Ursodeoxycholic acid as a chemopreventive agent in patients with ulcerative colitis and primary sclerosing cholangitis

Gastroenterology. 2003 Apr;124(4):889-93. doi: 10.1053/gast.2003.50156.


Background & aims: Ursodeoxycholic acid (UDCA) has shown effectiveness as a colon cancer chemopreventive agent in preclinical studies. In addition, a recent report suggests that it also may decrease the risk for developing colorectal dysplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We sought to evaluate the effect of UDCA on colorectal neoplasia in a group of patients with UC and PSC enrolled in a randomized, placebo-controlled trial.

Methods: From a prior, randomized, placebo-controlled trial of UDCA therapy in PSC at our center, we followed-up patients with concomitant UC to assess the effect of UDCA on the development of colorectal dysplasia and cancer as compared with placebo.

Results: Fifty-two subjects were followed-up for a total of 355 person-years. Those originally assigned to receive UDCA had a relative risk of 0.26 for developing colorectal dysplasia or cancer (95% confidence interval, 0.06-0.92; P = 0.034). Many of the patients originally assigned to the placebo group eventually received open-label UDCA. Assigning these patients to the UDCA group from the time they began active therapy did not change the magnitude of the protective effect (relative risk, 0.26; 95% confidence interval, 0.07-0.99; P = 0.049).

Conclusions: UDCA significantly decreases the risk for developing colorectal dysplasia or cancer in patients with UC and PSC.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aminosalicylic Acids / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Cholagogues and Choleretics / therapeutic use*
  • Cholangitis, Sclerosing / drug therapy
  • Cholangitis, Sclerosing / epidemiology*
  • Colitis, Ulcerative / drug therapy
  • Colitis, Ulcerative / epidemiology*
  • Colonic Neoplasms / epidemiology
  • Colonic Neoplasms / prevention & control*
  • Disease-Free Survival
  • Female
  • Folic Acid / therapeutic use
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Risk Factors
  • Ursodeoxycholic Acid / therapeutic use*


  • Aminosalicylic Acids
  • Anti-Inflammatory Agents, Non-Steroidal
  • Cholagogues and Choleretics
  • Ursodeoxycholic Acid
  • Folic Acid