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

The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome
• Intervention / Treatment: Other: Tung's acupuncture; Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tung's acupuncture; 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).	Other: Tung's acupuncture; 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).
Active Comparator: CPA/EE; 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).	Drug: Cyproterone acetate/ethinylestradiol (CPA/EE); Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). 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).; Other Names: Diane-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LH/FSH Ratio From Baseline to the End of Treatment	the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LH/FSH Ratio From Baseline to the 24th Week	the change in LH/FSH ratio, values at the 24th week minus the values at baseline	baseline to the 24th week
Changes in LH From Baseline to the End of Treatment	changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in FSH From Baseline to the End of Treatment	changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment	the changes in BMI, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in Total Testosterone (TT) From Baseline to the End of Treatment	changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in Ovarian Volume From Baseline to the End of Treatment	changes in ovarian volume, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in Polycystic Ovary Number From Baseline to the End of Treatment	the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Changes in the Number of Bleeding Events From Baseline to the End of Treatment	Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• Investigators: Study Director: Zhishun Liu, Doctor, Guang'anmen hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Androgen Antagonists; Contraceptive Agents, Male; Ethinyl Estradiol; Cyproterone Acetate; Cyproterone
• Other Study ID Numbers: JJ2015-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: to share data by publishing paper
• IPD Sharing Time Frame: after the paper published around the year of 2020
• IPD Sharing Access Criteria: researchers who are interested in this area
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)