The benefit of therapy for prevention of postoperative recurrence of Crohn's disease is limited.
Clinical relapse and severe endoscopic recurrence are the main outcomes in the evaluation of trials on prevention of recurrence.
Professor Mario Cottone and colleagues from Italy conducted a meta-analysis to focus on knowledge of the placebo rates of relapse and recurrence in postoperative Crohn’s disease and to identify factors influencing these rates.
The research team performed a meta-analysis of placebo-controlled, randomized clinical trials.
The trials evaluated therapies for postoperative maintenance of Crohn’s disease identified on MEDLINE from 1990 to 2006.
|The pooled estimate of the placebo relapse rate was 24%|
Primary outcomes were clinical relapse and severe endoscopic recurrence.
The pooled estimate of the placebo relapse rate was 24%.
There was a statistically significant heterogeneity among studies.
Heterogeneity in clinical relapse was present even if the trials were stratified according to the time of outcome.
The team found that the pooled estimate of the severe endoscopic recurrence rate was 50%.
There was significant heterogeneity among the studies.
The team noted that this heterogeneity was less apparent in studies carried out within 12 months.
The logistic analysis identified only duration of follow-up as a variable associated with different placebo relapse rates.
The research team observed no variable was identified as a predictor of a placebo endoscopic recurrence rate.
Professor Cottone’s team concludes, “There is significant heterogeneity among placebo rates in postoperative Crohn’s disease.”
“No single design variable was identified that explained the heterogeneity in placebo outcomes for clinical or endoscopic recurrence.”