Electroacupuncture added to metformin treatment in patients with polycystic ovary syndrome and overweight
| ISRCTN | ISRCTN45111863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45111863 |
| Secondary identifying numbers | 18-03-0254 |
- Submission date
- 13/08/2020
- Registration date
- 18/08/2020
- Last edited
- 07/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims:
Polycystic Ovary Syndrome (PCOS) is a common condition that affects how a woman's ovaries work, it is present in 10% of women population in reproductive age and is a common hormone disorder.
Acupuncture is a treatment derived from ancient Chinese medicine. Fine needles are inserted at certain sites in the body for therapeutic or preventative purposes.
Acupuncture has been shown to improve ovary function in PCOS patients.
This study aims to investigate the effectiveness of electroacupuncture and drug therapy on PCOS symptoms.
Who can participate?
Adult PCOS patients who are also overweight.
What does the study involve?
The intervention group receives adjuvant electroacupuncture in addition to pharmacological therapy. Participants have to make a visit for acupuncture therapy 3 times per week, with a break of 1 - 2 days between each visit, for a total of 12 visits. Participants also receive metformin drug treatment.
The control group receives the same procedure, with the difference of instead electroacupuncture, the participants have only needles with patches on the skin.
Patients will be interviewed about their condition at the start and end of the study. They will also have an ultrasound examination.
What are the possible benefits and risks?
Participants who are enrolled in the study benefit from receiving relatively safe adjuvant therapy which is believed to be more effective for no additional cost.
The risks and side effects that may arise during the study are local skin infection, mild pain or light bleeding during needle insertion, or electrical shock due to machine malfunction (a very rare occurrence).
Where is the study run from?
Cipto Mangunkusumo Hospital (Indonesia)
When is the study starting and how long is it run for?
March 2018 to August 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
R Muharam, MD, PhD, rmuharam@yahoo.com
Wenny Kurniawan, MD, wenikurniawan@yahoo.com
Contact information
Scientific
Jl. Pangeran Diponegoro No.71, RW.5
Kenari
Kec. Senen
Kota Jakarta Pusat
Daerah Khusus Ibukota
Jakarta
10430
Indonesia
 ORCID ID |
0000-0001-5712-3931 |
|---|---|
| Phone | +62 81285143491 |
| rmuharam@yahoo.com |
Public
Jl. Pangeran Diponegoro No.71, RW.5
Kenari
Kec. Senen
Kota Jakarta Pusat
Daerah Khusus Ibukota
Jakarta
10430
Indonesia
| ORCID ID |
0000-0001-5762-2212 |
|---|---|
| Phone | +62 8559968686 |
| wenikurniawan@yahoo.com |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Combination of electroacupuncture and pharmacological treatment in improving menstrual cycle and ovarian morphology in PCOS patients: double-blind randomized clinical trial |
| Study objectives | 1. Electroacupuncture and pharmacological combination therapy is more effective in shortening the menstrual cycle in PCOS patients, compared to conventional pharmacological therapy 2. Electroacupuncture and pharmacological combination therapy is more effective in decreasing ovarian volume in PCOS patients, compared to conventional pharmacological therapy 3. Electroacupuncture and pharmacological combination therapy is more effective in decreasing the number of antral follicles in PCOS patients, compared to conventional pharmacological therapy |
| Ethics approval(s) | Approved 26/03/2018, Health Research Ethics Committee - University of Indonesia and Cipto Mangunkusumo Hospital (HREC-FMUI/CMH, Jl. Salemba 6, Jakarta Pusat, DKI Jakarta, Indonesia; +62 21 315 7008; ec_fkui@yahoo.com), ref: 0243/UN2.F1/ETIK/2018 |
| Health condition(s) or problem(s) studied | Polycystic ovarian syndrome |
| Intervention | Treatment group (EA Group): The patient receives adjuvant electroacupuncture. Sites used are the Zhongji (CV3), Guanyuan (CV4), Qihai (CV6), Tianshu (ST25), Shuidao (ST28), Zusanli (ST36), Chengsan (BL57), and bilateral Sanyinjiao (SP6) with a continuous wave frequency of 2 Hz, the intensity is set based on the comfort of the patient. Subjects have to make a visit for acupuncture therapy 3 times per week, with a break of 1-2 days between each visit, for a total of 12 times. Pharmacological therapy used is metformin 2 x 500 mg per day. Control group (SA Group) received the same procedure, instead of electroacupuncture, they have only needles with patches on the skin (sham treatment). Pharmacological therapy used is metformin 2 x 500 mg per day. Randomization.com is used to allocate the subjects to treatment groups. The subjects and the evaluators are blinded to this allocation. Follow up: The total duration of follow up for all study arms is 1 month. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Menstrual cycle length is measured in days using interview at baseline (before 1st session) and the end of acupuncture sessions (after 12th session) 2. Ovarian volume is measured in ml using transvaginal ultrasonography at baseline (before 1st session) and the end of acupuncture sessions (after 12th session) 3. Number of antral follicles is measured using transvaginal ultrasonography at baseline (before 1st session) and the end of acupuncture sessions (after 12th session) |
| Secondary outcome measures | Menstruation occurrence is measured using interview at baseline (before 1st session) and the end of acupuncture sessions (after 12th session) |
| Overall study start date | 26/03/2018 |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. 18 - 40 years old 2. BMI > 23kg/m² 3. Volunteering to join this research and giving informed consent |
| Key exclusion criteria | 1. Suffering from malignancy 2. Suffering from hypertension (blood pressure >140/90 mmHg, JNC 7 criteria) 3. Suffering from diabetes mellitus (fasting blood sugar >126 mg/dL, PERKENI 2015 criteria) 4. Currently in lactation 5. Suffering from endocrine disorders associated with steroid sex hormones such as congenital adrenal hyperplasia, Cushing’s syndrome, and androgen-secreting tumor diagnosed by a gynecologist 6. Currently undergoing pharmacological therapy related to dominant follicles stimulation such as clomiphene citrate, letrozole, FSH within 3 months 7. Subjects undergoing acupuncture therapy in the 12 weeks prior to recruitment 8. Subjects with absolute contraindications to electroacupuncture therapy such as: the first trimester of pregnancy, patients in a state of shock or coma, body temperature >38 degrees C, septicemia, tuberculosis of the skin or other local skin infection, heart rhythm disorders and patients with pacemakers, hypertension 9. Subjects with relative contraindications to electroacupuncture therapy such as: a history of epilepsy, pain and acute edema, and in patients with metal implants |
| Date of first enrolment | 02/04/2018 |
| Date of final enrolment | 27/07/2018 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jakarta
10430
Indonesia
Sponsor information
University/education
Jl. Salemba 6
Jakarta
-
Indonesia
| Phone | +62 21 315 7008 |
|---|---|
| ec_fkui@yahoo.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned to be published in the International Journal of Reproductive Biomedicine (IJRM). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. |
Editorial Notes
07/07/2021: The following changes were made to the trial record:
1. The public title was changed from "Electroacupuncture added to metformin treatment in patients who have polycystic ovary syndrome and are overweight" to "Electroacupuncture added to metformin treatment in patients with polycystic ovary syndrome and overweight".
2. The scientific title was changed from "Combination of electroacupuncture and pharmacological treatment in improving menstrual cycle, ovarian volume, and antral follicle count in PCOS patients: double-blind randomized clinical trial" to "Combination of electroacupuncture and pharmacological treatment in improving menstrual cycle and ovarian morphology in PCOS patients: double-blind randomized clinical trial".
19/08/2020: Internal review.
14/08/2020: Trial’s existence confirmed by University of Indonesia.
