Hughes,Cochrane,2003

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GBS: i.v. immunoglobulin has same effect as plasma exchange

Inadequate evidence to compare iv immunoglobulin against supportive care alone.

Compared to plasma exchange, there was no increase in the rate of improvement of GBS disability score by one (standard end-point).

No added benefit of plasma exchange plus iv immunoglobulin versus plasma exchange alone: no evidence of improved recovery..

Level of Evidence 1⁺

Citation/s: Intravenous immunoglobulin for Guillain-Barre syndrome. Conchrane Database of Systematic Reviews. R Hughes, Department of Clinical Neurosciences, Guy's Hospital London. richard.a.hughes@kcl.ac.uk

Lead author's name and fax: R Hughes, Department of Cinical Neurosciences, Guy's Hospital, London. richard.a.hughes@kcl.ac.uk

Three-part Clinical Question: Does intravenous immunoglobulin improve outcome in Guillain Barre syndrome?

Search Terms: 1 guillain barre syndrome (16) (Cochrane Database of Syndrome Reviews)

The Review:

Data Sources: : Cochrane Library, Medline, Embase, Bibliographies of publ;ished trials and contacted authors plus "other experts".

Study Selection: Randomised and quasi-randomised trials. Studies of intravenous immunoglobulin versus standard supportive therapy, and intravenous immunoglobulin versus plasma exchange. All degrees of severity of GBS.

Data Extraction: Primary outcome measure improvement in GBS disability grade by 1. Secondary endpoints: till walking unaided; time to walking with an aid; till discontinuation of ventilation; mortality; proportion of patients dead or disabled; adverse events.

The studies were multiple independent reviews of individual reports. They were tested for heterogeneity.

The Evidence:

2 trials of iv immunoglobulin versus supportive treatment alone – insufficient to make judgement.

5 trials (536 patients: unable to walk unaided and had been ill for less than two weeks) of immunoglobulin v plasma exchange – no difference in treatment effect.

1 trial involving 249 patients of plasma exchange plus iv immunoglobulin versus plasma exchange alone – no evidence of benefit.

Adverse events: all trials reported more common (pooled) with plasma exchange, but different definitions used – not possible to combine results.

Comments:

1. No adequate comparison of iv immunoglobulin with placebo.

2. Intravenous immunoglobulin appears as good as plasma exchange. Immunoglobulin dose 0.4 mg/kg.

3. No evidence of benefit of adding iv immunoglobulin after plasma exchange.

4. Intravenous immunoglobulin is easier to give (no requirement for specialist teams or equipment) in comparison to plasma exchange.

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? Further RCTs needed to: define role in mild disease; use in children; role after 2 weeks of disease onset; and also to determine optimal dose.

6) Did they make any recommendations based on the results and were they appropriate? -YES.

7) Is the study relevant to my clinical practice? GBS is condition seen infrequently in ICU. Useful data on demographics and outcome of GBS.

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? Systematic review has pooled all available evidence.

11) Should I change my practice because of these results? No comparison against placebo. Intrravenous immunoglobulin seems to have similar effect to plasmapheresis. Easier to give and more likely to complete a course. Inconsistencies in reporting prevent comments on rates of adverse events. No evidence of benefit of adding iv immunoglobulin after plasma exchange.

12) Should I audit my current practice because of these results? Difficult: low incidence, limited data to collect / available to collect for individual practitioner / ICU; 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 2007

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