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Meta-Analysis
. 2014 Sep 19;2014(9):CD002063.
doi: 10.1002/14651858.CD002063.pub6.

Intravenous immunoglobulin for Guillain-Barré syndrome

Richard A C Hughes  1 , Anthony V Swan, Pieter A van Doorn
Affiliations
Meta-Analysis

Intravenous immunoglobulin for Guillain-Barré syndrome

Richard A C Hughes et al. Cochrane Database Syst Rev. .

Abstract

Background: Guillain-Barré syndrome (GBS) is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin (IVIg) is beneficial in other autoimmune diseases. This is an update of a review first published in 2001 and previously updated in 2003, 2005, 2007, 2010 and 2012. Other Cochrane systematic reviews have shown that plasma exchange (PE) significantly hastens recovery in GBS compared with supportive treatment alone, and that corticosteroids alone are ineffective.

Objectives: We had the following four objectives.1. To examine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the long-term morbidity from Guillain-Barré syndrome (GBS).2. To determine the most efficacious dose of IVIg in hastening recovery and reducing the long-term morbidity from GBS.3. To compare the efficacy of IVIg and plasma exchange (PE) or immunoabsorption in hastening recovery and reducing the long-term morbidity from GBS.4. To compare the efficacy of IVIg added to PE with PE alone in hastening recovery and reducing the long-term morbidity from GBS.

Search methods: We searched the Cochrane Neuromuscular Disease Group Specialized Register (2 December 2013), CENTRAL (2013, Issue 12 in The Cochrane Library), MEDLINE (January 1966 to November 2013) and EMBASE (January 1980 to November 2013). We checked the bibliographies in reports of the randomised trials and contacted the authors and other experts in the field to identify additional published or unpublished data.

Selection criteria: Randomised and quasi-randomised trials of IVIg compared with no treatment, placebo treatment, PE, or other immunomodulatory treatments in children and adults with GBS of all degrees of severity. We also included trials in which IVIg was added to another treatment.

Data collection and analysis: Two authors independently selected papers, extracted data and assessed quality. We collected data about adverse events from the included trials.

Main results: Twelve trials were found to be eligible for inclusion in this review. Seven trials with a variable risk of bias compared IVIg with PE in 623 severely affected participants. In five trials with 536 participants for whom the outcome was available, the mean difference (MD) of change in a seven-grade disability scale after four weeks was not significantly different between the two treatments: MD of 0.02 of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group; 95% confidence interval (CI) 0.25 to -0.20. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that IVIg significantly hastens recovery compared with supportive care. The primary outcome for this review, available for only one trial with 21 mildly affected children, showed significantly more improvement in disability grade after four weeks with IVIg than supportive treatment alone, MD 1.42, 95% CI 2.57 to 0.27.In one trial involving 249 participants comparing PE followed by IVIg with PE alone, the mean grade improvement was 0.2 (95% CI -0.14 to 0.54) more in the combined treatment group than in the PE alone group; not clinically significantly different, but not excluding the possibility of significant extra benefit. Another trial with 34 participants comparing immunoabsorption followed by IVIg with immunoabsorption alone did not reveal significant extra benefit from the combined treatment.Adverse events were not significantly more frequent with either treatment, but IVIg is significantly much more likely to be completed than PE.Small trials in children showed a trend towards more improvement with high-dose compared with low-dose IVIg, and no significant difference when the standard dose was given over two days rather than five days.

Authors' conclusions: A previous Cochrane review has shown that PE hastens recovery compared with supportive treatment alone. There are no adequate comparisons of IVIg with placebo in adults, but this review provides moderate quality evidence that, in severe disease, IVIg started within two weeks from onset hastens recovery as much as PE. Adverse events were not significantly more frequent with either treatment but IVIg is significantly much more likely to be completed than PE. Also, according to moderate quality evidence, giving IVIg after PE did not confer significant extra benefit. In children, according to low quality evidence, IVIg probably hastens recovery compared with supportive care alone. More research is needed in mild disease and in patients whose treatment starts more than two weeks after onset. Dose-ranging studies are also needed and one is in progress.

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Conflict of interest statement

RACH has or has had consultancies with the following firms which manufacture immunoglobulin: Baxter, CSL Behring, Grifols/Talecris, LFB and Octapharma. He was the principal investigator of a randomised trial included in this review.

PAvD and his institution have received consultancy fees from Talecris, CSL Behring and Baxter for membership of the Scientific boards of the ICE trial in CIDP, IVIg in chronic polyneuropathy, and IVIg and ScIgG in CIDP, respectively.

PAvD's department has the following grants or grants pending: from Baxter to conduct a RCT comparing IVIg vs IVIg and steroids in GBS, from Sanquin to conduct a RCT investigating the effect of a second course of IVIg (SID‐trial) in GBS patients with a poor prognosis, and from Talecris to conduct a prospective international study on the effect of a second course of IVIg in GBS patients with a poor prognosis.

AVS has no known commercial conflicts of interest. He was involved as a statistician in a randomised trial of IVIg in GBS.

This review is not compliant with the Cochrane Commercial Sponsorship Policy. An update is under way of which the majority of review authors and the lead author are free of conflicts.

Figures

1
1
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
2
2
Forest plot of comparison: 2 IVIg versus PE, outcome: 2.1 Change in disability grade 4 weeks after randomisation.
3
3
Forest plot of comparison: 2 IVIg versus PE, outcome: 2.2 Number improved by 1 or more disability grades after 4 weeks.
4
4
Forest plot of comparison: 2 IVIg versus PE, outcome: 2.3 Death.
5
5
Forest plot of comparison: 2 IVIg versus PE, outcome: 2.8 Number of patients with adverse events attributed to treatment.
1.1
1.1. Analysis
Comparison 1 IVIg versus no treatment, Outcome 1 Change in disability grade 4 weeks after randomisation.
2.1
2.1. Analysis
Comparison 2 IVIg versus PE, Outcome 1 Change in disability grade 4 weeks after randomisation.
2.2
2.2. Analysis
Comparison 2 IVIg versus PE, Outcome 2 Number improved by 1 or more disability grades after 4 weeks.
2.3
2.3. Analysis
Comparison 2 IVIg versus PE, Outcome 3 Death.
2.4
2.4. Analysis
Comparison 2 IVIg versus PE, Outcome 4 Dead or disabled after 12 months (48 weeks).
2.5
2.5. Analysis
Comparison 2 IVIg versus PE, Outcome 5 Relapse or treatment‐related fluctuation.
2.6
2.6. Analysis
Comparison 2 IVIg versus PE, Outcome 6 Patients in whom treatment was discontinued.
2.7
2.7. Analysis
Comparison 2 IVIg versus PE, Outcome 7 Multiple complications.
2.8
2.8. Analysis
Comparison 2 IVIg versus PE, Outcome 8 Number of patients with adverse events attributed to treatment.
2.9
2.9. Analysis
Comparison 2 IVIg versus PE, Outcome 9 Change in disability grade after 4 weeks in patients with a history of diarrhoea.
2.10
2.10. Analysis
Comparison 2 IVIg versus PE, Outcome 10 Change in disability grade after 4 weeks in patients who were being ventilated at randomisation.
3.1
3.1. Analysis
Comparison 3 PE followed by IVIg compared with PE alone, Outcome 1 Change in disability grade 4 weeks after randomisation.
3.2
3.2. Analysis
Comparison 3 PE followed by IVIg compared with PE alone, Outcome 2 Death.
3.3
3.3. Analysis
Comparison 3 PE followed by IVIg compared with PE alone, Outcome 3 Dead or disabled after 1 year.
3.4
3.4. Analysis
Comparison 3 PE followed by IVIg compared with PE alone, Outcome 4 Relapse or treatment‐related fluctuation.
3.5
3.5. Analysis
Comparison 3 PE followed by IVIg compared with PE alone, Outcome 5 Number improved by 1 disability grade after 4 weeks.
4.1
4.1. Analysis
Comparison 4 Immunoabsorption (IA) followed by IVIg compared with IA alone, Outcome 1 Improvement in disability grade 4 weeks after randomisation.
5.1
5.1. Analysis
Comparison 5 IVIg versus immunoabsorption (IA), Outcome 1 Change in disability grade 4 weeks after randomisation.
5.2
5.2. Analysis
Comparison 5 IVIg versus immunoabsorption (IA), Outcome 2 Death.
6.1
6.1. Analysis
Comparison 6 IVIg low dose (1.2 g/kg) versus high dose (2.4 g/kg), Outcome 1 Change in disability grade 4 weeks after randomisation.
7.1
7.1. Analysis
Comparison 7 Comparison of IVIg 1.0 g/kg daily for 2 days with 0.4 g/kg daily for 5 days, Outcome 1 Disability grade change 4 weeks after randomisation.
See this image and copyright information in PMC

Update of

References

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References to other published versions of this review

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