A randomised, double blind, multicentre trial of octreotide in moderate to severe acute pancreatitis

Abstract

Background: The pharmacological inhibition of exocrine pancreatic secretion with the somatostatin analogue octreotide has been advocated as a specific treatment of acute pancreatitis.

Aim: To investigate the efficacy of octreotide in acute pancreatitis in a randomised, placebo controlled trial.

Methods: 302 patients from 32 hospitals, fulfilling the criteria for moderate to severe acute pancreatitis within 96 hours of the onset of symptoms, were randomly assigned to one of three treatment groups: group P (n=103) received placebo, while groups O1 (n=98) and O2 (n=101) received 100 and 200 microg of octreotide, respectively, by subcutaneous injection three times daily for seven days. The primary outcome variable was a score composed of mortality and 15 typical complications of acute pancreatitis.

Results: The three groups were well matched with respect to pretreatment characteristics. An intent to treat analysis of all 302 patients revealed no significant differences among treatment groups with respect to mortality (P: 16%; O1: 15%; O2: 12%), the rate of newly developed complications, the duration of pain, surgical interventions, or the length of the hospital stay. A valid for efficacy analysis (251 patients) also revealed no significant differences.

Conclusions: This trial shows no benefit of octreotide in the treatment of acute pancreatitis.

Figures

Figure 1

Flow chart of the allocation of patients to the study groups. ITT, intent to treat analysis; VFE, valid for efficacy analysis. Some patients were excluded for more than one reason.

Figure 2

Scores for complications on enrolment, newly developed complications, and their difference in the intent to treat patient group. Results expressed as medians and ranges. The difference in complication scores (enrolment minus new complications) was computed for each patient. The median of the individual differences was then calculated.

Figure 3

Course of the Apache II score in the intent to treat patient group. Results are expressed as medians and ranges.