Division of Cancer Etiology, Department of Population Sciences, Beckman Research Institute, City of Hope, 1500 E. Duarte Rd., Duarte, CA 91010-3000, USA.
J Steroid Biochem Mol Biol. 2014 Jul;142:12-5. doi: 10.1016/j.jsbmb.2013.08.006. Epub 2013 Sep 9.
The Women's Health Initiative (WHI) clinical trials generated definitive answers to the specific questions they were designed to answer. Menopausal hormone therapy in the form of oral conjugated equine estrogens (CEE) alone or CEE plus medroxyprogesterone acetate (CEE+MPA) should not be used for primary prevention of chronic diseases among postmenopausal women because the risks outweigh the benefits. Before the WHI clinical trials were stopped early and those results were announced, there was a general, although not universal, consensus in the scientific literature and public at large that menopausal hormone therapy's benefits outweighed its risks. In the ten years since the surprising early termination of those two WHI clinical trials, substantial discussion, critique, reanalysis, and opinion has been offered to reconcile the differences between the WHI clinical trial results and a diverse set of a priori and a posteriori expectations. Some of that assessment has focused on epidemiologic studies, which had provided much of the data on which the original decision to launch the WHI trials was based. This review discusses a number of potential lessons that current and future epidemiology could take from the WHI. Epidemiologic observational studies should more often emulate the big-picture perspective of randomized clinical trials. Even apparently conflicting epidemiologic study observations and clinical trial results may have similar underlying data. Creative use of both intervention and observational study designs and data, for both menopausal hormone therapy and other important exposures, is essential to generating the research, clinical, and translational findings that advance public health. This article is part of a Special Issue entitled 'Menopause'.
妇女健康倡议 (WHI) 临床试验针对其设计目的给出了明确的答案。绝经期激素治疗，即单独使用口服结合雌激素（CEE）或 CEE 加醋酸甲羟孕酮（CEE+MPA），不应作为绝经后妇女预防慢性疾病的主要手段，因为风险大于益处。在 WHI 临床试验提前终止并公布结果之前，科学文献和公众普遍存在一种共识，即绝经激素治疗的益处大于其风险。自这两项 WHI 临床试验出人意料地提前终止以来的十年中，人们进行了大量的讨论、批评、重新分析和意见交流，以调和 WHI 临床试验结果与一系列事先和事后预期之间的差异。其中一些评估集中在流行病学研究上，这些研究提供了原始决定启动 WHI 试验所依据的大部分数据。这篇综述讨论了当前和未来的流行病学可以从 WHI 中吸取的一些经验教训。流行病学观察性研究应更经常地模仿随机临床试验的整体视角。即使是看似相互矛盾的流行病学研究观察结果和临床试验结果，也可能具有类似的潜在数据。为了产生推进公共卫生的研究、临床和转化发现，必须创造性地利用干预和观察性研究设计和数据，包括绝经激素治疗和其他重要暴露因素。本文是题为“更年期”的特刊的一部分。
