Provigil Fails to Reduce Post-Polio Fatigue

A Bruno Byte
From Richard L. Bruno, HD, PhD
Director, International Centre for Polio Education

Randomized controlled trial of modafinil for the treatment of fatigue in postpolio patients.

Chan KM, et al. Muscle Nerve. 2006 Jan;33(1):138-41.

Abstract

The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores improved by 27 +/- 40% (mean +/- SD) following modafinil and by 43 +/- 36% following placebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.

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Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.

Vasconcelos OM, et al. Neurology. 2007 May 15;68(20):1680-6.

Abstract
OBJECTIVE:

To determine if modafinil can improve fatigue in patients with post-polio syndrome.

METHODS:

We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects.

RESULTS:

Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments.

CONCLUSION:

Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.