[A critical analysis of clinical trials in acute pancreatitis published between 1983 and 1989]

The aim of the study was a critical review of recent clinical trials in acute pancreatitis (AP) to draw recommendations for future studies.

The pharmacological clinical trials in AP reported in English from 1983 to 1989 were identified through a computer assisted Medline search, and a manual review of the references in the initial articles. In addition to the characteristics of the studies, the results on the clinical variables were also recorded. In case of negative results, the power of the study to detect 50% reductions in mortality and complications was also calculated.

In the 12 identified studies 10 different drugs were used. Only 58% were double blind. The interval between the onset of symptoms and therapy was not specified in eight studies (67%) and was two days or longer in the rest. In six studies (50%), the duration of treatment was very short (less than three days). Except in two studies, mild forms of AP predominated. Some clinical efficacy of 5-FU, TRH and CaNa2-ED-TA was reported, although with small relevance. In no trial any beneficial effects on mortality or complications were found, although the statistical power was in general low, and therefore a false negative result cannot be excluded.

The guidelines for clinical trials in AP should be unified, particularly regarding the type of study, inclusion criteria and duration of treatments. Some treatments may be too early discarded owing to false negative results due to small sample size.