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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Mr R Muharam
Public

Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia

Phone ‭+62 (0)812 85143491‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
Email rmuharam@yahoo.com

Study information

Study designDouble-blind randomized clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleCombination of electroacupuncture and pharmacological treatment in improving insulin resistance (HOMA-IR) in polycystic ovary syndrome patients: a double-blind randomized clinical trial
Study objectivesThe 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) studiedPolycystic ovarian syndrome
InterventionRandomization 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 typeOther
Primary outcome measureMedian HOMA-IR index measured using initial fasting insulin and initial fasting blood glucose at the 1st and 12th session
Secondary outcome measures1. 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 date26/03/2018
Completion date20/09/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit40 Years
SexFemale
Target number of participants44
Total final enrolment44
Key inclusion criteria1. 18-40-year-old females
2. BMI >23 kg/m²
3. Volunteer to join and give informed consent
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment29/03/2018
Date of final enrolment19/09/2018

Locations

Countries of recruitment

  • Indonesia

Study participating centre

University of Indonesia – Cipto Mangunkusumo Hospital
Faculty of Medicine
Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia

Sponsor information

University of Indonesia
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
Email rmuharam@yahoo.com
Website http://www.ui.ac.id/
ROR logo "ROR" https://ror.org/0116zj450

Funders

Funder type

Other

investigator initiated and funded

No information available

Results and Publications

Intention to publish date11/11/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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.