1. Adverse events.
Study | Pts. in experimental group | Pts. in control group | AE in experimental group | AE in control group | Author's conclusion |
Beuers 1992 | 6 | 8 | Diarrhoea (1 pt.) | No Ae | The symptoms ceased after UDCA treatment termination. |
Lo 1992 | 8 | 10 | No AE | No AE | UDCA seemed to be well tolerated. |
Stiehl 1994 | 10 | 10 | Diarrhoea (2 pts.) | No AE | After a reduction of the dose to 500 mg and 250 mg/day, UDCA was well tolerated. Re‐exposure to the higher dose (750 mg) re‐induced diarrhoea. |
Lindor 1997 | 53 | 52 | No AE | Diarrhoea (1 pt.), flare of ulcerative colitis (1 pt.) | Ursodiol was well tolerated. |
Mitchell 2001 | 13 | 13 | No AE | No AE | No patients required alteration in the prescribed trial medication for diarrhoea or any other cause. |
Olsson 2005 | 110 | 109 | 37 | 34 | There seemed to be no difference between the two groups in the overall frequency of reported side effects attributed to the capsules (UDCA, 38.1%; placebo 33.7%) |
Charatcharoenwitthaya 2008 | 42 | No‐controls | Flare of ulcerative colitis (1 pt.) | No controls | UDCA was well tolerated, but one patient stopped medication after four years of therapy because of a flare of ulcerative colitis. |
pt(s) = patient(s). AE = adverse events.