A Randomized Double-Blind Controlled Trial on the Effectiveness and Safety of Oral Lorazepam and Diazepam in the Treatment of Patients With Alcohol Withdrawal

D.G. Villamangca

D.G. Villamangca, I.R. Makalinao, E.S. Castillo, N.P. Cortes-Maramba National Poison Control and Information Service, University of the Philippines College of Medicine

Alcohol withdrawal is a potentially fatal disease if not adequately treated. Intravenous diazepam is the current standard regimen being used to treat most cases of withdrawal. The use of oral lorazepam, because of its pharmacokinetic profile, may be a more effective and safer alternative to diazepam. The effectiveness and safety of oral lorazepam and diazepam in the treatment of alcohol withdrawal were evaluated and compared in a double-blind clinical trial at the University of the Philippines-Philippine General Hospital from March 2001 to August 2002. Twenty-two patients were enrolled into the study and given fixed doses every 6 hours and as-needed doses of either lorazepam (n = 10) or diazepam (n = 12). The severity of the withdrawal was monitored using the Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) scoring system. Clinically important outcomes such as length of hospital stay, occurrence of seizures, delirium tremens, persistent hallucinations, and death were the major endpoints. The two treatment groups were comparable as to patient age, years of drinking alcohol, hours abstinent from alcohol, initial CIWA-Ar scores, and all laboratory parameters. There was significant decline in the CIWA-Ar scores in both groups but there was no difference between the two groups. One patient being treated with diazepam had progression to delirium tremens. No patient had seizures nor died. Persistent hallucinations, present in two of the lorazepam-treated patients and three of the diazepam-treated patients, resolved prior to discharge. When given medications at 6-hour intervals, patients in the lorazepam-treated group showed a trend of requiring more as-needed doses than the diazepam-treated group (OR = 2.10; 0.29, 16.09). This can be attributed to the relatively shorter half-life of lorazepam compared with diazepam. The results of this study showed that, even in moderate to severe cases of alcohol withdrawal, both oral lorazepam and diazepam are effective in reducing the symptoms of withdrawal, preventing complications such as persistent hallucinations, seizures and delirium tremens, and avoiding death. Oral benzodiazepines are safe and may even be more cost-effective than the current practice of using parenteral benzodiazepine in the treatment of alcohol withdrawal.

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