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Carnitine for prevention of antituberculosis drug‐induced hepatotoxicity: A randomized, clinical trial
Author(s) -
Hatamkhani Shima,
Khalili Hossein,
Karimzadeh Iman,
DashtiKhavidaki Simin,
Abdollahi Alireza,
Jafari Sirous
Publication year - 2014
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.12474
Subject(s) - medicine , placebo , carnitine , gastroenterology , odds ratio , clinical trial , randomized controlled trial , surgery , pathology , alternative medicine
Background and Aim In the present study, the potential benefits of oral carnitine in preventing antituberculosis drug‐induced hepatotoxicity ( ATDH ) were evaluated. Methods Fifty‐four patients in the carnitine and 62 patients in the placebo group completed the study. The carnitine group received 1000 mg oral carnitine solution twice daily for 4 weeks. The placebo group received 10 m L of oral placebo solution twice daily for 4 weeks. ATDH was defined as an increase in the serum level of aspartate aminotransferase or alanine aminotransferase greater than three or five times of the upper limit of normal with or without clinical symptoms of hepatotoxicity, respectively. Results During the study period, 29 (25%) patients experienced ATDH . Among these patients, nine (16.7%) and 20 (32.3%) were in the carnitine and placebo groups, respectively ( P = 0.049). Based on multivariate logistic regression model, age over 35 years old (odds ratio [ OR ] = 7.01, P = 0.002), human immunodeficiency virus infection ( OR = 40.4, P < 0.001), diabetes mellitus ( OR = 37.6, P = 0.001), and placebo treatment ( OR = 0.1, P = 0.01) were identified as predisposing factors for ATDH . Conclusion Results of our preliminary clinical trial suggested that cotreatment with 2000 mg oral L ‐carnitine solution daily for 4 weeks significantly decreased the rate of ATDH .