Table 3.
Histologic changes in placebo-treated patients with NASH: Pooled results.
| Variable | Study (year) | Duration (months) | Delta Mean | % Patients with Any Improvement | % Patients with 2-Point Improvement | P-value |
|---|---|---|---|---|---|---|
| Steatosis (n=124) | Belfort (2006) | 6 | −0.29 | 38.1% (8/21) | 0% (0/21) | |
| Merat (2003) | 6 | -- | -- | -- | ||
| Ratziu (2008) | 12 | −0.16 | 16.1% (5/31) | |||
| Dufour (2006) | 24 | −0.50 | -- | -- | ||
| Lindor (2004) | 24 | −0.30 | 36.8% (21/57) | 1.8% (1/57) | ||
| Combined | −0.31 | 31.2% (34/109) | 1.3% (1/78) | <0.001 | ||
| Ballooning degeneration (n=124) | Belfort (2006) | 6 | −0.19 | 23.8% (5/21) | 4.8% (1/21) | |
| Merat (2003) | 6 | -- | -- | -- | ||
| Ratziu (2008) | 12 | 0.23 | 9.7% (3/31) | 0% (0/31) | ||
| Dufour (2006) | 24 | 0.17 | -- | -- | ||
| Lindor (2004) | 24 | −0.10 | 14.0% (8/57) | 1.8% (1/57) | ||
| Combined | 0.03 | 14.7% (16/109) | 1.8% (2/109) | 0.68 | ||
| Lobular inflammation (n=67) | Belfort (2006) | 6 | −0.29 | 28.6% (6/21) | 0% (0/21) | |
| Merat (2003) | 6 | -- | -- | -- | ||
| Ratziu (2008) | 12 | −0.13 | 35.5% (11/31) | |||
| Dufour (2006) | 24 | 0.17 | -- | -- | ||
| Lindor (2004) | 24 | -- | -- | -- | ||
| Combined | −0.08 | 32.7% (17/52) | 0% (0/21) | 0.19 | ||
| NASH fibrosis (n=122) | Belfort (2006) | 6 | −0.14 | 33.3% (7/21) | 4.8% (1/21) | |
| Merat (2003) | 6 | -- | -- | -- | ||
| Ratziu (2008) | 12 | −0.18 | 16.1% (5/31) | |||
| Dufour (2006) | 24 | 0.05 | -- | -- | ||
| Lindor (2004) | 24 | 0.00 | 21.8% (12/55) | 3.6% (2/55) | ||
| Combined | −0.07 | 22.4% (24/107) | 3.9% (3/76) | 0.44 | ||
| Combined Necro-inflammation or Nash Activity Score (n=107) | Belfort (2006) | 6 | -- | 38.1% (8/21) | 14.3% (3/21) | |
| Merat (2003) | 6 | -- | -- | -- | ||
| Ratziu (2008) | 12 | -- | 41.9% (13/31) | |||
| Dufour (2006) | 24 | -- | -- | -- | ||
| Lindor (2004) | 24 | -- | 23.6% (13/55) | 5.5% (3/55) | ||
| Combined | -- | 31.8% (34/107) | 7.9% (6/76) | 0.12 |
n, Number of patients that could be used to calculate Deltas and P-values out of a total N=162.