Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease

• Published in: British journal of surgery Vol. 97; no. 9; pp. 1340 - 1347
• Main Authors: Maeda, Y., Ng, S. C., Durdey, P., Burt, C., Torkington, J., Rao, P. Kumar Dhruva, Mayberry, J., Moshkovska, T., Stone, C. D., Carapeti, E., Vaizey, C. J.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01.09.2010; Wiley
• Subjects: Administration, Topical; Adult; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiparasitic agents; Anus Diseases - drug therapy; Biological and medical sciences; Crohn Disease - drug therapy; Double-Blind Method; Female; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Humans; Male; Medical sciences; Metronidazole - administration & dosage; Metronidazole - adverse effects; Ointments; Other diseases. Semiology; Pain - prevention & control; Patient Satisfaction; Pharmacology. Drug treatments; Quality of Life; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Treatment Outcome; Nitro compound; Imidazole derivatives; Ointment; Inflammatory disease; Medicine; Antiprotozoal agent; Crohn disease; Antifungal agent; Randomization; Treatment; Perianal; Surgery; Placebo; Digestive diseases; Intestinal disease; Parasiticide; Clinical trial; Metronidazole; Comparative study
• ISSN: 0007-1323; 1365-2168; 1365-2168
• DOI: 10.1002/bjs.7121

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). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Metronidazole ointment ineffective in perianal Crohn's