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. Author manuscript; available in PMC: 2012 Nov 6.
Published in final edited form as: Aliment Pharmacol Ther. 2010 Nov 2;33(1):127–137. doi: 10.1111/j.1365-2036.2010.04503.x

Table 2.

Association of silymain use with liver disease progression in 1049 participants of the HALT-C trial.

Categories Non-users Former users Current users p-trend

TPI + clinical outcomes* Cohort, No. (%) 661 (66.6) 165 (16.6) 167 (16.8)
Case, No. (%) 271 (70.6) 60 (15.6) 53 (13.8)
Crude, RR (95% CI) 1.00 (Ref) 0.87 (0.66–1.15) 0.73 (0.54–0.98) 0.029
Multivariate #1, RR (95% CI) 1.00 (Ref) 0.89 (0.67–1.18) 0.73 (0.54–0.99) 0.038
Multivariate #2, RR (95% CI) 1.00 (Ref) 0.74 (0.56–0.99) 0.84 (0.62–1.13) 0.089

TPI Cohort, No. (%) 368 (67.3) 91 (16.6) 88 (16.1)
Case, No. (%) 116 (76.3) 21 (13.8) 15 (9.9)
Crude, RR (95% CI) 1.00 (Ref) 0.75 (0.47–1.19) 0.54 (0.32–0.93) 0.015
Multivariate #1, RR (95% CI) 1.00 (Ref) 0.75 (0.47–1.20) 0.56 (0.32–0.97) 0.025
Multivariate #2, RR (95% CI) 1.00 (Ref) 0.82 (0.51–1.32) 0.57 (0.33–1.00) 0.042

Clinical outcomes Cohort, No. (%) 701 (66.8) 178 (17.0) 170 (16.2)
Case, No. (%) 187 (68.3) 46 (16.8) 41 (15.0)
Crude, RR (95% CI) 1.00 (Ref) 1.00 (0.73–1.38) 0.86 (0.61–1.20) 0.42
Multivariate #1, RR (95% CI) 1.00 (Ref) 1.07 (0.77–1.48) 0.89 (0.63–1.26) 0.65
Multivariate #2, RR (95% CI) 1.00 (Ref) 0.77 (0.54–1.08) 1.09 (0.77–1.56) 0.89

Abbreviations: TPI, two point increase in Ishak fibrosis score; No, Number; RR, relative risk; CI, confidence interval.

*

Excluding 56 participants with fibrosis at baseline who did not receive follow-up biopsies or have a clinical outcome.

Adjusted for continuous age, lifetime alcohol use, and coffee intake along with categorical variables for education (high school or less, some post high school, completed college), race/ethnicity (Caucasian, African American, Hispanic, and other), sex, diabetes, and ever use of other herbal products besides silymarin, such as green tea, garlic, ginsing, and Echinacea.

Additionally adjusted for continuous mental and physical SF-36 quality of life scores, AST/ALT ratio, albumin, platelets, bilirubin, as well as categorical variables for cirrhosis status at baseline and presence or absence of esophageal varices.