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A Randomized Double-blind Clinical Trial

Philippe Gajdos, MD; Christine Tranchant, MD; Bernard Clair, MD; Francis Bolgert, MD; Bruno Eymard, MD, PhD; Tanya Stojkovic, MD; Shahram Attarian, MD; Sylvie Chevret, MD, PhD; for the Myasthenia Gravis Clinical Study Group

Arch Neurol. 2005;62:1689-1693.

Background  The optimal dose of intravenous immunoglobulin (IVIG) in acute exacerbation of myasthenia gravis remains unknown. Increasing the treatment duration might provide added efficacy.

Objective  To determine the optimal dose of IVIG for treating myasthenia gravis exacerbation.

Design  Randomized double-blind placebo-controlled multicenter trial designed to demonstrate superiority of the 2 g/kg dose over the 1 g/kg dose of IVIG, conducted between November 13, 1996, and October 26, 2002.

Participants  One hundred seventy-three patients aged 15 to 85 years with acute exacerbation of myasthenia gravis.

Intervention  Participants were randomly assigned to receive 1 g/kg of IVIG on day 1 and placebo on day 2 (group 1) vs 1 g/kg of IVIG on 2 consecutive days (group 2).

Main Outcome Measure  Improvement in the myasthenic muscular score after 2 weeks.

Results  The mean improvements in the myasthenic muscular scores after 2 weeks were 15.49 points (95% confidence interval, 12.09-18.90 points) in group 1 and 19.33 points (95% confidence interval, 15.82-22.85 points) in group 2. However, the difference between the 2 groups was not significant (effect size, 3.84 [95% confidence interval, –1.03 to 8.71]; P = .12).

Conclusion  This trial found no significant superiority of 2 g/kg over 1 g/kg of IVIG in the treatment of myasthenia gravis exacerbation.

Author Affiliations: Medical Intensive Care Unit, Raymond Poincaré Teaching Hospital, Assistance publique–Hôpitaux de Paris, Garches (Drs Gajdos and Clair); Neurology Department, Strasbourg Civilian Hospitals, Strasbourg (Dr Tranchant); Neurology Department (Dr Bolgert) and Institute de Myologie (Dr Eymard), Salpêtrière Teaching Hospital, Assistance publique–Hôpitaux de Paris, Paris, Neurology Department, Roger Salengro Teaching Hospital, Lille (Dr Stojkovic); Neurology Department, La Timone Teaching Hospital, Marseille (Dr Attarian); and Biostatistics and Medical Informatics Department, Saint-Louis Teaching Hospital, Assistance publique–Hôpitaux de Paris, U717-INSERM, Paris (Dr Chevret), France.

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