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Selective serotonin reuptake inhibitors for fibromyalgia syndrome

机译:选择性5-羟色胺再摄取抑制剂治疗纤维肌痛综合征

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ABSTRACT BACKGROUND: Fibromyalgia is a clinically well-defined chronic condition with a biopsychosocial aetiology. Fibromyalgia is characterized by chronic widespread musculoskeletal pain, sleep problems, cognitive dysfunction, and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of fibromyalgia, drug therapy focuses on pain reduction and improvement of other aversive symptoms. OBJECTIVES: To assess the benefits and harms of selective serotonin reuptake inhibitors (SSRIs) in the treatment of fibromyalgia. METHODS: Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 5), MEDLINE (1966 to June 2014), EMBASE (1946 to June 2014), and the reference lists of reviewed articles. Selection criteria: We selected all randomized, double-blind trials of SSRIs used for the treatment of fibromyalgia symptoms in adult participants. We considered the following SSRIs in this review: citalopram, fluoxetine, escitalopram, fluvoxamine, paroxetine, and sertraline. Data collection and analysis: Three authors extracted the data of all included studies and assessed the risks of bias of the studies. We resolved discrepancies by discussion. MAIN RESULTS: The quality of evidence was very low for each outcome. We downgraded the quality of evidence to very low due to concerns about risk of bias and studies with few participants. We included seven placebo-controlled studies, two with citalopram, three with fluoxetine and two with paroxetine, with a median study duration of eight weeks (4 to 16 weeks) and 383 participants, who were pooled together. All studies had one or more sources of potential major bias. There was a small (10%) difference in patients who reported a 30% pain reduction between SSRIs (56/172 (32.6%)) and placebo (39/171 (22.8%)) risk difference (RD) 0.10, 95% confidence interval (CI) 0.01 to 0.20; number needed to treat for an additional beneficial outcome (NNTB) 10, 95% CI 5 to 100; and in global improvement (proportion of patients who reported to be much or very much improved: 50/168 (29.8%) of patients with SSRIs and 26/162 (16.0%) of patients with placebo) RD 0.14, 95% CI 0.06 to 0.23; NNTB 7, 95% CI 4 to 17. SSRIs did not statistically, or clinically, significantly reduce fatigue: standard mean difference (SMD) -0.26, 95% CI -0.55 to 0.03; 7.0% absolute improvement on a 0 to 10 scale, 95% CI 14.6% relative improvement to 0.8% relative deterioration; nor sleep problems: SMD 0.03, 95 % CI -0.26 to 0.31; 0.8 % absolute deterioration on a 0 to 100 scale, 95% CI 8.3% relative deterioration to 6.9% relative improvement. SSRIs were superior to placebo in the reduction of depression: SMD -0.39, 95% CI -0.65 to -0.14; 7.6% absolute improvement on a 0 to 10 scale, 95% CI 2.7% to 13.8% relative improvement; NNTB 13, 95% CI 7 to 37. The dropout rate due to adverse events was not higher with SSRI use than with placebo use (23/146 (15.8%) of patients with SSRIs and 14/138 (10.1%) of patients with placebo) RD 0.04, 95% CI -0.06 to 0.14. There was no statistically or clinically significant difference in serious adverse events with SSRI use and placebo use (3/84 (3.6%) in patients with SSRIs and 4/84 (4.8%) and patients with placebo) RD -0.01, 95% CI -0.07 to 0.05. AUTHORS' CONCLUSIONS: There is no unbiased evidence that SSRIs are superior to placebo in treating the key symptoms of fibromyalgia, namely pain, fatigue and sleep problems. SSRIs might be considered for treating depression in people with fibromyalgia. The black box warning for increased suicidal tendency in young adults aged 18 to 24, with major depressive disorder, who have taken SSRIs, should be considered when appropriate.
机译:摘要背景:纤维肌痛是一种临床上明确定义的具有生物社会心理病因的慢性病。纤维肌痛的特征是慢性广泛性肌肉骨骼疼痛,睡眠问题,认知功能障碍和疲劳。患者经常报告高残疾水平和较差的生活质量。由于没有改变纤维肌痛发病机理的特定治疗方法,药物治疗的重点是减轻疼痛和改善其他厌恶症状。目的:评估选择性5-羟色胺再摄取抑制剂(SSRIs)在治疗纤维肌痛中的利弊。方法:检索方法:我们检索了Cochrane对照试验中央注册簿(CENTRAL; 2014年第5期),MEDLINE(1966年至2014年6月),EMBASE(1946年至2014年6月)以及评论文章的参考文献清单。选择标准:我们选择了用于治疗成年参与者纤维肌痛症状的SSRI的所有随机,双盲试验。在本评价中,我们考虑了以下SSRI:西酞普兰,氟西汀,依西酞普兰,氟伏沙明,帕罗西汀和舍曲林。数据收集和分析:三位作者提取了所有纳入研究的数据,并评估了研究偏倚的风险。我们通过讨论解决了差异。主要结果:每个结果的证据质量很低。由于担心偏见风险和很少参与研究,我们将证据质量降至非常低。我们纳入了七项安慰剂对照研究,两项为西酞普兰,三项为氟西汀,两项为帕罗西汀,中位研究时间为八周(4至16周),共有383名参与者。所有研究都有一个或多个潜在的主要偏见来源。报告SSRI(56/172(32.6%))和安慰剂(39/171(22.8%))之间的疼痛减轻30%的患者之间存在很小的差异(10%),风险差异(RD)0.10,95%的置信度区间(CI)0.01至0.20;额外有益结局(NNTB)10、95%CI 5至100所需的治疗数字;总体改善(据报告有很大改善的患者比例:SSRIs患者为50/168(29.8%),安慰剂患者为26/162(16.0%))RD 0.14,95%CI 0.06至0.23; NNTB 7、95%CI 4到17。SSRIs并未在统计学上或临床上显着降低疲劳:标准平均差(SMD)-0.26,95%CI -0.55-0.03;在0到10的范围内,绝对值提高7.0%,95%CI相对改善14.6%,相对恶化0.8%;也没有睡眠问题:SMD 0.03,95%CI -0.26至0.31;在0到100的范围内,绝对劣化为0.8%,相对劣化的95%CI为8.3%,相对改进为6.9%。 SSRIs在减轻抑郁方面优于安慰剂:SMD -0.39,95%CI -0.65至-0.14;从0到10的绝对改善为7.6%,95%的CI为2.7%至13.8%的相对改善; NNTB 13,95%CI 7至37。SSRI使用不良事件导致的辍学率并不高于安慰剂使用(SSRI患者为23/146(15.8%),而SSRI患者为14/138(10.1%))安慰剂)RD 0.04,95%CI -0.06至0.14。使用SSRI和安慰剂的严重不良事件在统计学或临床上无显着差异(SSRI患者为3/84(3.6%),安慰剂患者为4/84(4.8%))RD -0.01,95%CI -0.07至0.05。作者的结论:没有公正的证据表明SSRIs在治疗纤维肌痛的关键症状(即疼痛,疲劳和睡眠问题)方面优于安慰剂。 SSRIs可考虑用于治疗纤维肌痛患者的抑郁症。在适当情况下,应考虑使用黑匣子警告,提示服用SSRI的18至24岁患有严重抑郁症的年轻人自杀倾向增加。

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