A clinical trial of glycosaminoglycan-peptide complex ('Rumalon') in patients with osteoarthritis of the knee.
A clinical trial was undertaken in 50 patients with osteoarthritis of the knee to assess the therapeutic value of glycosaminoglycan-peptide complex in treatment. The first year consisted of a randomized, double-blind, placebo-controlled, parallel-group trial (25 patients in each group), after which all patients received active treatment for a further 2 years. Treatment consisted of three 8-week courses in the first year and 2 such courses per year in subsequent years, each consisting of 2 ml intramuscular injections given 3 times per week. Patients were permitted to continue taking anti-inflammatory drugs and to receive physiotherapy during the trial period. At the end of the first year of the trial (double-blind phase), there were no significant differences between the two treatment groups. However, after the second year, those patients who had received glycosaminoglycan-peptide complex for 2 years had significantly greater improvements in night pain and rest pain than did those who had received active treatment for only 1 year. At the end of 3 years (when half the patients had received active treatment for 2 years and half for 3 years), there were significant overall improvements in relation to rest pain, pain on walking and morning stiffness, but not in respect to night pain, pain on standing or climbing stairs. At the same time, improvements were seen in radiological severity of disease (assessed double-blind) in 16% of patients, with 'no change' in 74% and deterioration in 10%, these figures being considerably better than might be expected with conventional therapy. Glycosaminoglycan-peptide complex was extremely well tolerated.
Katona
G
G
Department of Rheumatology, Hospital General, Mexico D.F., Mexico.
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011859:Radiography; D011897:Random Allocation; D014020:Tissue Extracts / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D014020:Tissue Extracts; C000562:Rumalon