Table 4.
Change in select fatty acids and liver function tests by level of response to intervention
| Positive response | No change | Negative response | P (positive response vs. no change) | |
|---|---|---|---|---|
| n | 8 | 13 | 2 | |
| Baseline patient characteristics | ||||
| Age, years, mean (±S.E.) | 48.8 (±4.8) | 46.1 (±4.7) | 56.5 (±14.5) | 0.7 |
| Gender, male (%) | 63 | 54 | 0 | |
| Mayo PSC risk score (±S.E.) | 0.8 (±0.4) | 1.2 (±0.2) | 1.8 (±1.0) | 0.4 |
| Ursodiol, % | 25 | 33 | 50 | |
| Change in fatty acids, LFTs, and fibrosis ELF score | ||||
| Fatty acids* mol% (±S.E.) | ||||
| DHA | ||||
| Baseline | 1.7 (±0.5) | 1.8 (±0.3) | 1.2† | 0.9 |
| 12 months | 3.9 (±0.7) | 3.3 (±0.3) | 3.2† | 0.4 |
| % change, mean (±S.E.) | 280 (±136.4) | 88 (±48.5) | 161† | 0.2 |
| AA | ||||
| Baseline | 7.6 (±0.6) | 5.7 (±0.6) | 6.4† | 0.04 |
| 12 months | 5.6 (±0.6) | 4.7 (±0.5) | 3.1† | 0.3 |
| % change, mean (±S.E.) | −26 (±6.1) | −7 (±13.7) | −52† | 0.2 |
| LA | ||||
| Baseline | 28.2 (±3.2) | 23.7 (±0.9) | 24.8† | 0.1 |
| 12 months | 29.5 (±1.6) | 24.1 (±2.4) | 26.3† | 0.1 |
| % change, mean (±S.E.) | 5 (±12.9) | 5 (±9.0) | 6† | 1.0 |
| LFTs, (normal range), mean (±S.E.) | ||||
| AP (35–130 IU/L) | ||||
| Baseline | 406.9 (±84.0) | 321.5 (±40.4) | 397.0 (±61.0) | 0.3 |
| 12 months | 214.5 (±72.8) | 297.2 (±30.0) | 627.0 (±94.0) | 0.2 |
| % change | −53 (±6.9) | −5 (±3.5) | 58 (±0.6) | <0.00001 |
| ALT (0–40 IU/L) | ||||
| Baseline | 93.8 (±37.9) | 144.0 (±51.5) | 100.0 (±59.0) | 0.5 |
| 12 months | 69.5 (±30.8) | 139.8 (±29.4) | 294.5 (±228.5) | 0.1 |
| % change | −26 (±8.4) | 24 (±12.5) | 145 (±84.0) | 0.01 |
| AST (0–40 IU/L) | ||||
| Baseline | 72.9 (±30.4) | 84.9 (±18.9) | 69.5 (±1.5) | 0.7 |
| 12 months | 63.1 (±30.0) | 92.5 (±14.9) | 217 (±117.0) | 0.3 |
| % change | −18 (±7.6) | 19 (±7.8) | 209 (±161.7) | 0.005 |
| GGT (5–61 IU/L) | ||||
| Baseline | 313.6 (±113.0) | 386.6 (±84.9) | 569.5 (±274.5) | 0.6 |
| 12 months | 193.0 (±72.3) | 504.2 (±102.9) | 708 (±354.0) | 0.04 |
| % change | −28 (±16.0) | 31 (±18.3) | 23 (±2.9) | 0.03 |
| Bilirubin (0–1.5 mg/dL) | ||||
| Baseline | 1.0 (±0.4) | 1.1 (±0.2) | 0.8 (±0.2) | 0.9 |
| 12 months | 1.6 (±0.9) | 1.7 (±0.4) | 2.2 (±0.1) | 0.5 |
| % change | 21 (±15.0) | 114 (±49.2) | 188 (±78.3) | 0.2 |
| Albumin (3.5–5.2 g/dL) | ||||
| Baseline | 4.3 (±0.1) | 4.2 (±0.1) | 3.9 (±0.6) | 0.5 |
| 12 months | 4.4 (±0.08) | 4.2 (±0.1) | 4.0 (±0.5) | 0.07 |
| % change | 3 (±2.7) | −8 (±7.9) | 3 (±3.0) | 0.3 |
| PT (35–130 s) | ||||
| Baseline | 10.9 (±0.6) | 12.3 (±1.8) | 9.9 (±1.4) | 0.6 |
| 12 months | 10.8 (±0.6) | 11.1 (±1.4) | 10.2 (±1.1) | 0.9 |
| % change | 2 (±1.7) | −14 (±13.7) | 4 (±3.5) | 0.4 |
| Fibrosis ELF score (normal 0–6.6), mean (±S.E.) | ||||
| Baseline | 9.1 (±0.9) | 10.5 (±0.5) | 12.3† | 0.2 |
| 12 months | 9.4 (±0.8) | 10.6 (±0.3) | 12.0† | 0.2 |
| % change | 7 (±3.0) | 3 (±5.7) | −2† | 0.6 |
S.E., standard error of the mean; DHA, docosahexaenoic acid; AA, arachidonic acid; LFTs, liver function tests; AP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma glutamyltransferase; PT, prothrombin time.
Positive response indicates a reduction in AP of >25%. No change indicates a reduction in AP of <25% or an increase in AP of <25%. Negative response denotes an increase in AP of >25%.
*
BIDMC patients only; Positive response n = 5; No change n = 7; Negative response n = 1.
†
Value for n = 1, S.E. not applicable, patient developed gall-bladder cancer.