A team from Texas, USA, investigated the use of clarithromycin and ethambutol in the treatment of Crohn's disease.
A mycobacterial infection may be the cause of Crohn's disease in some patients.
Thus, the researchers assessed the effect of a 3-month regimen of clarithromycin and ethambutol on the disease activity and intestinal permeability, in patients with Crohn's disease at high risk of relapse.
A total of 31 Crohn's patients, with a lactulose-mannitol permeability test above 0.03, were enrolled in the study.
The subjects were randomly assigned to receive either clarithromycin, 500 mg twice daily and ethambutol, 15 mg/kg daily (n = 15), or identically appearing placebo (n = 16). These 3-month regimens were given in addition to their regular therapy.
The Harvey-Bradshaw index and the lactulose-mannitol test were assessed in a blind fashion every 3 months, for 12 months.
| Anti-mycobacterial treatment did not improve Crohn's symptoms.
| Alimentary Pharmacology & Therapeutics |
The groups were similar in age, sex, duration of disease, location of disease, past complications, and disease severity.
The researchers found that there was no significant difference between the drug or placebo groups in the mean Harvey-Bradshaw index (4.8 vs 4.4), number with active disease (33% vs 44%), and mean lactulose-mannitol test (0.06 vs 0.10).
In addition, during the 12-month follow-up period, there were no consistent, statistically significant differences in the mean Harvey-Bradshaw index or lactulose-mannitol test between treatment and placebo groups.
Individual patients showed either improvement or worsening of these indices, but these were not related to study medication.
Author R. W. Goodgame, of the Texas Children's Hospital, Baylor College of Medicine, Houston, concluded on behalf of the group, "Three months of treatment with clarithromycin and ethambutol does not benefit Crohn's disease patients who are receiving standard medical therapy."