| Title: Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo.
| | Title Abreviation: Dig Dis Sci
| Date of Pub: 1991 Apr
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| Author: Afdhal NH; Long A; Lennon J; Crowe J; O'Donoghue DP;
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| Issue/Part/Supplement: 4
| Volume Issue: 36
| Pagination: 449-53
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| MESH Headings: Adult; Clofazimine (AE/*TU); Crohn Disease (*DT); Double-Blind Method; Drug Evaluation; Female; Human; Male; Middle Age; Recurrence; Remission Induction; -RN-;
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| Journal Title Code:
EAD
| Publication Type:
CLINICAL TRIAL
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| Date of Entry: 910502N | Entry Month: 9107
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| Country: UNITED STATES
| Index Priority: 1
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| Language: Eng
| Unique Identifier: 91176827
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| Unique Identifier: 91176827
| ISSN: 0163-2116
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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.
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| Abstract By: Author
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| Address: Department of Gastroenterology, St. Vincents Hospital, Dublin, Ireland.
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