Acupuncture or metformin to improve insulin resistance in women with polycystic ovary syndrome: study protocol of a combined multinational cross sectional case-control study and a randomised controlled trial

BMJ Open. 2019 Jan 4;9(1):e024733. doi: 10.1136/bmjopen-2018-024733.

Abstract

Introduction: Polycystic ovary syndrome (PCOS) is linked to hyperinsulinemia and insulin resistance with dysfunctional glucose metabolism. Pilot studies suggests that acupuncture treatment with combined manual and low-frequency electrical stimulation (electroacupuncture (EA)) of the needles decrease circulating glycated haemoglobulin (HbA1c) and homeostatic model assessment-insulin resistance. Therefore, we here aim to investigate if acupuncture treatment or metformin together with lifestyle or lifestyle management alone improves insulin sensitivity and related symptoms in overweight/obese women with PCOS.

Methods and analysis: This is a two-centre multinational (Sweden and China), cross-sectional case-control study combined with an open-labelled randomised controlled trial (RCT). Participants are randomised to one of three groups: (1) EA 2-3 times/week during 4 months+lifestyle management; (2) metformin, 500 mg, three/day during 4 months+lifestyle management; or (3) lifestyle management alone. The primary outcome measure in the RCT is changes in HbA1C. A total of 123 obese overweight women with PCOS will be enrolled and randomised into one of the three groups with a target power of at least 80% and 5% significance level based on two-sided tests.

Ethics and dissemination: The study has been approved by the Regional Ethical Review Board of Stockholm and of Peking University Third Hospital, China. Primary outcome data of the RCT will be published in a relevant journal together with supporting secondary outcome measurements. Further, outcome measurements will be published in separate papers as well as case-control data.

Expected results: We anticipate that EA and metformin, both with lifestyle management, are equally effective and superior to lifestyle management alone for improvement of glycaemic control.

Trial registration numbers: NCT02647827 and EudraCT2015-004250-18.

Keywords: acupuncture; glucose homeostasis; insulin resistance; life style; polycystic ovary syndrome.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acupuncture Therapy / methods*
  • Blood Glucose / analysis
  • Case-Control Studies
  • China
  • Combined Modality Therapy
  • Cross-Sectional Studies
  • Female
  • Glucose Tolerance Test
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Insulin Resistance*
  • Life Style
  • Metformin / administration & dosage*
  • Metformin / adverse effects
  • Multicenter Studies as Topic
  • Pilot Projects
  • Polycystic Ovary Syndrome / blood
  • Polycystic Ovary Syndrome / therapy*
  • Randomized Controlled Trials as Topic
  • Sweden

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Metformin

Associated data

  • ClinicalTrials.gov/NCT02647827