Table 2.
Ref. | Population, Study Design | Intervention | Results |
[79] | n = 15, open label study with histologically confirmed NAFLD adults | All patients received 20 mg/kg per day of metformin for 48 wk | In the initial 3 mo there was improvement in ALT and AST levels and insulin sensitivity, after 3 mo no further improvement noted |
[80] | n = 57 24-mo observational study with NAFLD or NASH overweight and obese children | Metformin was progressively titrated from 250-500 mg tid at weekly intervals and patients were given a hypocaloric or isocaloric diet and recommended to engage in 45 min/d of physical activity (n = 57) compared to control group (n = 30) with the same diet and physical activity recommendations | ALT significantly improved with decreasing body weight. NAS score decreased in both groups, no significant changes in fibrosis |
[85] | n = 63, randomized, double-blind placebo – controlled in NASH adults | 32 patients were given rosiglitazone (4 mg/d for 1 mo then 8 mg/d for 11 mo) vs placebo (n = 31) | Improved steatosis and normalized transaminase, only ½ responded. Improvement of insulin sensitivity |
[86] | n = 47, randomized control study in adults with impaired glucose tolerance or type 2 diabetes with NASH | 6 mo of hypocaloric diet and 45 mg (n = 26) of pioglitazone vs 6 mo of hypocaloric diet (n = 21) | Diet and pioglitazone improved glucose tolerance and normalized ALT. Histologic features of NASH improved, no significant reduction in fibrosis |
[87] | n = 13 patient cohort with NASH adults | All were treated with 30 mg/d of pioglitazone for 48 wk, than followed up 48 wk after stopping pioglitazone. | Stopping pioglitazone increased ALT, decreased adiponectin, worsened insulin sensitivity and increased hepatic fat, no change in fibrosis |
[89] | n = 247, randomization of adults with NASH without diabetes | 96 wk of either 30 mg pioglitazone (n = 80), vitamin E (800 IU/d) (n = 84) or placebo (n = 83) | Vitamin E significantly improved NASH. AST and ALT significantly improved in vitamin E and pioglitazone groups, and reduction in hepatic steatosis with no improvement in fibrosis score. |
[90] | n = 45 prospective, double-blind randomized, placebo controlled trial in NASH adults | Received vitamin E and C (1000 IU and 1000 mg) (n = 23) or placebo for 6 mo (n = 22) additionally patients received weight loss counselling and encouraged to follow a low fat diet | Vitamin treatment significantly improved fibrosis score |
NAFLD: Non-alcoholic fatty liver disease; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; tid: Three times a day; NASH: Nonalcoholic steatohepatitis.