Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy.
This multicenter, randomized, double-blind, crossover trial compared a six week course of oral prednisolone tapering from 60 mg to 10 mg daily with intravenous immunoglobulin (IVIg) 2.0 g/kg given over one to two days for treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Twenty-four of the thirty-two randomized patients completed both treatment periods. Both treatments produced significant improvements in the primary outcome measure, change in an 11-point disability scale two weeks after randomization. There was slightly, but not significantly, more improvement after IVIg than with prednisolone, the mean difference between the groups in change in disability grade being 0.16 (95% CI = -0.35 to 0.66). There were also slightly, but not significantly, greater improvements favoring IVIg in the secondary outcome measures: time to walk 10 meters after two weeks and improvement in disability grade after six weeks. Results may have been biased against IVIg by the eight patients who did not complete the second arm of the trial. A serious adverse event (psychosis) attributable to treatment occurred in one patient while on prednisolone and in none with IVIg.
Hughes
R
R
Department of Neuroimmunology, Guy's, King's, and St. Thomas' School of Medicine, Guy's Hospital, London, United Kingdom.
Bensa
S
S
Willison
H
H
Van den Bergh
P
P
Comi
G
G
Illa
I
I
Nobile-Orazio
E
E
van Doorn
P
P
Dalakas
M
M
Bojar
M
M
Swan
A
A
D000284:Administration, Oral; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020277:Polyradiculoneuropathy, Chronic Inflammatory Demyelinating / Q000188:drug therapy* / Q000503:physiopathology; D011239:Prednisolone / Q000008:administration & dosage* / Q000627:therapeutic use; D011379:Prognosis
D016756:Immunoglobulins, Intravenous; D011239:Prednisolone