薬理と治療

Abstract

Background　We conducted a randomized, double–blind, placebo–controlled clinical study to evaluate the effect of a test supplement containing collagen peptides, chondroitin sulfate and hyaluronic acid on participants with knee joint discomfort and reduced motor function without specific joint disorders. Methods　Healthy participants（n＝70, 52.0±8.1 years［mean±standard deviation｛SD｝］）with knee joint pain and reduced motor function without specific joint disorders（such as osteoarthritis）were randomly assigned to receive a test supplement（5 g/day）containing collagen peptides（4,000 mg）, chondroitin sulfate（12 mg）and hyaluronic acid（12 mg）（n＝35, test supplement group）or placebo supplement（n＝35, placebo group）for 12 weeks. We evaluated efficacy by analyzing the screening score for the locomotive syndrome risk, Japanese Knee Osteoarthritis Measure（JKOM）score, and visual analog scale（VAS）. Results　From 70 eligible participants, 68 completed the study. First, 65 eligible participants were analyzed. However, only the two–step test score（screening score for the locomotive syndrome risk）was substantially improved in the test supplement group compared with the placebo group at week 12 during the intervention. Next, to further clarify the effect of test supplement, we analyzed the participants with reduced mobile ability（two–step test score of ＜1.40）. Consequently, the administration of test supplement was efficient in significantly improving the two–step test scores, pain and stiffness in the knees（subscale II）of JKOM, and substantially reducing the degree of knee pain scores（subscale I）of JKOM and VAS（pain at rest, pain at walking, and pain at going up and down the stairs）. Furthermore, we observed no test supplement– related adverse events during and after the intervention. Conclusions　The present observations suggest that oral administration of test supplement（5 g/day）containing collagen peptides, chondroitin sulfate and hyaluronic acid potentially exerts a protective effect on elderly individuals with knee joint discomfort and reduced mobility by relieving the joint pain and improving motor function with knee flexion and extension（standing, walking, running, sitting, and going up and down the stairs）and quality of life without apparent adverse effects.（Jpn Pharmacol Ther 2023；51：1697‒711）