Moja P L, Cusi C, Sterzi R R, Canepari C
Centro Cochrane Italiano, Istituto Mario Negri, Via Eritrea, 62, Milano, Italy, 20157.
Cochrane Database Syst Rev. 2005 Jul 20(3):CD002919. doi: 10.1002/14651858.CD002919.pub2.
Headache is a common medical problem. In view of recent discoveries about the role of serotonin in pain mechanisms, selective serotonin re-uptake inhibitors (SSRIs) have been evaluated for the prevention of migraine and tension-type headaches (TTH).
To evaluate the efficacy and tolerability of SSRIs for preventing migraine and TTH.
We searched MEDLINE (1966-2004), EMBASE (1994-2003), the Cochrane Central Register of Controlled Trials (Issue 4, 2003), and reference lists of retrieved articles. Headache Quarterly was hand searched from 1990 to 2003.
We included randomised controlled trials comparing SSRIs with any type of control intervention in patients of either sex, over 18 years of age, with migraine or TTH.
Two authors independently extracted data (headache frequency, index, severity, and duration; use of symptomatic/analgesic medication; days off work; quality of life; mood improvement; cost-effectiveness; and adverse events) and assessed the methodological quality of trials.
Thirteen studies utilizing five SSRIs met the inclusion criteria (636 participants). Most of the included studies had methodological and/or reporting shortcomings; follow up rarely extended beyond 3 months. After 2 months SSRIs did not significantly lower headache index scores in patients with migraine when compared to placebo (SMD -0.14; 95% CI -0.57 to 0.30). Patients with chronic TTH treated with an SSRI had a significantly higher analgesic intake of 5 more doses per month when compared to patients treated with a tricyclic antidepressant (WMD 4.98; 95% CI 1.12 to 8.84). Tricyclics also significantly reduced headache duration by 1.26 hours per day (WMD 1.26; 95% CI 0.06 to 2.45) and marginally reduced headache indexes (SMD 0.42; 95% CI 0.00 to 0.85) when compared to SSRIs in patients with chronic TTH. When the data on adverse events were considered without regard to headache diagnostic subgroups, there were no significant differences between SSRIs and placebo for withdrawals due to adverse events (Peto OR 1.02; 95% CI 0.31 to 3.34). For minor adverse events, SSRIs were generally more tolerable than tricyclics (OR 0.34; 95% CI 0.13 to 0.92). However, there were no differences in the number of patients withdrawing due to any reason in the SSRI and tricyclic groups (OR 1.01; 95% CI 0.56 to 1.80).
AUTHORS' CONCLUSIONS: Over 2 months of treatment, SSRIs are no more efficacious than placebo in patients with migraine. In patients with chronic TTH, SSRIs are less efficacious than tricyclic antidepressants. In comparison with SSRIs, the burden of adverse events in patients receiving tricyclics was greater. These results are based on short-term trials and may not generalise to longer-term treatment.
头痛是一种常见的医学问题。鉴于最近关于血清素在疼痛机制中作用的发现，已对选择性血清素再摄取抑制剂（SSRI）用于预防偏头痛和紧张型头痛（TTH）进行了评估。
评估SSRI预防偏头痛和TTH的疗效及耐受性。
我们检索了MEDLINE（1966 - 2004年）、EMBASE（1994 - 2003年）、Cochrane对照试验中央注册库（2003年第4期）以及检索到文章的参考文献列表。对1990年至2003年的《头痛季刊》进行了手工检索。
我们纳入了比较SSRI与任何类型对照干预措施的随机对照试验，试验对象为18岁以上、患有偏头痛或TTH的男女患者。
两位作者独立提取数据（头痛频率、指数、严重程度和持续时间；对症/止痛药物的使用；误工天数；生活质量；情绪改善情况；成本效益；以及不良事件）并评估试验的方法学质量。
13项使用5种SSRI的研究符合纳入标准（636名参与者）。大多数纳入研究存在方法学和/或报告方面的缺陷；随访很少超过3个月。与安慰剂相比，2个月后SSRI并未显著降低偏头痛患者的头痛指数评分（标准化均数差 -0.14；95%可信区间 -0.57至0.30）。与接受三环类抗抑郁药治疗的慢性TTH患者相比，接受SSRI治疗的患者每月镇痛药物摄入量显著多5剂（加权均数差4.98；95%可信区间1.12至8.84）。与慢性TTH患者使用SSRI相比，三环类药物还显著缩短头痛持续时间，每天缩短1.26小时（加权均数差1.26；95%可信区间0.06至2.45），并略微降低头痛指数（标准化均数差0.42；95%可信区间0.00至0.85）。在不考虑头痛诊断亚组的情况下考虑不良事件数据时，SSRI与安慰剂因不良事件导致的撤药率无显著差异（Peto比值比1.02；95%可信区间0.31至3.34）。对于轻微不良事件，SSRI通常比三环类药物耐受性更好（比值比0.34；95%可信区间0.13至0.92）。然而，SSRI组和三环类药物组因任何原因撤药的患者数量无差异（比值比1.01；95%可信区间0.56至1.80）。
在偏头痛患者中，治疗超过2个月时，SSRI并不比安慰剂更有效。在慢性TTH患者中，SSRI不如三环类抗抑郁药有效。与SSRI相比，接受三环类药物治疗患者的不良事件负担更大。这些结果基于短期试验，可能不适用于长期治疗。
