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

• Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02729545
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome	Other: Tung's acupuncture; Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study was a randomized, drug-controlled, and parallel group trialThe study was a randomized, drug-controlled, and parallel group trial
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in LH/FSH Ratio From Baseline to the End of Treatment [baseline and 12 weeks]

   the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline

Secondary Outcome Measures

1. Change in LH/FSH Ratio From Baseline to the 24th Week [baseline to the 24th week]

   the change in LH/FSH ratio, values at the 24th week minus the values at baseline

2. Changes in LH From Baseline to the End of Treatment [baseline and 12 weeks]

   changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline

3. Changes in FSH From Baseline to the End of Treatment [baseline and 12 weeks]

   changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline

4. Changes in Body Mass Index (BMI) From Baseline to the End of Treatment [baseline and 12 weeks]

   the changes in BMI, values after 12-week treatment minus the values at baseline

5. Changes in Total Testosterone (TT) From Baseline to the End of Treatment [baseline and 12 weeks]

   changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline

6. Changes in Ovarian Volume From Baseline to the End of Treatment [baseline and 12 weeks]

   changes in ovarian volume, values after 12-week treatment minus the values at baseline

7. Changes in Polycystic Ovary Number From Baseline to the End of Treatment [baseline and 12 weeks]

   the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline

8. Changes in the Number of Bleeding Events From Baseline to the End of Treatment [baseline and 12 weeks]

   Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Hospital of Integrated Traditional Chinese and Western Medicine	Beijing	Beijing	China	100039

Sponsors and Collaborators

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

• Study Director: Zhishun Liu, Doctor, Guang'anmen Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2018

More Information

Publications

None provided.

• Responsible Party: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• ClinicalTrials.gov Identifier: NCT02729545
• Other Study ID Numbers: JJ2015-42
• First Posted: Apr 6, 2016
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Beijing Hospital of Integrated Traditional Chinese and Western Medicine: acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Cyproterone Acetate; Ethinyl Estradiol; Cyproterone

Study Results

Participant Flow

Recruitment Details	Participants were recruited through advertisements on local newspapers and posters.Of the 116 individuals who were initially recruited for this trial, 56 were excluded,sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30).

Arm/Group Title	Tung's Acupuncture Group	CPA/EE Group
Arm/Group Description	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).	CPA/EE 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).
Period Title: Overall Study
STARTED	30	30
COMPLETED	27	25
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Tung's Acupuncture	CPA/EE	Total
Arm/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).	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).	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.2 (4.18)	28.53 (4.28)	28.9 (4.21)
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	30 100%	30 100%	60 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	30 100%	30 100%	60 100%
course of disease (month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [month]	58.83 (54.04)	36.10 (25.56)	47.47 (43.45)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [ratio]	-0.66	-0.96

2. Secondary Outcome

Title	Change in LH/FSH Ratio From Baseline to the 24th Week
Description	the change in LH/FSH ratio, values at the 24th week minus the values at baseline
Time Frame	baseline to the 24th week

Outcome Measure Data

Analysis Population Description

During the long-term observation, three participants in the acupuncture group withdrew because of living far away from hospital, pregnancy and taking other medicine. Five participants in the CPA/EE group withdrew because of taking other medicine,pregnancy, losting contact and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	27	25
Mean (95% Confidence Interval) [ratio]	-0.39	-0.44

3. Secondary Outcome

Title	Changes in LH From Baseline to the End of Treatment
Description	changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [mIU/mL]	-3.92	-5.66

4. Secondary Outcome

Title	Changes in FSH From Baseline to the End of Treatment
Description	changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [mIU/mL]	-0.49	-0.22

5. Secondary Outcome

Title	Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
Description	the changes in BMI, values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [kg/m^2]	-0.90	-0.44

6. Secondary Outcome

Title	Changes in Total Testosterone (TT) From Baseline to the End of Treatment
Description	changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [nmol/L]	-0.67	-0.33

7. Secondary Outcome

Title	Changes in Ovarian Volume From Baseline to the End of Treatment
Description	changes in ovarian volume, values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [cm^3]	-1.70	-1.03

8. Secondary Outcome

Title	Changes in Polycystic Ovary Number From Baseline to the End of Treatment
Description	the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (Inter-Quartile Range) [polycystic ovaries]	0.00	0.00

9. Secondary Outcome

Title	Changes in the Number of Bleeding Events From Baseline to the End of Treatment
Description	Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

Arm/Group Title	Tung's Acupuncture	CPA/EE
Arm/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).	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).
Measure Participants	29	28
Mean (95% Confidence Interval) [bleeding events]	0.66	1.21

Adverse Events

Time Frame	24 weeks
Adverse Event Reporting Description	No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.
Arm/Group Title	Tung's Acupuncture Group		CPA/EE Group
Arm/Group Description	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).		CPA/EE 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).
All Cause Mortality
	Tung's Acupuncture Group		CPA/EE Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Tung's Acupuncture Group		CPA/EE Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Tung's Acupuncture Group		CPA/EE Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/30 (16.7%)		4/30 (13.3%)
Gastrointestinal disorders
nausea	0/30 (0%)	0	2/30 (6.7%)	2
Injury, poisoning and procedural complications
post-treatment soreness	2/30 (6.7%)	2	0/30 (0%)	0
Nervous system disorders
Headache	0/30 (0%)	0	3/30 (10%)	3
Skin and subcutaneous tissue disorders
Transient bruises at the sites of needle insertion	5/30 (16.7%)	9	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.