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A Randomized Double-blind Controlled Trial

Richard Saitz, MD, MPH; Michael F. Mayo-Smith, MD, MPH; Mark S. Roberts, MD, MPP; Harriet A. Redmond, MS, ARNP, CARN; Donald R. Bernard, MD; David R. Calkins, MD, MPP

JAMA. 1994;272(7):519-523.

Abstract
Objective.
—To assess the effect of an individualized treatment regimen on the intensity and duration of medication treatment for alcohol withdrawal.

Design.
—A randomized double-blind, controlled trial.

Setting.
—An inpatient detoxification unit in a Veterans Affairs medical center.

Patients.
—One hundred one patients admitted for the treatment of alcohol withdrawal who could give informed consent and had no history of seizures or medication use that might alter the clinical course of withdrawal.

Intervention.
—Patients were randomized to either a standard course of chlordiazepoxide four times daily with additional medication as needed (fixed-schedule therapy) or to a treatment regimen that provided chlordiazepoxide only in response to the development of the signs and symptoms of alcohol withdrawal (symptomtriggered therapy). The need for administration of "as-needed" medication was determined using a validated measure of the severity of alcohol withdrawal.

Main Outcome Measures.
—Duration of medication treatment and total chlordiazepoxide administered.

Results.
—The median duration of treatment in the symptom-triggered group was 9 hours compared with 68 hours in the fixed-schedule group (P<.001). The symptom-triggered group received 100 mg of chlordiazepoxide, and the fixed-schedule group received 425 mg (P<.001). There were no significant differences in the severity of withdrawal during treatment or in the incidence of seizures or delirium tremens.

Conclusions.
—Symptom-triggered therapy individualizes treatment, decreases both treatment duration and the amount of benzodiazepine used, and is as efficacious as standard fixed-schedule therapy for alcohol withdrawal.

(JAMA. 1994;272:519-523)

Author Affiliations
From the Division of General Internal Medicine, New England Deaconess Hospital (Drs Saitz, Roberts, and Calkins), Harvard Medical School, (Drs Saitz, MayoSmith, Roberts, and Calkins), Boston, Mass, the Alcohol Detoxification Unit, Department of Medicine, Department of Veterans Affairs Medical Center, Manchester, NH (Drs Saitz, Mayo-Smith, and Bernard and Ms Redmond), and Dartmouth Medical School, Lebanon, NH (Dr Bernard). Dr Saitz is now with the Section of General Internal Medicine, Boston (Mass) City Hospital/Boston University Medical Center. Dr Roberts is now with the Department of Medicine, Shadyside Hospital and Carnegie Mellon University, Pittsburgh, Pa. Ms Redmond is now with Lakes Region General Hospital, Laconia, NH.

Footnotes
Reprint requests to Research Unit, Section of General Internal Medicine, Talbot Bldg, Room 325, Boston City Hospital/Boston University Medical Center, 82 E Concord St, Boston, MA 02118 (Dr Saitz).

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