RANDOMIZED TRIAL OF PLASMA-EXCHANGE, INTRAVENOUS IMMUNOGLOBULIN, AND COMBINED TREATMENTS IN GUILLAIN-BARRE-SYNDROME

Background The relative efficacy of plasma exchange (PE) and intraveno us immunoglobulin (IVIg) for the treatment of Guillain-Barre syndrome has not been established. We compared PE with IVIg, and with a combine d regimen of PE followed by IVIg, in an international, multicentre, ra ndomised trial of 383 adult patients with Guillain-Barre syndrome. Met hods The patients were randomly assigned PE (five 50 mL/kg exchanges o ver 8-13 days), IVIg (Sandoglobulin, 0.4 g/kg daily for 5 days), or th e PE course immediately followed by the IVIg course. The inclusion cri teria were severe disease (aid needed for walking) and onset of neurop athic symptoms within the previous 14 days. Patients were followed up for 48 weeks. Findings Four patients were excluded because they did no t meet the randomisation criteria. All the remaining 379 patients were assessed for the major outcome criterion-change on a seven-point disa bility grade scale-by an observer unaware of treatment assignment, 4 w eeks after randomisation. At that time, the mean improvement was 0.9 ( SD 1.3) in the 121 PE-group patients, 0.8 (1.3) in the 130 IVIg-group patients, and 1.1 (1.4) in the 128 patients who received both treatmen ts (intention-to-treat analysis). None of the differences between the groups for this major outcome criterion was significant. The differenc e between PE alone and IVIg alone was so small that a 0.5 grade differ ence was excluded at the 95% level of confidence. There was no signifi cant difference between any of the treatment groups in the secondary o utcome measures: time to recovery of unaided walking, time to disconti nuation of ventilation, and trend describing the recovery from disabil ity up to 48 weeks. There was a non-significant trend towards a more f avourable outcome on some outcome measures with combined treatment. In terpretation In treatment of severe Guillain-Barre syndrome during the first 2 weeks after onset of neuropathic symptoms, PE and IVIg had eq uivalent efficacy. The combination of PE with IVIg did not confer a si gnificant advantage.