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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
  1. Elisabet Stener-Victorin1,
  2. Haolin Zhang2,
  3. Rong Li3,4,
  4. Cecilia Friden5,
  5. Dong Li2,
  6. Wei Wang4,
  7. Haining Wang6,
  8. Cuiqing Chang7,
  9. Shi Li3,
  10. ZeJun Huo2,
  11. Hua Zhang8,
  12. Xiaolan Ji2,
  13. Angelica Linden-Hirschberg9,
  14. Jie Qiao3,4
  1. 1 Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
  2. 2 Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China
  3. 3 Department of Obstetrics and Gynecology, Center for Reproductive Medicine, Peking University Third Hospital, Beijing, China
  4. 4 Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China
  5. 5 Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
  6. 6 Department of Endocrinology and Metabolism, Peking University Third Hospital, Beijing, China
  7. 7 Institute of Sports Medicine, Peking University Third Hospital, Beijing, China
  8. 8 Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, Beijing, China
  9. 9 Department of Obstetrics and Gynecology, Karolinska Institutet, Stockholm, Sweden
  1. Correspondence to Professor Elisabet Stener-Victorin; elisabet.stener-victorin{at}ki.se

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.

  • glucose homeostasis
  • insulin resistance
  • acupuncture
  • life style
  • polycystic ovary syndrome

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Footnotes

  • Patient consent for publication Obtained.

  • ES-V and JQ contributed equally.

  • Contributors ES-V conceived and designed the study, drafted the manuscript for important intellectual content and sought funding and ethical approval in Sweden and registered the trial in EudraCT and Clinicaltrials.gov. JQ sought funding and ethical approval in China. HZ, RL, CF, AL-H and JQ was involved in the planning and design of the study and critically revised the manuscript and protocols. HZ, DL, WW, HW, CC, SL, ZJH and XJ are involved in the screening, randomisation and treatment of participants. All authors read and approved the final manuscript.

  • Funding The work is supported by the Swedish Medical Research Council (Project No. 2018-0243599; Adlerbert Research Foundation; Novo Nordisk Foundation (NNF18OC0033992); Strategic Research Programme (SRP) in Diabetes at Karolinska Institutet; Swedish federal government under the Regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet (all ESV). In China, this study is supported by the National Key Research and Development Program (2016YFC100021), National Key Technology R&D Program (2015BAI13B06, 2014BAI05B04), National Natural Science Foundation of China (81603446), Beijing Municipal Natural Science Foundation (7174363).

  • Disclaimer The funders have had no role in study design and will not have any role in data collection and analysis, decision to publish or preparation of the manuscripts.

  • Competing interests None declared.

  • Ethics approval Regional Ethical Review Board of Stockholm and Regional Ethical Review Board of Peking University Third Hospital, China.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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