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Amantadine for treatment of fatigue in Guillain-Barré syndrome: a randomised, double blind, placebo controlled, crossover trial

¹ Department of Neurology, Erasmus Medical Center Rotterdam, the Netherlands
² Department of Statistics, Erasmus Medical Center Rotterdam, the Netherlands
³ Department of Immunology, Erasmus Medical Center Rotterdam, the Netherlands
⁴ Department of Neurology, Spaarne Hospital, Haarlem, the Netherlands

Correspondence to:
Correspondence to:
Dr M P J Garssen
Department of Neurology, Erasmus Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, the Netherlands; m.garssen{at}erasmusmc.nl

Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied.

Methods: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of 5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life.

Results: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found.

Conclusions: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended.

Abbreviations: CIDP, chronic inflammatory demyelinating polyneuropathy; EHQ, EuroQoL Health Questionnaire; FIS, Fatigue Impact Scale; FSS, Fatigue Severity Scale; GBS, Guillain-Barré syndrome; HAD, Hospital Anxiety and Depression scale; MS, multiple sclerosis; RHS, Rotterdam Handicap Scale; SF-36, Short Form-36

Keywords: Guillain-Barré syndrome; treatment of fatigue; Amantadine

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