Effect of combined electroacupuncture and medical therapy on insulin resistance in polycystic ovary syndrome patients
| ISRCTN | ISRCTN14490464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14490464 |
| Secondary identifying numbers | 0248/UN2.F1/ETIK/2018 |
- Submission date
- 04/11/2020
- Registration date
- 18/11/2020
- Last edited
- 17/11/2020
- 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 affects 7-10% of women worldwide. It is considered a serious problem as it lasts a lifetime and is not just tied to pregnancy. Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. This study aims to measure the effect of electroacupuncture and drug treatment on insulin resistance in PCOS patients.
Who can participate?
Women aged 18-40 with PCOS and body mass index (BMI) over 23 kg/m²
What does the study involve?
Participants are randomly allocated to be treated with electroacupuncture or sham electroacupuncture three times per week, with intervals of 1-2 days, for 12 times. The drug treatment used is metformin 2 x 500 mg per day. Blood samples are taken to measure insulin and blood glucose at the 1st and 12th session.
What are the possible benefits and risks of participating?
Participants could benefit from an improvement in insulin resistance. The risks include hematoma (collection of blood) at the point the acupuncture needle is inserted.
Where is the study run from?
University of Indonesia – Cipto Mangunkusumo Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
March 2018 to September 2018
Who is funding the study?
investigator initiated and funded
Who is the main contact?
R Muharam
rmuharam@yahoo.com
Contact information
Public
Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia
| Phone | +62 (0)812 85143491 |
|---|---|
| rmuharam@yahoo.com |
Study information
| Study design | Double-blind randomized clinical 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 the contact details to request a participant information sheet |
| Scientific title | Combination of electroacupuncture and pharmacological treatment in improving insulin resistance (HOMA-IR) in polycystic ovary syndrome patients: a double-blind randomized clinical trial |
| Study objectives | The combination of electroacupuncture and pharmacological therapy has better efficacy to improve insulin sensitivity. |
| Ethics approval(s) | Approved 26/03/2018, Ethics Committee of the Faculty of Medicine, University of Indonesia (Jl. Salemba Raya no.6 Jakarta 10430, PO Box 1358; +62 (0)21 3912477; humas@fk.ui.ac.id, office@fk.ui.ac.id), ref: 18-03-0254 |
| Health condition(s) or problem(s) studied | Polycystic ovarian syndrome |
| Intervention | Randomization was done using a computer-based random block table randomizer. The doctors, paramedics, and laboratory personnel do not know whether the subject receives electroacupuncture or sham electroacupuncture. The participants also do not know whether they receive electroacupuncture or sham electroacupuncture. Participants receive electroacupuncture three times per week, with intervals of 1-2 days, for 12 times. The pharmacological therapy used is metformin 2 x 500 mg per day. |
| Intervention type | Other |
| Primary outcome measure | Median HOMA-IR index measured using initial fasting insulin and initial fasting blood glucose at the 1st and 12th session |
| Secondary outcome measures | 1. Mean fasting blood glucose measured using a blood sample before and after intervention at the 1st and 12th session 2. Median fasting insulin measured using a blood sample before and after intervention at the 1st and 12th session |
| Overall study start date | 26/03/2018 |
| Completion date | 20/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. 18-40-year-old females 2. BMI >23 kg/m² 3. Volunteer to join and give informed consent |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 29/03/2018 |
| Date of final enrolment | 19/09/2018 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia
Sponsor information
University/education
Division of Reproductive Immunoendocrinology
Department of Obstetrics & Gynecology
Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia
| Phone | +62 (0)812 85143491 |
|---|---|
| rmuharam@yahoo.com | |
| Website | http://www.ui.ac.id/ |
"ROR" |
https://ror.org/0116zj450 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 11/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from R Muharam (rmuharam@yahoo.com). |
Editorial Notes
16/11/2020: Trial's existence confirmed by the Ethics Committee of the Faculty of Medicine, University of Indonesia.
