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

Table 3 Baseline demographic and disease characteristics in the intention-to-treat population

Characteristics of patients	Control	Trial	P
Sex
Male (%)	104 (54)	169 (53)	0.934
Female (%)	88 (46)	147 (47)	0.927
Age-yr median(IQR 25th & 5th)	35 (23.75-45)	35 (27-45)	0.229
Weight (kg, mean ± SD)	37.61 ± 5.94	38.32 ± 6.08	0.199
Ethnicity (%)1
Tribals	171(89)	287(91)	0.883
Others	21(11)	29(9)	0.559
Habits (%)
Smoking	58 (30.2)	103 (32.6)	0.685
Alcohol	23 (12)	33 (10.4)	0.633
Both	26 (13.5)	53 (16.7)	0.403
Socio-Economic status (%)
Upper-Middle	20 (10.4)	40 (12.6)	0.499
Middle	30 (15.6)	52 (16.4)	0.833
Lower	142 (74)	224 (71)	0.763
Pulmonary (%)2
Open cases (sputum +ve)	67 (35)	137 (43.4)	0.214
Parenchymal	152 (79.2)	258 (81.6)	0.822
Cavitary	18 (9.4)	66 (21)	0.003
Effusion	9 (4.6)	20 (6.3)	0.464
Fibrosis	27 (14)	68 (21.5)	0.081
Extra pulmonary (%)2
Cervical lymph node	18 (9.4)	31 (9.8)	0.883
Abdominal	4 (2.1)	6 (2)	0.886
Laryngeal	7 (3.6)	11 (3.5)	0.925
Central nervous system	6 (3.1)	6 (2)	0.389
Bones/Joints	10 (5.2)	19 (6)	0.72
Skin	0	3 (1)	0.598
Genito-Urinary	2 (1.04)	1 (0.3)	0.304
Type of case (%)
New	140 (73)	195 (61.7)	0.245
Relapse	43 (22.4)	97 (30.7)	0.122
Chronic	9 (4.7)	24 (7.6)	0.225
Hematology
Hb (%)	8.84 ± 1.93	8.95 ± 1.95	0.808
Total leucocyte count/mm3	10 179 ± 4 680	9575 ± 4075	0.478
ESR	66.79 ± 30.64	70.49 ± 27.91	0.517
Liver Function (mean, 95%CI)
Serum bilirubin	1.07 (0.7-1.3)	1.09 (0.8-1.4)	0.952
AST	34.35 (17-63)	32.4 (11-61)	0.658
ALT	27.45 (9-57)	31.15 (6-52)	0.655
ALP	100 (50-260)	107 (50-260)	0.092

Unless stated otherwise, P values were calculated with the use of a two sided t-test with Welch’s modification (when unequal variance) for continuous data and a χ² test for categorical data.

¹Ethnic group was assessed by investigation on screening. Tribal consists of Chaudhari, Gamit, Vasava, Bhil, Valvi, Nayka and Halpati.

²Patients may belong to more than one category. ALP: Alkaline phosphatase.