Trial Outcomes & Findings for The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome (NCT NCT02729545)

NCT ID: NCT02729545

Last Updated: 2019-10-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2019-10-08

Participant Flow

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).

Participant milestones

Measure	Tung's Acupuncture Group 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 Group 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).
Overall Study STARTED	30	30
Overall Study COMPLETED	27	25
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Tung's Acupuncture Group 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 Group 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).
Overall Study Pregnancy	1	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tung's Acupuncture n=30 Participants 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).	CPA/EE n=30 Participants 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 n=60 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 4.18 • n=5 Participants	28.53 years STANDARD_DEVIATION 4.28 • n=7 Participants	28.9 years STANDARD_DEVIATION 4.21 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
course of disease	58.83 month STANDARD_DEVIATION 54.04 • n=5 Participants	36.10 month STANDARD_DEVIATION 25.56 • n=7 Participants	47.47 month STANDARD_DEVIATION 43.45 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Change in LH/FSH Ratio From Baseline to the End of Treatment	-0.66 ratio Interval -1.03 to -0.28	-0.96 ratio Interval -1.34 to -0.59

SECONDARY outcome

Timeframe: baseline to the 24th week

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=27 Participants 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).	CPA/EE n=25 Participants 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).
Change in LH/FSH Ratio From Baseline to the 24th Week	-0.39 ratio Interval -0.77 to -0.01	-0.44 ratio Interval -0.85 to -0.24

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in LH From Baseline to the End of Treatment	-3.92 mIU/mL Interval -5.74 to -2.09	-5.66 mIU/mL Interval -7.84 to -3.48

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in FSH From Baseline to the End of Treatment	-0.49 mIU/mL Interval -1.06 to 0.08	-0.22 mIU/mL Interval -0.98 to 0.55

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment	-0.90 kg/m^2 Interval -1.36 to -0.43	-0.44 kg/m^2 Interval -0.71 to -0.17

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in Total Testosterone (TT) From Baseline to the End of Treatment	-0.67 nmol/L Interval -0.99 to -0.36	-0.33 nmol/L Interval -0.98 to -0.05

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in Ovarian Volume From Baseline to the End of Treatment	-1.70 cm^3 Interval -3.68 to 0.28	-1.03 cm^3 Interval -2.84 to 0.77

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in Polycystic Ovary Number From Baseline to the End of Treatment	0.00 polycystic ovaries Interval -1.0 to 0.0	0.00 polycystic ovaries Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Tung's Acupuncture n=29 Participants 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).	CPA/EE n=28 Participants 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).
Changes in the Number of Bleeding Events From Baseline to the End of Treatment	0.66 bleeding events Interval 0.33 to 0.98	1.21 bleeding events Interval 0.75 to 1.68

Adverse Events

Tung's Acupuncture Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

CPA/EE Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tung's Acupuncture Group n=30 participants at risk 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 Group n=30 participants at risk 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).
Skin and subcutaneous tissue disorders Transient bruises at the sites of needle insertion	16.7% 5/30 • Number of events 9 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.	0.00% 0/30 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.
Injury, poisoning and procedural complications post-treatment soreness	6.7% 2/30 • Number of events 2 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.	0.00% 0/30 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.
Gastrointestinal disorders nausea	0.00% 0/30 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.	6.7% 2/30 • Number of events 2 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.
Nervous system disorders Headache	0.00% 0/30 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.	10.0% 3/30 • Number of events 3 • 24 weeks No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.

Additional Information

Dr. Yu Cao

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Phone: 086

Email: howgreenbreeze@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place