Clinical trial NCT02785965: Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
Official title: Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Obesity, Abdominal
Keywords: electroacupuncture
lifestyle modification
diet
exercise
Dai Meridian
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: Beijing Municipal Science & Technology Commission
First posted: 2016-05-30
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rate of recovered ovulation
timeFrame: 12 weeks
Secondary outcomes:
measure: evidence of clinically definite hyperandrogenism confirmed by mF-G score
timeFrame: 12 weeks
measure: evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
timeFrame: 12 weeks
measure: frequency of menstruation
timeFrame: 12 weeks
measure: quantity of menstruation
timeFrame: 12 weeks
measure: Serum total testosterone (T)
timeFrame: 12 weeks
measure: FSH
timeFrame: 12 weeks
measure: LH
timeFrame: 12 weeks
measure: ovarian volume measured by ultrasound
timeFrame: 12 weeks
measure: follicle number pre ovary measured by ultrasound
timeFrame: 12 weeks
measure: ovarian stromal blood flow measured by ultrasound
timeFrame: 12 weeks
measure: body weight in kilograms
timeFrame: 4, 8 and 12 weeks
measure: waist circumference in centimeter
timeFrame: 4, 8 and 12 weeks
measure: BMI in kg/m^2
timeFrame: 4, 8 and 12 weeks
measure: waist-to-height ratio
timeFrame: 4, 8 and 12 weeks
measure: Fasting serum PAI-1 level
timeFrame: 12 weeks
measure: International physical activity scale (IPAQ) short version
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital Affiliated to Beijing University of Chinese
state: Beijing
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Hui HU, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abazar E, Taghian F, Mardanian F, Forozandeh D. Effects of aerobic exercise on plasma lipoproteins in overweight and obese women with polycystic ovary syndrome. Adv Biomed Res. 2015 Mar 25;4:68. doi: 10.4103/2277-9175.153892. eCollection 2015.
citation: Case problem: dietary recommendations to combat obesity, insulin resistance, and other concerns related to polycystic ovary syndrome. J Am Diet Assoc. 2000 Aug;100(8):955-7; discussion 957-60. doi: 10.1016/S0002-8223(00)00275-3. No abstract available.