Institute of Social and Preventive Medicine (ISPM), University of Bern, and CTU Bern, Bern University Hospital, Bern, Switzerland.
Ann Rheum Dis. 2013 Jun;72(6):955-62. doi: 10.1136/annrheumdis-2011-201249. Epub 2012 Jun 27.
To synthesise the available evidence on pharmacological and non-pharmacological interventions recommended for fibromyalgia syndrome (FMS).
Electronic databases including MEDLINE, PsycINFO, Scopus, the Cochrane Controlled Trials Registry and the Cochrane Library were searched for randomised controlled trials comparing any therapeutic approach as recommended in FMS guidelines (except complementary and alternative medicine) with control interventions in patients with FMS. Primary outcomes were pain and quality of life. Data extraction was done using standardised forms.
102 trials in 14 982 patients and eight active interventions (tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors (SNRIs), the gamma-amino butyric acid analogue pregabalin, aerobic exercise, balneotherapy, cognitive behavioural therapy (CBT), multicomponent therapy) were included. Most of the trials were small and hampered by methodological quality, introducing heterogeneity and inconsistency in the network. When restricted to large trials with ≥100 patients per group, heterogeneity was low and benefits for SNRIs and pregabalin compared with placebo were statistically significant, but small and not clinically relevant. For non-pharmacological interventions, only one large trial of CBT was available. In medium-sized trials with ≥50 patients per group, multicomponent therapy showed small to moderate benefits over placebo, followed by aerobic exercise and CBT.
Benefits of pharmacological treatments in FMS are of questionable clinical relevance and evidence for benefits of non-pharmacological interventions is limited. A combination of pregabalin or SNRIs as pharmacological interventions and multicomponent therapy, aerobic exercise and CBT as non-pharmacological interventions seems most promising for the management of FMS.
综合现有关于纤维肌痛综合征（FMS）推荐的药理学和非药理学干预措施的证据。
检索电子数据库，包括 MEDLINE、PsycINFO、Scopus、Cochrane 对照试验登记处和 Cochrane 图书馆，以比较任何治疗方法与 FMS 指南推荐的对照干预措施（除补充和替代医学外）在 FMS 患者中的随机对照试验。主要结局为疼痛和生活质量。使用标准化表格进行数据提取。
纳入了 14982 名患者的 102 项试验和 8 种活性干预措施（三环类抗抑郁药、选择性 5-羟色胺再摄取抑制剂、5-羟色胺去甲肾上腺素再摄取抑制剂（SNRIs）、γ-氨基丁酸类似物普瑞巴林、有氧运动、水疗、认知行为疗法（CBT）、多组分疗法）。大多数试验规模较小，受到方法学质量的限制，导致网络中的异质性和不一致性。当限制在每组≥100 名患者的大型试验中时，异质性较低，与安慰剂相比，SNRIs 和普瑞巴林的益处具有统计学意义，但较小且无临床意义。对于非药理学干预措施，只有一项关于 CBT 的大型试验可用。在每组≥50 名患者的中等规模试验中，多组分疗法与安慰剂相比显示出较小到中度的益处，其次是有氧运动和 CBT。
FMS 中药物治疗的益处具有可疑的临床相关性，并且非药物干预措施的证据有限。将普瑞巴林或 SNRIs 作为药物干预措施，以及多组分疗法、有氧运动和 CBT 作为非药物干预措施相结合，似乎是治疗 FMS 的最有希望的方法。
