DOI: 10.5061/dryad.cnp5hqc3g
title: Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial

description: STUDY QUESTION Does acupuncture improve insulin sensitivity more
 effectively than metformin or sham acupuncture in women with polycystic
 ovary syndrome (PCOS) and insulin resistance (IR)? SUMMARY ANSWER Among
 women with PCOS and IR, acupuncture was not more effective than metformin
 or sham acupuncture in improving insulin sensitivity. WHAT IS KNOWN
 ALREADY Uncontrolled trials have shown that acupuncture improved insulin
 sensitivity with fewer side effects compared with metformin in women with
 PCOS and IR. However, data from randomized trials between acupuncture and
 metformin or sham acupuncture are lacking. STUDY DESIGN, SIZE, DURATION
 This was a three-armed randomized controlled trial enrolling a total of
 342 women with PCOS and IR from three hospitals between November 2015 and
 February 2018, with a 3-month follow-up until October 2018.
 PARTICIPANTS/MATERIALS, SETTING, METHODS Women aged from 18 to 40 years
 with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR)
 ≥2.14 were randomly assigned (n = 114 per group) to receive true
 acupuncture plus placebo (true acupuncture), metformin plus sham
 acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus
 placebo (sham acupuncture) for 4 months, with an additional 3-month
 follow-up. True or sham acupuncture was given three times per week, and
 0.5 g metformin or placebo was given three times daily. The primary
 outcome was change in HOMA-IR from baseline to 4 months after baseline
 visit. Secondary outcomes included changes in the glucose AUC during an
 oral glucose tolerance test, BMI and side effects at 4 months after
 baseline visit. MAIN RESULTS AND THE ROLE OF CHANCE After 4 months of
 treatment, the changes of HOMA-IR were –0.5 (decreased 14.7%) in the true
 acupuncture group, –1.0 (decreased 25.0%) in the metformin group and –0.3
 (decreased 8.6%) in the sham acupuncture group, when compared with
 baseline. True acupuncture is not as effective as metformin in improving
 HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI,
 0.1–1.1). No significant difference was found in change in HOMA-IR between
 true and sham acupuncture groups at 4 months after baseline visit
 (difference, –0.2; 95% CI, –0.7 to 0.3). During the 4 months of treatment,
 gastrointestinal side effects were more frequent in the metformin group,
 including diarrhea, nausea, loss of appetite, fatigue, vomiting and
 stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%,
 respectively). Bruising was more common in the true acupuncture group
 (14.9%). LIMITATIONS, REASONS FOR CAUTION This study might have
 underestimated the sample size in the true acupuncture group with 4 months
 of treatment to enable detection of statistically significant changes in
 HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol).
 Participants who withdrew because of pregnancy did not have further blood
 tests and this can introduce bias. WIDER IMPLICATIONS OF THE FINDINGS True
 acupuncture did not improve insulin sensitivity as effectively as
 metformin in women with PCOS and IR, but it is better than metformin in
 improving glucose metabolism (which might reduce the risk of type 2
 diabetes) and has less side effects. Metformin had a higher incidence of
 gastrointestinal adverse effects than acupuncture groups, and thus
 acupuncture might be a non-pharmacological treatment with low risk for
 women with PCOS. Further studies are needed to evaluate the effect of
 acupuncture combined with metformin on insulin sensitivity in these women.
 STUDY FUNDING/COMPETING INTEREST(S) This work was supported by grants
 2017A020213004 and 2014A020221060 from the Science and Technology Planning
 Project of Guangdong Province. The authors have no conflicts of interest.
 TRIAL REGISTRATION NUMBER Clinicaltrials.gov number: NCT02491333. TRIAL
 REGISTRATION DATE 8 July 2015. DATE OF FIRST PATIENT’S ENROLLMENT 11
 November 2015.