Table 3.
Treatment | Trial | Year | Trial design | Patients (n) | Outcome |
Effective treatment | |||||
IVIg | Léger et al. | 2001 | IVIg (500 mg/kg/day, 5d 1 x month for 3 months versus placebo, double-blind, randomized, controlled crossover trial | 18 | 7/9 patients who received IVIg responded compared with 2/9 patients who received placebo (p¼0.03). No differences in MRC score, electrophysiological studies and changes in anti-GM1 antibody titers. |
IVIg | Federico et al. | 2000 | IVIg (0.4 g/kg/day, 5d) versus placebo, double-blind, randomized, controlled crossover trial | 16 | Improvement in NDS with IVIg treatment compared to placebo (p¼ 0.038) after 28 d. Improvement in grip strength (p¼0.0021) and conduction block (p¼0.037) with IVIg treatment. |
IVIg | Azulay et al. | 1994 | IVIg (0.4 g/kg/day, 5d) versus placebo, double-blind, randomized, controlled crossover trial | 12 | Improvement in muscle strength after IVIg treatment. |
IVIg | Van den Bergh et al. | 1997 | IVIg (2 x 0.4g/kg/day, 5d) (n = 4) and placebo; IVIg (1 x 0.4g/kg/day, 5 d) and placebo (n¼2), double-blind, randomized, controlled crossover trial | 6 | Clinical improvement in 5/6 patients with IVIg but not placebo. |
Presumably ineffective treatment | |||||
Combination of IVIg and mycophenolate mofetil | Pieper et al. | 2007 | Standard dose IVIg every 2–5 weeks+1000mg/d mycophenolate mofetil first week then 2000 mg/d versus placebo for 12 months, randomized, double-blind, placebo-controlled study | 28 | No statistical differences in primary endpoint (IVIg dose reduction of 50% during adjunctive treatment). |
PE, plasma exchange; IVIg, intravenous immunoglobulins; NDS, neurological disability score; MIU, million international units, s.c., subcutaneously.