Controlled trial of antimycobacterial therapy in Crohn's disease

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Abstract
In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N=25) or to steroids and matching placebo (N=24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12;P=NS) with a fall in disease activity score from 10.5±4.4 to 3.3±3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6;P=NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.