Randomized controlled trial of DOTS versus conventional regime for treatment of ileocecal and colonic tuberculosis.

ABSTRACT

There is limited information regarding the efficacy of 'directly observed treatment short course' (DOTS) in the treatment of intestinal tuberculosis. We randomized patients with ileocecal or colonic tuberculosis to receive daily tuberculosis chemotherapy (Group A) or DOTS (Group B). Patients received isoniazid, rifampicin, pyrazinamide and ethambutol daily for two months in group A and thrice weekly for 2 months in group B, followed by isoniazid and rifampicin daily for 7 months in group A and thrice weekly for 4 months in group B. Patients were followed up at 2 and 4 weeks and monthly thereafter until the end of treatment. Follow up colonoscopy was done at 2 and 6 months after starting treatment. The improvement in clinical symptoms was not different between Groups A (24) and B (23) at 2 and 6 months. Mean increase in weight was 5.1 (0.5) Kg and 5.7 (0.6) Kg at 2 months and 7.1 (1.7) Kg and 6.9 (1.9) Kg at 6 months in Group A and B, respectively. Complete healing of ulceration was noted in 75% of Group A patients and 79% of Group B patients at 2 months and in all patients in both groups at 6 months. We conclude that DOTS and daily chemotherapy are equally effective for treating ileocecal and colonic tuberculosis.