The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovarian Syndrome

Treatments: Drug: Cyproterone acetate/ethinylestradiol (CPA/EE); Other: Tung's acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02729545

JJ2015-42

Details and patient eligibility

About

This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group.

Full description

Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese;
2. 18-45 years old;
3. to meet the diagnostic criteria for polycystic ovary syndrome;
4. no need for pregnancy in the next six months;
5. volunteering to join this research and give informed consent prior to receiving treatment.

Exclusion criteria

1. hypertensive patients with blood pressure exceed 160/100 mmHg;
2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
3. having taken any pharmacological treatments affecting reproductive endocrine system;
4. having received acupuncture in the previous three months;
5. smoking more than 15 cigarettes per day;
6. having pacemakers, metal allergies or severe fear of acupuncture.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Tung's acupuncture

Experimental group

Description:

The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).

Treatment:

Other: Tung's acupuncture

CPA/EE

Active Comparator group

Description:

Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Treatment:

Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)