Hep573 study: A randomised, double-blind, placebocontrolled trial of silymarin alone and combined with antioxidants to improve liver function and quality of life in people with chronic hepatitis C

Ses J. Salmond, J. George, S. I. Strasser, K. Byth, B. Rawlinson, T. A. Mori, K. D. Croft, L. A. Adams, R. G. Batey

Research output: Contribution to journalArticle

Abstract

Background Chronic hepatitis C (CHC) is a viral liver disease characterised by oxidative stress and inflammation leading to fibrosis, liver injury, cirrhosis and increased risk of liver cancer and reduced quality of life (QOL). Antioxidant phytonutrients have potential to limit inflammation and reduce co-morbidities associated with CHC. This randomised, placebo-controlled trial investigated the effects of two naturopathic treatments consisting of antioxidant nutrients and herbal medicines against placebo on liver function and QOL in people with CHC. Methods A randomised, double-blind, placebo-controlled clinical trial was conducted in three Australian teaching hospitals in New South Wales. One hundred and eighteen participants with compensated CHC-related disease were recruited through liver outpatient clinics and randomised to one of three groups: silymarin; silymarin with 13 other antioxidants (SOX); or placebo. Study duration was 48 weeks: 24 weeks on active treatment or placebo, and 24 weeks follow-up post treatment. Outcome measures included alanine aminotransferase (ALT), F2-isoprostanes (oxidative stress), HCV RNA (viral load), FibroTest (liver damage), and QOL. Results The use of silymarin with antioxidants (SOX) achieved a higher rate of ALT normalisation (primary outcome) than placebo (P=0.02) or silymarin alone (P=0.003) at week 24. In addition, there was significant improvement in the Hepatitis Quality of Life Questionnaire (HQLQ) Mental Component Summary (MCS) in the SOX group (P=0.002). There were no significant changes in F2-isoprostanes, HCV RNA or FibroTest. Conclusions This study has shown that the use of a complex naturopathic herbal and nutritional treatment can normalise ALT and improve QOL in participants with compensated CHC-related disease.

Original languageEnglish
Pages (from-to)64-76
Number of pages13
JournalAustralian Journal of Herbal and Naturopathic Medicine
Volume31
Issue number2
DOIs
Publication statusPublished - 1 Jan 2019

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