Mv. Madden et al., DOUBLE-BLIND CROSSOVER TRIAL OF METRONIDAZOLE VERSUS PLACEBO IN CHRONIC UNREMITTING POUCHITIS, Digestive diseases and sciences, 39(6), 1994, pp. 1193-1196
Metronidazole has been used to treat pouchitis, but there are no contr
olled data that show it is effective. Chronic unremitting pouchitis is
a form of the disorder particularly difficult to manage. Diarrhea is
the main symptom of pouchitis, which results from acute inflammation o
f the mucosa of an ileal reservoir. To test the hypothesis that metron
idazole (400 mg thrice daily for seven days) is no better than placebo
at reducing stool frequency in chronic unremitting pouchitis, a doubl
e-blind placebo-controlled crossover study has been performed. Thirtee
n patients who had undergone restorative proctocolectomy for ulcerativ
e colitis were studied. The diagnosis of pouchitis was based on clinic
al, endoscopic, and histological criteria. At entry all patients had s
ymptomatic pouchitis and were passing more than six stools/24 hr or ha
d consistently bloody stools with at least four of six endoscopic crit
eria of mucosal inflammation. The median frequency of defecation decre
ased by 3 bowel actions/24 hr (conservative 95% confidence intervals 0
-4/24 hr) on metronidazole but increased by a median of 1/24 hr on pla
cebo. The difference between the median number of bowel motions, when
treatment with metronidazole was compared to placebo, was 4 motions/24
hr (P < 0.05) in favor of metronidazole. There was no significant cha
nge in the endoscopic or histological grade of inflammation, in the se
rum C-reactive protein level, or symptomatic scores. In a parallel stu
dy, metronidazole did not alter stool frequency in asymptomatic patien
ts without pouchitis who had endoscopically normal reservoirs (six pol
yposis, six colitis). Metronidazole significantly reduces the frequenc
y of defecation when compared with placebo in chronic pouchitis. The r
eduction in stool frequency is, however, of limited symptomatic benefi
t to the patient.