A long term trial with clofazimine in reactive lepromatous leprosy

Abstract

A report is given on 17 lepromatous patients, all but one steroid dependant because of repeated, serious reactions, treated with clofazimine in dosages of 100-600 mg daily, for periods up to 5 yr. In 14 patients who completed 21/2 2.5 of treatment the average annual decrease of BI in smears and biopsies was 13% and 14% resp., being somewhat slower than after sulphone treatment (17%). Out of 6 patients who completed 5 yr of treatment 5 became negative, one after 4 yr, 4 after 4.5 yr. In some patients, however, the decrease of the BI was slow and unsatisfactory. No evidence of resistance to lamprene was found. No correlation was found between slow response and long period of weaning off steroids or with other complications. The decrease was somewhat slower in patients with long duration of disease and long duration of previous (sulphone) treatment. In this series of patients the overall long term reaction suppressive effect was somewhat less than in other trials and not better than in patients treated with 100 mg daily. No correlation was found with duration of disease and bacteriological progress. In this series an unusually high proportion of the patients complained of abdominal pain, vomiting after medication and some of diarrhea, to the extent that clofazimine treatment had to be discontinued (7 out of 17 patients). No correlation was found with duration of disease, duration of previous treatment, steroid dependance or sex. The lower frequency of abdominal complaints reported from trials with lower dosages of clofazimine suggests a relationship with dosage. A history in several patients of severe enteritis or dysentery prior to clofazimine treatment suggests that clofazimine acts as an irritant particularly if the intestines have already become irritable by other factors.