17 The presence of acne
treatment provides the additional advantages of relieving
was defined by a positive response to the question ‘‘Do you
other symptoms and adverse effects.11
have acne?’’ Oligomenorrhea was defined as an inter-
Abdominal acupuncture offers the advantages of comfort
menstrual interval > 35 days and fewer than eight menstrual
and safety, as well as effectiveness and efficiency. A system-
bleeds in the previous year. Amenorrhea was defined as
atic study based on 30 years of clinical investigation assessed
absent menstrual bleeding or no menstrual bleeding in the
the mechanism of indications of abdominal points and their
previous 90 days. Women with PCOS were excluded if they
relation with the whole body; in addition, the first study of
were younger than 18 or older than 38 years of age or had
abdominal acupuncture assessed the Shenque (CV 8)-channel-
cardiovascular disease, diabetes mellitus, or endocrine or
collateral system.12 Considered to play a key role in abdom-
neoplastic causes of hyperandrogenemia. Women older than
inal acupuncture therapy, umbilical point CV 8 (on the
age 38 years were excluded because many women in that age
umbilicus) is the central nucleus of the meridian and collateral
group wish to become pregnant; as a result, they may prefer
regulatory system and is closely related to the qi and blood
assisted reproductive technology over the long-term treat-
circulation throughout the body. In TCM, the stomach chan-
ment for PCOS. All participants gave informed oral and
nel of foot-yangming regulates energy metabolism, and the
written consent.
conception vessel nourishes the whole genital system.
In this study, CV4, CV6, CV12, and CV13 and bilateral
Interventions
ST21, ST25, and ST28, which are located near the abdomen
and close to fat depositions, were selected as acupoints. Abdominal acupuncture. Patients in the acupuncture
Abdominal acupuncture may directly affect adipose tissue group received acupuncture twice a week for 6 months by a
and improve endocrine and metabolic functions. The needle registered acupuncturist educated in theoretical and practical
was placed in the abdomen and hind limb, thus exhibiting acupuncture at Guangzhou Medical College. The acupunc-
the same somatic innervation as the ovaries and uterus.13,14 ture protocol was based on the authors’ clinical experience in
Therefore, acupuncture on the abdomen, where somatic in- treating women with PCOS. Disposable, single-use, sterilized
nervation corresponds to the ovaries, may restore normal en- needles made of stainless steel (made in China, produced by
docrine, neuroendocrine, metabolic, and autonomic function. Suzhou Tianyi Acupuncture Apparatus; length, 40 mm; di-
This study aimed to assess the effectiveness of abdominal ameter, 0.25 mm) were inserted to a depth of 15–30 mm in
acupuncture as a treatment for obesity-type PCOS. The effect segmental acupuncture points located in abdominal muscles
of abdominal acupuncture therapy on obese women with with innervations corresponding to the ovaries; conception
PCOS, as well as a parallel comparison with metformin, was vessel CV4, CV6, CV10, and CV12; and stomach meridian
also studied. ST21, ST25, and ST28 bilaterally. All needles were retained
manually (de qi) once inserted and remained in place for 30
Materials and Methods minutes at each treatment.
Study design and ethics
Metformin. Patients in the metformin group received
This single-center randomized clinical trial examined the metformin hydrochloride tablets (Bristol-Myers Squibb,
effect of abdominal acupuncture on obese women with Shanghai, China; medicine accurate character, H20023370)
742 ZHENG ET AL.

for 6 months. Metformin is taken with food. In the first week Statistical analysis
of the study, patients received 250 mg three times daily;
Statistical analysis was performed by using SPSS software,
thereafter, the metformin dose was 500 mg three times daily.
version 13.0 (SPSS, Inc., Chicago, Illinois). A paired two-
tailed t test was used to analyze the change within each
Outcome measurements group before and after the treatments. The paired two-tailed
All measurements were performed in the morning after an t test was performed after the Kolmogorov–Smirnov test for
overnight fast. Because most women with PCOS had oligo- normalization of the distribution; a Student t test was used
menorrhea or amenorrhea, the examination day was chosen where appropriate. The results are expressed as the
independently of cycle day. Outcome measurements were mean – standard error, and p < 0.05 was considered to rep-
repeated after 6 months of intervention (within 1 week after resent a statistically significant difference.
the last treatment).
Results
Anthropometry. Height, weight, waist and hip circum- Demographics and measurements at baseline
ferences, sagittal diameter (the abdominal height as mea-
sured in the supine position), BMI, and waist-to-hip ratio Among the 146 women screened at the outpatient clinic,
(WHR) were measured or calculated by standard protocols. 86 were enrolled and randomly assigned to the abdominal
acupuncture group or the metformin group. No one with-
Insulin sensitivity. The homeostasis model assessment of drew from the study, and all 86 patients completed the study
insulin resistance (HOMA-IR) was used to quantify insulin (Fig. 1). As shown in Table 1, the demographic and clinical
resistance and b-cell function, according to the following profiles did not significantly differ between the two groups
formula: glucose (mmol/l) · insulin (lU/ml)/22.5.18 Fasting before the study.
blood samples for metabolism analyses were drawn between
7:30 am and 8:30 am and were immediately aliquoted on ice Outcomes at 6 months
and stored at - 80C until assay. Blood samples were taken Table 2 showed the post-treatment demographic and
independently of the follicular phase of the menstrual cycle clinical profiles of the two groups. BMI, WHR, Ferriman–
because most participants had oligomenorrhea or amenor- Gallwey score, ovarian volume, LH, ratio of LH to FSH,
rhea. A standard oral glucose tolerance test (75 g) was used testosterone, LDL-C, triglycerides, total cholesterol, fasting
to test for insulin resistance. Blood samples were drawn from blood glucose, 2-hour blood glucose, fasting insulin, 2-hour
the antecubital vein at 0 and 120 minutes for measurement of postprandial insulin, and HOMA-IR were reduced signifi-
plasma glucose and insulin concentrations. Fasting blood cantly in both the metformin and the abdominal acupuncture
glucose and 2-hour postprandial blood glucose were deter- groups ( p < 0.05). Menstrual frequency and HDL-C levels
mined by using the glucose oxidase method. Fasting insulin increased significantly ( p < 0.05) in both groups; FSH also
and 2-hour postprandial insulin levels were assessed with increased in the two groups, but the changes were not sig-
chemiluminescence at the Department of Clinical Chemistry, nificant ( p > 0.05). The abdominal acupuncture group ex-
First Affiliated Hospital of Guangzhou Medical College. hibited considerable advantages over the metformin group
in terms of reduced BMI and WHR and increased menstrual
Ovarian morphology. Transvaginal ultrasonography was frequency ( p < 0.05).
performed to measure ovarian volume. The women with
amenorrhea received an injection of intramuscular progestin, Adverse effects
20 mg/d for 3 days. The progestin injection induced with-
drawal bleeding. Transvaginal ultrasonography was per- Gastrointestinal symptoms (diarrhea, abdominal discom-
formed on the third day of the patient’s menstrual cycle or fort, and anorexia) are the most common adverse effects of
progestin-induced bleeding. The ovarian volume was taken metformin. The effects are usually dose dependent and can
as the mean of the volumes of the two ovaries.

Recruited
Menstrual frequency. Menstrual frequency was calcu- Excluded (n=60)
n=146
lated by the assessment of menstrual history, which involved Didn’t meet inclusion criteria (n=35)
recording menses in the 3 months before the study as a Didn’t want to take part in (n=16)
baseline. Baseline was calculated by dividing the number of Other reasons (n=9)
menstrual bleeds by 3. Monthly menstrual frequency from Randomized
baseline to 6 months was calculated by dividing by 6. n=86

Biochemical assessments. Plasma concentrations of to-


metformin Abdominal
tal cholesterol, high-density lipoprotein cholesterol (HDL-C),
n=43 acupuncture n=43
low-density lipoprotein cholesterol (LDL-C), and triglycer-
ides were determined by using the enzymatic colorimetric
method. Luteotrophic hormone (LH), follicle-stimulating
hormone (FSH), and free testosterone were analyzed by ra- After 6 After 6
dioimmunoassay at an accredited laboratory at the Depart- months n=43 months n=43
ment of Clinical Chemistry in the First Affiliated Hospital of
Guangzhou Medical College. FIG 1. Flowchart of the study.
EFFICACY OF ABDOMINAL ACUPUNCTURE FOR OBESE PCOS PATIENTS 743

Table 1. Baseline Characteristics be minimized by gradually increasing the metformin dose. In


this study, the starting dose of metformin was 250 mg three
Abdominal Metformin times daily in the first week. It was increased over a period of
acupuncture group p-
1 week, reaching a dose of 1500 mg/d. Twenty-one patients
Variable group (n = 43) (n = 43) Valuea
in the metformin group had mild adverse effects that oc-
Age (y) 26.5 – 3.0 24.9 – 4.9 > 0.05 curred in the first stages of metformin use (nausea or vo-
BMI (kg/m2) 29.4 – 3.7 29.1 – 3.9 > 0.05 miting in 7, mild diarrhea in 10, and slight dizziness or
Duration of disease (y) 3.5 – 2.8 3.6 – 2.2 > 0.05 weakness in 4). No one in the metformin group withdrew
WHR 0.81 – 0.07 0.81 – 0.08 > 0.05 from the study.
FGS 6.6 – 2.0 6.6 – 1.8 > 0.05 No uncomfortable symptoms occurred in the abdominal
Menstrual frequency 0.3 – 0.17 0.3 – 0.15 > 0.05 acupuncture group. Neither metformin nor abdominal acu-
(cycles/mo) puncture injured the liver or kidney: Serum creatinine and
Ovarian volume (cm3) 11.0 – 2.7 11.0 – 3.9 > 0.05
urea nitrogen levels were still normal after the interventions.
FSH (mIU/mL) 5.9 – 2.0 5.7 – 1.8 > 0.05
LH (mIU/mL) 13.5 – 4.8 13.8 – 5.2 > 0.05
LH/FSH ratio 3.0 – 0.8 2.8 – 0.9 > 0.05 Discussion
Testosterone (nmol/L) 3.0 – 0.8 2.9 – 1.0 > 0.05
Fasting blood glucose 5.5 – 2.2 5.6 – 1.8 > 0.05 PCOS is associated with high sympathetic nerve activity,
(mmol/L) and increased sympathetic nerve activity may be associated
2-hour blood glucose 6.2 – 1.6 5.9 – 1.3 > 0.05 with hyperandrogenism.19 Obesity may worsen all clinical
(mmol/L) features of PCOS; it is considered the most important de-
Fasting insulin (mU/L) 12.5 – 5.9 13.5 – 8.0 > 0.05 terminant of excessive sympathetic activation. Adiposity still
Insulin (mU/L) 12.5 – 5.9 13.5 – 8.0 > 0.05 remains the leading concern in the pathogenesis of PCOS.20
HOMA-IR 3.9 – 1.4 3.8 – 1.2 > 0.05 Recently, serum insulin, triglycerides, waist circumference,
Total cholesterol 5.1 – 1.1 5.1 – 1.0 > 0.05 and WHR were shown to be correlated positively with BMI
(mmol/L)
in women with PCOS. As an acceptable proxy for thinness
Triglyceride (mmol/L) 2.8 – 0.6 2.7 – 0.4 > 0.05
LDL-C (mmol/L) 3.4 – 1.2 3.2 – 1.0 > 0.05 and overweight or obesity, when BMI was > 23 kg/m2, the
HDL-C (mmol/L) 1.2 – 0.2 1.1 – 0.2 > 0.05 prevalence of metabolic syndrome was particularly in-
creased.21 As shown in Table 1, at baseline, the patients ex-
Values are expressed as the mean – SEM error. hibited metabolic dysfunction, such as high levels of
a
P-values are not significant. triglycerides and HOMA-IR. Approximately 50% of women
FGS, Ferriman–Gallwey score; FSH, follicle-stimulating hormone;
HDL-C, high-density lipoprotein cholesterol; HOMA-IR, homeostasis with PCOS are overweight or obese, and most have the ab-
model assessment for insulin resistance; LDL-C, low-density lipopro- dominal phenotype.22 WHR is used as a measurement of
tein cholesterol; LH, luteotrophic hormone; WHR, waist-to-hip ratio. obesity and indicator of central obesity, which, in turn, is a

Table 2. Characteristics after 6 Months of Treatment

Abdominal acupuncture group (n = 43) Metformin group (n = 43) p-Value for


difference
Variable Value Change (%) Value Change (%) between groups

BMI (kg/m2) 22.3 – 3.7* ** - 24 24.2 – 4.2* - 17 0.046


WHR 0.69 – 0.08* ** - 14 0.73 – 0.06* -9 0.044
FGS 4.8 – 1.6* - 27 5.6 – 2.2* - 16 > 0.05
Menstrual frequency (cycles/mo) 0.6 – 0.23* ** 100 0.46 – 0.21* 55 0.037
Ovarian volume (cm3) 8.9 – 2.8* - 19 9.8 – 3.6* - 18 > 0.05
FSH (mIU/mL) 5.6 – 1.4 -7 5.3 – 2.1 -5 > 0.05
LH (mIU/mL) 8.4 – 4.0* - 38 9.3 – 2.9* - 33 > 0.05
LH/FSH ratio 1.6 – 0.8* - 46 1.7 – 0.6* - 39 > 0.05
Testosterone (nmol/L) 1.9 – 0.8* - 37 2.4 – 0.6* - 17 > 0.05
Fasting blood glucose (mmol/L) 4.6 – 1.4* - 16 4.6 – 1.6* - 17 > 0.05
2-hour blood glucose (mmol/L) 4.0 – 1.0* - 35 4.2 – 1.2* - 29 > 0.05
Fasting insulin (mU/L) 8.7 – 3.7* - 30 8.6 – 4.4* - 36 > 0.05
Insulin (mU/L) 63.9 – 7.8* - 34 66.8 – 8.5* - 33 > 0.05
HOMA-IR 2.5 – 1.7* - 36 2.6 – 1.8* - 21 > 0.05
Total cholesterol (mmol/L) 3.9 – 1.1* - 24 4.0 – 1.1* - 21 > 0.05
Triglyceride (mmol/L) 1.9 – 0.9* - 32 2.0 – 0.8* - 26 > 0.05
LDL-C (mmol/L) 2.5 – 1.7* - 33 2.6 – 0.8* - 19 > 0.05
HDL-C (mmol/L) 1.6 – 0.4* 33 1.5 – 0.5* 36 > 0.05

*p < 0.05 (versus pretreatment value in each group).


**p < 0.05 (for comparison of the changes between the abdominal acupuncture and metformin groups at baseline and at 6 months of
treatment).
744 ZHENG ET AL.

possible indicator of other, more serious health conditions. may be more effective than metformin in restoring normal
WHRs > 0.9 in men and > 0.8 in women were associated with ovarian function and reducing the central fat that tends to
a significant increase in many risk factors.23 At baseline in the accumulate in women with PCOS.43
current study, the mean WHR in the two groups was > 0.8. The primary limitations of this study were the lack of
Metformin has been widely accepted as the therapeutic sham methods (such as placebo needles or superficial nee-
option for women with PCOS; it is prescribed to correct the dling) and follow-up data. In addition, the study was not a
characteristic metabolic and endocrine abnormalities (in- randomized, double-blind, controlled study because it is
cluding reducing luteinizing hormone and sex hormone– difficult to blind both the participant and the practitioner to
binding globulin levels) and to ameliorate hyperinsulinemia acupuncture treatment. However, the authors are preparing
and hyperandrogenemia.5,24 Currently, metformin is one of to conduct a well-designed randomized, double-blind, con-
the main pharmacotherapeutic options in the treatment of trolled study.
PCOS. As was seen in the current study, metformin exhibits
an apparent beneficial effect on weight reduction and im- Conclusion
provement in ovarian function, as assessed by menstrual
frequency and testosterone production.8,25 This study showed abdominal acupuncture to be effective
Acupuncture is a nonpharmacologic treatment widely in restoring the normal endocrine and metabolic function of
used in complementary and alternative medicine to reduce patients with obesity-type PCOS. Compared with metfor-
weight. It is also commonly used in reproductive endocri- min, abdominal acupuncture improved menstrual fre-
nology and fertility clinics.26,27 A meta-analysis of random- quency, BMI, and WHR.
ized controlled trials that evaluated the effect of various
types of acupuncture therapies suggested that acupuncture Acknowledgments
is an effective alternative for treating obesity.28 In addition, This work was supported by Natural Science Foundation
acupuncture significantly reduced BMI and abdominal adi- of China (30701119) and Natural Science Foundation of
pose tissue by reducing abdominal visceral adipose tissue.29 Guangdong Province (9151008901000050).
Weight loss may improve insulin sensitivity and ovarian
functions30,31 and enhance ovulation rates.32,33
Disclosure Statement
The physiologic effects of acupuncture are reported to
result from neuromodulation that occurs after direct nerve No competing financial interests exist.
stimulation.34 Needling the acupoints may activate the pe-
ripheral afferent nerve fibers and receptors, resulting in re- References
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