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薬理と治療
Abstract
Objective The aim of the present study was to examine the efficacy of nobiletin contained in Shikwasa fruit juice drink for lowering serum uric acid level, as well as its safety, in healthy male adults with marginal hyperuricemia. Methods The study was a 8-week exploratory open-label clinical trial on male adults whose baseline serum uric acid levels were ranging between 7.0 and 8.9 mg╱dL. Twenty -one participants were assigned to receive a low-dose test drink(50 mL containing 25 mg nobiletin per day)or a high-dose test drink(100 mL containing 50 mg nobiletin per day)daily for 8 weeks. To evaluate the efficacy of the test drink consumption, serum uric acid level and excreted amount of uric acid in urine were determined at baseline and at weeks 4 and 8 in all participants. Results Analyses of the total efficacy-evaluable population(n=10 each in both low-and high-dose groups)showed that the low-dose test drink intake virtually had no effect on the serum uric acid level throughout the treatment, whereas there was a trend for high-dose test drink intake to lower the serum uric acid level and a significant difference was observed at week 8 when compared with baseline. The test drink at both doses was well tolerated without any reported untoward side effects or laboratory abnormalities. Conclusion The results of the present study are the first finding that citrus nobiletin has the potential for safely lowering serum uric acid level in adult men with marginal hyperuricemia, suggesting the beneficial effect on hyperuricemia and related medical conditions. (UMIN︱CTR╱UMIN000028828)
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