Cochrane Review: Intravenous immunoglobulin for Guillain‐Barré syndrome
Abstract BackgroundGuillain‐Barré syndrome is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin is beneficial in other autoimmune diseases.ObjectivesWe aimed to determine the efficacy of intravenous immunoglobulin for Guillain‐Barré syndrome.Search strategyWe updated the searches of the Cochrane Neuromuscular Disease Group Trials Specialized Register, MEDLINE and EMBASE in June 2009 using the terms 'Guillain‐Barré syndrome' and 'acute polyradiculoneuritis' combined with 'intravenous immunoglobulin'.Selection criteriaWe included randomised and quasi‐randomised trials.Data collection and analysisTwo authors independently selected papers, extracted data and assessed quality.Main resultsAnother Cochrane systematic review has shown that plasma exchange significantly hastens recovery. In this review, five trials compared intravenous immunoglobulin with plasma exchange in 536 severely affected, mostly adult participants. The mean difference of change in a seven‐grade disability scale after four weeks was not significantly different between the two treatments: 0.02 (95% CI 0.25 to ‐0.20) of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that intravenous immunoglobulin significantly hastens recovery compared with supportive care.In one trial involving 249 participants comparing plasma exchange followed by intravenous immunoglobulin with plasma exchange alone, the mean grade improvement was 0.2 (95% CI ‐0.14 to 0.54) more in the combined treatment group than in the plasma exchange alone group, not significantly different but not excluding the possibility of significant extra benefit. Another trial with 37 participants comparing immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone did not reveal significant extra benefit from the combined treatment.Small trials in children showed a trend towards more improvement with high‐dose compared with low‐dose intravenous immunoglobulin and no significant difference when the standard dose was given over two days rather than five days.Authors' conclusionsA previous Cochrane review has shown that plasma exchange hastens recovery compared with supportive treatment alone. There are no adequate comparisons of intravenous immunoglobulin with placebo in adults but this review provides moderate quality evidence that, in severe disease, intravenous immunoglobulin started within two weeks from onset hastens recovery as much as plasma exchange. Adverse events were not significantly more frequent with either treatment but intravenous immunoglobulin is significantly much more likely to be completed than plasma exchange. Also according to moderate quality evidence, giving intravenous immunoglobulin after plasma exchange did not confer significant extra benefit. In children, according to low quality evidence, intravenous immunoglobulin 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.Plain Language SummaryIntravenous immunoglobulin for Guillain‐Barré syndromeGuillain‐Barré syndrome is an uncommon disease of the peripheral nerves. It causes weakness, numbness and breathing difficulty. Another Cochrane review has shown that plasma exchange (taking blood from one vein, separating the plasma from the blood cells and then returning the blood cells with a plasma substitute into another vein) is more effective than supportive care alone. In adults, moderate quality evidence shows that receiving intravenous immunoglobulin (antibodies that have been purified from donated blood) speeds recovery from severe Guillain‐Barré syndrome as much as plasma exchange. Intravenous immunoglobulin is slightly safer and much easier to give than plasma exchange. According to moderate quality evidence, intravenous immunoglobulin added to plasma exchange is not significantly more effective than either alone. A small amount of evidence suggests that intravenous immunoglobulin is also beneficial in children. More research is needed to determine the best dose in adults and children.
40
- 10.1111/j.1365-2133.1997.tb03773.x
- Sep 1, 1997
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260
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1702
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- Sep 22, 2008
105
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1
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219
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168
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197
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- Dec 1, 1984
- The Lancet
- Research Article
79
- 10.1016/j.jns.2020.117263
- Dec 9, 2020
- Journal of the Neurological Sciences
Guillain Barré Syndrome and its variants as a manifestation of COVID-19: A systematic review of case reports and case series
- Research Article
183
- 10.1371/journal.pmed.1003501
- Dec 30, 2020
- PLoS Medicine
BackgroundNumerous clinical trials and observational studies have investigated various pharmacological agents as potential treatment for Coronavirus Disease 2019 (COVID-19), but the results are heterogeneous and sometimes even contradictory to one another, making it difficult for clinicians to determine which treatments are truly effective.Methods and findingsWe carried out a systematic review and network meta-analysis (NMA) to systematically evaluate the comparative efficacy and safety of pharmacological interventions and the level of evidence behind each treatment regimen in different clinical settings. Both published and unpublished randomized controlled trials (RCTs) and confounding-adjusted observational studies which met our predefined eligibility criteria were collected. We included studies investigating the effect of pharmacological management of patients hospitalized for COVID-19 management. Mild patients who do not require hospitalization or have self-limiting disease courses were not eligible for our NMA. A total of 110 studies (40 RCTs and 70 observational studies) were included. PubMed, Google Scholar, MEDLINE, the Cochrane Library, medRxiv, SSRN, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov were searched from the beginning of 2020 to August 24, 2020. Studies from Asia (41 countries, 37.2%), Europe (28 countries, 25.4%), North America (24 countries, 21.8%), South America (5 countries, 4.5%), and Middle East (6 countries, 5.4%), and additional 6 multinational studies (5.4%) were included in our analyses. The outcomes of interest were mortality, progression to severe disease (severe pneumonia, admission to intensive care unit (ICU), and/or mechanical ventilation), viral clearance rate, QT prolongation, fatal cardiac complications, and noncardiac serious adverse events. Based on RCTs, the risk of progression to severe course and mortality was significantly reduced with corticosteroids (odds ratio (OR) 0.23, 95% confidence interval (CI) 0.06 to 0.86, p = 0.032, and OR 0.78, 95% CI 0.66 to 0.91, p = 0.002, respectively) and remdesivir (OR 0.29, 95% CI 0.17 to 0.50, p < 0.001, and OR 0.62, 95% CI 0.39 to 0.98, p = 0.041, respectively) compared to standard care for moderate to severe COVID-19 patients in non-ICU; corticosteroids were also shown to reduce mortality rate (OR 0.54, 95% CI 0.40 to 0.73, p < 0.001) for critically ill patients in ICU. In analyses including observational studies, interferon-alpha (OR 0.05, 95% CI 0.01 to 0.39, p = 0.004), itolizumab (OR 0.10, 95% CI 0.01 to 0.92, p = 0.042), sofosbuvir plus daclatasvir (OR 0.26, 95% CI 0.07 to 0.88, p = 0.030), anakinra (OR 0.30, 95% CI 0.11 to 0.82, p = 0.019), tocilizumab (OR 0.43, 95% CI 0.30 to 0.60, p < 0.001), and convalescent plasma (OR 0.48, 95% CI 0.24 to 0.96, p = 0.038) were associated with reduced mortality rate in non-ICU setting, while high-dose intravenous immunoglobulin (IVIG) (OR 0.13, 95% CI 0.03 to 0.49, p = 0.003), ivermectin (OR 0.15, 95% CI 0.04 to 0.57, p = 0.005), and tocilizumab (OR 0.62, 95% CI 0.42 to 0.90, p = 0.012) were associated with reduced mortality rate in critically ill patients. Convalescent plasma was the only treatment option that was associated with improved viral clearance rate at 2 weeks compared to standard care (OR 11.39, 95% CI 3.91 to 33.18, p < 0.001). The combination of hydroxychloroquine and azithromycin was shown to be associated with increased QT prolongation incidence (OR 2.01, 95% CI 1.26 to 3.20, p = 0.003) and fatal cardiac complications in cardiac-impaired populations (OR 2.23, 95% CI 1.24 to 4.00, p = 0.007). No drug was significantly associated with increased noncardiac serious adverse events compared to standard care. The quality of evidence of collective outcomes were estimated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The major limitation of the present study is the overall low level of evidence that reduces the certainty of recommendations. Besides, the risk of bias (RoB) measured by RoB2 and ROBINS-I framework for individual studies was generally low to moderate. The outcomes deducted from observational studies could not infer causality and can only imply associations. The study protocol is publicly available on PROSPERO (CRD42020186527).ConclusionsIn this NMA, we found that anti-inflammatory agents (corticosteroids, tocilizumab, anakinra, and IVIG), convalescent plasma, and remdesivir were associated with improved outcomes of hospitalized COVID-19 patients. Hydroxychloroquine did not provide clinical benefits while posing cardiac safety risks when combined with azithromycin, especially in the vulnerable population. Only 29% of current evidence on pharmacological management of COVID-19 is supported by moderate or high certainty and can be translated to practice and policy; the remaining 71% are of low or very low certainty and warrant further studies to establish firm conclusions.
- Discussion
2
- 10.1093/pm/pnaa371
- Oct 23, 2020
- Pain Medicine
Navigating the Gray Zone-Motor Weakness Due to Noncompressive Neuropathy: Experience at a Single Pain Clinic.
- Research Article
52
- 10.1002/14651858.cd002063.pub4
- Jun 16, 2010
- The Cochrane database of systematic reviews
Guillain-Barré syndrome is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin is beneficial in other autoimmune diseases. We aimed to determine the efficacy of intravenous immunoglobulin for Guillain-Barré syndrome. We updated the searches of the Cochrane Neuromuscular Disease Group Trials Specialized Register, MEDLINE and EMBASE in June 2009 using the terms 'Guillain-Barré syndrome' and 'acute polyradiculoneuritis' combined with 'intravenous immunoglobulin'. We included randomised and quasi-randomised trials. Two authors independently selected papers, extracted data and assessed quality. Another Cochrane systematic review has shown that plasma exchange significantly hastens recovery. In this review, five trials compared intravenous immunoglobulin with plasma exchange in 536 severely affected, mostly adult participants. The mean difference of change in a seven-grade disability scale after four weeks was not significantly different between the two treatments: 0.02 (95% CI 0.25 to -0.20) of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that intravenous immunoglobulin significantly hastens recovery compared with supportive care.In one trial involving 249 participants comparing plasma exchange followed by intravenous immunoglobulin with plasma exchange alone, the mean grade improvement was 0.2 (95% CI -0.14 to 0.54) more in the combined treatment group than in the plasma exchange alone group, not significantly different but not excluding the possibility of significant extra benefit. Another trial with 37 participants comparing immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone did not reveal significant extra benefit from the combined treatment.Small trials in children showed a trend towards more improvement with high-dose compared with low-dose intravenous immunoglobulin and no significant difference when the standard dose was given over two days rather than five days. A previous Cochrane review has shown that plasma exchange hastens recovery compared with supportive treatment alone. There are no adequate comparisons of intravenous immunoglobulin with placebo in adults but this review provides moderate quality evidence that, in severe disease, intravenous immunoglobulin started within two weeks from onset hastens recovery as much as plasma exchange. Adverse events were not significantly more frequent with either treatment but intravenous immunoglobulin is significantly much more likely to be completed than plasma exchange. Also according to moderate quality evidence, giving intravenous immunoglobulin after plasma exchange did not confer significant extra benefit. In children, according to low quality evidence, intravenous immunoglobulin 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.
- Research Article
468
- 10.1002/14651858.cd002063.pub6
- Sep 19, 2014
- The Cochrane database of systematic reviews
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. 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. 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. 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. Two authors independently selected papers, extracted data and assessed quality. We collected data about adverse events from the included trials. 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. 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.
- Research Article
87
- 10.1002/14651858.cd002063.pub5
- Jul 11, 2012
- The Cochrane database of systematic reviews
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 and 2010. 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. To determine the efficacy of IVIg for GBS. We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 August 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3), MEDLINE (January 1966 to August 2011) and EMBASE (January 1980 to August 2011). 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. 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. Two authors independently selected papers, extracted data and assessed quality. We collected data about adverse events from the included trials. 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.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 37 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. 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.
- Research Article
91
- 10.1002/14651858.cd002063.pub3
- Jan 25, 2006
- The Cochrane database of systematic reviews
Guillain-Barré syndrome is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin is beneficial in other autoimmune diseases. We aimed to determine the efficacy of intravenous immunoglobulin for treating Guillain-Barré syndrome. We searched the Cochrane Neuromuscular Disease Group Trials Register (March 2005), MEDLINE (January 1966 to March 2005) and EMBASE (January 1980 to March 2005) using the terms 'Guillain-Barré syndrome' and 'acute polyradiculoneuritis'. We included all randomised and quasi-randomised trials. Two authors independently selected papers, extracted data and assessed quality. Another Cochrane systematic review has shown that plasma exchange significantly hastens recovery. We found six randomised trials comparing intravenous immunoglobulin with plasma exchange. We undertook a meta-analysis of five trials involving 536, mostly adult participants who were unable to walk unaided and had been ill for less than two weeks. Our primary outcome measure was the change in a seven-grade disability scale four weeks after randomisation. The weighted mean difference of this measure was not statistically significant, being only -0.02 (95% confidence interval -0.25 to 0.20) of a disability grade more improvement in the intravenous immunoglobulin than the plasma exchange group. There were no statistically significant differences in other measures. One trial involving 249 participants compared plasma exchange followed by intravenous immunoglobulin with plasma exchange alone. Another involving 37 participants compared immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone. Neither revealed significant extra benefit from intravenous immunoglobulin. One study with 39 participants showed a trend towards more improvement with high-dose compared with low-dose intravenous immunoglobulin. Another trial with 51 children found no significant difference in outcome when the standard dose was given over two days rather than five days. Three studies including a total of 75 participants suggested that in children intravenous immunoglobulin significantly hastens recovery compared with supportive care. In adults, there are no adequate comparisons with placebo. Randomised trials in severe disease show that intravenous immunoglobulin started within two weeks from onset hastens recovery as much as plasma exchange, which is known to be more effective than supportive care. Treatment with intravenous immunoglobulin is significantly more likely to be completed than plasma exchange. Giving intravenous immunoglobulin after plasma exchange did not confer significant extra benefit. In children, intravenous immunoglobulin probably hastens recovery compared with supportive care alone. More research is needed in mild disease and in treatment starting more than two weeks after onset of the condition. Dose-ranging studies are also needed.
- Research Article
83
- 10.4103/0972-2327.83087
- Jan 1, 2011
- Annals of Indian Academy of Neurology
Guillain–Barre syndrome (GBS) is an acute onset, usually monophasic immune-mediated disorder of the peripheral nervous system. The term GBS is often considered to be synonymous with acute inflammatory demyelinating polyradiculoneuropathy (AIDP), but with the increasing recognition of variants over the past few decades, the number of diseases that fall under the rubric GBS have grown to include axonal variants and more restricted variants, such as Miller Fisher syndrome (MFS) [Table 1].[1] Table 1 Guillain–Barre syndrome—clinical variants Epidemiology The reported incidence rates for GBS are 1–2 per 100,000 population.[2–4] The lifetime likelihood of any individual acquiring GBS is 1:1000.[5] The subtypes of GBS have different incidence rates in different parts of the world. In Europe and North America AIDP is dominant contributing to 90% of the cases. In contrast in China and Japan AMAN being the most common subtype.[6,7] The picture is intermediate when we look at other population. In Indian series the incidence of AIDP and AMAN are virtually equal although AMAN is more common in younger patients.[8] There seems to be a slight preponderance of AIDP in studies by Gupta et al[9] and by Meena et al (unpublished data from NIMS, Hyderabad). Available Indian literature indicates a peak incidence between June–July and Sept–October.[10] In western countries, GBS is common in the 5th decade,[11] but in India it occurs more commonly at a younger age.[10,12] GBS is equally common in men and women and can occur at any age. There is a male preponderance among the hospitalized population.[10,12]
- Discussion
15
- 10.1212/wnl.62.9.1653-a
- May 10, 2004
- Neurology
Objective: To provide an evidence-based statement to guide physicians in the management of Guillain-Barre syndrome (GBS). Methods: Literature search and derivation of evidence-based statements concerning the use of immuno- therapy were performed. Results: Treatment with plasma exchange (PE) or IV immunoglobulin (IVIg) hastens recovery from GBS. Combining the two treatments is not beneficial. Steroid treatment given alone is not beneficial. Recommenda- tions: 1) PE is recommended for nonambulant adult patients with GBS who seek treatment within 4 weeks of the onset of neuropathic symptoms. PE should also be considered for ambulant patients examined within 2 weeks of the onset of neuropathic symptoms; 2) IVIg is recommended for nonambulant adult patients with GBS within 2 or possibly 4 weeks of the onset of neuropathic symptoms. The effects of PE and IVIg are equivalent; 3) Corticosteroids are not recommended for the management of GBS; 4) Sequential treatment with PE followed by IVIg, or immunoabsorption followed by IVIg is not recommended for patients with GBS; and 5) PE and IVIg are treatment options for children with severe GBS.
- Research Article
18
- 10.1016/j.ensci.2023.100468
- Jun 1, 2023
- eNeurologicalSci
Guillain- Barré syndrome (GBS) is a neuropathic condition that leads to the rapid development of impairments and is characterized by weakness and numbness or tingling sensation in the legs and arms and sometimes loss of movement and feeling in the legs, arms, upper body, and face. Currently, the cure for the disease is yet to be developed. However, treatment options such as intravenous immunoglobulin (IVIG) and plasma exchange (PE) have been used to minimize the symptoms and duration of the disease. Therefore, this systematic review and meta-analysis compared the efficacy of IVIG and PE in treating GBS patients with severe symptoms. Six electronic databases, including PubMed, Embase, Scopus, ScienceDirect, Medline, and Google scholar, were scoured for articles related and relevant to our research. Additionally, more studies were obtained through the reference lists of the studies retrieved from these electronic databases. Quality assessment and statistical data analysis were conducted using Review Manager software (RevMan 5.4.1). The search for relevant articles resulted in 3253 articles, of which only 20 were included for review in the current study. A sub-group analysis indicated no significant difference in the curative effect (Hughes score reduces by at least one score 4weeks after GBS treatment; OR: 1.00; 95% CI: 0.66-1.52; p=1.00 and Achieving grade 0 or 1 on Hughes scale; OR: 1.03; 95% CI: 0.27-3.94; p=0.97). Similarly, the statistical showed that the difference in length of hospitalization and duration of mechanical ventilation was insignificant between the IVIG and PE group (Standard Mean Difference (SMD): -0.45; 95% CI: -0.92, 0.02; I2=91%; p=0.06 and SMD: -0.54; 95% CI: -1.67, 0.59; I2=93%; p=0.35, respectively). Moreover, the meta-analysis did not find any significant difference in the risk of GBS relapse (RR: 0.47; 95% CI: 0.20-1.14; p=0.10) and risk of complications related to the treatment regimens (RR: 1.03; 95% CI: 0.71-1.48; p=0.89). However, the statistical analysis of outcomes from 3 studies showed that the risk of discontinuation was significantly lower in the IVIG group than in the PE group (RR: 0.22; 95% CI: 0.06-0.88; p=0.03). Our study suggests that IVIG and PE have similar curative effects. Similarly, IVIG seems easier to use and thus can be preferred for treating GBS.
- Research Article
1
- 10.1007/bf03259259
- Aug 1, 1994
- Clinical Immunotherapeutics
Guillain-Barre syndrome (GBS) is an acute immune-mediated demyelinating polyneuropathy that often results in severe muscular weakness. Most patients have an antecedent infection within the weeks before the onset of disease. GBS patients generally tend to recover spontaneously, but 20% of patients are still unable to walk independently at 6 months after the onset of disease. General medical care is essential for patients with GBS, but more specific treatment with plasma exchange significantly hastens recovery. High dosage intravenous immunoglobulin (IVIg) is at least as effective as plasma exchange, and may be superior. IVIg has some additional advantages over plasma exchange, because it is widely available, easy to administer and has hardly any contraindications. In clinical trials it was shown that relapse or treatment-related clinical fluctuation occurs in around 10% of GBS patients, irrespective of whether the patients were treated with plasma exchange or IVIg. When a GBS patient deteriorates during or shortly after a course of plasma exchange or IVIg, we recommend not to switch to the other treatment because plasma exchange, and probably IVIg also, is only effective when applied within the first 2 weeks of disease. It is impossible to decide for a single GBS patient whether a particular treatment is effective or not. This is partly due to the large clinical variation in the natural course of disease between individual patients. Subgroups of patients responding particularly favourably to plasma exchange or IVIg have not been identified. Although plasma exchange and IVIg treatment are important advances in the treatment of GBS, a considerable proportion of patients have significant clinical deficit many months or years after the onset of disease. The results of a recently completed nonblinded study suggest that the addition of methylprednisolone to IVIg is even more effective than IVIg alone. Whether this combined treatment is definitely superior to IVIg alone will be investigated in a randomised trial.
- Research Article
151
- 10.1002/14651858.cd001797.pub3
- Dec 30, 2013
- The Cochrane database of systematic reviews
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) causes progressive or relapsing weakness and numbness of the limbs, developing over at least two months. Uncontrolled studies suggest that intravenous immunoglobulin (IVIg) helps. This review was first published in 2002 and has since been updated, most recently in 2013. To review systematically the evidence from randomised controlled trials (RCTs) concerning the efficacy and safety of IVIg in CIDP. On 4 December 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, issue 11 in the Cochrane Library), MEDLINE and EMBASE to December 2012 and ISI from January 1985 to May 2008. We searched for ongoing trials through two metaRegistries (World Health Organization International Clinical Trials Registry Platform Search Portal and Current Controlled Trials). We selected RCTs testing any dose of IVIg versus placebo, plasma exchange or corticosteroids in definite or probable CIDP. Two authors reviewed literature searches to identify potentially relevant RCTs, scored their quality and extracted data independently. We contacted authors for additional information. We considered eight RCTs, including 332 participants, to be eligible for inclusion in the review. These trials were homogeneous and the overall risk of bias low. Five studies, in a total of 235 participants compared IVIg against placebo. One trial with 20 participants compared IVIg with plasma exchange, one trial compared IVIg with prednisolone in 32 participants, and one trial, newly included at this update, compared IVIg with intravenous methylprednisolone in 46 participants.A significantly higher proportion of participants improved in disability within one month after IVIg treatment as compared with placebo (risk ratio (RR) 2.40, 95% confidence interval (CI) 1.72 to 3.36; number needed to treat for an additional beneficial outcome 3.03 (95% CI 2.33 to 4.55), high quality evidence). Whether all these improvements are equally clinically relevant cannot be deduced from this analysis because each trial used different disability scales and definitions of significant improvement. In three trials, including 84 participants, the disability score could be transformed to the modified Rankin score, on which improvement of one point after IVIg treatment compared to placebo was barely significant (RR 2.40, 95% CI 0.98 to 5.83) (moderate quality evidence). Only one placebo-controlled study included in this review had a long-term follow-up. The results of this study suggest that IVIg improves disability more than placebo over 24 and 48 weeks.The mean disability score revealed no significant difference between IVIg and plasma exchange at six weeks (moderate quality evidence). There was no significant difference in improvement in disability on prednisolone compared with IVIg after two or six weeks, or on methylprednisolone compared to IVIg after two weeks or six months (moderate quality evidence).There were no statistically significant differences in frequencies of side effects between the three types of treatment for which data were available (IVg versus placebo or steroids). (moderate or high quality evidence) Mild and transient adverse events were found in 49% of participants treated with IVIg, while serious adverse events were found in six per cent. The evidence from RCTs shows that IVIg improves disability for at least two to six weeks compared with placebo, with an NNTB of three. During this period it has similar efficacy to plasma exchange, oral prednisolone and intravenous methylprednisolone. In one large trial, the benefit of IVIg persisted for 24 and possibly 48 weeks. Further research is needed to compare the long-term benefits as well as side effects of IVIg with other treatments.
- Research Article
84
- 10.1186/cc10305
- Jan 1, 2011
- Critical Care
IntroductionRespiratory failure is a life threatening complication of Guillain Barré syndrome (GBS). There is no consensus on the specific treatment for this subset of children with GBS.MethodsThis was a prospective randomized study to compare the outcome of intravenous immunoglobulin (IVIG) and plasma exchange (PE) treatment in children with GBS requiring mechanical ventilation. Forty-one children with GBS requiring endotracheal mechanical ventilation (MV) within 14 days from disease onset were included. The ages of the children ranged from 49 to 143 months.Randomly, 20 children received a five-day course of IVIG (0.4 g/kg/day) and 21 children received a five-day course of one volume PE daily. Lumbar puncture (LP) was performed in 36 patients (18 in each group).ResultsBoth groups had comparable age (p = 0.764), weight (p = 0.764), duration of illness prior to MV (p = 0.854), preceding diarrhea (p = 0.751), cranial nerve involvement (p = 0.756), muscle power using Medical Research Council (MRC) sum score (p = 0.266) and cerebrospinal fluid (CSF) protein (p = 0.606).Children in the PE group had a shorter period of MV (median 11 days, IQR 11.0 to 13.0) compared to IVIG group (median 13 days, IQR 11.3 to 14.5) with p = 0.037.Those in the PE group had a tendency for a shorter Pediatric Intensive Care Unit (PICU) stay (p = 0.094).A total of 20/21 (95.2%) and 18/20 (90%) children in the PE and IVIG groups respectively could walk unaided within four weeks after PICU discharge (p = 0.606).There was a negative correlation between CSF protein and duration of mechanical ventilation in the PE group (p = 0.037), but not in the IVIG group (p = 0.132).ConclusionsIn children with GBS requiring MV, PE is superior to IVIG regarding the duration of MV but not PICU stay or the short term neurological outcome.The negative correlation between CSF protein values and duration of MV in PE group requires further evaluation of its clinical usefulness.Trial RegistrationClinicaltrials.gov Identifier NCT01306578
- Research Article
3
- 10.3233/rnn-231369
- Jan 11, 2024
- Restorative neurology and neuroscience
Most previous studies comparing the effectiveness of Plasma Exchange (PE) or intravenous immunoglobulin (IVIG) in treating Guillain-Barre syndrome (GBS) have focused on the short-term outcome at around 1 month. To compare the long-term efficacy of PE and IVIG at one year in adult patients with GBS. Eighty-one adult patients with acute GBS were randomized into two groups with a ratio of 2 : 1: PE (N = 54) and IVIG (N = 27). Patients were assessed with the Medical Research Council sum score (MRC sum score), GBS Disability Scale (GDS), and Functional assessment of acute inflammatory neuropathy (FAAIN) at baseline, ten days, one month, three months, and one year. Neurophysiological examinations were performed at baseline and three months following treatment. There were no significant differences between groups in demographic, clinical, and laboratory data. Both treatments produced a significant improvement in all clinical rating scales in both groups that continued up to one year. There were significant differences in the time course of recovery in the MRC and FAAIN scales, with significantly more improvement in the IVIG group at 1 and 3 months, although there was no significant difference in outcome at one year. However the effect size showed measurable differences between the PE and IVIG groups across the different measures at one-year. Electrophysiological studies showed equal improvement in most measures in both groups at three months, with a slightly greater effect in the IVIG group. long term outcomes of IVIG and PE were equivalent. However the effect size showed measurable differences between the PE and IVIG groups across the different measures at one-year follow-up that indicate the superiorty of IVIG. There was also a tendency for improvement to be slightly faster in the IVIG group.
- Research Article
76
- 10.1002/14651858.cd002063.pub2
- Jan 26, 2004
- The Cochrane database of systematic reviews
Guillain-Barré syndrome is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin purified from donated blood is beneficial in other autoimmune diseases. We aimed to determine the efficacy of intravenous immunoglobulin for treating Guillain-Barré syndrome. We searched the Cochrane Neuromuscular Disease Group register (search updated 11 February 2003), MEDLINE and EMBASE (from January 2000 to February 2003) using Guillain-Barré syndrome and acute polyradiculoneuritis as the search terms. We also searched bibliographies of trials and made contact with their authors and other experts. We included all randomised and quasi-randomised trials. Two reviewers examined the titles and abstracts of all the papers retrieved by the search, extracted the data and assessed the quality of the trials independently. Two trials comparing intravenous immunoglobulin with supportive treatment were inadequate to establish its value. Another Cochrane systematic review has shown that plasma exchange hastens recovery. We found six randomised trials that compared intravenous immunoglobulin with plasma exchange. In a meta-analysis of five trials involving 536, mostly adult, participants who were unable to walk unaided and had been ill for less than two weeks. The primary outcome measure in this review was the change in a seven grade disability scale four weeks after randomisation. The weighted mean difference of this measure was not statistically significant, being only 0.04 (95% CI -0.26 to 0.19) of a disability grade more improvement in the intravenous immunoglobulin group than the plasma exchange group. There were also no statistically significant differences in time to walk unaided, mortality, and proportion of participants unable to walk without aid after a year. One trial involving 249 participants compared plasma exchange followed by intravenous immunoglobulin with plasma exchange alone, and another involving 37 participants compared immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone. Neither revealed significant extra benefit from intravenous immunoglobulin. One study of only 39 participants showed a trend towards more improvement with high-dose compared with low-dose intravenous immunoglobulin. Although there are no adequate comparisons with placebo, intravenous immunoglobulin hastens recovery from Guillain-Barré syndrome as much as plasma exchange. Giving intravenous immunoglobulin after plasma exchange is not significantly better than plasma exchange alone. Randomised trials are needed to decide the effect of intravenous immunoglobulin in children, in adults with mild disease and in adults who start treatment after more than two weeks.
- Research Article
16
- 10.1007/s11940-013-0231-z
- Apr 11, 2013
- Current Treatment Options in Neurology
Acute Inflammatory polyneuropathies are an important group of neuromuscular disorders and are referred to collectively as Guillain-Barré syndrome (GBS). Our knowledge regarding pathogenesis, diagnosis and management continues to expand, resulting in improved opportunities for identification and treatment. These autoimmune processes cause neuropathy by affecting various structures (myelin or axons), at different locations (nerve root, nerve cell bodies or peripheral nerve) with a variety of patterns. Most clinical neurologists will be involved in the management of patients with these disorders, and there are now a variety of reasonable therapies available for acquired demyelinating neuropathies. In this report, we review the distinctive clinical, laboratory and electro-diagnostic features that aid in their diagnosis, with emphasis on clinical characteristics that are of paramount importance in diagnosing specific conditions and determining the most appropriate therapies, and helpful in determining long-term prognosis.
- Research Article
18
- 10.1111/tme.12169
- Dec 16, 2014
- Transfusion medicine (Oxford, England)
To observe and compare the clinical curative effect of the plasma exchange (PE) and intravenous immunoglobulin (IVIg) for Guillian-Barre Syndrome (GBS). Overall, 64 adult patients with GBS for PE and IVIg treatment, respectively, and nerve function were observed pre-treatment and at 1 week/2 weeks after completion of treatment; the blood immunoglobulin, complement, fibrinogen (Fib) and monocyte percentage (MON%) were detected simultaneously. After PE treatment, nerve function defect appeared to improve better than the IVIg group and clinical effect was better than the IVIg group. Treatment effective rates of the two groups after 2 weeks, respectively, are 96 and 79%. PE and IVIg can significantly reduce the GBS patients' blood immunoglobulin IgG, IgA, IgM, C3 and C4, but these were significantly lower in the PE group than in the IVIg group. Fib and MON% were significantly lower in the PE group than in the IVIg group. Both PE and IVIg have a high response as therapy and are reasonable therapeutic options for GBS. However, PE treatment has a more significantly curative effect, as it can effectively improve symptoms and be helpful in the early rehabilitation of patients.
- Discussion
13
- 10.1016/s0140-6736(17)30055-7
- Jan 1, 2017
- The Lancet
Guillain-Barré syndrome: surveillance and cost of treatment strategies – Authors' reply
- Research Article
36
- 10.1002/ebch.1985
- Dec 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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34
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- Dec 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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15
- 10.1002/ebch.1984
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- Evidence-Based Child Health: A Cochrane Review Journal
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- 10.1002/ebch.1945
- Dec 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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- 10.1002/ebch.v9.4
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- Evidence-Based Child Health: A Cochrane Review Journal
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40
- 10.1002/ebch.1988
- Dec 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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20
- 10.1002/ebch.1987
- Dec 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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33
- 10.1002/ebch.1977
- Sep 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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- 10.1002/ebch.1944
- Sep 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
- Journal Issue
2
- 10.1002/ebch.v9.3
- Sep 1, 2014
- Evidence-Based Child Health: A Cochrane Review Journal
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