Table 1.
Treatment | Trial | Year | Trial design | Patients (n) | Outcome |
Effective treatment | |||||
Plasma exchange | The Guillain-Barré syndrome Study Group | 1985 | PE versus supportive care, single-blind | 245 | Improvement at 4 weeks, time to improve one clinical grade, time to independent walking, and outcome at 6 months in the PE-group. |
French CooperativeGroup on Plasma Exchange in Guillain-Barré syndrome | 1987 | PE (4x) with albumin (n=57) versus PE (4x) with fresh frozen plasma (n=52) versus no PE (n= 111), non-blind | 220 | Shorter time to recover walking with assistance (30 d versus 44 d, p<0.01) in PE group. Reduced number of patients requiring assisted ventilation, shorter time to onset of motor recovery. No differences between PE groups. | |
The French Cooperative Group on Plasma Exchange in Guillain– Barré Syndrome | 1997 | 3 groups: ‘mild’ affected: 0 versus 2 PE treatments; ‘moderate’ affected: 2 versus 4 PEs; ‘severe’ affected: 4 versus 6 PEs. non-blind | 556 | 2 PEs more effective than 0 for time to onset of motor recovery (4 d versus 8d, p=0.0002) in mild group. 4 PEs superior as 2 PEs for time to walk with assistance (20 versus 24 d; p=0.04) in moderate group. No difference between 4 and 6 PEs in the severe group. | |
IVIg | The Dutch Guillain–Barré Study Group | 1992 | IVIG (0.4 g/kgxd, 5x), versus PE (5x) non-blind, bias-controlled | 150 | Improvement one or more points on functional score 34% in PE-group versus 53% in IVIGgroup (p=0.024). Time to improvement by one grade 41 d versus 27 d (p=0.05). Both treatments are of equal efficacy. |
Plasma Exchange/ Sandog lobulin Guillain–Barré Syndrome Trial Group | 1997 | PE 5x(n=121) versus IVIG (0.4 g/kg, 5d) (n=130) versus PE (5x)+IVIG (0.4 g/kg, 5 d), single-blind | 383 | No significant difference in major outcome measure (improvement on disability scale after 4 weeks and in secondary outcome measures (time to recovery of unaided walking, time to discontinuation of ventilation) | |
Uncertain benefit or resumably ineffective treatment (compared to PE or IVIg) | |||||
Combination of PE and IVIg | Plasma Exchange/ Sandog lobulin Guillain–Barré Syndrome Trial Group | 1997 | PE 5x(n=121) versus IVIG (0.4 g/kg, 5d) (n=130) versus PE (5x)+IVIG (0.4 g/kg, 5 d), single-blind | 383 | No significant difference in major outcome measure (improvement on disability scale after 4 weeks and in secondary outcome measures (time to recovery of unaided walking, time to discontinuation of ventilation) |
Combination of IVIg and Methylprednisolone (intravenously) | Konigsveld et al., Dutch GBS trial group | 2004 | IVIg (0.4 g/kg, 5 d)+methylprednisolone (n=112) versus IVIg (0.4 g/kg, 5d)+placebo (n=113), double-blind, randomized-controlled | 225 | No significant difference between number of patients improved by 1 disability grade after 4 weeks. No significant differences in secondary outcome measures (ability to walk unaided after 8 weeks or time to walk independently) |
Combination of IVIg, methylprednisolone and mycophenolate mofetil | Garssen et al. | 2007 | IVIg (0.4 g/kg/5 d+500mg methylprednisolone i.v. 5 d+mycophenolate mofetil (2000 mg/d 6 weeks) (n=26) compared to historical control (Koningsveld et al.) IVIg (0.4 g/kg, 5d)+methylprednisolone (n=112), open-labeled pilot study | 26 | No statistical differences in primary endpoint (improvement by at least one grade on the GBS disability score after 4 weeks) |
Combination of IVIg, and interferon beta 1a | Pritchard et al. | 2003 | IVIg+interferon beta 1a (22 mg 1 week then 44 mg up to 24 weeks) (n=13) versus IVIg+placebo (n=6) | 19 | No statistical differences between the two groups |
PE, plasma exchange; IVIg, intravenous immunoglobuUns; NDS, neurological disability score; i.v., intravenously.