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

[Dolphin]

I'm mainly highlighting this study for one reason: they used a motion-sensing device as an outcome measure in a paper that was published 17.5 years ago (and probably was devised in the region of 20 years ago). Why did it take so long before they were used more widely?

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

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

Vercoulen JH, Swanink CM, Zitman FG, Vreden SG, Hoofs MP, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G.

Source
Department of Medical Psychology, University Hospital, Nijmegen, The Netherlands.

Abstract

BACKGROUND:

No somatic treatment has been found to be effective for chronic fatigue 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 a study to assess the effect of fluoxetine in depressed and non-depressed CFS patients.

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 the non-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.


PMID: 8622391 [PubMed - indexed for MEDLINE]

 

[wdb]

It's amazing how far ME psychological research methodology has come on in the last 17 years

 

[anciendaze]

Did anyone mention that most ME/CFS patients tolerate fluoxetine poorly?

 

[Snow Leopard]

Did anyone mention that most ME/CFS patients tolerate fluoxetine poorly?

Likewise, this study shows that Fluoxetine is ineffective for depression in CFS patients, yet it is still not uncommon for it to be prescribed. Why is that?

 

[Dolphin]

Likewise, this study shows that Fluoxetine is ineffective for depression in CFS patients, yet it is still not uncommon for it to be prescribed. Why is that?

It's interesting with evidence-based reviews that antidepressants tend to get an easy ride. All sorts of edicts can come down to not prescribe X drug, as it's not evidence-based but this doesn't tend to happen with antidepressants.

 

[Shell]

We need a smiley for banging head against wall!