Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo.
Journal - Digestive diseases and sciences (UNITED STATES )
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.
|ISSN : ||0163-2116|
|Mesh Heading : ||Adult Clofazimine Crohn Disease Double-Blind Method Drug Evaluation Female Humans Male Middle Aged Recurrence Remission Induction adverse effects|
|Mesh Heading Relevant : ||therapeutic use drug therapy|