Table 4.
Comparison of non-responders to responders.
Non-responders | Responders | p-value# | |||||||
---|---|---|---|---|---|---|---|---|---|
Combined VitE and Placebo (N=38) | Placebo (N=21) | Vitamin E (N=17) | p-value# | Combined VitE and Placebo (N=21) | Placebo (N=8) | Vitamin E (N=13) | p-value$ | ||
H&E Histologic changes | |||||||||
Steatosis | 0[−1, 0.25] | 0[−0.5, 1] | 0[−2, 0] | 0.0624 | −1[−1.5, 0] | −0.5[−1, 0] | −1[−2, 0] | 0.2819 | 0.0104 |
Lobular inflammation | 0[−0.25, 0] | 0[0, 0.5] | 0[−1, 0] | 0.1238 | −1[−1,0] | −1[−1,0.25]§ | −1[−1, 0] | 0.7186 | 0.0003 |
Hepatocyte ballooning | 0[0, 1] | 0[0, 1] | 0[0, 1] | 0.8593 | −1[−2, −1] | −1.5[−2 ,−1]§ | −1[−1, −1] | 0.1057 | <0.0001 |
Mallory-Denk bodies | 0[0, 0] | 0[0, 0] | 0[−1, 0] | 0.2594 | 0[−1, 0] | 0[−0.75, 0] | 0[−1, 0] | 0.5647 | 0.0311 |
Portal inflammation | 0[0, 0] | 0[0, 0] | 0[0, 0] | 0.9545 | 0[−0.5, 0] | 0[0, 0.75] | 0[−1, 0]§ | 0.0147 | 0.1859 |
Fibrosis | 0[−1, 0.25] | 0[0, 0] | 0[−1, 1] | 0.9748 | 0[−1, 0] | 0[−1, 0] | 0[−1, 0] | 0.8006 | 0.1140 |
Biochemical changes | |||||||||
Serum ALT change, U/L | −11.2±47.8 | 0.2±30.3 | −26.1±61.9 | 0.0215 | −49.1±50.6 | −32.8±40.5§ | −59.2±55.0 | 0.4254 | 0.0078 |
Serum AST change, U/L | −1.6±34.3 | 9.4±29.8 | −16.1±35.2 | 0.0205 | −24.7±29.2 | −12.9±23.5 | −31.9±30.8 | 0.1282 | 0.0103 |
IHC parameter changes | |||||||||
Shh-positive hepatocytes, cells/HPF | 0.74±10.3 | 2.6±12.2 | −1.9±6.2 | 0.0464 | −3.6±8.2 | −2.4±2.9§ | −4.3±10.2 | 0.7705 | 0.0067 |
K8/18 negative cells or ubiquitin-positive foci/HPF | −0.91±6.8 | 0.4±7.5 | −2.5±5.7 | 0.1451 | −2.5±5.9 | −0.8±0.9 | −3.5±7.3 | 0.5002 | 0.1556 |
α-SMA-positive stain score | 0[0, 0] | 0[0, 0] | 0[0, 0] | 0.3736 | 0[−1, 0] | 0[0, 0] | 0[−1, 0] | 0.2388 | 0.0468 |
gli2/sox9-positive stain score | 0[0, 0] | 0[0, 0] | 0[−1, 0] | 0.0876 | 0[−1, 0] | 0[−0.75, 0] | 0[−1, 0] | 0.7050 | 0.0805 |
: p-values for non-responders vs. responders (combined groups: vitamin E and placebo).
: p-values for placebo vs. vitamin E.
: p-value<0.05 vs. non-responders within the same treatment group.