Table 4.
Summary of outcome data relating to prespecified biochemical liver parameters (randomized studies)
| Parameter | Study | Disease | Intervention |
Baseline |
After treatment |
Statistical method | P value | ||
| AdoMet | Placebo / comparator | AdoMet | Placebo / comparator | ||||||
| ALT | |||||||||
| ALT (μkat/L) | Frezza et al[33], 1990 | Chronic liver disease with IHC (N = 220) | AdoMet (n = 110) vs placebo (n = 110) | 3.3 ± 0.4 (mean ± SE) | 2.8 ± 0.3 | 2.3 ± 0.2 (Week 1), 1.5 ± 0.1 (Week 2) | 2.4 ± 0.2 (Week 1), 2.2 ± 0.2 (Week 2) | Split-plot analysis | Not reported at Week 1, P < 0.05 vs placebo at Week 2 |
| ALT (μkat/L) | Manzillo et al[38], 1992 | IHC (N = 343) | AdoMet (n = 180) vs placebo (n = 163) | 1.2 (1.1, 1.4) (mean, 95% CI) | 1.2 (1.1, 1.4) | 0.8 (0.7, 0.9) | 1.0 (0.9, 1.2) | Split-plot analysis (MANOVA) | P < 0.01 treatment-to-time interaction vs placebo at Week 2 |
| ALT (U/L) | Qin et al[37], 20001 | Intrahepatic cholestatic viral hepatitis (N = 30) | AdoMet (n = 15) vs potassium magnesium aspartate (n = 15) | 198.5 ± 75.2 (mean ± SD) | 190.6 ± 71.2 | 127.0 ± 47.5 (Week 2), 48.2 ± 43.5 (Week 4) | 130.2 ± 47.2 (Week 2), 67.7 ± 27.2 (Week 4) | x2 test for comparison of rates; t test for comparison of means | NS at Week 2 P < 0.05 vs comparator at Week 4 |
| AST | |||||||||
| AST (μkat/L) | Frezza et al[33], 1990 | Chronic liver disease with IHC (N = 220) | AdoMet (n = 110) vs placebo (n = 110) | 2.4 ± 0.2 (mean ± SE) | 2.1 ± 0.2 | 1.8 ± 0.1 (Week 1), 1.3 ± 0.1 (Week 2) | 1.8 ± 0.2 (Week 1), 1.7 ± 0.2 (Week 2) | Split-plot analysis | NS vs placebo at Weeks 1 and 2 |
| AST (μkat/L) | Manzillo et al[38], 1992 | IHC (N = 343) | AdoMet (n = 180) vs placebo (n = 163) | 1.4 (1.2, 1.6) (mean, 95% CI) | 1.3 (1.2, 1.5) | 0.9 (0.9, 1.1) | 1.0 (0.9, 1.2) | Split-plot analysis (MANOVA) | P < 0.05 treatment-to-time interaction vs placebo at Week 2 |
| AST (U/L) | Qin et al[37], 20001 | Intrahepatic cholestatic viral hepatitis (N = 30) | AdoMet (n = 15) vs potassium magnesium aspartate (n = 15) | 127.0 ± 60.7 (mean ± SD) | 118.2 ± 58.7 | 84.6 ± 33.8 (Week 2), 45.6 ± 28.2 (Week 4) | 78.3 ± 38.5 (Week 2), 52.7 ± 25.3 (Week 4) | x2 test for comparison of rates; t test for comparison of means | NS at Week 2 P < 0.05 vs comparator at Week 4 |
| ALP | |||||||||
| ALP (μkat/L) | Frezza et al[33], 1990 | Chronic liver disease with IHC (N = 220) | AdoMet (n = 110) vs placebo (n = 110) | 4.5 ± 0.3 (mean ± SE) | 4.7 ± 0.3 | 3.7 ± 0.3 (Week 1), 3.2 ± 0.2 (Week 2) | 4.6 ± 0.3 (Week 1), 4.4 ± 0.3 (Week 2) | Split-plot analysis | P < 0.05 vs placebo at Week 1, P < 0.01 vs placebo at Week 2 |
| ALP (μkat/L) | Manzillo et al[38], 1992 | IHC (N = 343) | AdoMet (n = 180) vs placebo (n = 163) | 4.8 (4.2, 5.5) (mean, 95% CI) | 4.9 (4.3, 5.7) | 3.9 (3.4, 4.4) | 4.0 (3.4, 4.7) | Split-plot analysis (MANOVA) | NS vs placebo at Week 2 |
| ALP (U/L) | Qin et al[37], 20001 | Intrahepatic cholestatic viral hepatitis (N = 30) | AdoMet (n = 15) vs potassium magnesium aspartate (n = 15) | 203.2 ± 39.5 (mean ± SD) | 202.8 ± 39.4 | 93.5 ± 33.7 (Week 2), 85.6 ± 20.6 (Week 4) | 97.5 ± 33.0 (Week 2), 89.1 ± 27.8 (Week 4) | x2 test for comparison of rates; t test for comparison of means | NS vs comparator at Weeks 2 and 4 |
| γGT | |||||||||
| γGT (μkat/L) | Frezza et al[33], 1990 | Chronic liver disease with IHC (N = 220) | AdoMet (n = 110) vs placebo (n = 110) | 2.5 ± 0.3 (mean ± SE) | 2.2 ± 0.2 | 1.9 ± 0.3 (Week 1), 1.5 ± 0.2 (Week 2) | 1.9 ± 0.1 (Week 1), 1.7 ± 0.1 (Week 2) | Split-plot analysis | NS at Week 1 or Week 2 |
| γGT (μkat/L) | Manzillo et al[38], 1992 | IHC (N = 343) | AdoMet (n = 180) vs placebo (n = 163) | 1.9 (1.6, 2.2) (mean, 95% CI) | 1.8 (1.6, 2.2) | 1.2 (1.0, 1.3) | 1.3 (1.1, 1.6) | Split-plot analysis (MANOVA) | P < 0.05 treatment-to-time interaction vs placebo at Week 2 |
1
Published studies translated to English from original language. AdoMet: S-adenosylmethionine; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CI: Confidence interval; γGT: Gamma-glutamyl transferase; IHC: Intrahepatic cholestasis; MANOVA: Multivariate analysis of variance; NS: Not significant; SD: Standard deviation; SE: Standard error.