상심자추출복합물의 퇴행성관절염 개선 효능에 대한 동물실험 및 임상연구

Abstract

Objectives : This study was performed to investigate the efficacy and safety of the Mulberry Extract Complex in a placebo-controlled randomized clinical trial and animal study on degenerative arthritis. Methods : Animal study: Mulberry Extract Complex is composed of extracts of mulberry (Morus alba L.) fruit, mulberry leaves and black beans (Glycine max (L.) Merr.). To evaluate the serum level of interleukin-2, interferon-<TEX>$\gamma$</TEX>, and prostaglandin E2, an animal model of degenerative arthritis induced by monosodium iodoacetate was employed. Clinical study: The efficacy index (VAS, K-WOMAC) was compared among patients with symptoms of degenerative arthritis before and after Mulberry Extract Complex ingestion as well as the one in groups. Evaluations of the improvement by the subjects and by doctor assessment were also performed. Results : Animal study: Mulberry Extract Complex reduced the serum level of interferon-<TEX>$\gamma$</TEX> and prostaglandin E2 in an animal model with degenerative arthritis. Clinical study: The VAS change showed statistical significance in the experimental groups after 4 weeks (PP set) and 8 weeks (ITT set) of ingestion. When the K-WOMAC was analyzed using a modified ITT set to determine the effectiveness, statistically significant results were obtained in the fields of pain & symptom within the Mulberry Extract Complex group as well as between the Mulberry Extract Complex and placebo groups after 8 weeks of ingestion. Results from the improvement evaluation by subjects and the assessment of improvement by doctors showed statistical significance in the experimental groups (PP set) after 8 weeks. Conclusions : Mulberry Extract Complex could be useful for the improvement of various symptoms of degenerative arthritis based on its anti-inflammatory activity and its reduction of VAS and K-WOMAC pain scores.