Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

Not Applicable

• Conditions: Polycystic Ovarian Syndrome; Obesity, Abdominal
• Interventions: Device: electroacupuncture; Behavioral: lifestyle modification

• Registration Number: NCT02785965
• Lead Sponsor: Dongfang Hospital Beijing University of Chinese Medicine

Brief Summary

The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.

Detailed Description

Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.

Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Study Start: 2016-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12
• Primary Completion: 2019-01
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Clinical diagnosis of Polycystic Ovarian Syndrome.
• Clinical diagnosis of abdominal obesity.
• Agree to participate in clinical trials.

Exclusion Criteria

• Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
• Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
• Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
• Pregnant or breast feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture & lifestyle modification	lifestyle modification	Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.
lifestyle modification	lifestyle modification	diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks
acupuncture & lifestyle modification	electroacupuncture	Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
rate of recovered ovulation	12 weeks	the proportion of patients who have ovulation after treatment

Secondary Outcome Measures

Name	Time	Method
evidence of clinically definite hyperandrogenism confirmed by mF-G score	12 weeks
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System	12 weeks
frequency of menstruation	12 weeks
quantity of menstruation	12 weeks	pictorial blood loss assessment chart
Serum total testosterone (T)	12 weeks
FSH	12 weeks	follicle stimulating hormone (FSH)
LH	12 weeks	luteinizing hormone (LH)
ovarian volume measured by ultrasound	12 weeks
follicle number pre ovary measured by ultrasound	12 weeks
ovarian stromal blood flow measured by ultrasound	12 weeks
body weight in kilograms	4, 8 and 12 weeks
waist circumference in centimeter	4, 8 and 12 weeks
BMI in kg/m^2	4, 8 and 12 weeks
waist-to-height ratio	4, 8 and 12 weeks	waist-to-height ratio=waist circumference in centimeter/height in centimeter
Fasting serum PAI-1 level	12 weeks
International physical activity scale (IPAQ) short version	4, 8 and 12 weeks

Trial Locations

Locations (2)

Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Dongfang Hospital Affiliated to Beijing University of Chinese; 🇨🇳 Beijing, Beijing, China