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Clinical trial: randomized study of clarithromycin versus placebo in active Crohn’s disease
Author(s) -
LEIPER K.,
MARTIN K.,
ELLIS A.,
WATSON A. J. M.,
MORRIS A. I.,
RHODES J. M.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03661.x
Subject(s) - clarithromycin , medicine , placebo , crohn's disease , gastroenterology , budesonide , randomized controlled trial , antibiotics , post hoc analysis , tolerability , disease , adverse effect , corticosteroid , pathology , helicobacter pylori , alternative medicine , microbiology and biotechnology , biology
Summary Background Crohn’s disease is characterized by defective innate immune responses to intestinal bacteria. Clarithromycin is a broad‐spectrum antibiotic that has good penetration into macrophages. Aim To assess the efficacy of clarithromycin in active Crohn’s disease. Methods Patients with Crohn’s disease activity index > 200 and serum C‐reactive protein ≥ 10 mg/L were randomized to receive clarithromycin 1 g o.d. or placebo for 3 months. Patients taking more than 10 mg/day prednisolone or 3 mg/day budesonide were excluded. Primary outcome was remission (CDAI ≤ 150) or response (fall in CDAI ≥ 70 from pre‐treatment level) at 3 months. Results The trial was stopped after 41 patients had been recruited because of poor overall efficacy. There was no difference in combined remission or response rates at 3 months between clarithromycin: 26% (five of 19) and placebo: 27% (six of 22) ( P = 1.00). The mean (s.d.) fall in Crohn’s disease activity index was 35 (80) clarithromycin and −2 (114) placebo ( P = 0.24). However, post hoc analysis showed a significant difference in response/remission determined by Crohn’s disease activity index after 1 month: 53% (10 of 19) clarithromycin vs. 14% (three of 22) placebo ( P = 0.01). Conclusion Clarithromycin 1 g for 3 months is ineffective in active Crohn’s disease but possible benefit was observed at 1 month, suggesting that an initial effect may be attenuated by subsequent bacterial resistance.