关键词: CFS ME NICE chronic fatigue syndrome eminence-based medicine evidence-based medicine post-infectious disease

来  源:   DOI:10.3390/healthcare10050898

Abstract:
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 The Lancet, 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.
摘要:
英国国家健康与护理卓越研究所(NICE)最近发布了针对肌痛性脑脊髓炎/慢性疲劳综合征(ME/CFS)的最新指南。NICE总结道,在对文献进行了广泛的回顾之后,分级运动疗法(GET)是有害的,不应该使用,认知行为疗法(CBT)只是一种辅助治疗,而不是治愈性治疗。认知行为模型(CBmodel)的主要支持者发现很难接受这种范式转变。In,例如,《柳叶刀》上的一篇文章,他们试图争辩说,新的NICE指南是基于意识形态而不是科学。在本文中,我们回顾了他们用来支持其主张的证据。我们的分析表明,他们用于支持的试验存在严重缺陷,其中包括设计不当的对照组,在非盲研究中依赖于主观的主要结果,包括试验中没有被调查的疾病或患有自限性疾病的患者,选择性报告,结果转换和进行广泛的端点更改,这造成了进入和恢复标准的重叠,使用事后恢复的定义,其中包括重病,不发表与自己的结论相矛盾的结果,忽略他们自己的(客观)无效效果,等。这些试验中的缺陷都造成了对干预措施的偏见。尽管有这些缺陷,据说可以恢复的治疗方法并不能带来客观的改善。因此,这些研究不支持CBT和GET是有效治疗的说法.此外,用来声称NICE是错误的论点,在现实中,强调缺乏CBT和GET安全性和有效性的证据,并加强NICE决定放弃CBT和GET作为ME/CFS的治愈性治疗。
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