Table 3.
Primary histological outcomes
| Characteristic | PUFA | Placebo | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| Number | 18 | 19 | ||||
| Entry | End of trt | Entry | End of trt. | |||
|
| ||||||
| NAFLD activity score | 6.12±0.99 | 5.41±1.20 | 5.83±1.25 | 4.11±1.45a | ||
| Decrease by ≥ 2 points | 8 (44.4%) | 9 (47.4%) | ||||
| Unchanged | 7 (38.9%) | 8 (42.1%) | ||||
| Worsened by ≥ 2 points | 3 (16.7%) | 2 (10.5%) | ||||
|
| ||||||
| Steatosis | 2.29±0.77 | 2.06±0.75 | 2.06±0.75 | 1.47±0.72b | ||
| Improved | 8 (44.4%) | 10 (52.6%) | ||||
| Unchanged | 7 (38.9%) | 8 (42.1%) | ||||
| Worsened | 3 (16.7%) | 1 (5.3%) | ||||
|
| ||||||
| Lobular inflammation | 1.88±0.60 | 2.12±0.60 | 1.50±0.51 | 2.17±0.51a | ||
| Improved | 7 (38.9%) | 10 (52.6%) | ||||
| Unchanged | 8 (44.4%) | 8 (42.1%) | ||||
| Worsened | 3 (16.7%) | 1 (5.3%) | ||||
|
| ||||||
| Ballooning | 1 (5.3%) | 1.47±0.51 | 1.69±0.48 | 1.38±0.50 | ||
| Improved | 6 (33.3%) | 10 (52.6%) | ||||
| Unchanged | 11 (61.1%) | 7 (36.8%) | ||||
| Worsened | 1 (5.6%) | 1 (5.6%) | ||||
|
| ||||||
| Fibrosis | 2.13±1.02 | 2.06±0.85 | 1.94±0.77 | 2.00±0.82 | ||
| Improved | 3 (16.7%) | 3 (16.7%) | ||||
| Unchanged | 12 (66.7%) | 9 (47.4%) | ||||
| Worsened | 3 (16.6%) | 4 (21.1%) | ||||
a
p<0.001 compared to Entry;
b
p<0.05 compared to entry.