Cooperative study in the evaluation of therapy in multiple sclerosis; ACTH vs placebo in acute exacerbations

Abstract

The problems encountered in evaluating the effectiveness of treatment methods in multiple sclerosis are well recognized. They result in large part from the nature of the disease, which is characterized by a variable course and many different clinical manifestations. It has been estimated that approximately twothirds of multiple sclerosis patients experience a remission of symptoms at some time during their illness. Many forms of treatment have been proposed with claims of beneficial results for patients at all stages of the disease. Yet, most of these regimens are generally believed to be useless. If the empirical search for an effective treatment for multiple sclerosis is to have any chance of success, it is apparent that a reliable method of accurate assessment must be developed. In 1960, a symposium concerned with the evaluation of drug therapy in neurological and sensory diseases recognized the many serious difficulties involved in clinical trials of therapy in multiple sclerosis including those pertaining to the conduct of cooperative studies.1 In the months following that symposium, an Ad Hoc committee agreed upon certain diagnostic criteria, scoring systems and principles of design for a suitable protocol for such clinical trials.2 The work of the Ad Hoc committee provided the basis for a subsequently designed protocol for a cooperative study utilizing ACTH vs placebo in the treatment of multiple sclerosis patients in acute exacerbations. A group of neurologists representing ten university treatment centers undertook a cooperative study utilizing this protocol beginning in April 1965. This preliminary report, based on observations of the first 135 cases entered, pre sents the characteristics of the study, demonstrates that adequate randomization of patients can be obtained in this disease and describes means for reasonably accurate evaluation of the many clinical changes seen in multiple sclerosis patients under treatment. Because the study is …