Table 1.
Baseline demographic, clinical, and lab features of 1049 participants of the HALT-C trial by category of silymarin use.
| Variables | ||||
|---|---|---|---|---|
|
| ||||
| Never | Former | Current | P for trend* | |
|
| ||||
| Number in cohort, No. (%) | 701 (66.8) | 178 (17.0) | 170 (16.2) | |
| Duration of silymarin use, months, Median (IQR) | 0 | 6 (3–12) | 35 (20–53) | |
| Age, years, Median (IQR) | 50 (46–54) | 48 (45–53) | 50 (47–53) | 0.52 |
| Gender, female, No. (%) | 216 (70.8) | 52 (17.1) | 37 (12.1) | 0.027 |
| Race/ethnicity, Caucasian, No. (%) | 474 (63.1) | 134 (17.8) | 143 (19.0) | 0.001 |
| Treatment group, No. (%) | 337 (65.3) | 93 (18.0) | 86 (16.7) | 0.41 |
| Source of patient randomized | ||||
| Lead-in non-responder | 431 (65.1) | 122 (18.4) | 109 (16.5) | 0.11 |
| Lead-in breakthrough or relapse | 97 (64.2) | 27 (17.9) | 27 (17.9) | |
| Express | 173 (73.3) | 29 (12.3) | 34 (14.4) | |
| Education†, Completed college, No. (%) | 164 (60.1) | 51 (18.7) | 58 (21.3) | <.0001 |
| Lifetime alcohol consumption, # of drinks, Median (IQR) | 6758 (972–21,168) | 7622 (1850–20,398) | 9580 (1644–27,512) | 0.035 |
| Coffee intake,† drinks/day, Median (IQR) | 1 (0.03–2) | 1 (0.3–2) | 1 (0.3–2) | 0.023 |
| Body Mass Index, Median (IQR) | 29.3 (26.3–32.8) | 29.4 (26.3–32.8) | 28.5 (25.8–31.8) | 0.23 |
| Diabetes, Glucose ≥ 126 mg/dl, No. (%) | 186 (73.2) | 36 (14.2) | 32 (12.6) | 0.016 |
| Mental summary score from SF-36,† Median (IQR) | 53 (46–57) | 51 (45–56) | 53 (47–57) | 0.25 |
| Physical summary score from SF-36,† Median (IQR) | 47 (35–54) | 47 (37–54) | 50 (41–54) | 0.038 |
|
| ||||
| AST, U/L, Median (IQR) | 70 (50–102) | 72 (54–124) | 71 (49–113) | 0.24 |
| ALT, U/L, Median (IQR) | 82 (57–123) | 94 (67–140) | 90 (60–139) | 0.009 |
| AST/ALT Ratio, Median (IQR) | 0.82 (0.69–1.04) | 0.79 (0.64–1.00) | 0.80 (0.64–0.94) | 0.004 |
| Albumin, g/dL, Median (IQR) | 3.9 (3.6–4.1) | 3.9 (3.6–4.1) | 4.0 (3.7–4.2) | 0.018 |
| Alk. Phos. U/L, Median (IQR) | 90 (71–118) | 89 (71–113) | 84 (68–106) | 0.012 |
| Bilirubin, mg/dL, Median (IQR) | 0.7 (0.5–0.9) | 0.7 (0.5–0.9) | 0.8 (0.5–1.0) | 0.40 |
| Platelets, 1000/mL, Median (IQR) | 159 (116–208) | 161 (114–205) | 158 (119–197) | 0.42 |
| Prothrombin time, INR, Median (IQR) | 1.0 (1.0–1.1) | 1.0 (1.0–1.1) | 1.0 (1.0–1.1) | 0.49 |
| Log10 HCV RNA level, Median (IQR) | 6.5 (6.1–6.8) | 6.5 (6.2–6.8) | 6.6 (6.2–6.8) | 0.58 |
| HCV genotype 1, No. (%) | 649 (66.3) | 167 (17.1) | 163 (16.7) | 0.12 |
|
| ||||
| Cirrhosis on biopsy, No. (%) | 280 (65.4) | 74 (17.3) | 74 (17.3) | 0.38 |
| Hepatic steatosis, ≥ Grade 2 | 279 (64.0) | 88 (20.2) | 69 (15.8) | 0.38 |
| Ishak inflammation score, Median (IQR) | 7 (6–9) | 7 (6–9) | 8 (6–9) | 0.67 |
| Esophageal varices†, No. (%) | 158 (60.5) | 52 (19.9) | 51 (19.5) | 0.021 |
| Collagen content†, Median (IQR) | 0.04 (0.02–0.08) | 0.04 (0.02–0.09) | 0.04 (0.02–0.07) | 0.36 |
Abbreviations: No: Number; IQR: Interquartile range; AST, aspartate aminotransferase; ALT, alanine aminotransferase; Alk. Phos., Alkaline phosphatase; HCV, hepatitis C.
*
Mantel-Haenszel test for trend for categorical variables. Jonckheere-Terpstra test for trend for continuous variables.
†
Data not available for all participants: Coffee was available for 791 participants; Collagen content for 558 patients; Education available for 1045 participants; Esophageal varices for 1016 participants; SF-36 scores for 1043 participants.