Vink Mark, Vink-Niese Alexandra
Independent Researcher, 1096 HZ Amsterdam, The Netherlands.
Independent Researcher, 30159 Hannover, Germany.
Healthcare (Basel). 2022 May 12;10(5):898. doi: 10.3390/healthcare10050898.
The British National Institute for Health and Care Excellence (NICE) recently published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded, after an extensive review of the literature, that graded exercise therapy (GET) is harmful and should not be used, and that cognitive behavioural therapy (CBT) is only an adjunctive and not a curative treatment. Leading proponents of the cognitive behavioural model (CBmodel) find it difficult to accept this paradigm shift. In, for example, an article in , they try to argue that the new NICE guideline is based on ideology instead of science. In this article we reviewed the evidence they used to support their claims. Our analysis shows that the trials they used in support suffered from serious flaws which included badly designed control groups, relying on subjective primary outcomes in non-blinded studies, including patients in their trials who didn't have the disease under investigation or had a self-limiting disease, selective reporting, outcome switching and making extensive endpoint changes, which created an overlap in entry and recovery criteria, using a post-hoc definition of recovery which included the severely ill, not publishing results that contradict their own conclusion, ignoring their own (objective) null effect, etc. The flaws in these trials all created a bias in favour of the interventions. Despite all these flaws, treatments that are said to lead to recovery in reality do not lead to objective improvement. Therefore, these studies do not support the claim that CBT and GET are effective treatments. Moreover, the arguments that are used to claim that NICE was wrong, in reality, highlight the absence of evidence for the safety and efficacy of CBT and GET and strengthen the decision by NICE to drop CBT and GET as curative treatments for ME/CFS.
英国国家卫生与临床优化研究所(NICE)最近发布了关于肌痛性脑脊髓炎/慢性疲劳综合征(ME/CFS)的更新指南。NICE在对文献进行广泛审查后得出结论,分级运动疗法(GET)有害,不应使用,认知行为疗法(CBT)只是一种辅助治疗,而非治愈性治疗。认知行为模型(CBmodel)的主要支持者发现很难接受这一范式转变。例如,在某篇文章中,他们试图辩称新的NICE指南是基于意识形态而非科学。在本文中,我们审查了他们用于支持其主张的证据。我们的分析表明,他们用于支持的试验存在严重缺陷,包括对照组设计糟糕、在非盲法研究中依赖主观主要结局、在试验中纳入没有所研究疾病或患有自限性疾病的患者、选择性报告、结果转换和进行大量终点更改,这导致纳入和恢复标准重叠、使用包括重症患者在内的事后恢复定义、不发表与自己结论相矛盾的结果、忽视自己(客观)的无效结果等。这些试验中的缺陷都造成了有利于干预措施的偏差。尽管存在所有这些缺陷,但据称能导致康复的治疗实际上并未带来客观改善。因此,这些研究并不支持CBT和GET是有效治疗方法的说法。此外,那些声称NICE错误的论点,实际上凸显了缺乏CBT和GET安全性和有效性的证据,并强化了NICE放弃将CBT和GET作为ME/CFS治愈性治疗方法的决定。