Mokkarala Sameera, Kamuyango Asantesana, Kiarie James, Kidula Nancy, Jiang Li, Sonalkar Sarita
Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States.
Department of Sexual and Reproductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.
Contraception. 2025 Sep;149:110983. doi: 10.1016/j.contraception.2025.110983. Epub 2025 Jun 20.
The World Health Organization's (WHO) Medical Eligibility Criteria for contraceptive use (MEC) provides recommendations on the safety and efficacy of a range of contraceptive methods for users with various medical conditions. However, there are methods with medical regulatory agency approval that are not included in WHO guidance. Our objectives were to evaluate the evidence on methods that have regulatory approval for use in any member state, but which are not included in the MEC 2015, and to determine whether the evidence should be systematically reviewed to inform possible inclusion in a new WHO guideline.
We conducted a scoping review of experimental studies found through two bibliographic databases (PubMed, Embase) from database inception to December 2023. Two reviewers screened abstracts and full texts to determine eligibility based on a priori inclusion and exclusion criteria; one additional reviewer resolved conflicts. Reviewers extracted data on method safety, efficacy, and acceptability using a standardized tool.
We identified three methods that met our review criteria: ormeloxifene, quinestrol-containing contraception, and mifepristone for emergency contraception (EC). Our initial search strategies yielded 386 total results. Five publications related to ormeloxifene, five to quinestrol-containing contraception, and 10 to mifepristone for EC were included. The data on these methods was highly variable.
Rigorous systematic reviews of the evidence on safety, efficacy and dosage of ormeloxifene, quinestrol-containing contraception, and mifepristone for EC are needed to inform WHO recommendations on these methods. As these methods are already being used, international guidance for practitioners is essential.
世界卫生组织(WHO)的《避孕方法医学适用性标准》(MEC)针对患有各种疾病的使用者,就一系列避孕方法的安全性和有效性提供了建议。然而,有一些获得医学监管机构批准的方法未被纳入WHO指南。我们的目的是评估那些已获得监管批准可在任何成员国使用,但未被纳入2015年MEC的方法的相关证据,并确定是否应对这些证据进行系统评价,以为可能纳入新的WHO指南提供参考。
我们对通过两个文献数据库(PubMed、Embase)从建库至2023年12月期间检索到的实验性研究进行了范围综述。两名评审员根据预先设定的纳入和排除标准筛选摘要和全文以确定其是否符合要求;另一名评审员解决分歧。评审员使用标准化工具提取有关方法安全性、有效性和可接受性的数据。
我们确定了三种符合我们综述标准的方法:奥美拉唑、含炔雌醚的避孕方法以及用于紧急避孕(EC)的米非司酮。我们最初的检索策略共产生386条结果。纳入了5篇与奥美拉唑相关的出版物、5篇与含炔雌醚的避孕方法相关的出版物以及10篇与用于EC的米非司酮相关的出版物。这些方法的数据差异很大。
需要对奥美拉唑、含炔雌醚的避孕方法以及用于EC的米非司酮的安全性、有效性和剂量的证据进行严格的系统评价,以为WHO对这些方法的建议提供参考。由于这些方法已经在使用,为从业者提供国际指导至关重要。