title: Prevention of hepatotoxicity due to anti tuberculosis treatment: a novel integrative approach.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  The herbal formulation prevented hepatotoxicity significantly and improved the disease outcome as well as patient compliance without any toxicity or side effects.
authors: 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
authors: Meghna R
authors: MR
authors: Adhvaryu
authors: Narsimha
authors: N
authors: Reddy
authors: Bhasker C
authors: BC
authors: Vakharia
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects*; D001799:Blood Sedimentation; D001835:Body Weight / Q000187:drug effects; D056486:Chemical and Drug Induced Liver Injury; D030024:Curcuma; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007538:Isoniazid / Q000009:adverse effects; D008107:Liver Diseases / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D028321:Plant Preparations / Q000627:therapeutic use*; D011718:Pyrazinamide / Q000009:adverse effects; D012293:Rifampin / Q000009:adverse effects; D031610:Tinospora; D016896:Treatment Outcome; D014376:Tuberculosis / Q000097:blood / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D006454:Hemoglobins; D028321:Plant Preparations; D011718:Pyrazinamide; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin