title: A randomised controlled trial of intravenous immunoglobulin in IgM paraprotein associated demyelinating neuropathy.
abstract: This multicentre randomised double blind crossover trial tested the short term efficacy of intravenous immunoglobulin (IVIg) 2.0 g/kg given over 24 or 48 hours in patients with paraproteinaemic demyelinating neuropathy (PDN). Twenty-two patients were randomised and completed the trial. After 2 weeks, the overall disability grade decreased during both IVIg treatment and placebo but neither change was significant nor was the mean difference between the treatment effects. After 4 weeks the overall disability decreased by a mean of 0.55 [0.67] grades during the IVIg period (p = 0.001) while it was substantially unmodified during the placebo period. The mean difference between the treatment effects was significant (p = 0.05). Overall during the IVIg period 10 patients improved and 11 were stable and one got worse. During the placebo period 4 patients improved, 4 deteriorated and 14 were stable. Many secondary outcome measures, including Rankin scale, time to walk 10 metres, grip strength, sensory symptoms score were significantly better during IVIg treatment. Two serious adverse events occurred during the trial, both during placebo treatment. In conclusion the trial showed some short-term benefit of IVIg in about half of the patients confirming previous observation.
authors.affiliation: Department of Neurology, Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. g.comi@hsr.it
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Luisa
authors.initials: L
authors.lastname: Roveri
authors.forename: Antony
authors.initials: A
authors.lastname: Swan
authors.forename: Hugh
authors.initials: H
authors.lastname: Willison
authors.forename: Martin
authors.initials: M
authors.lastname: Bojar
authors.forename: Isabel
authors.initials: I
authors.lastname: Illa
authors.forename: Clementine
authors.initials: C
authors.lastname: Karageorgiou
authors.forename: Eduardo
authors.initials: E
authors.lastname: Nobile-Orazio
authors.forename: Peter
authors.initials: P
authors.lastname: van den Bergh
authors.forename: Tony
authors.initials: T
authors.lastname: Swan
authors.forename: Richard
authors.initials: R
authors.lastname: Hughes
authors.forename: Jaques
authors.initials: J
authors.lastname: Aubry
authors.forename: Nicole
authors.initials: N
authors.lastname: Baumann
authors.forename: Robert
authors.initials: R
authors.lastname: Hadden
authors.forename: Michael
authors.initials: M
authors.lastname: Lunn
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Léger
authors.forename: Pierre
authors.initials: P
authors.lastname: Bouche
authors.forename: Radim
authors.initials: R
authors.lastname: Mazanec
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Meucci
authors.forename: Frans
authors.initials: F
authors.lastname: van der Meché
authors.forename: Klaus
authors.initials: K
authors.lastname: Toyka
mesh_terms: D000368:Aged; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000276:immunology; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008297:Male; D010265:Paraproteinemias / Q000188:drug therapy / Q000276:immunology; D011129:Polyradiculoneuropathy / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous