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primary studies published RCT

Placebo-controlled trial of misoprostol in cystic fibrosis.

  • Year: 1990
  • Date: 1990
  • Author: Robinson P
Source

J Pediatr Gastroenterol Nutr. 1990 Jul;11(1):37-40.

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

6-week double-blind, placebo-controlled, crossover trial

Participants

17 children with cystic fibrosis on pancreatic enzyme therapy

Interventions

misoprostol, 100 micrograms, four times a day

Outcome measures

efficacy (fat absorption)

Main results

In those patients who had greater than 90% absorption on enzyme therapy alone, no further significant increase in absorption was achieved with misoprostol administration. Those patients who had absorption of less than 90% on standard enzyme therapy showed a significant improvement with misoprostol administration (p less than 0.01). One patient had a significant elevation in the eosinophil count during the period of misoprostol administration, but there were no significant changes in any other hematological or biochemical parameter.

Authors' conclusions

Misoprostol appears to be of benefit to those children with cystic fibrosis who have residual malabsorption on standard enzyme therapy.

Keywords: Alprostadil; Child; Drug Administration Schedule; Gastrointestinal Agents; Misoprostol; pharmacological_intervention; placebo; 4-phenylbutyrate; Prostaglandins;