Abstract

Objectives : This study was performed to investigate the efficacy and safet y 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-γ , 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 a s 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-γ 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.

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