Table 3 Histologic findings of recent clinical trials

Neuschwander-Tetri et al⁴⁵

30 overweight

Rosi

22

48 weeks

45% no longer NASH; improved grade, steatosis, inflammation, ballooning (P=0.004)

Shift toward increased portal CI (P=0.02)

No change in fibrosis score, shift from dense to delicate perisinusoidal fibrosis (P=0.02)

Promrat et al⁵⁶

18 overweight, nondiabetic

Pio

18

48 weeks

67% had histologic response; decreased steatosis, ballooning, lobular inflammation, Mallory's hyaline, fibrosis (P<0.05)

No change in portal inflammation

Lindor et al⁵⁹

166 multicenter

Urso v

Placebo

107

104 weeks

Both groups had decreased steatosis, and no significant change in inflammation or fibrosis

No statistical differences between groups

Dixon et al⁵⁷

36 morbid obesity; 12 steatosis only

LAGB

36

36–204 weeks

83% no longer NASH; significant improvement in steatosis, inflammation, fibrosis (P<0.001). No change in portal inflammation

Fibrosis: stage ≥2: 78% → 13% (P<0.001)

Huang et al⁵⁸

23 overweight

Diet to reduce IR

15

48 weeks

60% had histologic response; compared with nonresponders, significant improvement in steatosis (P=0.003), total score (P<0.0001)