Derry Christopher J, Derry Sheena, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford,UK.
Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD009664. doi: 10.1002/14651858.CD009664.
Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Rectal administration may be preferable to oral for individuals experiencing nausea and/or vomiting.
To determine the efficacy and tolerability of rectal sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
We included randomised, double-blind, placebo- and/or active-controlled studies using rectally administered sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
Three studies (866 participants) compared rectally administered sumatriptan with placebo or an active comparator. Most of the data were for the 12.5 mg and 25 mg doses. For the majority of efficacy outcomes, sumatriptan surpassed placebo. For sumatriptan 12.5 mg versus placebo the NNTs were 5.2 and 3.2 for headache relief at one and two hours, respectively. Results for the 25 mg dose were similar to the 12.5 mg dose, and there were no significant differences between the two doses for any of the outcomes analysed. The NNTs for sumatriptan 25 mg versus placebo were 4.2, 3.2, and 2.4 for pain-free at two hours, headache relief at one hour, and headache relief at two hours, respectively.Relief of functional disability was greater with sumatriptan than with placebo, with NNTs of 8.0 and 4.0 for the 12.5 mg and 25 mg doses, respectively. For the most part, adverse events were transient and mild and were more common with sumatriptan than with placebo, but there were insufficient data to perform any analyses.Direct comparison of sumatriptan with active treatments was limited to one study comparing sumatriptan 25 mg with ergotamine tartrate 2 mg + caffeine 100 mg.
AUTHORS' CONCLUSIONS: Based on limited amounts of data, sumatriptan 25 mg, administered rectally, is an effective treatment for acute migraine attacks, with participants in these studies experiencing a significant reduction in headache pain and functional disability within two hours of treatment. The lack of data on relief of headache-associated symptoms or incidence of adverse events limits any conclusions that can be drawn.
偏头痛对个体而言是一种严重致残的疾病,对社会、医疗服务及经济也有着广泛影响。舒马曲坦是一种用于偏头痛发作的终止性药物,属于曲坦类药物。对于出现恶心和/或呕吐的个体,直肠给药可能优于口服给药。
确定直肠给予舒马曲坦与安慰剂及其他活性干预措施相比,在治疗成人急性偏头痛发作中的疗效和耐受性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、在线数据库,并检索了截至2011年10月13日的研究的参考文献列表。
我们纳入了使用直肠给予舒马曲坦治疗偏头痛发作的随机、双盲、安慰剂和/或活性对照研究,每个治疗组至少有10名参与者。
两位综述作者独立评估试验质量并提取数据。我们使用达到各结局的参与者数量来计算相对风险(或“风险比”)以及与安慰剂或不同活性治疗相比的获益所需治疗人数(NNT)或伤害所需治疗人数(NNH)。
三项研究(866名参与者)比较了直肠给予舒马曲坦与安慰剂或活性对照药。大多数数据针对的是12.5毫克和25毫克剂量。对于大多数疗效结局,舒马曲坦优于安慰剂。舒马曲坦12.5毫克与安慰剂相比,1小时和2小时时头痛缓解的NNT分别为5.2和3.2。25毫克剂量的结果与12.5毫克剂量相似,且对于所分析的任何结局,两剂量之间均无显著差异。舒马曲坦25毫克与安慰剂相比,2小时无痛、1小时头痛缓解及2小时头痛缓解的NNT分别为4.2、3.2和2.4。舒马曲坦比安慰剂能更好地缓解功能残疾,12.5毫克和25毫克剂量的NNT分别为8.0和4.0。在大多数情况下,不良事件短暂且轻微,舒马曲坦组比安慰剂组更常见,但数据不足无法进行任何分析。舒马曲坦与活性治疗的直接比较仅限于一项比较舒马曲坦25毫克与酒石酸麦角胺2毫克+咖啡因100毫克的研究。
基于有限的数据量,直肠给予25毫克舒马曲坦是治疗急性偏头痛发作的有效方法,这些研究中的参与者在治疗后两小时内头痛疼痛和功能残疾显著减轻。关于头痛相关症状缓解或不良事件发生率的数据缺乏限制了所能得出的任何结论。