An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis

Twisk Fnm,Corsius Lamm

doi:10.15761/gmo.1000117

Abstract

An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis

Highlights

Myalgic Encephalomyelitis (ME) [1,2,3] and Chronic Fatigue Syndrome (CFS) [4] are considered to be controversial diseases [5,6]
To investigate if the proposed effectiveness of CBT+ in ME and CFS is substantiated by the data, we carried out an analysis of five hallmark studies conducted in the Netherlands, with a focus on the patients investigated in the studies, the subjective and objective measures and cut-off scores used to select participants and to define improvement or recovery, the consistency of the definitions of caseness and definitions of improvement or recovery, and the objective effects
2001 [7] concluded that “[CBT+] was significantly more effective than both control conditions for fatigue severity [..] and for functional impairment [..]” in CFS at 14 months. Both CBT+ and non-intervention had a positive effect on the means of the two primary outcomes, the CIS fatigue (CIS F) subscore [16] and the Sickness Impact Profile (SIP 8) score [18], the positive effect of CBT+ on these measures was significantly larger

Summary

Introduction

Myalgic Encephalomyelitis (ME) [1,2,3] and Chronic Fatigue Syndrome (CFS) [4] are considered to be controversial diseases [5,6]. The (bio)psychosocial model assumes a clear distinction between initiating factors, e.g. infections, predisposing factors, e.g. stress, and ‘illness-perpetuating’ factors [7]. In this model all symptoms can be fully explained by psychosocial ‘illnessperpetuating’ factors (cognitions and behaviour), which are fully independent from the initiating factors. Justified by this model two types of interventions have been developed: CBT, targeting “cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity), the latter being responsible for the symptoms”, and GET or graded activity (GA) aimed at gradually increasing activity to reverse ‘deconditioning’ [8]. In order to position the analysis of the five studies and the overall analysis, it is relevant to discuss two factors directly related to the claim that CBT+ is effective for CFS (ME): the participants studied (selection criteria: diagnostic criteria and additional criteria), and the type of measures to assess the symptoms (in order to diagnose patients) and to determine the effectiveness of interventions

Methods

Results

Discussion

Conclusion