Ranjani Ramanujam1, Padma L2, Swaminath G3, Rohini S Thimmaiah4. 1. Postgraduate, Department of Pharmacology, Dr. B. R. Ambedkar Medical College , Bangalore, India . 2. Professor and Head, Department of Pharmacology, Dr. B. R. Ambedkar Medical College , Bangalore, India . 3. Professor and Head, Department of Psychiatry, Dr. B. R. Ambedkar Medical College , Bangalore, India . 4. Assistant Professor, Department of Psychiatry, Dr. B. R. Ambedkar Medical College , Bangalore, India .
Abstract
BACKGROUND: Currently, benzodiazepines are the preferred drugs in the management of alcohol withdrawal symptoms. Chlordiazepoxide and diazepam, the most frequently used drugs have a long duration of action and are converted to active metabolites in the liver, while lorazepam is shorter acting, with no active metabolites. OBJECTIVE: To compare and evaluate the safety and efficacy of lorazepam and chlordiazepoxide in patients with alcohol dependence syndrome with symptoms of alcohol withdrawal. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, study carried out at a teaching hospital in Bangalore. Sixty patients aged ≥18 y with alcohol dependence syndrome with mild-to-moderate withdrawal symptoms were allocated at a ratio of 1:1 to either lorazepam or chlordiazepoxide, by means of a computer-generated randomization chart. Thirty patients each were started withlorazepam tablets 8 mg/day and chlordiazepoxide 80 mg/day. For both treatment groups, the dose was tapered and at the end of 8 days, the patients were drug-free. The severity of alcohol dependence was assessed using the Severity of Alcohol Dependence Questionnaire (SADQ). The CIWA-Ar was used for quantification of withdrawal symptoms. Liver function tests were performed at baseline and at the end of the study. RESULTS: Of the 60 patients included in the study, 15 patients each had mild and moderate withdrawal symptoms in the chlordiazepoxide group and 17 and 13 patients respectively in the lorazepam group, based on the SADQ score. At baseline, the mean CIWA-Ar scores were similar in both the treatment groups: 24.77±5.98 in the chlordiazepoxide group and 24.90±6.12 in the lorazepam group. There was a significant intragroup decrease in the CIWA-Ar scores measured from baseline to the end of 8 days (p<0.0001) and 12 days (p<0.0001) in both treatment groups; however, there was no significant difference between the two groups. There was no significant difference observed in the liver function tests done at baseline and at the end of study period. CONCLUSION:Lorazepam is noninferior to chlordiazepoxide in reducing alcohol withdrawal symptoms.
RCT Entities:
BACKGROUND: Currently, benzodiazepines are the preferred drugs in the management of alcohol withdrawal symptoms. Chlordiazepoxide and diazepam, the most frequently used drugs have a long duration of action and are converted to active metabolites in the liver, while lorazepam is shorter acting, with no active metabolites. OBJECTIVE: To compare and evaluate the safety and efficacy of lorazepam and chlordiazepoxide in patients with alcohol dependence syndrome with symptoms of alcohol withdrawal. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, study carried out at a teaching hospital in Bangalore. Sixty patients aged ≥18 y with alcohol dependence syndrome with mild-to-moderate withdrawal symptoms were allocated at a ratio of 1:1 to either lorazepam or chlordiazepoxide, by means of a computer-generated randomization chart. Thirty patients each were started with lorazepam tablets 8 mg/day and chlordiazepoxide 80 mg/day. For both treatment groups, the dose was tapered and at the end of 8 days, the patients were drug-free. The severity of alcohol dependence was assessed using the Severity of Alcohol Dependence Questionnaire (SADQ). The CIWA-Ar was used for quantification of withdrawal symptoms. Liver function tests were performed at baseline and at the end of the study. RESULTS: Of the 60 patients included in the study, 15 patients each had mild and moderate withdrawal symptoms in the chlordiazepoxide group and 17 and 13 patients respectively in the lorazepam group, based on the SADQ score. At baseline, the mean CIWA-Ar scores were similar in both the treatment groups: 24.77±5.98 in the chlordiazepoxide group and 24.90±6.12 in the lorazepam group. There was a significant intragroup decrease in the CIWA-Ar scores measured from baseline to the end of 8 days (p<0.0001) and 12 days (p<0.0001) in both treatment groups; however, there was no significant difference between the two groups. There was no significant difference observed in the liver function tests done at baseline and at the end of study period. CONCLUSION:Lorazepam is noninferior to chlordiazepoxide in reducing alcohol withdrawal symptoms.