Combining cognitive-behavioral therapy and milnacipran for fibromyalgia: a feasibility randomized-controlled trial.
Combining cognitive-behavioral therapy and milnacipran for fibromyalgia: a feasibility randomized-controlled trial.
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DOI：
10.1097/ajp.0b013e31827a784e
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发表时间：
2013-09
期刊：
影响因子：
--
通讯作者：
Saha C
中科院分区：
文献类型：
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作者：
Ang DC;Jensen MP;Steiner JL;Hilligoss J;Gracely RH;Saha C
评估随机对照试验（RCT）的可行性，并获得认知行为疗法（CBT）和米那普仑联合治疗纤维肌痛（FM）的疗效估计。58例FM患者被随机分配至3个治疗组之一：（1）联合治疗（n=20），（2）米那普仑+教育（n=19），（3）安慰剂+ CBT（n=19）。受试者接受米那普仑（100 mg/天）或安慰剂。受试者还接受了8次电话传递的CBT或教育指导，但仅从基线到第9周。在基线、第9周和第21周进行评估。主要终点为基线至第21周每周平均疼痛强度和身体功能（SF-36身体功能量表）的变化。与米那普仑相比，联合治疗对改善SF-36身体功能（平均差异（SE）= 9.42（5.48），p=0.09，效应量（ES）=0.60）和降低每周平均疼痛强度（平均差异（SE）=-1.18（0.62），p=0.07，ES=0.67）具有中度影响。与米那普仑相比，CBT在改善SF-36身体功能方面具有中度至重度影响（平均差异（SE）= 11.0（5.66），p=0.06，ES=0.70）。尽管存在伴随中枢作用治疗，但脱落率低于预期（第21周为15%）。重要的是，89%的受试者成功完成了8个基于电话的治疗会话中的至少6个;并且对治疗方案的依从性> 95%。在这项初步研究中，结合基于电话的CBT和米那普仑的治疗方法是可行的和可接受的。此外，初步数据支持进行完全有效的RCT。
To evaluate the feasibility of a randomized-controlled trial (RCT) and to obtain estimates of the effects of combined cognitive behavioral therapy (CBT) and milnacipran for the treatment of fibromyalgia (FM). Fifty eight patients with FM were randomized to one of the 3 treatment arms: (1) combination therapy (n=20), (2) milnacipran + education (n=19), and (3) placebo + CBT (n=19). Subjects received either milnacipran (100 mg/day) or placebo. Subjects also received 8 sessions of phone-delivered CBT or educational instructions, but only from baseline to week 9. Assessments were conducted at baseline, week 9 and 21. The primary endpoints were baseline to week 21 changes in weekly average pain intensity and physical function (SF-36 physical function scale). Compared to milnacipran, combination therapy demonstrated a moderate effect on improving SF-36 physical function (mean difference (SE) = 9.42 (5.48), p=0.09, effect size (ES) =0.60) and in reducing weekly average pain intensity (mean difference (SE) = −1.18 (0.62), p=0.07, ES=0.67). Compared to milnacipran, CBT had a moderate to large effect in improving SF-36 physical function (mean difference (SE) = 11.0 (5.66), p=0.06, ES=0.70). Despite the presence of concomitant centrally-acting therapies, dropout rate was lower than anticipated (15% at week 21). Importantly, at least 6 out of the 8 phone-based therapy sessions were successfully completed by 89% of the subjects; and adherence to the treatment protocols was >95%. In this pilot study, a therapeutic approach that combines phone-based CBT and milnacipran was feasible and acceptable. Moreover, the preliminary data supports conducting a fully powered RCT.