Vlaeyen J W, Teeken-Gruben N J, Goossens M E, Rutten-van Mölken M P, Pelt R A, van Eek H, Heuts P H
Institute for Rehabilitation Research, Hoensbroek, The Netherlands.
J Rheumatol. 1996 Jul;23(7):1237-45.
This randomized controlled clinical trial evaluates the effectiveness of outpatient group cognitive/educational treatment for patients with the fibromyalgia (FM) syndrome. We hypothesized that the combination of group education with cognitive treatment aimed at developing pain coping skills would be more effective than group education alone.
131 patients with FM were randomly assigned to 3 conditions: an experimental condition, which was the combined cognitive/educational intervention (ECO); an attention control condition consisting of group education plus group discussion (EDI); and a waiting list control (WLC). For the treatment conditions ECO and EDI, assessments were made 2 weeks before treatment, at start of treatment, at post-treatment, and at 6 and 12 mo followup. WLC patients received only 3 assessments.
There were no pretreatment differences between the groups, or between dropouts and patients who remained in the study. At post-treatment, and compared with the WLC, the ECO patients improved in knowledge about FM (p = 0.007) and pain coping (p < 0.001). EDI patients improved on pain coping (p = 0.005) and pain control (p = 0.002). EDI patients reported significantly less fear than ECO patients (p = 0.005). There were no other differential effects between ECO and EDI at post-treatment or 6 mo or 12 mo followup. Based on the reliability of change index for clinical significance, the relative short term success rates are 6.4 and 18.4% for ECO and EDI, respectively.
The surplus value of a highly structured, 12 session group cognitive treatment added to group education cannot be supported by our study. In EDI, fear reduction might have enhanced pain coping and pain control, while poor compliance, the difficulty of homework assignments, and lack of individual support may have limited the effectiveness of ECO.
本随机对照临床试验评估门诊小组认知/教育治疗对纤维肌痛（FM）综合征患者的有效性。我们假设，旨在培养疼痛应对技能的小组教育与认知治疗相结合，将比单纯的小组教育更有效。
131例FM患者被随机分配到3种情况：一种是实验情况，即认知/教育联合干预（ECO）；一种是注意力控制情况，包括小组教育加小组讨论（EDI）；还有一种是等待名单控制组（WLC）。对于治疗情况ECO和EDI，在治疗前2周、治疗开始时、治疗后以及6个月和12个月随访时进行评估。WLC组患者仅接受3次评估。
各小组之间，以及退出研究的患者与留在研究中的患者之间，治疗前均无差异。治疗后，与WLC组相比，ECO组患者在FM知识（p = 0.007）和疼痛应对（p < 0.001）方面有所改善。EDI组患者在疼痛应对（p = 0.005）和疼痛控制（p = 0.002）方面有所改善。EDI组患者报告的恐惧明显少于ECO组患者（p = 0.005）。在治疗后、6个月或12个月随访时，ECO和EDI之间没有其他差异效应。根据临床意义的变化指数可靠性，ECO和EDI的相对短期成功率分别为6.4%和18.4%。
我们的研究无法支持将高度结构化的、为期12节的小组认知治疗添加到小组教育中的额外价值。在EDI组中，恐惧减轻可能增强了疼痛应对和疼痛控制，而依从性差、家庭作业难度大以及缺乏个人支持可能限制了ECO的有效性。
