Randomised, double-blind, placebo-controlled study of fluoxetine in chronic fatigue syndrome.

Title: Randomised, double-blind, placebo-controlled study of fluoxetine in chronicfatigue syndrome.

Authors: Vercoulen JH, Swanink CM, Zitman FG, Vreden SG, Hoofs MP, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G
Location: Department of Medical Psychology, University Hospital, Nijmegen, TheNetherlands.

Source: Lancet 1996 Mar 30;347(9005):858-61


BACKGROUND: No somatic treatment has been found to be effective for chronicfatigue syndrome (CFS). Antidepressant therapy is commonly used. Fluoxetine is recommended in preference to tricyclic agents because it has fewer sedative and autonomic nervous system effects. However, there have been no randomised, placebo-controlled, double-blind studies showing the effectiveness of antidepressant therapy in CFS. We have carried out such astudy to assess the effect of fluoxetine in depressed and non-depressed CFSpatients.

METHODS: In this randomised, double-blind study, we recruited 44 patients to the depressed CFS group, and 52 to the non-depressed CFS group.In each group participants were randomly assigned to receive either fluoxetine (20 mg once daily) or placebo for 8 weeks. The effect of fluoxetine was assessed by questionnaires, self-observation lists, standard neuropsychological tests, and a motion-sensing device (Actometer), which were applied on the day treatment started and on the last day.

FINDINGS:The two groups were well matched in terms of age, sex distribution,employment and marital status, and duration of CFS. There were no significant differences between the placebo and fluoxetine-treated groups in the change during the 8-week treatment period for any dimension of CFS.There was no change in subjective assessments of fatigue, severity of depression, functional impairment, sleep disturbances, neuropsychological function, cognitions, or physical activity in the depressed or thenon-depressed subgroup.

INTERPRETATION: Fluoxetine in a 20 mg daily dose does not have a beneficial effect on any characteristic of CFS. The lack of effect of fluoxetine on depressive symptoms in CFS suggests that processes underlying the presentation of depressive symptoms in CFS may differ from those in patients with major depressive disorder.

Inez's note: Show this to your CFS doctor when he tries to prescribe Prozac. Of course, when a doctor prescribes Prozac, he usually also prescribes Trazadone (so you can sleep). If the doctor has any blank sheets left on his prescription pad, you'll probably get some Clonazepam (Klonopin) too. Klonopin is a very srong and addictive anti-seisure medicine; and in my opinion has no place on the shelf of a person suffering from CFS/FMS.

Another note: There is another article entitled "Randomized, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatgie syndrome" in Br J Psychiatry, 1998 Jun; 172:485-90. I do not what the conclusion of this study is.

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