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.
Ontology highlight
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.
SUBMITTER: Stener-Victorin E
PROVIDER: S-EPMC6326273 | biostudies-literature | 2019 Jan
REPOSITORIES: biostudies-literature
ACCESS DATA