title: Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00509639 (http://www.clinicaltrials.gov).
authors.affiliation: Physiology Unit, St Mark's Hospital, Harrow, UK. yazmaeda@googlemail.com
authors.forename: Y
authors.initials: Y
authors.lastname: Maeda
authors.forename: S C
authors.initials: SC
authors.lastname: Ng
authors.forename: P
authors.initials: P
authors.lastname: Durdey
authors.forename: C
authors.initials: C
authors.lastname: Burt
authors.forename: J
authors.initials: J
authors.lastname: Torkington
authors.forename: P Kumar Dhruva
authors.initials: PK
authors.lastname: Rao
authors.forename: J
authors.initials: J
authors.lastname: Mayberry
authors.forename: T
authors.initials: T
authors.lastname: Moshkovska
authors.forename: C D
authors.initials: CD
authors.lastname: Stone
authors.forename: E
authors.initials: E
authors.lastname: Carapeti
authors.forename: C J
authors.initials: CJ
authors.lastname: Vaizey
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001004:Anus Diseases / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D009824:Ointments; D010146:Pain / Q000517:prevention & control; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D009824:Ointments; D008795:Metronidazole