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.
RCT Entities:
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.
Authors: D Buljevac; H Z Flach; W C J Hop; D Hijdra; J D Laman; H F J Savelkoul; F G A van Der Meché; P A van Doorn; R Q Hintzen Journal: Brain Date: 2002-05 Impact factor: 13.501
Authors: Ingemar S J Merkies; Paul I M Schmitz; Frans G A Van Der Meché; Johnny P A Samijn; Pieter A Van Doorn Journal: Muscle Nerve Date: 2002-03 Impact factor: 3.217
Authors: M P J Garssen; J B J Bussmann; P I M Schmitz; A Zandbergen; T G Welter; I S J Merkies; H J Stam; P A van Doorn Journal: Neurology Date: 2004-12-28 Impact factor: 9.910