Amantadine for treatment of fatigue in Guillain-Barre syndrome: a randomised, double blind, placebo controlled, crossover trial.
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 > or = 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.
Garssen
M P J
MP
Department of Neurology, Erasmus Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, the Netherlands. m.garssen@erasmusmc.nl
Schmitz
P I M
PI
Merkies
I S J
IS
Jacobs
B C
BC
van der Meché
F G A
FG
van Doorn
P A
PA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000547:Amantadine / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D018592:Cross-Over Studies; D003863:Depression / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D020275:Guillain-Barre Syndrome / Q000150:complications / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology
D000998:Antiviral Agents; D000547:Amantadine