Double-blind study of cyamemazine and diazepam in the alcohol withdrawal syndrome.

Abstract

OBJECTIVE:

Cyamemazine is an original phenothiazine derivative which showed similar efficacy and tolerability to lorazepam during ethanol withdrawal in mice. This study investigated cyamemazine for its efficacy and tolerability in alcohol-dependent patients electing an alcohol withdrawal procedure, in comparison with diazepam.

METHOD:

A multicenter, randomized, double-blind study in 89 alcohol-dependent patients (CIWA-Ar score between 10 and 30), electing an alcohol withdrawal procedure, was used to find effective doses of cyamemazine and to compare it with diazepam for efficacy and tolerability. On day 1 (D(1)), cyamemazine or diazepam (50 mg and 10 mg capsule, respectively) were administered at hourly intervals to reduce CIWA-Ar = 5, up to a maximum of eight administrations. Starting from D(2), the compounds were given twice a day in progressively decreasing doses during a maximum period of 13 days (D(end)).

RESULTS:

At h(8) (8 h after the first treatment of D(1)), therapeutic success (CIWA-Ar score </= 5) was achieved in 32 out of 43 ITT patients treated with cyamemazine (74.4%), a value very similar to that of diazepam (32/44; 72.7%). Most such patients (29/32) were controlled with 2-6 capsules of cyamemazine (100-300 mg). In the PP population, cyamemazine (n = 28) was significantly non-inferior to diazepam (n = 33), with a threshold of 10% for non-inferiority bound and 2.5% for one-sided type I error rate. Such therapeutic similarity was confirmed by the analysis of other efficacy criteria. Safety analysis did not show substantial differences between the two treatments.

CONCLUSIONS:

Cyamemazine showed similar efficacy and tolerability to diazepam for the treatment of alcohol withdrawal symptoms at therapeutic doses in the range 100-300 mg.

• Authors: Jean-Daniel Favre, Hervé Allain, Henri-Jean Aubin, Elisabeth Frija-Orvoen, Claudine Gillet, Michel Lejoyeux, Alain Payen, Michel Weber, Stéphanie Garcia-Acosta, Imane Kermadi, Michel Dib
• Journal: Human psychopharmacology (Hum Psychopharmacol) Vol. 20 Issue 7 Pg. 511-9 (Oct 2005) ISSN: 0885-6222 [Print] England
• PMID: 16118830 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright (c) 2005 John Wiley & Sons, Ltd.

Chemical References

• Antipsychotic Agents
• Hypnotics and Sedatives
• Phenothiazines
• cyamemazine
• Diazepam
• Oxygen

Topics

• Alcohol Withdrawal Delirium (drug therapy)
• Alcoholism (drug therapy, psychology)
• Antipsychotic Agents (adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Diazepam (adverse effects, therapeutic use)
• Double-Blind Method
• Dyskinesia, Drug-Induced (epidemiology)
• Humans
• Hypnotics and Sedatives (adverse effects, therapeutic use)
• Oxygen (blood)
• Patient Compliance
• Phenothiazines (adverse effects, therapeutic use)
• Psychiatric Status Rating Scales