Table 2.
Characteristics of patients and interventions.
| Author/year | Age (experimental/control) | Male (%) | Co-administration regimens | Intervention group | Control group | Exclusion criteria for other risk factors of DILI development | Starting date and duration of intervention (weeks) | Time to follow up (wks) |
|---|---|---|---|---|---|---|---|---|
| Adhvaryu et al. (2008)12 | 35/35 | 53.74 |
2IRZE/4IRE – INH (300 mg/day) – RIF (450 mg/day) – PZA (20 mg/kg/day) – EMB (800 mg/day) |
Curcumin enriched (25%) and a hydro-ethanolic extract enriched (50%) Tinosporacordifolia 1 g/day twice a day | No treatment |
– Patients taking other alternative therapies for tuberculosis – Pregnant females – Heavy alcoholism history – AST, ALT raised > twice upper normal – Sickle cell disease with history of crisis, anemia and jaundice History of gout – Recent drop-outs from other TB due to complications and side effects, – Patients on steroid and/or antimetabolite for other collagen, autoimmune or neoplastic diseases |
The same of anti-TB drug, 24 | Every 2 week until week 24 |
| Baniasadi et al. (2010)13 | 74.46/73.41 | 51.76 |
IRZE – INH (5 mg/kg/ day) – RIF (10 mg/kg/day) – PZA (25 mg/ kg/day) – EMB (15 mg/kg/day) |
600 mg N-Acetylcysteine orally twice a day (1200 mg/day) | No Treatment |
– Alcohol consumption – Viral hepatitis, – Abnormal pretreatment liver functions level, chronic disease – Additional hepatotoxic drug use – HIV positive, liver TB, and a moribund state |
The same of anti-TB drug, 2 | 1, 2 |
| Gu et al. (2015)14 | 37.42/36.16 | 65.84 |
2IRZE(S)/4IR – INH (300 mg/day) – RIF: ≥ 50 kg (600 mg/day) – ≤ 50 kg (450 mg/day) – PZA (500 mg 3 times a day) – EMB: ≥ 50 kg(1000 mg/day) – ≤ 50 kg (750 mg/day) – Streptomycin (750 mg/day) |
2 capsules of 35 mg Silibinin phospholipid complex 3 times a day (210 mg/day) | No treatment |
– Liver diseases (such as alcoholic liver disease, autoimmune liver disease, non-alcoholic fatty hepatitis, hepatitis B or C virus) – Severe heart, brain, kidney, gastrointestinal diseases and systemic diseases – Positive for HIV antibody – Taking medications that could affect curative effect in the study – Pregnant, lactating |
The same of anti-TB drug, 8 | 2, 4,6,8 |
| Hatamkhani et al. (2014)15 | 36.9/38.6 | 75 |
IRZE – INH (5 mg/kg/day) – RIF (10 mg/kg/day) – EMB (15 mg/kg/day) – PZA (25 mg/kg/day) |
10 mL from 500 mg 5 mLof l-carnitine solution orally twice a day (1000 mg/day) | Placebo |
– Concomitant administration of known hepatotoxic drugs or herbal products, history of active renal – Liver diseases – Underlying thyroid abnormalities |
The same of anti-TB drug, 4 | 4 |
| Heo et al. (2017)16 | 57.73/58.53 | 66.22 |
2IRZE – No detail of dosing |
140 mg Silymarin tablets twice a day (280 mg/day) | Placebo |
– Abnormal baseline liver enzyme – Pregnant or lactating |
The same of anti-TB drug, 8 | 2,4,8 |
| Luangchosiri et al. (2015)17 | 56/51.5 | 40.0 |
2IRZE – INH (5 mg/kg/ day) – RIF (10 mg/kg/day) – PZA (25 mg/ kg/day) – EMB (15 mg/kg/day) |
140 mg Silymarin tablets 3 times a day (420 mg/day) | Placebo |
– Active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson’s disease,hemochromatosis, or cirrhosis) – Acquired immune deficiency syndrome – Concurrently taking of herbal medicine – Significant alcohol – Pregnant or lactating women, – Elevated ALT > 2 UNL |
The same of anti-TB drug, 8 | 2,4 |
| Chu et al. (2015)28 | 40.51/40.21 | 74.85 |
2HRZE/4HR – INH (300 mg/day) – RMP: ≥ 50 kg (600 mg/day) – ≤ 50 kg (450 mg/day) – PZA (1500 mg/day) – EMB: ≥ 50 kg (1000 mg/day) – ≤ 50 kg (750 mg/day) |
25 mg Bicyclolcapsules 3 times a day(75 mg/day) + 200 mg Glucurolactone tablets 3 times a day (600 mg/day) | Glucurolactone 600 mg/day |
– Other liver diseases – Serum creatinine > 1.5 ULN – Use of any drugs that could influence the efficacy of the study – Pregnant, lactating or fertile women |
The same of anti-TB drug, 24 | 2,4,8,12,24 |
| Zhang et al. (2014)34 |
39.60/44.42 55.37/44.42 55.40/44.42 |
64.55 |
2IRZE/4IR – INH (5 mg/kg/ day) – RIF (10 mg/kg/day) – PZA (25 mg/ kg/day) – EMB (15 mg/kg/day) |
– HuganPian0.35 g × 4 pieces3 times a day (4.2 g/day) – Glucuronolactone0.1 g × 2 to 4 pieces 3 times a day (0.6–1.2 g/day) – Glutathione injection 1.2 g or 1.8 g/day |
Jian’ganle 15 g twice a day (30 g/day) |
– Hepatitis or any other liver dysfunction and the history of liver disease – Combination of various hepatinicas at the same time and irrational drug use |
The same of anti-TB drug, 24 | 8 |
| Xiong et al. (2021)33 |
43.5/45.0 44.5/45.0 45.0/45.0 |
76.09 |
2IRZE/4IR – INH (5 mg/kg/ day) – RIF (10 mg/kg/day) – PZA (25 mg/ kg/day) – EMB (15 mg/kg/day) |
– The Vitamin A group; vitamin A oral capsule (2000 IU/day) – The Vitamin D group; vitamin D oral capsule (400 IU/day) – The ViataminA and D group; vitamin A oral capsule (2000 IU/day) and an additional vitamin D oral capsule (400 IU/day) |
No treatment |
– Pregnancy or lactation – Use of corticosteroids, vitamin A or D supplementation, or immunosuppressive drugs – Creatinine concentration higher than 250 mmol/L or AST three times higher than ULN; and history of nephrolithiasis, hyperparathyroidism,organ transplantation – Hepatic cirrhosis or cancer |
The same of anti-TB drug, 8 |
1,2,3,4,8,12,24 |
| Zhang et al. (2016)35 | 53.69/45.59 | 74.05 |
2IRZE – No detail of dosing |
200 mg S. Marianum capsule twice a day (400 mg/day) | Vitamin C |
– Disorders directly affecting liver function (e.g. acute hepatitis, cirrhosis of the liver, encephalopathy, or cancer) – Patients taking concomitant hepatotoxic medications; and heavy alcohol intake, abnormal renal function, severe cardiovascular, cerebrovascular, renal, or thyroid disease |
The same of anti-TB drug, 8 | 8 |
| Gulati et al. (2010)29 | NA | NA |
2IRZE/4IR – INH (300 mg/day) – RIF (400 mg/day) – PZA (1500 mg/day) – EMB (800 mg /day) |
2 capsules of 500 mg poly-herbal preparation (Livina) twice a day (2000 mg/day) | Placebo |
– Abnormal liver function tests – Pregnancy – Presence of Hepatitis B or HIV – Current alcohol use, any other systemic disease, use of corticostreroids, silymarin or other hepatoprotective or immunomodulatory agents |
The same of anti-TB drug, 24 | 4,8 |
| Marjani al.(2016)31 | 50.1/49.6 | 53.0 |
IRZE – INH (5 mg/kg/ day) – RIF (10 mg/kg/day) – PZA (20 mg/ kg/day) – EMB (15 mg/kg/day) |
140 mg Silymarin tablets 3 times a day (420 mg/day) | Placebo |
– Patients with concomitant HIV, HBV or HCV infection – Preexisting liver disease, abnormal liver function tests (LFT) at the beginning of TB treatment – Pregnant and nursing mothers HIV |
The same of anti-TB drug, 2 | 2 |
| Tabarsi et al. (2014)32 | 37.25/35.55 | 50.43 |
IRZE – No detail of dosing |
1000 mg garlic tablets once daily (1000 mg/day) | Placebo |
– Patients with positive HIV – Confirmed hepatitis, cirrhosis – Renal failure |
The same of anti-TB drug, 2 | 2,4,8 |
| Hasanain et al. (2017)30 | 37.5/34.3 | 43.0 |
2IRZE/4IR – INH (5 mg/kg/day) – RIF (10 mg/kg/day) – PZA (30 mg/kg/day) – EMB (20 mg/kg/day) |
600 IU cholecalciferol once daily (600 IU/day) | No treatment |
– Pregnant – Pre‑existing elevated liver chemistry (ALT, AST, and bilirubin),hepatitis virus HCV, HBV – Human immunodeficiency virus (HIV) infection – Evidence of fatty liver disease, liver cirrhosis or portal hypertension – Any alcohol intake – Receiving hepatotoxic drugs other than ATT, renal disorder (elevated serum creatinine level), and hemolytic receiving corticosteroids or antimetabolites for any other indication |
The same of anti-TB drug, 24 | 8 |
*INH Isoniazid, RIF Rifampicin, PZA Pyrazinamide, EMB Ethambutol, wks weeks, anti-TB drug anti-tuberculosis drug.