Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Consultant, World Health Organization, Geneva, Switzerland
BMJ Open. 2019 Oct 7;9(10):e030373. doi: 10.1136/bmjopen-2019-030373.
To systematically identify and map the available evidence on effectiveness, side effects, pharmacokinetics and mechanism of action of centchroman as a contraceptive pill.
Centchroman was introduced in the Indian national family planning programme in 2016 as a once-a-week short-term contraceptive pill/oral contraceptive. At present there are no WHO recommendations on this method of contraception. We examined the available evidence through a scoping review.
A search was conducted inclusive to the years 1970-2019 on electronic databases, grey literature sources and reference lists of included studies to identify studies. The five stages of Arksey and O'Malley's scoping review framework were applied in undertaking this scoping review.
The review identified 33 studies conducted between 1976 and 2017. Two studies reported mechanism of action of centchroman. Pharmacokinetics was reported by five studies among non-breastfeeding women and four studies among breastfeeding women. Eight studies reported on effectiveness ranging from 93% to 100%. Pregnancies due to user failure ranged from 2.6% to 10.2%. Although side effects were reported in 13 studies, the incidence varied greatly between the studies. Continuous bleeding and prolonged cycles >45 days were the most commonly reported side effects. All studies conducted had a small sample size and the duration of follow-up of women was 12 months or less. Fifty-five per cent of studies were by the developers of the pill (Central Drug Research Institute) and results of the phase IV clinical trial were unavailable.
The scoping review shows that studies with robust designs and conducted in international context are lacking. Insufficient evidence exists on centchroman use as a postcoital contraceptive pill. The broad uncertainty in range of side effects and effectiveness in the studies implies insufficient evidence to make global recommendations on centchroman that is currently licensed as a contraceptive in India.
系统地识别和绘制关于屈螺酮作为避孕药的有效性、副作用、药代动力学和作用机制的现有证据。
屈螺酮于 2016 年被引入印度国家计划生育计划，作为一种每周一次的短期避孕药/口服避孕药。目前，世界卫生组织（WHO）没有关于这种避孕方法的建议。我们通过范围审查来检查现有证据。
对 1970 年至 2019 年的电子数据库、灰色文献来源和纳入研究的参考文献进行了搜索，以确定研究。采用阿特塞尔和奥马利的范围审查框架的五个阶段进行了这项范围审查。
该综述共识别出 1976 年至 2017 年进行的 33 项研究。两项研究报告了屈螺酮的作用机制。药代动力学由五名非哺乳期妇女和四名哺乳期妇女进行了研究。八项研究报告了有效性，范围从 93%到 100%。由于使用者失败导致的妊娠率为 2.6%至 10.2%。虽然有 13 项研究报告了副作用，但各研究之间的发生率差异很大。持续出血和周期延长>45 天是最常见的副作用。所有进行的研究样本量都很小，对女性的随访时间为 12 个月或更短。55%的研究是由该药丸的开发者（中央药物研究机构）进行的，第四阶段临床试验的结果无法获得。
范围审查表明，缺乏设计严谨且在国际范围内进行的研究。关于屈螺酮作为事后避孕药的使用，证据不足。研究中副作用和有效性的范围广泛存在不确定性，这意味着没有足够的证据可以对目前在印度获得许可的屈螺酮做出全球建议。
