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May 31, 2016

Caveat needed on ‘safe and effective’ declaration

Dear Editor,

Your recent article on the study in The Lancet refers to chronic fatigue syndrome and chronic fatigue indiscriminately and gives the impression that cognitive behavioural therapy (CBT) and graded exercise are “safe and effective for all” (‘Cognitive behavioural therapy not harmful in chronic fatigue’, Irish Medical Times, March 18, 2011, http://www.imt.ie/clinical/2011/03/cognitive-behavioural-therapy-not-harmful-in-chronic-fatigue.html).

The PACE criteria included post-exertional ‘fatigue’ as a key symptom, not ‘malaise’, and in any case no severely affected patients were included in the study.

For those ME patients who have the key symptom of post-exertional malaise, graded exercise has proved dangerous, as surveys by the major ME charities have repeatedly shown. Many patients with post-exertional malaise would refuse to take part in such a study, as they are well aware of the risk.

Would any drug for whom so many adverse effects have been reported been declared ‘safe and effective’ with no caveat, when selection criteria had been so broad and no trials had been done on the sickest patients?

Veronica Jones,
BA Hons (London) PGCE (Cantab),