Clinical Research
Copyright ©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Aug 14, 2008; 14(30): 4753-4762
Published online Aug 14, 2008. doi: 10.3748/wjg.14.4753
Prevention of hepatotoxicity due to anti tuberculosis treatment: A novel integrative approach
Meghna R Adhvaryu, Narsimha M Reddy, Bhasker C Vakharia
Meghna R Adhvaryu, Narsimha M Reddy, Bapalal Vaidya Botanical Research Centre, Department of Biosciences, Veer Narmad South Gujarat University, Surat 395007, India
Bhasker C Vakharia, Shree Gurudev Sarvajanik Charitable Trust Mobile Clinic, Ramnagar, Rander Road, Surat 395005, India
Author contributions: Adhvaryu MR and Vakharia BC conducted the clinical trial; Adhvaryu MR, Reddy MN and Vakharia BC designed research; Adhvaryu MR and Reddy MN devised the formulation and carried out pilot studies; Adhvaryu MR, and Vakharia BC analyzed data; and Adhvaryu MR, Reddy MN and Vakharia BC wrote the paper.
Supported by (in part) The Mukul Trust Bardoli, India
Correspondence to: Meghna R Adhvaryu, Bapalal Vaidya Botanical Research Centre, Department of Biosciences, Veer Narmad South Gujarat University, 110, Nehru Nagar Society, Ichchhanath Road, Surat 395007, India. meghna.adhvaryu@gmail.com
Telephone: +91-261-2252234 Fax: +91-261-2772143
Received: April 18, 2008
Revised: July 7, 2008
Accepted: July 14, 2008
Published online: August 14, 2008
Abstract

AIM: To evaluate the ability of Curcuma longa (CL) and Tinospora cordifolia (TC) formulation to prevent anti-tuberculosis (TB) treatment (ATT) induced hepatotoxicity.

METHODS: Patients with active TB diagnosis were randomized to a drug control group and a trial group on drugs plus an herbal formulation. Isoniazid, rifampicin, pyrazinamide and ethambutol for first 2 mo followed by continuation phase therapy excluding Pyrazinamide for 4 mo comprised the anti-tuberculous treatment. Curcumin enriched (25%) CL and a hydro-ethanolic extract enriched (50%) TC 1 g each divided in two doses comprised the herbal adjuvant. Hemogram, bilirubin and liver enzymes were tested initially and monthly till the end of study to evaluate the result.

RESULTS: Incidence and severity of hepatotoxicity was significantly lower in trial group (incidence: 27/192 vs 2/316, P < 0.0001). Mean aspartate transaminase (AST) (195.93 ± 108.74 vs 85 ± 4.24, P < 0.0001), alanine transaminase (ALT) (75.74 ± 26.54 vs 41 ± 1.41, P < 0.0001) and serum bilirubin (5.4 ± 3.38 vs 1.5 ± 0.42, P < 0.0001). A lesser sputum positivity ratio at the end of 4 wk (10/67 vs 4/137, P = 0.0068) and decreased incidence of poorly resolved parenchymal lesion at the end of the treatment (9/152 vs 2/278, P = 0.0037) was observed. Improved patient compliance was indicated by nil drop-out in trial vs 10/192 in control group (P < 0.0001).

CONCLUSION: The herbal formulation prevented hepatotoxicity significantly and improved the disease outcome as well as patient compliance without any toxicity or side effects.

Keywords: Hepatoprotection; Anti-tuberculous treatment; Curcumin longa; Tinospora cordifolia