Polycystic Ovarian Syndrome
Conditions
Keywords
acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)
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.
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.
Interventions
OTHERTung'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).
DRUGCyproterone 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).
Sponsors
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
The study was a randomized, drug-controlled, and parallel group trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 30 |
| 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). | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Tung's Acupuncture | CPA/EE | Total |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 4.18 | 28.53 years STANDARD_DEVIATION 4.28 | 28.9 years STANDARD_DEVIATION 4.21 |
| course of disease | 58.83 month STANDARD_DEVIATION 54.04 | 36.10 month STANDARD_DEVIATION 25.56 | 47.47 month STANDARD_DEVIATION 43.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 30 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 5 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Change in LH/FSH Ratio From Baseline to the End of Treatment | -0.66 ratio |
| CPA/EE | Change in LH/FSH Ratio From Baseline to the End of Treatment | -0.96 ratio |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Change in LH/FSH Ratio From Baseline to the 24th Week | -0.39 ratio |
| CPA/EE | Change in LH/FSH Ratio From Baseline to the 24th Week | -0.44 ratio |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in Body Mass Index (BMI) From Baseline to the End of Treatment | -0.90 kg/m^2 |
| CPA/EE | Changes in Body Mass Index (BMI) From Baseline to the End of Treatment | -0.44 kg/m^2 |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in FSH From Baseline to the End of Treatment | -0.49 mIU/mL |
| CPA/EE | Changes in FSH From Baseline to the End of Treatment | -0.22 mIU/mL |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in LH From Baseline to the End of Treatment | -3.92 mIU/mL |
| CPA/EE | Changes in LH From Baseline to the End of Treatment | -5.66 mIU/mL |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in Ovarian Volume From Baseline to the End of Treatment | -1.70 cm^3 |
| CPA/EE | Changes in Ovarian Volume From Baseline to the End of Treatment | -1.03 cm^3 |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in Polycystic Ovary Number From Baseline to the End of Treatment | 0.00 polycystic ovaries |
| CPA/EE | Changes in Polycystic Ovary Number From Baseline to the End of Treatment | 0.00 polycystic ovaries |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in the Number of Bleeding Events From Baseline to the End of Treatment | 0.66 bleeding events |
| CPA/EE | Changes in the Number of Bleeding Events From Baseline to the End of Treatment | 1.21 bleeding events |
Secondary
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tung's Acupuncture | Changes in Total Testosterone (TT) From Baseline to the End of Treatment | -0.67 nmol/L |
| CPA/EE | Changes in Total Testosterone (TT) From Baseline to the End of Treatment | -0.33 nmol/L |