Pancreatic enzyme replacement therapy no help in patients with chronic pancreatitis

Treatment with non-enteric-coated pancreatic enzyme replacement therapy (NEPERT) does not appear to relieve pain in patients with chronic pancreatitis, according to a study.

The study included 107 adult patients (mean age 34.4 years, 71 percent male) with chronic pancreatitis (66 percent idiopathic) and chronic abdominal pain. These patients were randomly assigned to receive NEPERT (protease 30,000 U/lipase 25,000 U/amylase 8,000 U per capsule; n=54) or placebo (n=53) for 12 weeks.

The primary outcome was change in Izbicki pain score from baseline to 12 weeks. Secondary outcomes included Izbicki and Visual Analogue Scale (for pain) at 24 weeks, painful days, analgesic/hospitalisation requirements, patient’s global impression of change, and quality of life at 12 and 24 weeks. The rationale for 24-week secondary outcome assessment was to evaluate carry-over effects after NEPERT.

At 12 weeks, the change in Izbicki pain score from baseline did not significantly differ between the NEPERT and placebo groups (mean between-group difference, −2.5, 95 percent confidence interval [CI], −9.3 to 4.2; p=0.49). Findings were similar at 24 weeks.

Secondary outcomes were also similar between the two treatment groups at 12 and 24 weeks, except for a higher percentage of participants reporting painful days at 12 weeks in the NEPERT vs the placebo group (mean between-group difference, −14.5, 95 percent CI, −26.0 to −3.0; p=0.02).

Adverse events were mild, self-limiting and comparable between groups.