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Randomized Controlled Trial
. 2008 Aug 14;14(30):4753-62.
doi: 10.3748/wjg.14.4753.

Prevention of hepatotoxicity due to anti tuberculosis treatment: a novel integrative approach

Meghna R Adhvaryu  1 , Narsimha Reddy, Bhasker C Vakharia
Affiliations
Randomized Controlled Trial

Prevention of hepatotoxicity due to anti tuberculosis treatment: a novel integrative approach

Meghna R Adhvaryu et al. World J Gastroenterol. .

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.

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Figures

Figure 1
Figure 1
Study design and enrollment and follow-up of patients.
Figure 2
Figure 2
A: HPTLC finger print of formulation of Curcuma longa. Sample was extracted in MeOH and Solvent system for Mobile phase used was Chloroform: MeOH (99.5: 0.5). Note: Before loading the material on TLC plate, it was impregnated with di NaHPO4 (anhydrous)-1.25 g dissolved in 25 mL double distilled water (DDW). B: HPTLC finger print of formulation of Tinospora cordifolia. Sample was extracted in-MeOH and NH4OH: MeOH (9:1) and solvent system for mobile phase used was -Chloroform: MeOH (8:2).
See this image and copyright information in PMC

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