Linde Klaus, Rossnagel Karin
Centre for Complementary Medicine Research, Department of Internal Medicine II, Technical University Munich, Munich, Germany.
Institute of Social Medicine & Epidemiology, Charité University Hospital, Humboldt University, Berlin, Germany, 10098.
Cochrane Database Syst Rev. 2017 Feb 17;2(2):CD003225. doi: 10.1002/14651858.CD003225.pub3.
Propranolol is one of the most commonly prescribed drugs for migraine prophylaxis.
We aimed to determine whether there is evidence that propranolol is more effective than placebo and as effective as other drugs for the interval (prophylactic) treatment of patients with migraine.
Potentially eligible studies were identified by searching MEDLINE/PubMed (1966 to May 2003) and the Cochrane Central Register of Controlled Trials (Issue 2, 2003), and by screening bibliographies of reviews and identified articles.
We included randomised and quasi-randomised clinical trials of at least 4 weeks duration comparing clinical effects of propranolol with placebo or another drug in adult migraine sufferers.
Two reviewers extracted information on patients, methods, interventions, outcomes measured, and results using a pre-tested form. Study quality was assessed using two checklists (Jadad scale and Delphi list). Due to the heterogeneity of outcome measures and insufficient reporting of the data, only selective quantitative meta-analyses were performed. As far as possible, effect size estimates were calculated for single trials. In addition, results were summarised descriptively and by a vote count among the reviewers.
A total of 58 trials with 5072 participants met the inclusion criteria. The 58 selected trials included 26 comparisons with placebo and 47 comparisons with other drugs. The methodological quality of the majority of trials was unsatisfactory. The principal shortcomings were high dropout rates and insufficient reporting and handling of this problem in the analysis. Overall, the 26 placebo-controlled trials showed clear short-term effects of propranolol over placebo. Due to the lack of studies with long-term follow up, it is unclear whether these effects are stable after stopping propranolol. The 47 comparisons with calcium antagonists, other beta-blockers, and a variety of other drugs did not yield any clear-cut differences. Sample size was, however, insufficient in most trials to establish equivalence.
AUTHORS' CONCLUSIONS: Although many trials have relevant methodological shortcomings, there is clear evidence that propranolol is more effective than placebo in the short-term interval treatment of migraine. Evidence on long-term effects is lacking. Propranolol seems to be as effective and safe as a variety of other drugs used for migraine prophylaxis.
普萘洛尔是偏头痛预防性治疗中最常用的药物之一。
我们旨在确定是否有证据表明普萘洛尔在偏头痛患者的间歇期(预防性)治疗中比安慰剂更有效,且与其他药物效果相当。
通过检索MEDLINE/PubMed(1966年至2003年5月)和Cochrane对照试验中央注册库(2003年第2期),以及筛选综述的参考文献和已识别的文章,来确定可能符合条件的研究。
我们纳入了至少为期4周的随机和半随机临床试验,这些试验比较了普萘洛尔与安慰剂或另一种药物在成年偏头痛患者中的临床效果。
两名综述员使用预先测试的表格提取有关患者、方法、干预措施、测量的结局和结果的信息。使用两份清单(Jadad量表和德尔菲清单)评估研究质量。由于结局测量的异质性和数据报告不足,仅进行了选择性定量荟萃分析。尽可能为单个试验计算效应量估计值。此外,结果通过描述性总结和综述员投票计数进行汇总。
共有58项试验、5072名参与者符合纳入标准。所选的58项试验包括26项与安慰剂的比较和47项与其他药物的比较。大多数试验的方法学质量不令人满意。主要缺点是高失访率以及在分析中对该问题的报告和处理不足。总体而言,26项安慰剂对照试验显示普萘洛尔在短期内比安慰剂有明显效果。由于缺乏长期随访研究,尚不清楚停用普萘洛尔后这些效果是否稳定。与钙拮抗剂、其他β受体阻滞剂以及多种其他药物的47项比较未产生任何明确差异。然而,大多数试验的样本量不足以确定等效性。
尽管许多试验存在相关的方法学缺陷,但有明确证据表明普萘洛尔在偏头痛的短期间歇期治疗中比安慰剂更有效。缺乏长期效果的证据。普萘洛尔似乎与用于偏头痛预防的多种其他药物一样有效和安全。