Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
– Source: Bulletin of the IACFS/ME, Fall 2011
By Tom Kindlon
[Note: The full text of this article is available at www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk%3D&tabid=501]
Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomized 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.
• 51% 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 behavior therapy: A randomized evaluation) trial, which explicitly aimed to assess “safety”, as well as effectiveness, is also analyzed in detail.
Healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET.