Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease
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 dis...
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| Published in | British journal of surgery Vol. 97; no. 9; pp. 1340 - 1347 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article Conference Proceeding |
| Language | English |
| Published |
Chichester, UK
John Wiley & Sons, Ltd
01.09.2010
Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0007-1323 1365-2168 1365-2168 |
| DOI | 10.1002/bjs.7121 |
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| Abstract | 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 |
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| AbstractList | 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.
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.
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.
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.
NCT00509639 (http://www.clinicaltrials.gov). 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.BACKGROUNDThe 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.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.METHODSSubjects 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.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.RESULTSSeventy-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.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.CONCLUSIONMetronidazole 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.NCT00509639 (http://www.clinicaltrials.gov).REGISTRATION NUMBERNCT00509639 (http://www.clinicaltrials.gov). 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 |
| Author | Burt, C. Ng, S. C. Stone, C. D. Vaizey, C. J. Rao, P. Kumar Dhruva Torkington, J. Maeda, Y. Mayberry, J. Carapeti, E. Durdey, P. Moshkovska, T. |
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| Contributor | Mayberry, J Simpson, M F Burt, C Maeda, Y Ng, S C Nkolo, C U Durdey, P Ngatchu, T Eaden, J A Torkington, J McDonald, A Thornton, P M Stringer, S Menon, M Rao, P Kumar Dhruva Stone, C D Thompson, R Moshkovska, T Carapeti, E Vaizey, C J Hall, D Cole, A T Boaden, A |
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| Copyright | Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. 2015 INIST-CNRS Copyright 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. |
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| Keywords | 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 |
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| References_xml | – reference: Ng SC, Plamondon S, Gupta A, Burling D, Swatton A, Vaizey CJ et al. Prospective evaluation of anti-tumor necrosis factor therapy guided by magnetic resonance imaging for Crohn's perineal fistulas. Am J Gastroenterol 2009; 104: 2973-2986. – reference: Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Dhurava-Rao P et al. Metronidazole 10 per cent ointment improves symptoms in perianal Crohn's disease with low systemic exposure. Gut 2009; 58(Suppl 1): A14. – reference: Arndt H, Palitzsch KD, Grisham MB, Granger DN. Metronidazole inhibits leukocyte-endothelial cell adhesion in rat mesenteric venules. Gastroenterology 1994; 106: 1271-1276. – reference: Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology 1980; 79: 599. – reference: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-233. – reference: Nguyen GC, Torres EA, Regueiro M, Bromfield G, Bitton A, Stempak J et al. Inflammatory bowel disease characteristics among African Americans, Hispanics, and non-Hispanic Whites: characterization of a large North American cohort. Am J Gastroenterol 2006; 101: 1012-1023. – reference: Brandt LJ, Bernstein LH, Boley SJ, Frank MS. Metronidazole therapy for perineal Crohn's disease: a follow-up study. Gastroenterology 1982; 83: 383-387. – reference: Irvine EJ. Usual therapy improves perianal Crohn's disease as measured by a new disease activity index. McMaster IBD Study Group. J Clin Gastroenterol 1995; 20: 27-32. – reference: Kamm MA, Ng SC. Perianal fistulizing Crohn's disease: a call to action. Clin Gastroenterol Hepatol 2008; 6: 7-10. – reference: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR et al. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology 2002; 122: 875-880. – reference: Stringer EE, Nicholson TJ, Armstrong D. Efficacy of topical metronidazole (10 percent) in the treatment of anorectal Crohn's disease. Dis Colon Rectum 2005; 48: 970-974. – reference: Bressler B, Sands BE. Review article: Medical therapy for fistulizing Crohn's disease. Aliment Pharmacol Ther 2006; 24: 1283-1293. – reference: Nishimuta K, Ito Y. Effects of metronidazole and tinidazole ointments on models for inflammatory dermatitis in mice. Arch Dermatol Res 2003; 294: 544-551. – reference: Jeshion WC, Larsen KL, Jawad AF, Piccoli DA, Verma R, Maller ES et al. Azathioprine and 6-mercaptopurine for the treatment of perianal Crohn's disease in children. J Clin Gastroenterol 2000; 30: 294-298. – reference: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004; 350: 876-885. – reference: Jakobovits J, Schuster MM. 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McMaster IBD Study Group publication-title: J Clin Gastroenterol – volume: 1 start-page: 104 year: 1986 end-page: 107 article-title: Current status and influence of operation on perianal Crohn's disease publication-title: Int J Colorectal Dis – volume: 6 start-page: 7 year: 2008 end-page: 10 article-title: Perianal fistulizing Crohn's disease: a call to action publication-title: Clin Gastroenterol Hepatol – volume: 48 start-page: 970 year: 2005 end-page: 974 article-title: Efficacy of topical metronidazole (10 percent) in the treatment of anorectal Crohn's disease publication-title: Dis Colon Rectum – volume: 101 start-page: 1012 year: 2006 end-page: 1023 article-title: Inflammatory bowel disease characteristics among African Americans, Hispanics, and non‐Hispanic Whites: characterization of a large North American cohort publication-title: Am J Gastroenterol – volume: 83 start-page: 383 year: 1982 end-page: 387 article-title: Metronidazole therapy for perineal Crohn's disease: a follow‐up study publication-title: Gastroenterology – volume: 34 start-page: 220 year: 1996 end-page: 233 article-title: A 12‐Item Short‐Form Health Survey: construction of scales and preliminary tests of reliability and validity publication-title: Med Care – volume: 48 start-page: 163 year: 2001 end-page: 167 article-title: Protective effect of metronidazole on uncoupling mitochondrial oxidative phosphorylation induced by NSAID: a new mechanism publication-title: Gut – volume: 58 start-page: A14 issue: Suppl 1 year: 2009 article-title: Metronidazole 10 per cent ointment improves symptoms in perianal Crohn's disease with low systemic exposure publication-title: Gut – volume: 294 start-page: 544 year: 2003 end-page: 551 article-title: Effects of metronidazole and tinidazole ointments on models for inflammatory dermatitis in mice publication-title: Arch Dermatol Res – volume: 121 start-page: 1064 year: 2001 end-page: 1072 article-title: A comparison of endoscopic ultrasound, magnetic resonance imaging, and exam under anesthesia for evaluation of Crohn's perianal fistulas publication-title: Gastroenterology – volume: 104 start-page: 2973 year: 2009 end-page: 2986 article-title: Prospective evaluation of anti‐tumor necrosis factor therapy guided by magnetic resonance imaging for Crohn's perineal fistulas publication-title: Am J Gastroenterol – volume: 122 start-page: 875 year: 2002 end-page: 880 article-title: The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota publication-title: Gastroenterology – volume: 30 start-page: 294 year: 2000 end-page: 298 article-title: Azathioprine and 6‐mercaptopurine for the treatment of perianal Crohn's disease in children publication-title: J Clin Gastroenterol – volume: 350 start-page: 876 year: 2004 end-page: 885 article-title: Infliximab maintenance therapy for fistulizing Crohn's disease publication-title: N Engl J Med – volume: 79 start-page: 599 year: 1980 article-title: Healing of perineal Crohn's disease with metronidazole publication-title: Gastroenterology – volume: 24 start-page: 1283 year: 2006 end-page: 1293 article-title: Review article: Medical therapy for fistulizing Crohn's disease publication-title: Aliment Pharmacol Ther – volume: 106 start-page: 1271 year: 1994 end-page: 1276 article-title: Metronidazole inhibits leukocyte–endothelial cell adhesion in rat mesenteric venules publication-title: Gastroenterology – volume: 79 start-page: 533 year: 1984 end-page: 540 article-title: Metronidazole therapy for Crohn's disease and associated fistulae publication-title: Am J Gastroenterol |
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The potential for metronidazole 10 per cent ointment to exert therapeutic benefit in perianal Crohn's disease, while minimizing the adverse effects... The potential for metronidazole 10 per cent ointment to exert therapeutic benefit in perianal Crohn's disease, while minimizing the adverse effects found with... |
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| SubjectTerms | 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 |
| Title | Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease |
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