Double-blind trial of the efficacy of pentoxifylline vs thalidomide for the treatment of type II reaction in leprosy

Type II reaction in leprosy, or erythema nodosum leprosum (ENL), is often characterized by severe clinical symptoms together with nerve function impairment leading to permanent disabilities. Thalidomide has been shown to be a highly effective drug for the treatment of ENL. It is, however, contraindicated for women of childbearing age due to its teratogenicity. On the other hand, pentoxifylline, used to treat hypercoagulable states, is not teratogenic and, like thalidomide, can inhibit the synthesis of tumor necrosis factor-a and other cytokines. In the present randomized double-blind clinical study we compared the effectiveness of orally administered pentoxifylline vs thalidomide in treating type II reaction in 44 patients. Daily doses of 300 mg thalidomide or 1.2 g pentoxifylline were administered for 30 days to multibacillary leprosy patients undergoing type II reaction. Randomly chosen patients were included in the study before, during, and after specific multidrug therapy. Clinical evaluations were performed on the 1st, 7th, 14th, 21st, and 30th days of treatment and laboratory tests were carried out on the 1st and 30th days. As expected, overall, thalidomide proved to be more effective in the treatment of type II leprosy reaction. Nevertheless, continuous treatment with pentoxifylline was effective in relieving the clinical signs of ENL, especially limb edema and systemic symptoms, in 62.5 percent of the patients.

The use of pentoxifylline in the treatment of type 2 reactional episodes in leprosy.

It has been suggested that erythma nodosum leprosum (ENL) is associated with enhanced production of TNF-alpha resulting in increased inflammation of the skin and nerve function impairment. Thalidomide and steroids are the major drugs used in the treatment of ENL, but due to the serious problems associated with their use, alternative therapeutic interventions are being considered. In the present retrospective study, the authors report their clinical observations on the effect of pentoxifylline (PTX) in the treatment of ENL. Parameters, such as the clinical involution of reactional lesions, the regression of the inflammatory symptoms associated with the lesions, and the impact on the systemic symptoms common to ENL were assessed at regular intervals during PTX therapy. It was found that PTX therapy led to total elimination of systemic symptoms within the first week of treatment. This improvement was maintained until the end of the study (60 days of treatment). Moreover, the evolution of nodular lesions showed a 100% improvement within the first 14 days of treatment. However, by the 60th day, worsening of the lesions was noted in 20% of the cases. The impression is that PTX is well tolerated, and it may be used for improving patient's clinical condition during ENL reaction. Nevertheless, a randomized, double blind, controlled trial to compare the effects of the widely-accepted thalidomide and the yet untested pentoxifylline for treatment of type 2 reaction is still necessary.