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Alcohol. Clin. Exp. Res. · Sep 2001
Randomized Controlled Trial Comparative Study Clinical TrialDivalproex sodium in alcohol withdrawal: a randomized double-blind placebo-controlled clinical trial.
- J P Reoux, A J Saxon, C A Malte, J S Baer, and K L Sloan.
- Veterans Affairs Puget Sound Health Care System and Department of Psychiatry, University of Washington School of Medicine, Seattle, Washington 98108, USA. joe.reoux@med.va.gov
- Alcohol. Clin. Exp. Res. 2001 Sep 1;25(9):1324-9.
BackgroundDivalproex sodium, an anticonvulsant and antikindling agent and gamma-aminobutyric acid enhancer, has been proposed as an alternative to benzodiazepines for treating alcohol withdrawal. This study reports on a randomized, double-blind, placebo-controlled trial of divalproex sodium in acute alcohol withdrawal.MethodsThirty-six hospitalized patients experiencing moderate alcohol withdrawal as measured by a score of at least 10 on the revised Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) were randomized to receive either divalproex sodium 500 mg three times per day for 7 days or matched placebo in a double-blind manner. All subjects received a baseline dose of oxazepam and had additional oxazepam available as a rescue medication in accordance with a standard, symptom-triggered detoxification protocol. Mean total milligrams of oxazepam received, progression of withdrawal symptoms, psychological distress as measured by the Symptom Checklist-90, side effects, and adverse outcomes were compared between groups.ResultsUse of divalproex sodium resulted in less use of oxazepam (p < 0.033). Group differences seemed primarily driven by those subjects who experienced symptoms above threshold level (CIWA-Ar >or=10) after 12 hr. The progression in severity of withdrawal symptoms (increase in CIWA-Ar above baseline) was also significantly greater in the placebo group (p < 0.05).ConclusionsThis placebo-controlled pilot study suggests that divalproex sodium significantly affects the course of acute alcohol withdrawal and reduces the need for treatment with a benzodiazepine. A more aggressive loading dose strategy may demonstrate a more robust or earlier response.
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