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Data on harms done by CBT & GET therapies for ME/CFS

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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.

Source: Bulletin of the IACFS/ME, Fall 2011;19(2):59-111, by Kindlon T. Irish ME/CFS Association, Dublin, Republic of Ireland [Email: tkindlon@maths.tcd.ie or info@irishmecfs.org]

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2 thoughts on “Data on harms done by CBT & GET therapies for ME/CFS”

  1. QuayMan says:

    The paper is long and this might put some people off looking at it.

    But information that can be looked at without too much effort is Table 2 which is a summary of the survey results collated in Table 1. You don’t need to be able to understand fancy mathematics to understand the tables – they are just percentages and the like.

  2. spiketheartist says:

    This is a very important article for those who have severe Chronic Fatigue Syndrome and are besieged by oh-so-helpful friends who want to put you on an exercise program when you can barely get out of bed. This explains that, while most reports of trials of Graduated Exercise Training and Cognitive Behavioral Training focus only on the positive and short-term outcomes, there are often NEGATIVE outcomes from these trials, including increased fatigue, muscle pain, etc., with after-effects that might last for years. The possibility of negative outcomes seems to be higher the more severe the CFS is at the outset of these programs. Also, the article explains that very often severely fatigued CFS patients are excluded from these trials – one (ridiculously in my opinion) excluded everyone who could NOT work 40 hours a week.
    The possibility of increased fatigue, pain, etc. is especially likely in the case of a graduated exercise program. Table 2 at the end of the article shows that on average, 51% of the participants in the studies included showed a negative outcome.
    So as usual, the lesson I learn from this is that generally, if you have CFS, don’t push yourself to do anything you feel you cannot do.

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