Purpose: This double blind random controlled study was designed to determine if there is an effect of a specific oral preparation containing Hyal-Joint DS on osteoarthritis knee pain. Methods: 40 symptomatic knee osteoarthritis (OA) patients were recruited sequentially at the time of an outpatient visit for OA. OA was documented by either MRI or radiograph. Adult male and female subjects were between the ages of 50-75 years, had a knee effusion and a pain visual analog score (VAS) >50mm on a 10 cm line marked by the patient. Patients were excluded for any inflammatory joint disorder such as crystalline disease and autoimmune disorders. None had intra-articular injections such or corticosteroids within 4 weeks or hyaluronic acid within 6 months. Any use of oral corticosteroids within a month or topical corticosteroids within a week was excluded. Therewas no trauma within 6 months or arthroscopy within 3 months. After consent was obtained, patients had a knee aspiration and blood sample saving the fluid for later analysis. To date, 20 have completed. 10 had been randomly selected to receive 80 mg of an oral preparation (Oralvisc(plus or minus) containing Hyal-Joint DS) used daily and the remaining 10 had identical appearing placebos. High and low VAS pain scores as well as WOMAC pain scores (0-20) and functional WOMAC scores were recorded at the first and follow-up visits at 4, 8 and 12 weeks. On the final visit a repeat knee aspiration and blood sample was obtained. Age, sex, body mass index (BMI), activity level, pain medication use, and metabolic syndrome risk factors were recorded for all patients. For the first 20 patients there was no significant difference for these measures comparing active agent and placebo groups. Results: The initial high VAS and WOMAC pain scores for the treatment group was 6.70(plus or minus)0.28 standard error of the mean (SE) and 7.95(plus or minus)0.81 SE. For the placebo group these were 5.82(plus or minus)0.24 SE and 7.20(plus or minus)1.17 SE. There was no significance difference. There was no statistical difference between placebo and treatment groups for any of the four visits over the twelve weeks. However, comparing group VAS high scores the treatment scores for 8 and 12 weeks were lower with p=0.086 and 0.63. At 3 months the WOMAC pain and WOMAC function scores were lower in the treatment group p=0.065 and 0.067. The change from the initial high VAS score within the treatment group to the 8th and 12th week was significantly different p=0.0140 and 0.0108. The WOMAC pain score was significantly lower at the 12th visit for the treatment group p=0.0492. There was no significant change in the placebo group or for the WOMAC functional scores. Conclusions: The use of Oralvisc(trademark), an oral preparation containing Hyal-Joint DS, has a significant impact on knee pain in this group of OA patients. Specific inflammatory cytokines and chemokines associated with articular cartilage degradation are being measured and will be compared to the clinical results in the expanded study of 40 patients. (Figure presented).
Nelson, F., Wu, W. C., Zvirbulis, R., Zonca, B., Pasierb, M., & Wilton, P. (2012). An oral preparation containing Hyal-Joint DS can reduce osteoarthritis knee pain. Osteoarthritis and Cartilage, 20, S173. https://doi.org/10.1016/j.joca.2012.02.262