Seo Jihye, Kim Cheol Hyun, Chu Hongmin, Moon Yeonju, Lee Sangkwan
Clinical Trial Center, Wonkwang University Gwangju Hospital, Gwangju Department of Internal Medicine, College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
Medicine (Baltimore). 2018 Mar;97(11):e0119. doi: 10.1097/MD.0000000000010119.
BACKGROUND: Migraine is a common disease of primary headache, which it causes many kinds of secondary diseases or symptoms. The treatment drugs have sometimes shown side effects such as overuse headache, stroke, and cardiovascular disease. Therefore, the demand for complementary and alternative interventions for migraine has increased. Herbal medicines are a representative intervention to treat migraine traditionally. Among these herbal medicines, Banhabaekchulchunma-tang (BBT) and Chongsanggeontong-tang (CGT) have been most commonly used for migraine treatment in traditional clinical practice. However, to our knowledge, there has been no systematic review considering the efficacy and safety of BBT or CGT on migraine. This protocol aims to perform a systematic review for assessing the effectiveness and safety of BBT or CGT on Migraine. METHODS: This protocol was developed according to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) and registered on the international prospective register of systematic reviews (PROSPERO). The randomized controlled clinical trials of BBT or CGT for migraine treatment will be searched in following 8 databases from their inception to December 2016: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, OASIS, the Korean Traditional Knowledge Portal, the Korean Medical Database, DBPIA, and the China National Knowledge Infrastructure. Study selection, data extraction, assessment with risk of bias, and data analysis will be performed in order. In this study, headache pain intensity and the total treatment effective rate will be evaluated as primary outcomes. RESULTS AND CONCLUSION: we propose the current protocol to evaluate the effectiveness and safety of BBT or CGT for migraine systematically. ETHICS AND DISSEMINATION: This systematic review will not need ethical approval, because it does not involve human beings. We will publish this systematic review electronically in a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018076171 for BBT and CRD42018085130 for CGT.
背景：偏头痛是一种常见的原发性头痛疾病，可引发多种继发性疾病或症状。其治疗药物有时会出现诸如药物过量使用性头痛、中风和心血管疾病等副作用。因此，对偏头痛补充和替代干预措施的需求有所增加。草药是传统上治疗偏头痛的一种代表性干预手段。在这些草药中，半夏白术天麻汤（BBT）和芎辛葛根汤（CGT）在传统临床实践中最常用于偏头痛治疗。然而，据我们所知，尚无关于BBT或CGT治疗偏头痛的疗效和安全性的系统评价。本方案旨在对BBT或CGT治疗偏头痛的有效性和安全性进行系统评价。 方法：本方案依据系统评价与Meta分析方案首选报告项目（PRISMA-P）中概述的指南制定，并在国际系统评价前瞻性注册库（PROSPERO）中注册。将从以下8个数据库自建库起至2016年12月搜索BBT或CGT治疗偏头痛的随机对照临床试验：医学期刊数据库（Medline）、荷兰医学文摘数据库（EMBASE）、考克兰对照试验中心注册库、东方医学期刊全文数据库（OASIS）、韩国传统知识门户、韩国医学数据库、韩国学术期刊全文数据库（DBPIA）和中国知网。将依次进行研究选择、数据提取、偏倚风险评估和数据分析。在本研究中，头痛疼痛强度和总治疗有效率将作为主要结局进行评估。 结果与结论：我们提出本方案以系统评价BBT或CGT治疗偏头痛的有效性和安全性。 伦理与传播：本系统评价无需伦理批准，因为它不涉及人类。我们将在同行评审期刊上以电子方式发表本系统评价。 系统评价注册：BBT的注册号为PROSPERO CRD42018076171，CGT的注册号为PROSPERO CRD42018085130。
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