一项多中心随机试验，比较个体化针灸、常规针灸、来曲唑和安慰剂来曲唑对多囊卵巢综合征不孕女性活产率的影响。
A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome.
机构信息
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Institute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
出版信息
Trials. 2020 Mar 4;21(1):239. doi: 10.1186/s13063-020-4154-1.
BACKGROUND
Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual patient differences. We have designed a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births in infertile women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesize that letrozole is more effective than personalized acupuncture, which in turn is more effective than fixed acupuncture, and that placebo letrozole is the least effective intervention. Moreover, we hypothesize that personalized acupuncture is more likely to reduce the miscarriage rate and the risk of pregnancy complications compared with letrozole.
METHODS/DESIGN: The study is designed as an assessor-blinded RCT. A total of 1100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated to 4 groups: personalized acupuncture, fixed acupuncture, letrozole, or placebo letrozole. They will receive treatment for 16 weeks, and the primary outcome is live birth. Secondary outcomes include ovulation rate, conception rate, pregnancy rate, pregnancy loss rate, changes in hormonal and metabolic parameters, and changes in quality of life scores. Adverse events will be recorded throughout the trial. All statistical analyses will be performed using IBM SPSS Statistics version 21.0 software (IBM Corp., Armonk, NY, USA), and a P value < 0.05 will be considered statistically significant.
DISCUSSION
This study will be the first multicenter RCT to compare the effect of personalized or fixed acupuncture with letrozole or placebo letrozole on live birth in infertile women with PCOS. The findings will inform whether personalized acupuncture therapy can be considered an alternative treatment to improve the live birth rate in infertile women with PCOS.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03625531. Registered on July 13, 2018. Chinese Clinical Trial Registry, ChiCTR1800017304. Registered on July 23, 2018.
背景
中医（TCM）通常涉及辨证论治。针灸是中医的一种形式，需要选择合适的穴位和针刺技术，但许多针灸的临床试验都使用了固定的针灸方案，而没有考虑到个体患者的差异。我们设计了一项多中心随机对照试验（RCT），以评估与来曲唑或安慰剂来曲唑相比，个体化或固定针灸是否更能提高多囊卵巢综合征（PCOS）不孕妇女的活产率。我们假设来曲唑比个体化针灸更有效，而个体化针灸又比固定针灸更有效，安慰剂来曲唑是最无效的干预措施。此外，我们假设与来曲唑相比，个体化针灸更有可能降低流产率和妊娠并发症的风险。
方法/设计：该研究设计为评估员设盲的 RCT。将从 28 家医院招募 1100 名患有 PCOS 的不孕妇女，将她们随机分为 4 组：个体化针灸组、固定针灸组、来曲唑组和安慰剂来曲唑组。她们将接受 16 周的治疗，主要结局是活产。次要结局包括排卵率、受孕率、妊娠率、妊娠丢失率、激素和代谢参数的变化以及生活质量评分的变化。整个试验过程中记录不良事件。所有统计分析将使用 IBM SPSS Statistics 版本 21.0 软件（IBM 公司，纽约州阿蒙克）进行，P 值<0.05 被认为具有统计学意义。
讨论
这将是第一项比较个体化或固定针灸与来曲唑或安慰剂来曲唑对 PCOS 不孕妇女活产率影响的多中心 RCT。研究结果将为个体化针灸疗法是否可以被认为是改善 PCOS 不孕妇女活产率的替代治疗方法提供依据。
试验注册
ClinicalTrials.gov，NCT03625531。于 2018 年 7 月 13 日注册。中国临床试验注册中心，ChiCTR1800017304。于 2018 年 7 月 23 日注册。
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