EFFICACY AND SAFETY OF GINGER EXTRACT NANOPARTICLES RELIEVES PAINS IN KNEE OSTEOARTHRITIS

Abstract

Background: Ginger ( Zingiber officinale Roscoe) is one of the most common used for treating osteoarthritis. The studies reported to contain the active compound namely,6-gingerol were evaluated anti-inflammatory action. However, the major adverse event of oral ginger is heartburn and gastrointestinal disturbances and due to poor absorptions, rapid metabolism and elimination of active ingredient. Objectives: An evaluation of the efficacy and safety of ginger ( Zingiber officinale Roscoe) extract nanoparticles were used for treatment of the knee OA. Material and Methods: A randomized, double-blind, active controlled was conducted at Tha Chang Hospital, Singburi Province between May and October 2014. One hundred and twenty patients between the age of 50-75 years with knee OA, based on American College of Rheumatology (ACR) criteria, were randomized into two groups applying 5%w/w ginger extracts NLC and control 1%w/w diclofenac gel for 12 weeks. The efficacy of treatment was monitored at 4, 8, and 12 weeks by using the WOMAC OA composite index, KOOS and PGA.The t-test was used to compare the mean scores at baseline in each group. Repeated ANOVA was used to compare the mean scores and Chi-square test was used to compare the dichotomous variables between two groups at 4, 8 and 12 weeks. The safety of ginger extract NLC was proved by laboratory tests after 12 weeks of treatment. Results: One hundred and eighteen participants completed the study. Both ginger extract NLC and diclofenac gel could significantly improve knee pain, stiffness, physical function and PGA of treatment in 12 weeks. In the repeated ANOVA, there were no differences in the results between these two groups.The response rate of 5%w/w ginger extract NLC was significantly greater than 1%w/w topical diclofenac [40/59(67.7%) vs. 27/59(45.7%) p<0.05] with at least a 50% reduce in pain. There were no serious adverse events or abnormal laboratory values. Conclusion:Ginger extract nanoparticles relieves joint pain and improves problematic symptoms and improves the quality of life in knees OA during a 12 week treatment with no different to 1%w/w diclofenac gel group.