Amantadine for treatment of fatigue in Guillain-Barré syndrome: a randomised, double blind, placebo controlled, crossover trial
- 1Department of Neurology, Erasmus Medical Center Rotterdam, the Netherlands
- 2Department of Statistics, Erasmus Medical Center Rotterdam, the Netherlands
- 3Department of Immunology, Erasmus Medical Center Rotterdam, the Netherlands
- 4Department of Neurology, Spaarne Hospital, Haarlem, the Netherlands
- Correspondence to: Dr M P J Garssen Department of Neurology, Erasmus Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, the Netherlands;
- Received 24 May 2004
- Accepted 4 July 2005
- Revised 7 June 2005
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.
- 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
Competing interests: none
Ethics approval: The study was approved by the ethics committee of Erasmus Medical Center in May 2000. Informed consent was obtained.