Randomised, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome.
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Graded exercise produced improvements in functional work capacity and fatigue, while fluoxetine improved depression only.
Wearden
A J
AJ
University of Manchester, Department of Psychiatry, Withington Hospital.
Morriss
R K
RK
Mullis
R
R
Strickland
P L
PL
Pearson
D J
DJ
Appleby
L
L
Campbell
I T
IT
Morris
J A
JA
D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005081:Exercise Therapy / Q000379:methods*; D015673:Fatigue Syndrome, Chronic / Q000188:drug therapy* / Q000534:rehabilitation*; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome; D016312:Treatment Refusal
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine