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Results of a Randomized Clinical Trial

Ralph I. Horwitz, MD; Louis D. Gottlieb, MD; Mark L. Kraus, MD

Arch Intern Med. 1989;149(5):1089-1093.

Abstract
• We conducted a randomized, double-blind, clinical trial of atenolol compared with placebo in the outpatient management of patients with the alcohol withdrawal syndrome. In addition to receiving customary therapy, 88 patients were randomly assigned to receive atenolol and 92 to receive placebo. Outcome during the next 14 days was assessed using two main measures: the patient's clinical course as assessed by an alcohol withdrawal severity index; and the occurrence of treatment failure (composite measure including return to drinking, dropouts, and withdrawal lasting longer than 5 days). In addition, levels of craving for alcohol were assessed as an associated response variable. Overall, treatment failure occurred for 37% of the patients receiving atenolol and 52% of those receiving placebo. Among patients who had withdrawal symptoms at baseline, vital signs became normal more rapidly in the patients receiving atenolol, and their abnormal behavioral characteristics also resolved more rapidly. Levels of craving for alcohol were strongly associated with treatment failure; the group of patients who received atenolol included significantly fewer who reported high levels of craving 24 hours after treatment began (7% of patients receiving atenolol and 20% of those receiving placebo). We conclude that the outpatient management and treatment outcomes of the alcohol withdrawal syndrome are improved in patients who receive atenolol, and that the beneficial effects are associated with reduced levels of craving for alcohol. If these results are confirmed by other investigators, atenolol may prove to play an important role in the outpatient management of the alcohol withdrawal syndrome.

(Arch Intern Med. 1989;149:1089-1093)

Author Affiliations
From the Departments of Medicine and Epidemiology, Yale University School of Medicine, New Haven, Conn (Dr Horwitz), and the Department of Medicine, St Mary's Hospital, Waterbury, Conn (Drs Gottlieb and Kraus).

Footnotes
Accepted for publication December 23, 1988.

Reprint requests to Yale University School of Medicine, Room IE-61 SHM, PO Box 3333, New Haven, CT 06510 (Dr Horwitz).

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