Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomised trial

Abstract

SummaryBackground Despite available treatment with intravenous immunoglobulin (IVIg), morbidity and mortality are considerable in patients with Guillain-Barré syndrome (GBS). Our aim was to assess whether methylprednisolone, when taken with IVIg, improves outcome when compared with IVIg alone.Methods We did a double-blind, placebo-controlled, multicentre, randomised study, to which we enrolled patients who were unable to walk independently and who had been treated within 14 days after onset of weakness with IVIg (0·4 g/kg bodyweight per day) for 5 days. We assigned 233 individuals to receive either intravenous methylprednisolone (500 mg per day; n=116) or placebo (n=117) for 5 days within 48 h of administration of first dose of IVIg. Because age is an important prognostic factor, we split treatment groups into two age-groups-ie, younger than age 50 years, or 50 years and older. Our primary outcome was an improvement from baseline in GBS disability score of one or more grades 4 weeks after randomisation. Analysis was by intention to treat.Findings We analysed 225 patients. GBS disability scores increased by one grade or more in 68% (76 of 112) of patients in the methylprednisolone group and in 56% (63 of 113) of controls (odds ratio [OR] 1·68, 95% CI 0·97-2·88; p=0·06). After adjustment for age and degree of disability at entry, treatment OR was 1·89 (95% CI 1·07-3·35; p=0·03). Side-effects did not differ greatly between groups.Interpretation We noted no significant difference between treatment with methylprednisolone and IVIg and IVIg alone. Because of the relevance of prognostic factors and the limited side-effects of methylprednisolone, the potential importance of combination treatment with the drug and IVIg, however, warrants further investigation.

Guillain–Barré syndrome: a century of progress

“…Trials have examined whether combined plasma exchange and IVIg 89 , combined IVIg and steroids 90 or steroids alone 91 are more effective treatments. Disappointingly, none of these approaches have been superior to standard therapy in the long term, although a possible minor short-term benefit was seen with intravenous methylprednisone in addition to IVIg.…”

Mannose-Binding Lectin Contributes to the Severity of Guillain-Barré Syndrome

“…The protocol of this study was reviewed and approved by the Medical Ethical Committee of the Erasmus Medical Center, and all patients gave their written informed consent. Of these patients, 153 participated in one of the Dutch GBS trials and are therefore documented in detail (25,26). At randomization, these patients were clinically examined and pretreatment blood samples were obtained for screening for the most common antecedent infections in GBS (Campylobacter jejuni, CMV, EBV, and Mycoplasma pneumoniae) and the presence of the most frequent Abs in GBS to the gangliosides GM1 and GD1a (29,30).…”

Immunotherapy in Peripheral Neuropathies

“…In addition, in another RCT, the combination of PLEX followed by IVIG was not significantly better than PLEX or IVIG alone [16]. An interesting issue is the inefficacy of steroids in GBS, even when given as part of an IV regimen (IV methylprednisolone) in combination with IVIG [17].…”