A double-blind controlled clinical trial to assess the role of anti-histamines in the treatment of multi-bacillary leprosy.

A double blind controlled clinical trial to assess the role of anti-histamines as a supplement in the treatment of leprosy was conducted in multi-bacillary cases of leprosy. In all, 120 patients with lepromatous or borderline leprosy were randomly allocated to a regimen of clofazimine and dapsone for 12 months with or without a supplement of pheniramine maleate for the first 3 months. During the 12-month period, 92% of the patients who received the supplement and 86% of the patients who had not received it had moderate or marked clinical improvement. The BI values decreased from 4.1 to 3.4 and 4.2 to 3.3, respectively. The results over the 12-month period showed that the addition of the antihistamine had not enhanced the efficacy of the regimen as evidenced by clinical and bacteriological findings.