Comparative clinical evaluation of the activity of Ser-316 suppository in the treatment of lumbar osteoarthrosis

Abstract

In a double-blind, randomized study, 47 patients suffering from lumbar osteoarthrosis were treated with either Ser-316 suppository (horse immune serum directed against bone and parathyroidal glands) or placebo over a period of 6 months at a dose of 3 suppositories/week. Efficacy was assessed based on the reduction in severity of pain on motion, consumption of paracetamol tablets, functional disability in normal and professional life; on the improvement of motility as shown by fingers-floor distance, Schober Index, extension, lateral flexions; and on the global evolution of the disease. Statistically significant improvements for fingers-floor distance, lateral flexions, paracetamol consumption, pain on motion, disability in normal life and evolution of the disease were seen in the Ser-316 group compared with the results obtained in placebo-treated patients, and were evident mainly from the third month of treatment. Globally, 17 (74%) of 23 patients receiving Ser-316 were considered by both patients and physician to have shown a good or excellent response compared with only 3 (14%) of 22 patients on placebo. There were no reports of any adverse reactions in either treatment group.