Background: Boiogito (Japanese herbal medicine, Tsumura Co. Tokyo, Japan) contains sinomenin which inhibits\r\ninflammatory reactions. Since sinomenine is a principle component of the Boiogito, there is a possibility of it being\r\neffective on osteoarthritis (OA) of the knee with joint effusion. However, there is no report concerning the effectiveness\r\nof Boiogito on knee OA. The objective of the present study is to investigate the therapeutic effect of Boiogito on OA of\r\nthe knee associated with joint effusion in a comparative study among randomly assigned groups.\r\nMethods: Study was performed using 50 patients who were diagnosed with primary osteoarthritis of the knee\r\nwith joint effusion. The patients were randomly assigned to two groups: one group (25 patients) using both\r\nloxoprofen (2-{4-[(2-oxocyclopentyl) methyl]} propanoic acid) and Boiogito and the other group (25 patients) using\r\nloxoprofen, and were evaluated during a 12 week observation period. The assessment parameters including knee\r\nscores in the Knee Society Rating System including Knee score and Functional scores, amount of joint effusion by\r\njoint puncture in clinically detected cases, the 36-items short form of the Medical Outcome Study Questionnaire\r\n(SF-36) as a measurement of health related quality of life were used.\r\nResults: The knee scores based on the Knee Society Rating System were improved in both groups. The staircase\r\nclimbing up and down ability in the Knee society rating system functional score was significantly improved in the\r\ngroup using Boiogito and loxoprofen compared to the loxoprofen group. In the evaluation using SF-36, significant\r\nimprovements were found in the scores in both groups in physical functioning after 12 weeks. The amount of\r\njoint fluid was significantly decreased at 4, 8 and 12 weeks compared to pre-administration baseline in the group\r\nusing Boiogito and loxoprofen. A side effect of Boiogito, dry mouth, was found in one case. The symptom was\r\nmild and improved immediately after discontinuation of administration.\r\nConclusion: The results indicated that Boiogito have a possibility for a treatment modality for joint effusion with\r\nosteoarthritis of the knee.
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