Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Essen, Germany.
Headache Science Center, C. Mondino Foundation (IRCCS), Pavia, Italy.
Cephalalgia. 2020 Sep;40(10):1026-1044. doi: 10.1177/0333102420941839. Epub 2020 Jul 28.
Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the . Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the (2018), the (2019), and (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of episodic migraine in adults. A guideline for clinical trials with devices will be published separately.
临床试验是头痛疾病治疗证据基础的关键组成部分。1991 年，国际头痛协会临床试验常务委员会制定并发布了第一版《头痛治疗临床试验方法的建议》。此后近 30 年来，随着药物、器械和生物制品的进步以及新的试验设计，该建议已经多次更新，最近的更新包括《头痛治疗临床试验方法的建议（2018 年）》《头痛治疗临床试验方法的建议（2019 年）》和《头痛治疗临床试验方法的建议（2019 年）》。本次更新纳入了新研究的结果，旨在优化成人发作性偏头痛预防性药物治疗的对照临床试验设计。器械临床试验指南将单独发布。
