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GBS: Steroids don’t improve outcome
Lead author's name and fax: R van Knoningsveld, Department of Neurology, Erasmus University, Rotterdam. r.vankoningsveld@erasmusmc.nl
Three-part Clinical Question: What is the effect of adding steroids to standard therapy for Guillain Barre syndrome?
Search Terms: 1. exp guillain barre syndrome/ (997), 2. exp steroids/ (117448), 3. RCT filter (142816), 4. 1 and 2 and 3 (5)
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Recruited July 1994 - August 2000. Assessed GBS admissions in 32 participating centres. 285 assessed, 233 randomise. Inclusions: onset within 2 weeks, unable to walk 10 m unaided, consent. Exclusions: < 6 years old, allergy to blood products, IgA deficiency, pregnancy, steroid Rx, severe concurrent disease, not able to follow-up. Endpoint: improvement in GBS disability score ³ 1 at 4 weeks.
Control group (N = 117; 113 analysed): All patients received immunoglobulin 0.4 mg/kg per day for 5 consecutive days. Given identical placebo. Assessed GBS disability score (0=healthy, 1=minor symptoms, capable of running, 2=able to walk 10 m unassisted, but unable to run, 3=able to walk 10 over open space with help, 4=bedridden or chair bound, 5=needs ventilator at least for part of day, 6=dead.)
Experimental group (N = 116; 112 analysed): All patients received immunoglobulin 0.4 mg/kg per day for 5 consecutive days. Given 500 mg methylprednisolone for 5 days, within 48 h of starting immunoglobulin.
The Evidence:
EBM Comments: 1) Do the methods allow accurate testing of the hypothesis? - YES 2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? - YES 3) Are conclusions valid in light of the results? - YES 4) Did results get omitted, and why? - NO 5) Did they suggest areas of further research? The group concerned is still interested in identifying sub-groups who may benefit. 6) Did they make any recommendations based on the results and were they appropriate? No clear benefit. 7) Is the study relevant to my clinical practice? GBS is condition seen infrequently in ICU. Useful data on demographics and outcome of GBS (to tell our patients and their relatives). Multicentre study. Mortality rate in trial 4%. During treatment ventilator support needed by a fifth of patients (21% in steroid, 23% in placebo group). 8) What level of evidence does this study represent? Level 1+ evidence 9) What grade of recommendation can I make on this result alone? Grade A recommendation 10) What grade of recommendation can I make when this study is considered along with other available evidence? This is supported by work of Cochrane Group on role of steroids in GBS. 11) Should I change my practice because of these results? No evidence of benefit from steroids. If a patient requires a corticosteriod for another reason - it will probably not worsen the GBS: however note increased infection rate. For every 8 patients given methylprednisolone, compared to placebo, one extra urinary tract infection occurs (95% CI 4 to 40). 12) Should I audit my current practice because of these results? Difficult: low incidence, limited data to collect / available to collect for individual practitioner unit; unless solely neurological service.
Appraised by: Malcolm Daniel, Department of Anaesthesia, Glasgow Royal Infirmary, G4 0SF ; Monday, June 28, 2004 Email: md23s@udcf.gla.ac.uk Kill or Update By: August 2006.
©2004 Scottish Intensive Care Society Evidence-Based Medicine Group | |||||||||||||||||||||||||||||||||||
