Randomized clinical trial of metronidazole ointment versus placebo in perianal
Crohn's disease.
Author(s): Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T,
Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study
Group.
Collaborators: Maeda Y, Ng SC, Vaizey CJ, Durdey P, Burt C, Torkington J, Rao PK,
Mayberry J, Moshkovska T, Stone CD, Carapeti E, McDonald A, Simpson MF, Nkolo CU,
Eaden JA, Stringer S, Thompson R, Ngatchu T, Hall D, Cole AT, Thornton PM, Menon
M, Boaden A.
Affiliation(s): Physiology Unit, St Mark's Hospital, Harrow, UK. yazmaeda@googlemail.com
Publication date & source: 2010, Br J Surg. , 97(9):1340-7
BACKGROUND: The potential for metronidazole 10 per cent ointment to exert
therapeutic benefit in perianal Crohn's disease, while minimizing the adverse
effects found with oral metronidazole, was evaluated in a randomized
placebo-controlled study.
METHODS: Subjects with perianal Crohn's disease were randomized to metronidazole
10 per cent ointment, 0.7 g applied perianally three times daily, or placebo
ointment. The Perianal Crohn's Disease Activity Index (PCDAI) was scored at
baseline and after 4 weeks of treatment. Perianal pain was assessed on a visual
analogue scale.
RESULTS: Seventy-four subjects (33 metronidazole, 41 placebo) were evaluated. The
mean(s.e.m.) reduction in PCDAI score at 4 weeks was 2.4(0.5) in the
metronidazole group and 2.2(0.4) in the placebo group (P = 0.660). More subjects
in the metronidazole group than the placebo group showed a reduction in PCDAI
score of at least 5 points (10 of 27 versus 4 of 34; P = 0.031). Perianal
discharge was reduced significantly in metronidazole-treated subjects (P =
0.012). A greater reduction in perianal pain was seen in the metronidazole group,
which approached statistical significance (P = 0.059). No serious adverse events
were reported.
CONCLUSION: Metronidazole 10 per cent ointment was not effective in the reduction
of PDCAI score, but some secondary outcomes showed improvement suggestive of a
treatment effect. It is well tolerated, with minimal adverse effects, and has
potential as treatment for pain and discharge associated with perianal Crohn's
disease. Registration number: NCT00509639 (http://www.clinicaltrials.gov).
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