Randomised, double-blind, placebo-controlled treatment trial of fluoxetine & graded exercise for CFS

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.

METHOD: Six-month

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


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