Non-enteric-coated pancreatic enzymes did not reduce pain in chronic pancreatitis

Design

Double-blind, placebo-controlled randomised trial, 24 weeks, two academic centres

Population

107 adults aged 18 to 60 with chronic pancreatitis and chronic abdominal pain

Primary outcome

Change in Izbicki pain score at 12 weeks

Effect

Between-group difference -2.5 (95% CI -9.3 to 4.2; P = 0.49)

This 24-week, double-blind, placebo-controlled trial at two academic centres randomised 107 adults aged 18 to 60 with chronic pancreatitis (Mayo Clinic criteria) and chronic abdominal pain. Participants received non-enteric-coated pancreatic enzyme replacement (protease 30,000 U, lipase 25,000 U and amylase 8,000 U per capsule) or placebo for 12 weeks. Mean age was 34.4 years, 71% were men and 66% had idiopathic disease.

The primary outcome was change in the Izbicki pain score at 12 weeks. There was no significant difference between groups (-2.5, 95% CI -9.3 to 4.2; P = 0.49), and results were similar at 24 weeks. Secondary outcomes were also similar, except that a higher proportion of those on enzymes reported painful days at 12 weeks (difference -14.5, -26.0 to -3.0). Adverse events were mild and similar between groups.

The trial was small and used one formulation and one dose for 12 weeks. It does not address enzyme replacement for malabsorption, where the indication is different, and it does not rule out a small benefit. Pain in chronic pancreatitis is multifactorial, and this result argues against enzymes as an analgesic strategy.

• Do not prescribe pancreatic enzymes for pain alone in chronic pancreatitis on the basis of this trial.
• Continue enzymes for exocrine insufficiency or steatorrhoea where that is the indication.
• Pain scores did not differ at 12 or 24 weeks.
• Look at the other contributors to pain: ductal disease, complications, alcohol, and analgesic strategy.

Why it matters

It tests a long-standing idea for treating pancreatic pain, and the answer was no benefit.

Don't overread it

The trial was small, used one non-enteric-coated formulation for 12 weeks and says nothing about enzyme use for malabsorption.

The statistics, in plain English

A difference of -2.5 with an interval from -9.3 to 4.2 on the Izbicki scale spans both benefit and harm, so the trial shows no evidence of a pain benefit rather than proof of none. With 107 patients, only a sizeable effect would have been detected.

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