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Background:The aim of this study was to observe the effect and safety of Heyan Kuntai Capsule (HYKT) on glucose and lipid metabolism in patients with polycystic ovary syndrome (PCOS).Methods:Hundred patients with PCOS were randomly divided into HYKT group (n = 50) and placebo groups (n = 50) in which the individuals were treated with HYKT and its placebo continuously for 6 months. Meanwhile, all participants received health education (such as exercise and diet). The primary outcomes were serum sex hormone levels, a series of blood lipid, fasting and postprandial 2 hours blood glucose. Body mass index (BMI), waist–hip ratio (WHR), insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and insulin-sensitive index (ISI) were also observed. In addition, adverse events were recorded to evaluate the drug safety.Results:After treatment, the BMI and WHR of all the patients were decreased. The fasting and postprandial 2 hours blood glucose levels were significantly declined when treated with HYKT, which were not observed in the placebo group. Similarly, serum sex hormones including luteinizing hormone (LH), LH/follicle-stimulating hormone (FSH), and testosterone were lowered after treated with HYKT instead of the placebo. Besides, blood lipids outcomes such as total cholesterol, triglyceride, and low-density lipoprotein cholesterol, as well as insulin and HOMA-IR were decreased with significance in HYKT group when compared with those in the placebo group, whereas high-density lipoprotein cholesterol and ISI increased obviously.Conclusion:HYKT showed the effect on ameliorating the glucose and lipid metabolism disorder and improving insulin resistance and increase insulin sensitivity of PCOS patients, which is similar to insulin sensitizing agent.

Background Letrozole is superior to clomiphene in infertile women with polycystic ovary syndrome and leads to higher ovulation and live birth rates. Berberine, a major active component of Chinese herbal medicine Rhizoma coptidis and found in Cortex Phellodendri and Cortex Berberidis in the rest of the world, has similar but even more profound metabolic eff ects than metformin. Our hypothesis was that a combination of letrozole and berberine would result in a higher live birth rate than letrozole or berberine alone in infertile women with polycystic ovary syndrome. MethodsIn this multicentre, randomised, double-blind, placebo-controlled trial in 19 participating centres in mainland China, we compared the eff ect of three interventions for up to six menstrual cycles: letrozole plus berberine placebo (letrozole group), berberine plus letrozole placebo (berberine group), or the combination of letrozole and berberine (combination group). The randomisation (1:1:1) was done through a web-based computer program operated by an independent data center in the China Academy of Chinese Medical Sciences. Participants, investigators, doctors, laboratory technicians, and data analysers were masked to the assignments. Eligible women (age 20-40 years) had polycystic ovary syndrome, as defi ned by the Rotterdam criteria, had at least one open Fallopian tube and normal uterine cavity, and had at least 1 year of infertility. Berberine or berberine placebo were administrated orally at a daily dose of 1∧5 g for 6 months.Patients received an initial dose of 2∧5 mg of letrozole or placebo on days 3-7 of the fi rst three treatment cycles. This dose was increased to 5 mg letrozole or placebo on days 3-7 of the last three treatment cycles if not pregnant. Couples were instructed to have regular intercourse two to three times a week until becoming pregnant. The primary outcome was live birth rate after intervention for up to six menstrual cycles. We used either a χ² test or Fisher's exact test a two-sided signifi cance level of 0∧05 to test diff erences between groups. Data were analysed according to the intention-to-treat principle. This study was approved by an Ethics Committee (2009LL-001) at First Affi liated Hospital in Heilongjiang University of Chinese Medicine. This trial is registered at Chinese Clinical Trials Registration, identifi er ChiCTR-TRC-09000376, and at ClinicalTrials.gov, number NCT01116167. All participants provided written informed consent.

BackgroundEndometriosis is a chronic gynecological disease that is characterized by the presence of endometrial tissue outside the uterine cavity. The main symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility. These symptoms impair the lives of most of the women suffering from the disease. Surgical resection of endometriotic lesions is an effective means of treating dysmenorrhea, but the risk of recurrence is high. Western medicine has limited use for treating it due to side effects and ineffectiveness. The purpose of this study is to verify the effectiveness and safety of acupuncture.Methods/designThis trial will be carried out in four parts. A total of 106 eligible patients with pelvic pain related to endometriosis will be randomly assigned into two groups, in a 1:1 ratio, as the treatment group or the control group. The participants assigned to the treatment group will be treated with acupuncture treatment at Guanyuan (CV4), Sanyinjiao (SP6), Taichong (LR3), Zhaohai (KI6) and Qichong (ST30) while the control group will receive acupuncture at non-acupoints. The trial will include three menstrual cycles of treatment and three menstrual cycles of follow-up. The primary outcome is pelvic pain that will be assessed by means of a 10-cm visual analog scale (VAS). At each stage, we will evaluate the safety of the acupuncture treatment.DiscussionThe study will compare the effectiveness and safety of acupuncture with comfort needles on pelvic pain related to endometriosis in the hope of providing significant evidence for using acupuncture on pelvic pain related to endometriosis.Trial registrationClinicalTrials.gov, ID: NCT03125304. Registered on 30 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2684-6) contains supplementary material, which is available to authorized users.