Effects of Danazol on Clinical Improvement of Patients with Human T-cell Lymphotropic Virus Type I Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP): A Placebo-Controlled Clinical Trial

Abstract

Objective(s): Human T-Cell Lymphotropic Virus Type I (HTLV-I) associated myelopathy/tropical spastic paraparesis (HAM/TSP) is an endemic disease observed in Japan, Africa, Caribbean basin, and north-east Iran. It is usually presented as a chronic and progressive spastic paraparesis. There are some options for treatment of HAM/TSP patients. The aim of this study was to compare the effects of danazol controlled with placebo in relieving the symptoms and signs of HAM/TSP patients.

Materials and methods: Among 77 patients with definite diagnosis of HAM/TSP based on clinical and para-clinical findings, 71 patients had the required criteria for entering the study. Severity of symptoms and the degree of motor disability were determined before the beginning of treatment based on motor disability grading (MDG) in both groups of patients and were followed during 6 months in 1 month intervals for changes in symptoms and their motor disabilities.

Results: Among 38 patients of the first group, after 6 months therapy with danazol, mean difference between MDG0 (before starting the treatment) and MDG6 (after six months), as an indicator of motor improvement in the patients, was 0.89. Meanwhile, among the 33 patients treated with identical appearing placebo, there was no significant difference between MDG0 and MDG6 (P< 0.001). Moreover, there was a significant difference in improvement of symptoms between two study groups.

Conclusion: This study showed that danazol provides relative effects on improving motor disabilities and symptoms of HAM/TSP patients that can be considered according to its lower side effects compared to other suggested treatments such as corticosteroids, and its lower costs in particular patients.

Keywords: Danazol; HTLV-I; Myelopathy.