Abstract
Department of Gastroenterology, Academisch Ziekenhuis, Maastricht, The Netherlands.
OBJECTIVE: To assess the influence of pancreatic enzyme supplementation on symptoms, energy intake, bowel habits, and fat malassimilation in patients after total gastrectomy. DESIGN: A prospective, double-blind, randomized, parallel, placebo-controlled, multi-centre trial. SETTING: Institutionalized patients in three gastroenterological rehabilitation clinics. PARTICIPANTS: 52 institutionalized patients with a faecal fat output > or = 14 g/day, operated on for malignant gastric disease a median of 198 days (interquartile range (IQR) 47-608) previously, and free from recurrence and/or metastasis. INTERVENTIONS: Nine sachets of pancreatic enzymes per day (each containing lipase 36,000, amylase 27,000, protease 2400 FIP (Federation International Pharmaceutique)) or identical-looking placebo were given for 14 days. MAIN OUTCOME MEASURES: Abdominal symptoms, energy intake, bowel habits and fat malassimilation. RESULTS: After treatment, patients on enzyme therapy felt better overall (P = 0.006), but no improvement of a specific symptom could be identified. During the intervention, the median kilojoule intake per kilogram body weight was 9% higher in the placebo group (170.8 (IQR 146.9-202.6)) than in the enzyme-treated group (157.0 (IQR 134.8-170.4)) (P = 0.03). Enzyme treatment did not result in a significant difference between the placebo and the enzyme-treated group regarding bowel habits or fat malassimilation. CONCLUSIONS: The effect of high-dose pancreatic enzymes supplementation on symptoms and steatorrhoea after total gastrectomy is marginal and does not justify its routine use.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
OBJECTIVE: To assess the influence of pancreatic enzyme supplementation on symptoms, energy intake, bowel habits, and fat malassimilation in patients after total gastrectomy. DESIGN: A prospective, double-blind, randomized, parallel, placebo-controlled, multi-centre trial. SETTING: Institutionalized patients in three gastroenterological rehabilitation clinics. PARTICIPANTS: 52 institutionalized patients with a faecal fat output > or = 14 g/day, operated on for malignant gastric disease a median of 198 days (interquartile range (IQR) 47-608) previously, and free from recurrence and/or metastasis. INTERVENTIONS: Nine sachets of pancreatic enzymes per day (each containing lipase 36,000, amylase 27,000, protease 2400 FIP (Federation International Pharmaceutique)) or identical-looking placebo were given for 14 days. MAIN OUTCOME MEASURES: Abdominal symptoms, energy intake, bowel habits and fat malassimilation. RESULTS: After treatment, patients on enzyme therapy felt better overall (P = 0.006), but no improvement of a specific symptom could be identified. During the intervention, the median kilojoule intake per kilogram body weight was 9% higher in the placebo group (170.8 (IQR 146.9-202.6)) than in the enzyme-treated group (157.0 (IQR 134.8-170.4)) (P = 0.03). Enzyme treatment did not result in a significant difference between the placebo and the enzyme-treated group regarding bowel habits or fat malassimilation. CONCLUSIONS: The effect of high-dose pancreatic enzymes supplementation on symptoms and steatorrhoea after total gastrectomy is marginal and does not justify its routine use.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
Original language | English |
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Pages (from-to) | 231-237 |
Number of pages | 7 |
Journal | European Journal of Gastroenterology & Hepatology |
Volume | 11 |
Issue number | 3 |
DOIs | |
Publication status | Published - 1 Jan 1999 |