NO EFFECT OF LONG-TERM TREATMENT WITH PANCREATIC EXTRACT ON RECURRENTABDOMINAL-PAIN IN PATIENTS WITH CHRONIC-PANCREATITIS

Background: This study was aimed to investigate the effect of long-ter m treatment with high-protease pancreatic extract on the recurrent abd ominal pain of patients with chronic pancreatitis. Methods: Twenty-six patients with a firm diagnosis of chronic pancreatitis and a pattern of recurrent pain were recruited and randomly assigned to treatment wi th pancreatic extract (Pancrex-Duo(R) capsules, each containing 34,375 USP units of protease in enteric-coated microspheres) or placebo, st a dose of four capsules four times daily, for 4 months. At the end of the first period patients were switched to the other medication for th e next 4 months. Four patients did not complete the study because of u nbearable recurring pain or inadequate compliance with treatment. The other 22 patients daily recorded the presence, intensity, and duration of pain and the consumption of analgesics, for 8 months. Results: No difference was found when intraindividual records during placebo and e xtract treatment periods were compared. Conversely, in the second 4 mo nths of follow-up. regardless of the treatment given in the first peri od, there was a significant reduction in the cumulative pain score (me dian, 95; range, 0-1005, versus 134; 0-972; p < 0.05), in the number o f days (8; 0-132, versus 13; 0-126; p < 0.02) and hours (54; 0-680, ve rsus 80; 0-602; p < 0.05) of pain, and in the analgesic consumption sc ore (0; 0-22, versus 12; 0-44; p = 0.02). Conclusions: Chronic supplem entation with pancreatic extract is not beneficial in the management o f recurrent pain in patients with chronic pancreatitis.