| アブストラクト | ETHNOPHARMACOLOGICAL RELEVANCE: Herbal medicine in Japan is known as Kampo preparation, a traditional medicine that combines multiple medicinal herbs and is widely used in medical practice. Pseudoaldosteronism is an issue associated with herbal medicines that contain licorice. However, the relationship between licorice intake and pseudoaldosteronism is not fully understood and is debatable. AIM OF THE STUDY: This study evaluates the association between herbal medicine preparations containing licorice and pseudoaldosteronism using data from the Japanese Adverse Drug Reaction Reporting System (JADER) database. MATERIALS AND METHODS: The JADER database contained 961,171 reports published between April 2004 and December 2024. The association between herbal medicines and pseudoaldosteronism was evaluated using the pharmacovigilance index as the reporting odds ratio (ROR) and logistic regression models. RESULTS: There were 537 cases of pseudoaldosteronism (PT code: 10037113). The reporting ratio of pseudoaldosteronism was higher in the licorice-containing herbal medicines group than in the overall herbal medicines group. The RORs of the top 20 herbal medicines with the highest number of pseudoaldosteronism reports, all of which contained licorice, exceeded one, and a signal was detected. The risk of pseudoaldosteronism increased with increasing licorice intake. According to the receiver operating characteristic (ROC) curve for pseudoaldosteronism (area under the curve (AUC) = 0.71, sensitivity = 0.8493, 1-specificity = 0.5530), the cutoff value was 1.125 g/day. CONCLUSIONS: This study is the first to clarify the association between licorice intake from herbal medicines and pseudoaldosteronism using Japan's spontaneous adverse event-reporting database. These findings will be useful and informative for medical professionals considering treatments with herbal medicines. |
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| 投稿者 | Nakao, Satoshi; Liao, Jun; Ino, Yoko; Oura, Keita; Ito, Seiichiro; Kageyama, Koichi; Sato, Mugita; Murakami, Yuko; Ishida, Shigeru; Hirota, Takeshi; Endo, Satoshi; Uchida, Mayako; Iguchi, Kazuhiro; Nakamura, Mitsuhiro |
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| 組織名 | Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4,;Daigaku-nishi, Gifu, 501-1196, Japan; Department of Pharmacy, Kyushu University;Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.;Department of Pharmaceutical Informatics and Biological Statistics, China;Pharmaceutical University, #639 Longmian Avenue, Jiangning District, Nanjing,;211198, China.;Laboratory of Pharmaceutical Health Care and Promotion, Gifu Pharmaceutical;University, 1-25-4, Daigaku-nishi, Gifu, 501-1196, Japan.;Daigaku-nishi, Gifu, 501-1196, Japan.;Department of Pharmacy, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku,;Fukuoka, 812-8582, Japan.;United Graduate School of Drug Discovery and Medical Information Sciences, Gifu;University, 1-1, Yanagido, Gifu, 501-1194, Japan.;Laboratory of Community Pharmacy, Gifu Pharmaceutical University, 1-25-4,;Daigaku-nishi, Gifu, 501-1196, Japan. Electronic address:;mnakamura@gifu-pu.ac.jp. |
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