CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Treatment of steatorrhoea in cystic fibrosis: a comparison of enteric-coated microspheres of pancreatin versus non-enteric-coated pancreatin and adjuvant cimetidine.

Study design (if review, criteria of inclusion for studies)

open, randomized crossover study

Participants

14 adults with steatorrhoea due to cystic fibrosis

Interventions

Enteric-coated microspheres of pancreatin were compared with non-enteric-coated pancreatin combined with cimetidine taken 40 min before meals in the treatment of patients with cystic fibrosis. two consecutive 28-day treatment periods. Lipase intake was adjusted to each patient's previous requirements and was the same during both months; they were instructed to continue with their normal diet.

Outcome measures

Patients collected faeces for 72 h at the end of each month and completed diary cards daily throughout.

Main results

Bowel actions were less frequent on enteric-coated microspheres of pancreatin than on non-enteric-coated pancreatin/cimetidine (1.7 vs. 2.4/day; P less than 0.001) and stool character was improved (P less than 0.001). Mean daily faecal weight was similar on enteric-coated microspheres of pancreatin to that on the combination (254 g vs. 291 g; N.S.), whereas daily faecal fat excretion tended to be less on enteric-coated microspheres of pancreatin (21 g vs. 27 g; N.S.), and percentage fat absorption tended to be greater (81% vs. 73%; N.S.). Mean body weight increased by 0.3 kg on enteric-coated microspheres of pancreatin and fell by 0.1 kg on the combination (N.S.).

Authors' conclusions

These data indicate that enteric-coated microspheres of pancreatin are at least as effective as non-enteric-coated pancreatin with cimetidine in the treatment of steatorrhoea in cystic fibrosis.

Keywords: Adult; Cimetidine; Combined Modality Therapy; Enteric-Coated; Gastrointestinal Agents; Microspheres; Pancreatic Enzyme Replacement Therapy; pharmacological_intervention; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Histamine H2 Antagonists;