August 20, 2013
[Prosultiamine Treatment as a Novel Treatment for the Chronic Neurological Disease HAM]
Nagasaki University Graduate School of Biomedical Sciences Molecular Microbiology and Immunology
Associate Professor Tatsufumi Nakamura
Nagasaki University Graduate School Associate Professor Tatsufumi Nakamura (Molecular Microbiology and Immunology), together with Nagasaki University Assistant Professor Tomohiro Matsuo (Department of Urology) and other researchers, published a paper on the efficacy of vitamin B1 formulation prosultiamine (product name: Alinamin) in the treatment of HTLV-I-associated myelopathy (HAM), titled "Efficacy of prosultiamine treatment in patients with HTLV-I-associated myelopathy/tropical spastic paraparesis: results from an open-label clinical trial" in the August 15 edition of the British electronic journal "BMC Medicine."
HAM is a chronic neurological disease specified by the Ministry of Health, Labour and Welfare. Epidemiological studies estimate that approximately 3600 people in Japan have HAM. The disease is especially prominent in Kyushu, where there are many sufferers of HTLV-I. HAM is caused by HTLV-I-infected lymphocytes infiltrating the spinal cord, causing chronic myelitis. Clinically, it is characterized by motor dysfunction of the lower extremities and disturbance of urination/defecation. Treatments include corticosteroid hormone and interferon alpha treatments, but there are many problems with these treatments, such as insufficient effectiveness and side-effects associated with long-term use. There is a pressing need for the development of new treatment methods for this disease, which steadily progresses once it develops.
Nakamura's team, noting that prosultiamine acts on HTLV-I-infected cells, carried out a clinical trial on 24 male and female HAM patients. Prosultiamine was administered once daily for 12 weeks. The researchers found that low extremity spasticity was reduced in 15 of 19 patients, walking and stair descending times decreased, and lower limb motor functions were improved. With regards to urinary functions, the team noted improvements such as increased bladder capacity and detrusor pressure, and the elimination of detrusor overactivity in 11 of 16 patients. Peripheral blood HTLV-I proviral volume fell by an average of approximately 15%. For some patients, it fell by as much as half. During the study, three of the patients reported abdominal discomfort, but all three to a minor degree, and there were no serious side-effects.
The clinical research verified the efficacy and safety of prosultiamine treatment, finding it to have a high potential as a HAM treatment. Further clinical testing will be required in order to receive pharmaceutical approval.