Wider Barbara, Pittler Max H, Ernst Edzard
Institute of Health Research, University of Exeter Medical School, South Cloisters, room 1.36, St Luke's Campus, Exeter, UK, EX1 2LU.
Cochrane Database Syst Rev. 2015 Apr 20;4(4):CD002286. doi: 10.1002/14651858.CD002286.pub3.
BACKGROUND: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on 'Feverfew for preventing migraine' (2004, Issue 1). Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine. OBJECTIVES: To systematically review the evidence from double-blind randomised controlled trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine. SEARCH METHODS: For this updated version of the review we searched CENTRAL, MEDLINE, EMBASE and AMED to January 2015. We contacted manufacturers of feverfew and checked the bibliographies of identified articles for further trials. SELECTION CRITERIA: We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in patients of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication. DATA COLLECTION AND ANALYSIS: We systematically extracted data on patients, interventions, methods, outcome measures, results and adverse events. We assessed risk of bias using the Cochrane 'Risk of bias' tool and evaluated methodological quality using the Oxford Quality Scale developed by Jadad and colleagues. Two review authors (BW and MHP for this update, MHP and EE for the original version) independently selected studies, assessed methodological quality and extracted data. We resolved disagreements concerning evaluation of individual trials through discussion. MAIN RESULTS: We identified one new study for this update, resulting in six trials (561 patients) meeting the inclusion criteria. Five of the six trials reported on the main outcome, migraine frequency. Although five of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs.The most recent trial added to this version of the review is rigorous and larger (n = 218), using a stable feverfew extract at a dose determined by a previous dose-finding trial. It reports that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month, resulting in a difference in effect between feverfew and placebo of 0.6 attacks per month. For the secondary outcome measures intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences were reported. Results of previous trials are not convincing: three trials reporting positive effects of feverfew are all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo. Only mild and transient adverse events, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials. AUTHORS' CONCLUSIONS: Since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.
背景:本综述是对Cochrane系统评价数据库中之前发表的关于“小白菊预防偏头痛”(2004年第1期)的综述的更新。小白菊(Tanacetum parthenium L.)提取物是一种草药疗法,一直用于预防偏头痛发作。 目的:系统评价双盲随机对照试验(RCT)的证据,评估小白菊单一制剂与安慰剂相比预防偏头痛的临床疗效和安全性。 检索方法:对于本综述的更新版本,我们检索了截至2015年1月的Cochrane系统评价数据库、MEDLINE、EMBASE和AMED。我们联系了小白菊的制造商,并查阅了已识别文章的参考文献以寻找更多试验。 入选标准:我们纳入了随机、安慰剂对照、双盲试验,评估小白菊单一制剂对任何年龄患者预防偏头痛的疗效。我们纳入了使用临床结局指标的试验,而排除了仅关注生理参数的试验。对发表语言没有限制。 数据收集与分析:我们系统地提取了关于患者、干预措施、方法、结局指标、结果和不良事件的数据。我们使用Cochrane“偏倚风险”工具评估偏倚风险,并使用Jadad及其同事开发的牛津质量量表评估方法学质量。两位综述作者(本次更新为BW和MHP,原始版本为MHP和EE)独立选择研究、评估方法学质量并提取数据。我们通过讨论解决了关于个别试验评估的分歧。 主要结果:本次更新我们识别出一项新研究,共有六项试验(561例患者)符合纳入标准。六项试验中的五项报告了主要结局,即偏头痛发作频率。尽管其中五项试验的方法学质量总体良好,但所有研究在样本量方面的偏倚风险均不明确或较高。由于缺乏共同的结局指标以及研究在参与者、干预措施和设计方面的异质性,无法对结果进行汇总分析。本次综述版本中新增的最新试验设计严谨且样本量更大(n = 218),使用了在前一项剂量探索试验中确定的剂量的稳定小白菊提取物。该试验报告称,小白菊使偏头痛发作频率每月从4.8次减少至2.9次,安慰剂使发作频率每月从4.8次减少至3.5次,小白菊与安慰剂的效果差异为每月0.6次发作。对于次要结局指标,偏头痛发作的强度和持续时间、恶心和呕吐的发生率及严重程度以及总体评估,均未报告有统计学显著差异。之前试验的结果也不令人信服:三项报告小白菊有积极效果的试验样本量都很小(17至60名参与者),而两项严谨的试验(n = 50、147)未发现小白菊与安慰剂之间有显著差异。纳入的试验中仅报告了轻微和短暂的不良事件,最常见的是胃肠道不适和口腔溃疡。 作者结论:自本综述的上一版本以来,纳入了一项规模更大、设计严谨的研究,报告小白菊与安慰剂的效果差异为每月0.6次发作。这为之前综述中混合且无定论的结果增添了一些积极证据。然而,这构成了低质量证据;在得出确切结论之前,需要在使用稳定小白菊提取物且偏头痛人群明确界定的更大规模严谨试验中加以证实。从所审查的数据来看,小白菊似乎不存在任何重大安全问题。
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