Servicio de Psiquiatría, Hospital Miguel Servet y Universidad de Zaragoza, Instituto Aragonés de Ciencias de la Salud (I+CS), Red de Actividades Preventivas y de Promoción de la Salud (REDIAPP) (G06/170 and RD06/0018/0017), Avda Isabel La Catolica 1, 5009 Zaragoza, Spain.
Arthritis Res Ther. 2011;13(5):R173. doi: 10.1186/ar3496. Epub 2011 Oct 23.
No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.
We conducted a six-month, multicenter, randomized, blinded, parallel group, controlled trial in which patients were randomly assigned to one of three study arms: CBT (n = 57), RPT (n = 56) and TAU at the primary care level (n = 56). The major outcome of this study was PC in patients with fibromyalgia. The secondary variables were pain acceptance, depression, anxiety, pain, global function and quality of life.
CBT significantly decreased global PC at the six-month follow-up examination with effect sizes of Cohen's d = 0.73 and 1.01 compared with RPT and TAU, respectively. CBT was also more effective than RPT and TAU at increasing pain acceptance at the six-month follow-up examination (effect sizes of Cohen's d = 0.77 and 0.80, respectively). Compared with RPT and TAU, CBT was more effective at improving global function based on the Fibromyalgia Impact Questionnaire (six-month effect sizes Cohen's d = 0.44 and 0.53, respectively) and quality of life based on the European Quality of Life Scale (six-month effect sizes Cohen's d = 0.11 and 0.40, respectively). There were no differences among the three treatments with regard to pain and depression.
CBT shows higher efficacy than RPT and TAU not only in key outcomes in FM, such as function and quality of life, but also in relevant mediators of treatment effects, such as pain catastrophising and pain acceptance.
ISRCTN: ISRCTN10804772.
目前尚无关于心理和药物治疗对纤维肌痛患者疼痛灾难化（PC）疗效的随机对照试验。本研究旨在评估认知行为疗法（CBT）和推荐的药物治疗（RPT）与初级保健水平的常规治疗（TAU）相比，在治疗纤维肌痛患者 PC 方面的有效性。
我们进行了一项为期六个月、多中心、随机、双盲、平行组、对照试验，将患者随机分配至三个研究组之一：CBT（n = 57）、RPT（n = 56）和初级保健水平的 TAU（n = 56）。该研究的主要结局是纤维肌痛患者的 PC。次要变量是疼痛接受度、抑郁、焦虑、疼痛、整体功能和生活质量。
CBT 在六个月随访检查时显著降低了整体 PC，与 RPT 和 TAU 相比，Cohen's d 的效应大小分别为 0.73 和 1.01。CBT 在六个月随访检查时增加疼痛接受度也比 RPT 和 TAU 更有效（Cohen's d 的效应大小分别为 0.77 和 0.80）。与 RPT 和 TAU 相比，CBT 在基于纤维肌痛影响问卷的整体功能改善方面更有效（六个月时的 Cohen's d 效应大小分别为 0.44 和 0.53），在基于欧洲生活质量量表的生活质量改善方面更有效（六个月时的 Cohen's d 效应大小分别为 0.11 和 0.40）。三种治疗方法在疼痛和抑郁方面没有差异。
CBT 不仅在 FM 的关键结局（如功能和生活质量）方面，而且在治疗效果的相关中介因素（如疼痛灾难化和疼痛接受度）方面，均显示出比 RPT 和 TAU 更高的疗效。
ISRCTN：ISRCTN85067064。
