RANDOMIZED CONTROLLED CLINICAL-TRIAL OF SHORT-COURSE CHEMOTHERAPY IN ABDOMINAL TUBERCULOSIS - A 5-YEAR REPORT

OBJECTIVES: To assess and compare the efficacy of a 6-month short-cour se chemotherapy regimen (SCC) with that of a 12-month standard regimen in the treatment of abdominal tuberculosis. DESIGN AND SUBJECTS: A to tal of 193 adult patients with evidence of abdominal tuberculosis were randomly allocated to one of two daily regimens: 1) a 6-month SCC reg imen with rifampicin, isoniazid and pyrazinamide for 2 months followed by rifampicin with isoniazid for another 4 months (6R series) and 2) a 12-month standard regimen of ethambutol and isoniazid with streptomy cin supplemented for 2 weeks (12E series). Surgery was undertaken only for patients suspected to have obstruction or perforation of the inte stine. RESULTS: A total of 163 (85 6R, 78 12E) patients were available for efficacy analysis after exclusion of 30 patients for various reas ons. At the end of treatment clinical status was normal in 84 (99%) in 6R patients and in 73 (94%) in 12E patients. Of these, 147 patients c ompleted follow-up for 5 years; none had relapsed requiring treatment for abdominal tuberculosis. CONCLUSION: A 6-month SCC regimen has been found to be as effective as the standard 12-month regimen in the trea tment of all forms of abdominal tuberculosis.