Randomised controlled clinical trial of short course chemotherapy in abdominal tuberculosis: a five-year report

OBJECTIVES: To assess and compare the efficacy of a 6-month short-course chemotherapy regimen (SCC) with that of a 12-month standard regimen in the treatment of abdominal tuberculosis. DESIGN AND SUBJECTS: A total of 193 adult patients with evidence of abdominal tuberculosis were randomly allocated to one of two daily regimens: 1) a 6-month SCC regimen 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 streptomycin supplemented for 2 weeks (12E series). Surgery was undertaken only for patients suspected to have obstruction or perforation of the intestine. RESULTS: A total of 163 (85 6R, 78 12E) patients were available for efficacy analysis after exclusion of 30 patients for various reasons. 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 completed 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 treatment of all forms of abdominal tuberculosis.