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June 1983


Author Affiliations

Department of Neurology Mt Sinai Medical Center 1 Gustave Levy PI New York, NY 10029

Arch Neurol. 1983;40(6):391-392. doi:10.1001/archneur.1983.04050060091024

To the Editor.  —It is axiomatic that MS varies greatly in its clinical presentation and in the pattern of remission and exacerbation shown during its course. In view of these facts and the problems inherent in defining and quantifying the illness in individual patients, the need for rigorous controls in trials of any new therapeutic modality has been widely recognized and carefully spelled out.1 The great variability in all aspects of the illness requires that a large number of subjects be included for the study to have statistical validity. The subjects should be matched for as many characteristics as possible and randomly assigned to treatment and control groups under double-blind methodology. Any departure from these basic rules can radically affect the validity of the study and must be specifically recognized and compensated for in some way by appropriate changes in experimental design.The recently reported therapeutic trial of intrathecal interferon-β (Archives 1982;39:609-615)