STEPHEN WEITZMAN, M.D.; STEPHEN BERGER, M.D.
Thirty-two studies of corticosteroid therapy for bacterial infection were examined for adherence to eight standards of clinical trial design. Only 44% used a concurrent control population; 41% were prospective experimental trials; but 84% did not use a double-blind technique, and 75% did not allocate treatment in a random manner. Only 59% of the studies adequately described criteria for diagnosis of the illness treated. The presence of underlying disease was tabulated in 12 studies, and the clinical extent of disease, a standard applicable to 22 studies, was considered in only 14. Possible complications of steroid administration were sought in only 12 studies. Reports on steroid therapy for septic shock adhered less to methodologic standards than did other studies. The therapeutic use of corticosteroids in acute infections has long been a controversy; this has been perpetuated by studies that are unsatisfying in their use of clinical trial design.
WEITZMAN S, BERGER S. Clinical Trial Design in Studies of Corticosteroids for Bacterial Infections. Ann Intern Med. 1974;81:36–42. doi: 10.7326/0003-4819-81-1-36
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Published: Ann Intern Med. 1974;81(1):36-42.
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