Reporting of Harms Associated with GET & CBT in ME/CFS

[Tom K.]

This is from a peer-reviewed journal.

Free full text at: http://iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk%3d&tabid=501&forcedownload=true

Reporting of Harms Associated with Graded Exercise Therapy and
Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome

Tom Kindlon
Information Officer (voluntary position)
Irish ME/CFS Association
PO Box 3075, Dublin 2, Rep. of Ireland
Tel: +353-1-2350965
Email: tkin...@maths.tcd.ie or in...@irishmecfs.org

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.

Bulletin of the IACFS/ME. 2011;19(2):59-111.

[Tom K.]

A summary is at: http://www.mediafire.com/?j3obuik5xu8gx19

The 25% ME Group adjusted it - mainly to include some quotes from one
of their surveys that was quoted from in the paper.
They have mentioned this in their latest mailing:
http://25megroup.org/campaigning_awareness.html#aware2012

This version can be downloaded from:
http://25megroup.org/Campaignging/ME%20TOPICS/Challenging%20Exercise%20&%20CBT/Tom%20Kindlon's_paper%20summary%20for%20website.doc