The efficacy of goshuyuto, a typical Kampo (Japanese herbal medicine) formula, in preventing episodes of headache
The efficacy of goshuyuto, a typical Kampo (Japanese herbal medicine) formula, in preventing episodes of headache
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DOI：
10.1185/030079906x112769
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发表时间：
2006-08-01
影响因子：
2.3
通讯作者：
Hanawa, Toshihiko
中科院分区：
文献类型：
--
作者：
Odaguchi, Hiroshi;Wakasugi, Akino;Hanawa, Toshihiko
目的：本临床试验的目的是评估典型的汉方方剂五酒汤对预防慢性头痛患者头痛发作的功效。 研究设计和方法：由于汉方方的治疗目标是根据与西药不同的基础确定的，因此在进行通常的随机对照试验之前，我们首先选择属于对五酒汤有反应的亚组患者。在第一阶段，受试者被指示口服 goshuyuto 4 周。只有那些被判定为有反应的受试者才能进入第二阶段，在此期间进行了一项双盲、随机、安慰剂对照研究。受试者服用相同剂量的 goshuyuto 或安慰剂 12 周。结果：在第一阶段登记的 91 名受试者中，60 名被判定为有反应者。其中，53 人进入第二阶段； 28 人被分配到 goshuyuto 组，25 人被分配到安慰剂组。 goshuyuto 组头痛发作天数的减少幅度大于安慰剂组（2.6 +/- 3.7 天 vs. 0.3 +/- 4.0 天，p = 0.034）；在服用缓解药物的频率减少方面没有观察到差异（2.2 +/- 4.0 vs. 1.4 +/- 8.2，p = 0.672）。 Goshuyuto 组中超过 50% 的受试者观察到相关症状得到改善。 结论：Goshuyuto 可有效预防慢性头痛患者的头痛发作。响应者限制设计是评估汉方医学的候选方案。
Objective: The purpose of this clinical trial was to assess the efficacy of goshuyuto, a typical Kampo formula, in preventing episodes of headache in chronic headache patients.Research design and methods: Because the treatment target of a Kampo formula is decided on a basis different to that of Western medicine, we first selected patients belonging to a subgroup that responded to goshuyuto before conducting the usual randomized controlled trial. During stage 1, the subjects were instructed to orally consume goshuyuto for 4 weeks. Only those subjects judged as responders advanced to stage 2, during which a double-blind, randomized, placebo-controlled study was conducted. The subjects consumed the same dose of goshuyuto or placebo for 12 weeks.Results: Of the 91 subjects enrolled in stage 1, 60 were judged as responders. Of these, 53 advanced to stage 2; 28 were assigned to the goshuyuto group and 25 to the placebo group. The decrease in the number of days on which headache episodes occurred was greater in the goshuyuto group than in the placebo group (2.6 +/- 3.7 vs. 0.3 +/- 4.0 days, p = 0.034); no difference was observed with regard to the reduction in the frequency of consuming reliever medications (2.2 +/- 4.0 vs. 1.4 +/- 8.2, p = 0.672). Improvement in the associated symptoms was observed in more than 50% of the subjects in the goshuyuto group.Conclusion: Goshuyuto is useful in preventing episodes of headache in chronic headache patients. Responder-limited design is a candidate for evaluating Kampo medicine.