O'Dowd H, Gladwell P, Rogers C A, Hollinghurst S, Gregory A
Pain Management Centre, Frenchay Hospital, Bristol, UK.
Health Technol Assess. 2006 Oct;10(37):iii-iv, ix-x, 1-121. doi: 10.3310/hta10370.
To test the hypothesis that group cognitive behavioural therapy (CBT) will produce an effective and cost-effective management strategy for patients in primary care with chronic fatigue syndrome/myalgic encephalopathy (CFS/ME).
A double-blind, randomised controlled trial was adopted with three arms. Outcomes were assessed at baseline and 6 and 12 months after first assessment and results were analysed on an intention-to-treat basis.
A health psychology department for the management of chronic illness in a general hospital in Bristol, UK.
Adults with a diagnosis of CFS/ME referred by their GP.
The three interventions were group CBT incorporating graded activity scheduling, education and support group (EAS) and standard medical care (SMC).
The primary outcome measure was the Short Form with 36 Items (SF-36) physical and mental health summary scales. Other outcome measures included the Chalder fatigue scale, Hospital Anxiety and Depression Scale, General Health Questionnaire, physical function (shuttles walked, walking speed and perceived fatigue), health utilities index and cognitive function (mood, recall and reaction times).
A total of 153 patients were recruited to the trial and 52 were randomised to receive CBT, 50 to EAS and 51 to SMC. Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up, but not both. The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline. Three outcome measures, SF-36 mental health score, Chalder fatigue scale and walking speed, showed statistically significant differences between the groups. Patients in the CBT group had significantly higher mental health scores [difference +4.35, 95% confidence interval (CI) +0.72 to +7.97, p = 0.019], less fatigue (difference -2.61, 95% CI -4.92 to -0.30, p = 0.027) and were able to walk faster (difference +2.83 shuttles, 95% CI +1.12 to +5.53, p = 0.0013) than patients in the SMC group. CBT patients also walked faster and were less fatigued than those randomised to EAS (walking speed: difference +1.77, 95% CI +0.025 to +3.51, p = 0.047; fatigue: difference -3.16, 95% CI -5.59 to -0.74, p = 0.011). Overall, no other statistically significant difference across the groups was found, although for many measures a trend towards an improved outcome with CBT was seen. Except for walking speed, which, on average, increased by +0.87 shuttles (95% CI +0.09 to +1.65, p = 0.029) between the 6- and 12-month follow-ups, the scores were similar at 6 and 12 months. At baseline, 30% of patients had an SF-36 physical score within the normal range and 52% had an SF-36 mental health score in the normal range. At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients. For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%. Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health. For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively. The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions.
Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME. It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life. There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy. Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.
检验以下假设，即团体认知行为疗法（CBT）将为基层医疗中患有慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）的患者产生一种有效且具有成本效益的管理策略。
采用双臂双盲随机对照试验。在基线以及首次评估后的6个月和12个月对结果进行评估，并基于意向性分析原则对结果进行分析。
英国布里斯托尔一家综合医院中负责慢性病管理的健康心理学部门。
由其全科医生转诊的确诊为CFS/ME的成年人。
三种干预措施分别为包含分级活动安排的团体CBT、教育与支持组（EAS）以及标准医疗护理（SMC）。
主要结局指标为36项简明健康调查问卷（SF - 36）的身心健康汇总量表。其他结局指标包括查尔德疲劳量表、医院焦虑抑郁量表、一般健康问卷、身体功能（步行穿梭次数、步行速度和感知疲劳）、健康效用指数以及认知功能（情绪、记忆力和反应时间）。
共153名患者被纳入试验，52名被随机分配接受CBT，50名接受EAS，51名接受SMC。12名患者未参加12个月的随访，19名患者参加了一次随访，但并非两次随访都参加。研究发现该样本具有患者群体代表性，且三组在基线时的特征相似。三项结局指标，即SF - 36心理健康评分、查尔德疲劳量表和步行速度，在组间显示出统计学上的显著差异。CBT组患者的心理健康评分显著更高[差异 +4.35，95%置信区间（CI）+0.72至 +7.97，p = 0.019]，疲劳程度更低（差异 -2.61，95%CI -4.92至 -0.30，p = 0.027），并且比SMC组患者能够走得更快（差异 +2.83次穿梭，95%CI +1.12至 +5.53，p = 0.0013）。CBT组患者也比随机分配到EAS组的患者走得更快且疲劳程度更低（步行速度：差异 +1.77，95%CI +0.025至 +3.51，p = 0.047；疲劳：差异 -3.16，95%CI -5.59至 -0.74，p = 0.011）。总体而言，尽管在许多指标上CBT组有改善结果的趋势，但未发现组间其他具有统计学意义的差异。除了步行速度在6个月和12个月随访之间平均增加了 +0.87次穿梭（95%CI +0.09至 +1.65，p = 0.029）外，6个月和12个月时的评分相似。在基线时，30%的患者SF - 36身体评分在正常范围内，52%的患者SF - 36心理健康评分在正常范围内。在12个月时，CBT组46%的患者身体评分在正常范围内，EAS组为26%，SMC组为44%。对于心理健康评分，相应百分比分别为CBT组74%、EAS组67%和SMC组70%。在CBT组中，32%的患者身体功能至少提高了15%，64%的患者心理健康有类似改善。对于EAS组和SMC组，身体和心理健康的改善分别为40%和60%（EAS组）以及49%和53%（SMC组）。干预措施的成本效益极难评估，未得出可靠结论。
团体CBT未在主要结局指标上实现预期变化，因为相当数量的患者在干预后未达到正常范围内的评分。该治疗在这一领域未使大量受试者恢复到正常范围内；然而，在某些方面有显著改善。团体CBT在治疗CFS/ME患者的疲劳、情绪和身体素质症状方面有效。发现在这些领域它与使用个体治疗的试验效果一样。然而，它未带来认知功能或生活质量的改善。EAS组也有改善的证据，这表明治疗的非特异性效果价值有限。需要进一步研究以开发更好的结局指标、评估该疾病更广泛的成本以及更清楚地了解最适合这种干预类型的特征。
