A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome
| Autor: | R. Manjunatha, Lakshmi V. Pandit, R. Shruthi, R. Vijendra, H.P. Pundarikaksha, Moulya Nagraj, K. Vasundara, K. Girish, K. Vikram Reddy |
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| Jazyk: | angličtina |
| Předmět: |
Agonist
Adult Male Baclofen Alcohol Drinking medicine.drug_class Lorazepam Chlordiazepoxide 03 medical and health sciences chemistry.chemical_compound Alcohol withdrawal syndrome 0302 clinical medicine medicine Humans 030212 general & internal medicine lcsh:QH301-705.5 Uncomplicated alcohol withdrawal lcsh:R5-920 Diazepam Group study business.industry Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale organic chemicals musculoskeletal neural and ocular physiology General Medicine Middle Aged medicine.disease Substance Withdrawal Syndrome body regions Treatment Outcome chemistry Tolerability lcsh:Biology (General) nervous system Anesthesia Clinical Global Impression scores Open label business lcsh:Medicine (General) 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Biomedical Journal, Vol 39, Iss 1, Pp 72-80 (2016) |
| ISSN: | 2319-4170 |
| DOI: | 10.1016/j.bj.2015.09.002 |
| Popis: | 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. Conclusion: 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. |
| Databáze: | OpenAIRE |
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