Department of Neurology, University of Copenhagen, Glostrup Hospital, Danish Headache Centre, DK-2600 Glostrup,Denmark.
Cephalalgia. 2010 Jan;30(1):1-16. doi: 10.1111/j.1468-2982.2009.01948.x.
The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments in tension-type headache. These Guidelines are intended to assist in the design of well-controlled clinical trials in tension-type headache.
国际头痛学会临床试验小组委员会于 1995 年发布了第一版关于紧张型头痛药物对照试验的指南。这些指南旨在“提高紧张型头痛对照临床试验的质量”,因为“高质量的对照试验是令人信服地证明药物疗效的唯一途径,也是国际药物治疗协议的基础”。该委员会还为偏头痛和丛集性头痛的临床试验发布了类似的指南。自 1995 年以来,已经发表了几项关于治疗阵发性和慢性紧张型头痛的研究,为这种疾病的试验方法提供了新的信息。此外,头痛的分类,包括紧张型头痛,已经修订。这些发展支持修订紧张型头痛药物治疗指南的必要性。本指南旨在帮助设计紧张型头痛的对照临床试验。