Long-term treatment of high intestinal output syndrome with budesonide in patients with Crohn's disease and ileostomy.
OBJECTIVE
In a previous, controlled study, it was shown that orally administered budesonide increases the absorptive capacity of the intestinal mucosa in patients with ileostomies caused by Crohn's disease. This open, nonrandomized study was designed to analyze this functional, not inflammation-dependent steroid-effect in the long-term course comparing exposure, withdrawal, and reexposure.


METHODS
Phase 1: 23 patients without inflammatory activity of the disease received oral budesonide (3 mg t.i.d.) for at least four weeks (36.7 weeks; standard deviation, 45.3 weeks) because of high intestinal output syndrome. Phase 2: Medication was stopped for four weeks. Phase 3: Medication as in Phase 1. In each phase the weight of the ileostomy bags was measured with a spring balance before emptying and documented in a diary. Mean values per day and per week were calculated and the differences statistically evaluated by the Wilcoxon-(Pratt)-test.


RESULTS
Comparing the last week of Phase 1 to first week of Phase 2, a significant (P < 0.0001) increase of the intestinal output (295 g; standard deviation, 313 g) was observed after omitting budesonide. In contrast, comparing the last week of Phase 2 to Phase 3, a significant (P < 0.0001) decrease of the intestinal output by 323.7 g (standard deviation, 322.2 g) was noticed reaching the same level as in Phase 1.


CONCLUSIONS
These data show that the functional, inflammation-independent effect of budesonide on the intestinal mucosa is strongly correlated to the administration of the drug and may be maintained long-term. These results should be confirmed by a larger number of patients.
Ecker
Karl W
KW
Department of General, Visceral and Vascular Surgery, Müritz-Hospital, Weinbergstrasse 19, D-17192 Waren, Germany.
Stallmach
Andreas
A
Löffler
Jürgen
J
Greinwald
Roland
R
Achenbach
Ulrike
U
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D006801:Humans; D007081:Ileostomy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric; D013577:Syndrome; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D019819:Budesonide