Mount Sinai IRB approved message:
(GCO 02-1185 CM)

Mount Sinai Medical Center and the Foundation for Integrative AIDS Research (FIAR) conducted a study of the herb milk thistle (Silybum marianum) in people who have both chronic hepatitis C and HIV infections. An abstract and poster presentation were accepted at the XVII International Conference on HIV/AIDS held in Mexico City, Mexico in August, 2008.
*** FIAR Milk Thistle Study Abstract:
Topic: B12 Hepatitis co-infections: (including HBV, HCV)
Cross-cutting Theme: 5. "Do the Right Thing" and Evidence-informed policies & Programmes
Category: Track B Opportunistic Infections
Title: Pilot trial of milk thistle in HIV/hepatitis C co-infection
Author(s): G. Carter1, J. Godbold2, R. MacKay2, M. Smirnoff2, E. Chusid2, D. Pagano2, H.S. Sacks2
Institute(s): 1Foundation for Integrative AIDS Research (FIAR), Brooklyn, United States, 2Mount Sinai School of Medicine, New York, United States

Background: Co-infection of HIV with hepatitis C (HCV) represents a significant challenge and increased risk for morbidity and mortality. Standard treatment with pegylated interferon and ribavirin often does not achieve sustained viral response, especially among those with genotype 1 and/or African-American ethnicity. Interventions that improve liver function are urgently needed. Silybum marianum, Linn. (milk thistle (MT)) has been shown to have some benefit on liver function and fibrosis in various settings.

Methods: In a double-blind, 52-week trial, HIV+/HCV+ individuals were randomized to receive either placebo or 180 mg thrice daily of an 80% standardized silymarin extract (MT). Primary outcomes were safety and feasibility.

Results: 21 subjects were enrolled; demographic characteristics between arms were similar, approximately half men, half women in each arm with a similar distribution of ethnicities, mainly African-American (47.5%) and Latino (47.5%), reflecting our clinic population. No significant hematological or blood chemistry abnormalities were noted. No beneficial or adverse effect on CD4 count or HIV or HCV viral load was observed between arms, nor were there statistically significant differences in quality of life parameters. There were no serious adverse events in either arm. There was good retention in both arms (15 of 21 completed the study- 7 MT, 8 placebo). No clinically apparent effect of milk thistle was seen on HIV load, suggesting a lack of interaction with antiretrovirals. There was a trend to decline in serum aspartate aminotransferase (AST) in the MT arm of 8.4, versus an increase of 27.9 in the placebo arm (p=0.099)

Conclusions: Milk thistle was safe in this study population, with no clinically significant interactions with antiretroviral therapy. The trend toward reduction in AST suggests possible benefit and deserves further study.

Supported by Grants no. 1R21-NR08860, 1K07-AT00591 and MO1-RR-00071 from the National Institutes of Health. Country of research: United States

Some reviews of the study may be found here:
AIDSMEDS article
Clinical Care Options
Grupo de Trabajo sobre Tratamientos del VIH (scroll down for article).

This research study is being funded by a grant from the National Institutes of Health (NIH).

The total duration of the study will be 52 weeks and will include a total of 8 study visits.