Clinical trial: randomized study of clarithromycin versus placebo in active Crohn's disease.
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.


OBJECTIVE
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 > or = 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 < or = 150) or response (fall in CDAI > or = 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).


CONCLUSIONS
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.
Leiper
K
K
Department of Gastroenterology, Royal Liverpool and Broadgreen University Hospitals, Liverpool, UK.
Martin
K
K
Ellis
A
A
Watson
A J M
AJ
Morris
A I
AI
Rhodes
J M
JM
D000328:Adult; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D017291:Clarithromycin / Q000494:pharmacology / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010919:Placebos; D017291:Clarithromycin