Comparison of DDS with two combined chemotherapy regimens for multibacillary leprosy. Results after 3 years of treatment. A prospective randomized multicentre study.

Three hundred and seven lepromatous and borderline lepromatous patients in five participating centres (Freetown, Karachi , Bombay, Madras, Chetput) were randomized to receive one of the three following drug regimens : A, DDS 1 00 mg/ day; B, DDS 1 00 mg/day + Rifa 600 mg/day; and C, Rifa 600 mg/day + Isopro­ dian (PTH 1 75 mg, INH 1 75 mg, dapsone 50 mg) , 2 tablets/day. An adjustment was made for patients with less than 60 kg or more than 80 kg of body-weight. Criteria for exclusion included active tuberculosis, any other wasting disease, and psychic disorders . Patients who had been on regular or irregular DDS treatment for 3 years or more were ·excluded . The main characteristics of the study population are shown in Table 1 . A complete physical examination, basic laboratory tests (BUN, GOT, GPT, Hb), skin smears and histology were done before treatment and at regular intervals during the 3 years of treatment. Prior to chemotherapy, a DDS-resistance test was performed and in case of DDS resistance the patient was treated as in Group C, but excluded from the study and evaluated separately. Of the 228 patients who are still in the study 1 0 (Group D) showed to be fully resistant to DDS. The study design was to treat patients for 3 years and to have a follow-up period of 5 years . We report the results after 3 years of treatment. Of the 1 80 cases evaluated so far, a total number of 1 60 showed regression of leprosy while 20 were clinically classified as stable leprosy. There is no progression. The results for the different treatment groups are shown in Figure 1 . The bacteriological index (BI) decreases by the same amount in all treatment groups (Figure 2) . Histological serial examinations (number of AFB, staining properties, histopathological status) reveal good therapeutic effect with no statistically different response within groups. A leprosy reaction (Type I or II) was seen in 49 % , ranging from 48 % in Group A to 64% in Group D. The three drug regimens were tolerated