Abstract
BackgroundPolycystic ovary syndrome is a common cause of infertility and shows a high incidence in women of reproductive age. Acupuncture is an appropriate adjunctive treatment for PCOS. However, the add-on effect of acupuncture as an adjunctive treatment for obese women with PCOS has not been studied, and previous studies indicate that there are individual differences in the curative effect of acupuncture, while deeper research on the mechanism of differences in the individual curative effect of acupuncture for obese women with PCOS is still lacking. This trial aims to assess the add-on treatment efficacy of acupuncture for obese women with PCOS and to explore the role of the gut microbiome on the differences in the individual curative effect of acupuncture based on metagenomic analysis.Methods/designThis is an open-label, randomized, controlled trial. A total of 86 obese women with PCOS will be recruited. Subjects will be randomly assigned to a study group and a control group in a 1:1 ratio, with 43 subjects in each group (10 patients from each group who meet the study criteria will participate in the metagenomic analysis). An additional 10 subjects who meet the study criteria will be recruited to a healthy control group. The study group will receive acupuncture and clomiphene citrate treatment; the control group will only receive clomiphene citrate. Acupuncture treatment will be conducted three times a week from the fifth day of menstruation or withdrawal bleeding until the start of the next menstruation, for up to three menstrual cycles. The primary outcome will be LH/FSH. The secondary outcomes will comprise biometric features, hormone biomarkers, metabolic biomarkers, inflammatory biomarkers, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and metagenomic analysis. The outcomes will be measured at baseline and post-intervention. Data will be analyzed using SPSS 19.0, and the gut microbiome will be analyzed using metagenomic analysis.DiscussionIn this study, we are evaluating the add-on effects of acupuncture and exploring the mechanism of the differences in the individual curative effect of acupuncture based on the gut microbiome, which may provide evidence to explain the different outcomes of different trials on acupuncture for PCOS and hopefully to provide a new aspect to study the mechanism of acupuncture’s treatment effect.Trial registrationChinese Clinical Trial Registry ChiCTR2000029882. Registered on 16 February 2020
Highlights
Polycystic ovary syndrome is a common cause of infertility and shows a high incidence in women of reproductive age
In this study, we are evaluating the add-on effects of acupuncture and exploring the mechanism of the differences in the individual curative effect of acupuncture based on the gut microbiome, which may provide evidence to explain the different outcomes of different trials on acupuncture for Polycystic ovary syndrome (PCOS) and hopefully to provide a new aspect to study the mechanism of acupuncture’s treatment effect
Acupuncture is an acceptable adjunct to lifestyle interventions for weight loss in obese women with PCOS [30] and so could improve the treatment of PCOS
Summary
Polycystic ovary syndrome is a common cause of infertility and shows a high incidence in women of reproductive age. The add-on effect of acupuncture as an adjunctive treatment for obese women with PCOS has not been studied, and previous studies indicate that there are individual differences in the curative effect of acupuncture, while deeper research on the mechanism of differences in the individual curative effect of acupuncture for obese women with PCOS is still lacking. The increasing prevalence of obesity has an important bearing on the PCOS phenotype [11, 12], and women diagnosed with PCOS who have higher body mass index (BMI) are more likely to have menstrual irregularity, hyperandrogenemia, hirsutism, and insulin resistance [13,14,15], which can exacerbate the reproductive and metabolic abnormalities of PCOS [16]. Clomiphene citrate, as the first-line ovulation induction drug, has been used among infertile PCOS women with fertility desires for decades. An increasing number of patients with PCOS are seeking complementary and alternative medicine (CAM) methods such as acupuncture for fertility assistance [21, 22]
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