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PapersPMID:22797645

Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial.

JAMA2012The record ↗

findings
2
compound
1
endpoints
2
  1. Finding, moderate evidenceno difference foundAlanine aminotransferase
  2. Finding, moderate evidenceno difference foundSerious adverse event incidence
Study, every finding
RCT · 6 months
Dose studied, every finding
420 mg or 700 mg silymarin three times daily for 24 weeks

No finding here moved its endpoint.

  • “Furthermore, there was no statistically significant difference across treatment groups (P=.75) when changes in serum ALT levels from baseline to end of treatment were analyzed as a continuous variable (mean decline, −4.3 [95% CI, −17.3 to 8.7] U/L for placebo, −14.4 [95% CI, −41.6 to 12.7] U/L for 420-mg silymarin, and −11.3 [95% CI, −27.9 to 5.4] U/L for 700-mg silymarin).”
    Interests
    Industry funded
    Population
    Adults with chronic hepatitis C who had not responded to interferon-based therapy and had serum ALT of 65 U/L or greater; three-group comparison of silymarin 420 mg, silymarin 700 mg and placebo; change in ALT from baseline to end of treatment
  • “Comparing placebo vs silymarin (either dose), the proportion of patients with at least 1 serious adverse event in the silymarin groups (7/102) did not differ significantly from the proportion in the placebo group (1/52) (P =.27).”
    Interests
    Industry funded
    Population
    Adults with chronic hepatitis C who had not responded to interferon-based therapy; silymarin at either dose (420 mg or 700 mg three times daily, pooled) versus placebo

Study record

Design
randomised controlled trial
Species
human
Population
Adults with chronic hepatitis C (ALT 65 U/L or greater) previously unsuccessfully treated with interferon-based therapy; SyNCH trial; silymarin as Legalon 140, a dry extract of milk thistle fruits (S marianum)
Participants
154
Comparator
placebo
Duration
168 days
Endpoints measured
30