Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Journal: Bulletin of the IACFS/ME. 2011;19(2):59-111
Author: Tom Kindlon
Affiliation:
Information Officer (voluntary position)
Irish ME/CFS Association
PO Box 3075, Dublin 2, Rep. of Ireland
Tel: +353-1-2350965
Email: tkindlon@maths.tcd.ie or info@irishmecfs.org
ABSTRACT
Across different medical fields, authors have placed a greater emphasis=20
on the reporting of efficacy measures than harms in randomised=20
controlled trials (RCTs), particularly of nonpharmacologic=20
interventions. To rectify this situation, the Consolidated Standards of=20
Reporting Trials (CONSORT) group and other researchers have issued=20
guidance to improve the reporting of harms. Graded Exercise Therapy=20
(GET) and Cognitive Behavioural Therapy (CBT) based on increasing=20
activity levels are often recommended for Myalgic=20
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). However,=20
exercise-related physiological abnormalities have been documented in=20
recent studies and high rates of adverse reactions to exercise have been=20
recorded in a number of patient surveys. Fifty-one percent of survey=20
respondents (range 28-82%, n=3D4338, 8 surveys) reported that GET worsene=
d=20
their health while 20% of respondents (range 7-38%, n=3D1808, 5 surveys)=20
reported similar results for CBT.
Using the CONSORT guidelines as a starting point, this paper identifies=20
problems with the reporting of harms in previous RCTs and suggests=20
potential strategies for improvement in the future. Issues involving the=20
heterogeneity of subjects and interventions, tracking of adverse events,=20
trial participants' compliance to therapies, and measurement of harms=20
using patient-oriented and objective outcome measures are discussed. The=20
recently published PACE (Pacing, graded activity, and cognitive=20
behaviour therapy: a randomised evaluation) trial which explicitly aimed=20
to assess "safety", as well as effectiveness, is also analysed in=20
detail. Healthcare professionals, researchers and patients need high=20
quality data on harms to appropriately assess the risks versus benefits=20
of CBT and GET.
[Full text in PDF:
http://www.iacfsme.org/LinkClick.aspx?fileticket=3DRd2tIJ0oHqk%3d&tabid=3D=
501 ]
=A9 2011 IACFS/ME
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