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. 2011 Jul;4(4):249–263. doi: 10.1177/1756283X11403809

Table 1.

Studies of thiazolidinediones in adult patients with biopsy-proven nonalcoholic steatohepatitis.

Study n Design % Diabetes mellitus Drug* Daily dose (mg) Compared with Duration Liver enzymes Liver fat by imaging Histology
Caldwell et al. [2001] 10 Open label, single arm 10 Troglitazone 400 Baseline <6 months Improved NA Unchanged
Neuschwander- Tetri et al. [2003a, 2003b] 30 Open label, single arm 50 Rosiglitazone 8 Baseline 48 weeks Improved Improved (CT) Improved steatosis, inflammation
Promrat et al. [2004] 18 Open label, single arm 0 Pioglitazone 30 Baseline 48 weeks Improved (normalized in 95%) (NS) Improved (MRS) Improved steatosis, inflammation and fibrosis
Sanyal et al. [2004] 20 Open label, RCT 0 Pioglitazone  + vitamin E 30 Vitamin E 6 months Improved NA Improved steatosis and inflammation. Fibrosis improved (NS)
Belfort et al. [2006] 55 Blinded, RCT 48 Pioglitazone 45 Placebo 6 months Improved Improved (MRS) Improved steatosis and inflammation. Fibrosis improved (NS)
Aithal et al. [2008] 74 Blinded, RCT 0 Pioglitazone 30 Placebo 12 months Improved (NS) NA Improved hepatocellular injury and fibrosis; steatosis and inflammation improved (NS)
Idilman et al. [2008] 74 Open label, RCT NR Rosiglitazone 8 Metformin or diet + exercise 48 weeks NA Improved steatosis
Ratziu et al. [2008] 63 Blinded, RCT 31 Rosiglitazone 8 Placebo 12 months Improved (normalized in 38%) NA Improved steatosis, necroinflammation, NAS and fibrosis improved (NS)
Sanyal et al. [2010] 74 Blinded, RCT 0 Pioglitazone 30 Placebo 24 months Improved NA Improved steatosis and inflammation (NS)
*

All patients in the study arm were also placed on lifestyle modifications with diet and exercise.

CT, computed tomography; MRS, magnetic resonance spectroscopy; NA, not assessed; NAS, Nonalcoholic fatty liver disease Activity Score; NR, not reported; NS, nonsignificant; RCT, randomized controlled trial.