Comparative clinical evaluation of the activity of Ser-316 suppository in the treatment of lumbar osteoarthrosis.
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.
Ginsberg
F
F
Département de Rhumatologie et de Médecine Physique, CMC Assubel, Brussels, Belgium.
D000082:Acetaminophen / Q000008:administration & dosage; D000203:Activities of Daily Living; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007114:Immunization; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement / Q000187:drug effects; D017060:Patient Satisfaction; D016059:Range of Motion, Articular / Q000187:drug effects; D013488:Suppositories
D013488:Suppositories; D000082:Acetaminophen