Table 3.
Randomized clinical trials of antioxidant agents in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
| Author (Ref.) (Yr) | Population (sample size) | Antioxidant and Dose | Duration | ALT | Insulin sensitivity | Oxidative stress markers | Histology |
|---|---|---|---|---|---|---|---|
| Nobili(108) (2006) | Biopsy proven pediatric NAFLD (90) | Diet + Exercise ± Vitamin E 600 IU/d and Vitamin C 500 mg/d | 24 months | Improved with >20% weight loss | Body weight improved in both groups | Improved with >20% weight loss | NA |
| Bugianesi(112) (2005) | Non diabetic NAFLD or NASH(110) | Metformin 2 g/d vs. Vitamin E 800 IU/d vs Diet only | 12 months | Normal ALT 56% vs. 31% vs. 15% with metfromin, vitamin E, and diet+exercise | Improved with metfromin only | NA | Improved steatosis, necro- inflammation, and fibrosis with metfromin (P=0.02) |
| Harrison(106) (2003) | Biopsy proven NASH(45) | 1000 mg Vitamin E +1000 mg Vitamin C | 6 months | No change | NA | NA | Improved fibrosis with vitamin E in diabetics (P=0.002) |
| Sanyal (107) (2010) | Biopsy proven NASH(250) | Vitamin E 800 IU/D vs. Pioglitazone 30 mg/d vs. placebo | 24 months | NA | NA | NA | Improved NASH but not fibrosis with both vitamin E and pioglitazone |
| Foster (116) (2011) | NAFLD (1005) | 20 mg atorvastatin +1000 IU Vitamin E + 1 g Vitamin C vs Placebo | 42 months | NA | NAw | NA | Lower NAFLD at end of study (73% vs. 34%; P<0.0001) on CT scan |
| Pamuk (117) (2003) | Biopsy proven NASH(35) | NAC 600 mg/d | 1 month | Improved at 4 weeks with NAC(P<0.05) | NA | NA | NA |
| Abdelmalek (123) (2009) | NASH (35) | Betaine 20 mg per day | 12 months | No change | NA | No change | Improved steatosis and no effect on fibrosis |
ALT – Alanine aminotransferase; USG – Ultrasound; NAS – NASH activity score; NA: Not available