BACKGROUND: The Joint Working Group of the Royal Colleges of
Physicians, Psychiatrists and General Practitioners (1996)
recommended graded exercise and antidepressants for patients
with chronic fatigue syndrome. We assessed efficacy and
acceptability of these treatments.
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prospective randomised placebo and therapist contact time
controlled trial with allocation to one of four treatment
cells: exercise and 20 mg fluoxetine, exercise and placebo
drug, appointments only and 20 mg fluoxetine, appointments and
placebo drug. Drug treatment was double blind and patients
were blind to assignment to exercise or appointments.
Ninety-six (71%) of 136 patients completed the trial. Patients
were more likely to drop out of exercise than non-exercise
treatment (P = 0.05). In an intention to treat analysis,
exercise resulted in fewer patients with case level fatigue
than appointments only at 26 weeks (12 (18%) v. 4 (6%)
respectively P = 0.025) and improvement in functional work
capacity at 12 (P = 0.005) and 26 weeks (P = 0.03). Fluoxetine
had a significant effect on depression at week 12 only (P =
0.04). Exercise significantly improved health perception (P =
0.012) and fatigue (P = 0.028) at 28 weeks.
Graded exercise produced improvements in functional work
capacity and fatigue, while fluoxetine improved depression