A Double Blind Study For Efficacy Of Diazepam and Baclofen In The Treatment Of Alcohol Withdrawal Syndrome (Journal of Pharmaceutical and Biomedical Sciences, 2014)
Autoren: Anshul Jhanwar, O.P.Patidar, R. N. Sharma, Ashutosh Chourishi, Abhay Jain
(pp, 11.10.2014)
Struktur des Inhalts
Abstract im englischen Original
Aim: To compare the efficacy of Baclofen and Diazepam in alcohol withdrawal syndrome.
Materials and Methods: This was a 15 days, randomized, parallel, double blind comparative study. Fourty eight in-patients were randomized in two groups (Group I (Baclofen =24), mean age = 33±6.76 and Group II (Diazepam = 24), mean age = 35±8.16. All patients with mild to moderate AWS were enrolled for study after obtaining informed written consent. The patients were administered either Baclofen 10mg or Diazepam 10mg tablets at the dose of one tablets twice a day for five days followed by one tablet once a day for the next five days. The in-patient unit offered a 10-day in-patient stay with flexibility to allow negotiation of the discharge date between day 10 and day 15.
Statistics: The data were analyzed by using the statistical software SPSS, version 16.0.The continuous variables were analyzed by using the Student t-test while categorical data was analyzed by using the Chi-square (x2) test. The results were presented as median (range) and number (percentage) for continuous variables. Main outcome measures: Primary variables were CIWA-Ar total score (The revised Clinical Institute Withdrawal Assessment for Alcohol). Clinical trial registry: India (CTRI) number: CTRI/2011/08/001938.
Results: In both groups, from 2nd to 3rd day all participants had achieved a clinically relevant improvement of their withdrawal symptoms. There was drastic reduction on the scores of CIWA-Ar scale from baseline to day 10 & day 15. These changes were statistically highly significant (p < 0.001), which shown that both drugs were efficacious in the treatment of acute mild to moderate AWS. But there were no statistically significant differences between both of the treatment groups on day 10 & day 15 in all efficacy measures, so that the results obtained with them can be considered as equal. Side-effects were slightly more common in the Diazepam group than in Baclofen group.
Conclusions: From the present study it can be concluded that, Baclofen is equivalent in efficacy to Diazepam in the treatment of mild to moderate AWS.
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