Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial

Abstract

BackgroundOur prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving the insulin sensitivity of PCOS. But there is still no randomized controlled trial to determine the effect of acupuncture on the insulin sensitivity in women with PCOS and IR. In this article, we present the protocol of a randomized controlled trial to compare the effect of true acupuncture on the insulin sensitivity of these patients compared with metformin and sham acupuncture. Acupuncture may be an effective therapeutic alternative that is superior to metformin and sham acupuncture in improving the insulin sensitivity of PCOS combined with IR.MethodsThis study is a multi-center, controlled, double-blind, and randomized clinical trial aiming to evaluate the effect of acupuncture on the insulin sensitivity in PCOS combined with IR. In total 342 patients diagnosed with PCOS and IR will be enrolled. Participants will be randomized to one of the three groups: (1) true acupuncture + metformin placebo; (2) sham acupuncture + metformin, and (3) sham acupuncture + metformin placebo. Participants and assessors will be blinded. The acupuncture intervention will be given 3 days per week for a total of 48 treatment sessions during 4 months. Metformin (0.5 g per pill) or placebo will be given, three times per day, and for 4 months.Primary outcome measures are changes in homeostasis model assessment of insulin resistance (HOMA-IR) and improvement rate of HOMA-IR by oral glucose tolerance test (OGTT) and insulin releasing test (Ins). Secondary outcome measures are homeostasis model assessment-β (HOMA-β), area under the curve for glucose and insulin, frequency of regular menstrual cycles and ovulation, body composition, metabolic profile, hormonal profile, questionnaires, side effect profile, and expectation and credibility of treatment.Outcome measures are collected at baseline, at the end of treatments, and 3 months after the last acupuncture treatment. On completion of the screening visit, randomization will be conducted using a central randomization system.DiscussionThis study will investigate the effects of acupuncture on the insulin sensitivity of PCOS and IR women compared with metformin and sham acupuncture. We will test whether true acupuncture with needles placed in skeletal muscles and stimulated manually and by electrical stimulation is more effective than metformin and sham acupuncture with superficial needle placement with no manual or electrical stimulation in improving the insulin sensitivity in PCOS women with IR.Trial registrationClinicalTrials.gov, NCT02491333; Chinese Clinical Trial Registry, ChiCTR-ICR-15006639. Registered on 24 June 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1854-2) contains supplementary material, which is available to authorized users.

Beneficial effects of Heqi san on rat model of polycystic ovary syndrome through the PI3K/AKT pathway

“…For example, 3-iodothyronamine was found to reprogram lipid metabolic pathways [ 10 ], and soy isoflavones had beneficial effects through the inhibition of aromatase activity [ 11 ]. Furthermore, physical therapy, such as acupuncture, has been shown to be effective in improving the insulin resistance of PCOS patients [ 12 ].…”

The Treatment with Complementary and Alternative Traditional Chinese Medicine for Menstrual Disorders with Polycystic Ovary Syndrome

“…e IR of PCOS is caused by hyperinsulinemia and deficiency of insulin signaling pathway; therefore, high concentration of the insulin reduces the circulating level of SHBG and increases the level of free T, resulting in menstrual disorder [73,74]. Consequently, it is essential to reduce insulin levels.…”

“…Nevertheless, the advantages of the abdominal acupuncture are more outstanding apparently, which reflected in less side effects, reducing BMI significantly by reducing visceral adipose tissue [ 72 ]. In Li et al's double-blind, placebo-controlled, multicenter randomized controlled study [ 73 ] subsequently, 342 patients with PCOS and IR were randomly divided into three groups: true acupuncture + metformin placebo, sham acupuncture + metformin, and sham acupuncture + metformin placebo, with 114 patients in each group. Results of the oral glucose tolerance test and insulin release test collected 3 months after treatment showed that acupuncture could improve the sensitivity of insulin in PCOS patients.…”

Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: protocol for a randomised controlled feasibility study

“…De qi will be obtained for each point using thrusting, twirling, and rotating, until the participant reports numbness, heaviness, pressure, soreness, or tingling, and needles are manipulated every 10 min to obtain de qi. Electroacupuncture will be applied to ST 28 and SP 6 acupuncture points bilaterally (located on the lower abdomen and lower leg) and delivered using Therapeutics Goods Administration (TGA)-approved electro-acupuncture devices at low frequency (2 Hz) electrical pulses, 0.3 ms pulse width [42,43], and continuous stimulation to the attached needles. The intensity of electro-acupuncture will be increased gently during each session until muscle contractions are felt or seen, but below the threshold of any discomfort or pain.…”