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J Neurol Neurosurg Psychiatry 77:61-65 doi:10.1136/jnnp.2004.046227
  • Paper

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

  1. M P J Garssen1,
  2. P I M Schmitz2,
  3. I S J Merkies4,
  4. B C Jacobs1,3,
  5. F G A van der Meché1,
  6. P A van Doorn1
  1. 1Department of Neurology, Erasmus Medical Center Rotterdam, the Netherlands
  2. 2Department of Statistics, Erasmus Medical Center Rotterdam, the Netherlands
  3. 3Department of Immunology, Erasmus Medical Center Rotterdam, the Netherlands
  4. 4Department of Neurology, Spaarne Hospital, Haarlem, the Netherlands
  1. 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
  • Received 24 May 2004
  • Accepted 4 July 2005
  • Revised 7 June 2005

Abstract

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.

Footnotes

  • Competing interests: none

  • Ethics approval: The study was approved by the ethics committee of Erasmus Medical Center in May 2000. Informed consent was obtained.

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