School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Department of Reproductive Medicine, Sichuan Women's and Children's Hospital, Chengdu, China.
Trials. 2021 Jul 15;22(1):454. doi: 10.1186/s13063-021-05426-y.
Polycystic 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/DESIGN: This 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.
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 PCOS and hopefully to provide a new aspect to study the mechanism of acupuncture's treatment effect.
Chinese Clinical Trial Registry ChiCTR2000029882 . Registered on 16 February 2020.
多囊卵巢综合征是一种常见的不孕原因，在育龄妇女中的发病率较高。针灸是多囊卵巢综合征的一种合适的辅助治疗方法。然而，针灸作为多囊卵巢综合征肥胖妇女的辅助治疗的附加效果尚未得到研究，并且先前的研究表明针灸的疗效存在个体差异，而对于多囊卵巢综合征肥胖妇女针灸个体疗效差异的机制的更深入研究仍然缺乏。本试验旨在评估针灸对肥胖型多囊卵巢综合征妇女的附加治疗效果，并基于宏基因组分析探索肠道微生物组在针灸个体疗效差异中的作用。
方法/设计：这是一项开放标签、随机、对照试验。共招募 86 例肥胖型多囊卵巢综合征妇女。受试者将以 1:1 的比例随机分配到研究组和对照组，每组 43 例（每组各有 10 例符合研究标准的患者将参与宏基因组分析）。还将招募 10 例符合研究标准的额外健康对照组受试者。研究组将接受针灸和克罗米酚治疗；对照组仅接受克罗米酚。针灸治疗将在月经或撤退性出血的第 5 天开始，每周 3 次，持续至下一次月经开始，共 3 个月经周期。主要结局将是 LH/FSH。次要结局将包括生物特征、激素生物标志物、代谢生物标志物、炎症生物标志物、焦虑自评量表、抑郁自评量表和宏基因组分析。在基线和干预后测量结局。使用 SPSS 19.0 分析数据，使用宏基因组分析分析肠道微生物组。
在这项研究中，我们正在评估针灸的附加作用，并基于肠道微生物组探索针灸个体疗效差异的机制，这可能为解释不同试验中针灸治疗多囊卵巢综合征的不同结果提供证据，并有望为研究针灸治疗效果的机制提供一个新的方面。
中国临床试验注册中心 ChiCTR2000029882 。于 2020 年 2 月 16 日注册。
