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

Obesity, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02785965
• Other study ID #: Z161100000516057
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2016
• Last updated: September 11, 2017
• Start date: July 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2017
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: September 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	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

Sponsors (3)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing Municipal Science & Technology Commission, Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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