Gender modifies the effect of ursodeoxycholic acid in a randomized controlled trial in colorectal adenoma patients

Patricia A Thompson1, Betsy C Wertheim, Denise J Roe

  • 1Arizona Cancer Center, 1515 North Campbell Avenue, P.O. Box 245024, Tucson, AZ 85724, USA. pthompson@azcc.arizona.edu

Abstract

Insights

Ursodeoxycholic acid (UDCA) may prevent advanced colorectal adenomas in men, but increases risk in women, particularly those with high fat intake. Further research is needed to understand these sex-specific effects and potential harms.

Area of Science:

  • Gastroenterology
  • Oncology
  • Pharmacology

Background:

  • Ursodeoxycholic acid (UDCA) has been explored for colorectal cancer prevention.
  • Previous large trials indicated UDCA's inefficacy in preventing colorectal adenomas.
  • Sex-specific differences in bile acid metabolism may influence UDCA's efficacy.

Purpose of the Study:

  • To re-evaluate the efficacy of UDCA in preventing colorectal adenomas, analyzing men and women separately.
  • To investigate potential sex-specific variations in UDCA's effect on colorectal adenoma development.

Main Methods:

  • Secondary analysis of a phase III randomized, placebo-controlled trial data.
  • Examined UDCA efficacy in preventing colorectal adenoma in 804 men and 388 women.
  • Assessed the influence of age, obesity, and dietary fat intake on UDCA's effects in women.

Main Results:

  • UDCA did not reduce the risk of any metachronous adenoma in men or women.
  • UDCA significantly lowered the odds of advanced colorectal lesions in men (OR, 0.62).
  • UDCA increased the odds of advanced lesions in women, especially those younger than 65, obese, or with high dietary fat intake.

Conclusions:

  • UDCA may be beneficial for preventing advanced colorectal adenomas in men.
  • High dietary fat intake appears to mediate increased adenoma risk with UDCA in women.
  • Potential unrecognized harm of UDCA in specific female subgroups warrants further investigation.

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