Efficacy and Safety of Phyllanthus Amarus Cream Treatment in Knee Osteoarthritis

Abstract

Background: Knee osteoarthritis (OA) is a chronic degenerative joint disease and inflammatory pain which decreases daily activities. Objective: The aim of the present investigation was to examine skin permeation and skin irritation test of Phyllanthus Amarus (PA) cream including the effects of four weeks of treatment with PA cream in patients with osteoarthritis (OA) of the knee. Methods: The permeation study of PA cream was determined by Franz diffusion cells using a stillborn piglet skin. The primary irritation test was evaluated in rabbits and human volunteers following the Draize test. The study included sixty respondents diagnosed with symptomatic knee OA (12 males, 48 females). All the respondents volunteered to participate and randomly allocated into 3 groups including (n =20 in each group), followed by the placebo group and Phyllanthus Amarus (PA) cream group and NSAIDs cream group. They used a cream twice per day for four weeks. The patients were tested on 3 occasions; before two weeks and four weeks for the treatment period. The respondents were completely assessed for pain and function assessment by the visual analog scale (VAS) and the Western Ontario and McMaster Universities O-osteoarthritis Index questionnaire (WOMAC), respectively. Results: The PA cream showed good skin permeation after 10 hours. It had a high accumulative amount in the dermis and the receiving chamber more than the stratum corneum. Therefore, it could help to relieve pain and prolong the effect. The PA cream did not irritate the skin of rabbits and human volunteers. It is safe to be used in clinical treatment. The VAS and total WOMAC scores significantly decreased after 2 weeks (P < 0.001) and 4 weeks (P < 0.001) of intervention compared with before treatment in both the PA cream and NSAIDs groups in OA knee. However, the VAS and total WOMAC score of PA cream were not significantly compared with the NSAIDs groups. Conclusion: The Phyllanthus amarus cream is a new choice, and effective method for OA of the knee treatment. These data indicate that the treatment through Phyllanthus amarus cream improves pain relief and function.