Department of Obstetrics and Gynecology, National Key Discipline, Specialty and Clinical Base, Heilongjiang University of Chinese Medicine, Harbin, China.
BMJ Open. 2013 Nov 25;3(11):e003934. doi: 10.1136/bmjopen-2013-003934.
Letrozole is being used as an alternative to clomiphene citrate in women with polycystic ovary syndrome (PCOS) requiring ovulation induction. Berberine, a major active component of Chinese herbal medicine rhizoma coptidis, has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS but there is no study reporting the live birth or its potential as a complementary treatment to letrozole. We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 660 infertile women with PCOS in Mainland China.
This study is a multicentre randomised, double-blind trial. The randomisation scheme is coordinated through the central mechanism and stratified by the participating site. Participants are randomised into one of the three treatment arms: (1) letrozole and berberine, (2) letrozole and berberine placebo, or (3) letrozole placebo and berberine. Berberine is administered three times a day (1.5 g/day) for up to 24 weeks, starting on day 1 after a spontaneous period or a withdrawal bleeding. Either letrozole or letrozole placebo 2.5 mg is given daily from day 3 to day 7 of the first three cycles and the dose is increased to 5 mg/day in the last three cycles, if not pregnant. The primary hypothesis is that the combination of berberine and letrozole results in a significantly higher live birth rate than letrozole or berberine alone.
The study was approved by the ethics committee of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine. Study findings will be disseminated through peer-reviewed publications and conference presentations.
ClinicalTrials.gov identifier: NCT01116167.
在多囊卵巢综合征（PCOS）患者中，枸橼酸氯米酚是诱导排卵的一线药物。然而，对于需要诱导排卵的 PCOS 患者，有时会选择使用来曲唑。小檗碱是黄连根茎的主要活性成分之一，已被用于改善胰岛素抵抗以促进 PCOS 患者排卵，但尚无研究报道其活产率或作为来曲唑的辅助治疗的潜力。本研究旨在评估在中国内地 660 名 PCOS 不孕妇女中，使用来曲唑联合或不联合小檗碱是否能提高活产率。
这是一项多中心随机双盲试验。通过中央机制进行随机分组，并按参与地点进行分层。参与者随机分为三组治疗方案：（1）来曲唑+小檗碱，（2）来曲唑+小檗碱安慰剂，或（3）来曲唑安慰剂+小檗碱。小檗碱每日 3 次（1.5 g/天），最多使用 24 周，从自然周期或撤退性出血后的第 1 天开始使用。前三个周期的第 1-7 天每日给予来曲唑或来曲唑安慰剂 2.5 mg，如果未怀孕，则在最后三个周期中剂量增加至 5 mg/天。主要假设是，小檗碱和来曲唑联合使用的活产率显著高于单独使用来曲唑或小檗碱。
该研究已获得黑龙江中医药大学附属第一医院伦理委员会的批准。研究结果将通过同行评议的出版物和会议报告进行传播。
ClinicalTrials.gov 标识符：NCT01116167。
