In an eight-week trial, an oral controlled-release preparation of budesonide at an optimal daily dose of 9 mg was well tolerated and effective against active Crohn's disease of the ileum and proximal colon.

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Numerous epidemiological studies have been performed to determine factors that might contribute to the development of inflammatory bowel disease. Although the role oforal contraceptive agents in Crohn's disease (CD) and ulcerative colitis (UC) have been assessed, most studies were of small sample size and characterised by low statistical precision. A meta-analysis was performed to increase the statistical power and to investigate the association between the use of oral contraceptives and the development of CD and UC. The study was based on a search of a Medline database from 1975 to October 1993 and a review of reference lists from published articles, reviews, symposia proceedings, and abstracts from major gastrointestinal meetings. All studies specifically designed to evaluate this association were selected. The combined results of nine studies -two cohort studies (30 379 unexposed and 30 673 exposed patients) and seven case-control studies (482 CD, 237 UC, and 3198 controls) -which satisfied our selection criteria were evaluated. The pooled relative risk (adjusted for smoking) associated with oral contraceptive use was 1.44 (1.12, 1.86) for CD and 1.29 (0.94, 1.77) for UC. These results suggest modest associations between the use of oral contraceptives and the development of CD and UC. As these associations are weak, non-causal explanations for the findings cannot be eliminated. (Gut 1995; 37: 668-673)

Treatment of patients with primary biliary cirrhosis eral prognostic indicators have been proposed and (PBC) using ursodeoxycholic acid (UDCA) leads to a re-prognostic indexes developed to predict survival. duction in serum bilirubin. The first objective of this Shapiro et al. 1 showed that serum bilirubin is a good study was to assess the performance of certain prognos-predictor of survival in PBC, and elevated serum bilirutic indicators for PBC after the introduction of treat-bin levels have been used to decide when to refer pament with UDCA. Serum bilirubin is an important prog-tients for transplantation.2 Other groups have develnostic indicator for PBC and an important component oped prognostic indexes that combine bilirubin with of the Mayo model for grading patients into risk categoseveral other variables to arrive at a predictive score. ries. In an analysis of patients enrolled in the CanadianThe European model 3 uses serum bilirubin, serum almulticenter trial, the Mayo score was calculated before bumin, age, the presence of cirrhosis and cholestasis and after treatment with UDCA. After treatment, the Mayo score continued to divide patients with PBC into on liver biopsy, and azathioprine use. The Yale model groups with varying risk. In addition, the serum biliru-combines age, serum bilirubin, hepatomegaly, and the bin alone was shown to do the same even after the intro-presence of portal fibrosis or cirrhosis. 4 A third model duction of treatment with UDCA. A second objective was developed for nonalcoholic cirrhosis and PBC uses seto establish whether UDCA had an effect on long-term rum bilirubin, serum albumin, age, hepatitis B surface The Mayo group 6 devised a further model which emPrimary biliary cirrhosis (PBC) is a chronic progres-ploys serum bilirubin, serum albumin, age, prothromsive cholestatic liver disease for which the only defini-bin time, and the presence of edema. The Mayo model tive treatment is orthotopic liver transplantation. One was based on data from a group of 312 patients inof the most difficult questions in the management of volved in a trial of D-penicillamine and has been exterpatients with PBC is when to intervene with trans-nally cross-validated. 7 plantation to optimize quality and length of life. SevAll of the models mentioned above use the patient's data collected at the time of referral to predict the remaining life span. Both the European and Mayo models Abbreviations: PBC, primary biliary cirrhosis; UDCA, ursodeoxycholic acid.