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

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovarian Syndrome; Obesity, Abdominal
• Intervention / Treatment: Device: electroacupuncture; Behavioral: lifestyle modification

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
    • Beijing, Beijing, China, 100078
      • Dongfang Hospital Affiliated to Beijing University of Chinese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture & 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.	Device: electroacupuncture; Disposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min.; Behavioral: lifestyle modification; The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.
Active Comparator: lifestyle modification; diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks	Behavioral: lifestyle modification; The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of recovered ovulation	the proportion of patients who have ovulation after treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pictorial blood loss assessment chart	12 weeks
Serum total testosterone (T)		12 weeks
FSH	follicle stimulating hormone (FSH)	12 weeks
LH	luteinizing hormone (LH)	12 weeks
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	waist-to-height ratio=waist circumference in centimeter/height in centimeter	4, 8 and 12 weeks
Fasting serum PAI-1 level		12 weeks
International physical activity scale (IPAQ) short version		4, 8 and 12 weeks

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: Beijing Municipal Science & Technology Commission; Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Hui HU, Doctor, Dongfang Hospital Beijing University of Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: exercise; diet; electroacupuncture; lifestyle modification; Dai Meridian
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Polycystic Ovary Syndrome; Syndrome; Obesity; Obesity, Abdominal
• Other Study ID Numbers: Z161100000516057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided