A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.
BACKGROUND
Alcohol withdrawal syndrome (AWS) is a distressing condition, generally controlled by benzodiazepines (BZD's). Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has also shown promising results in controlling AWS. As there are few studies comparing the efficacy and tolerability of chlordiazepoxide with baclofen, the present study was taken up. The objective of this study was to compare efficacy and tolerability of baclofen with chlordiazepoxide in uncomplicated AWS.


METHODS
Sixty subjects with uncomplicated AWS were randomized into two groups of 30 each, to receive baclofen (30 mg) or chlordiazepoxide (75 mg) in decremented fixed dose regime for 9 days. Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events. Lorazepam was used as rescue medication. Secondary efficacy parameters were Clinical Global Impression scores, symptom-free days, and subject satisfaction as assessed by visual analog scale. This study was registered with Clinical Trial Registry-India (CTRI/2013/04/003588), also subsequently registered with WHO's ICTRP clinical trial portal.


RESULTS
Both baclofen and chlordiazepoxide showed a consistent reduction in the total CIWA-Ar scores. However, chlordiazepoxide showed a faster and a more effective control of anxiety and agitation requiring lesser lorazepam supplementation, and also showed a better subject satisfaction compared to baclofen. Both the drugs showed good tolerability with mild self-limiting adverse events.


CONCLUSIONS
The present study demonstrates that baclofen is not as good as chlordiazepoxide in the treatment of uncomplicated AWS. However, baclofen might be considered as an alternative.
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
K
K
Girish
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India. Electronic address: vikramred777@gmail.com.
K
K
Vikram Reddy
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India; Department of Psychiatry, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
Lakshmi V
LV
Pandit
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
H P
HP
Pundarikaksha
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R
R
Vijendra
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
K
K
Vasundara
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R
R
Manjunatha
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
Moulya
M
Nagraj
Department of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R
R
Shruthi
D000328:Adult; D000428:Alcohol Drinking; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002707:Chlordiazepoxide / Q000009:adverse effects / Q000627:therapeutic use*; D003975:Diazepam / Q000627:therapeutic use; D006801:Humans; D008140:Lorazepam / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D002707:Chlordiazepoxide; D001418:Baclofen; D008140:Lorazepam; D003975:Diazepam
Alcohol withdrawal syndrome; Baclofen; Chlordiazepoxide; Clinical Global Impression scores; Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale