The Bulletin of the International Association for CFS/ME has published an assesment of the process for ‘Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’.
ABSTRACT:
Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomised controlled trials (RCTs), particularly of nonpharmacologic interventions. To rectify this situation, the Consolidated Standards of Reporting Trials (CONSORT) group and other researchers have issued guidance to improve the reporting of harms. Graded Exercise Therapy
(GET) and Cognitive Behavioural Therapy (CBT) based on increasing activity levels are often recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys. Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.
Using the CONSORT guidelines as a starting point, this paper identifies problems with the reporting of harms in previous RCTs and suggests potential strategies for improvement in the future. Issues involving the heterogeneity of subjects and interventions, tracking of adverse events, trial participants’ compliance to therapies, and measurement of harms using patient-oriented and objective outcome measures are discussed. The recently published PACE (Pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial which explicitly aimed to assess “safety”, as well as effectiveness, is also analysed in detail. Healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET.
FROM THE CONCLUSION:
It is hoped that this paper will lead to a greater focus on the reporting of harms in ME/CFS, not just those that might be associated with GET or CBT, but from any posited treatment.
Interventions should not be presumed to be harmless when there exists evidence of potential harm and there have not been well-planned systematic methods to track and assess harms both within and outside trials. Potential strategies to improve reporting of harms are summarized in Table 3.
ME/CFS research should at least conform to standards being recommended for the majority of medical research while taking into account the unique features of the disease, such as its relapsing-remitting nature. Moreover, in the ME/CFS field, comparisons are often not made just within the classes of pharmacologic interventions and non- pharmacologic interventions but also between pharmacologic and non-pharmacologic treatments. False conclusions could be reached that a non-pharmacologic intervention is “safer” than a pharmacologic agent if harms-related data was collected more rigorously for the latter.
Individuals with ME/CFS can face many challenges and have not always been treated as well as they should have been by healthcare professionals. Many feel that their symptoms have been downplayed and their negative experiences of some treatments ignored.
