| Project/Area Number |
17K08938
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical sociology
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| Research Institution | Morinomiya University of Medical Sciences |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
増山 祥子 森ノ宮医療大学, 保健医療学部, 准教授 (10454688)
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| Project Period (FY) |
2017-04-01 – 2021-03-31
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| Project Status |
Completed (Fiscal Year 2020)
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| Budget Amount *help |
¥2,730,000 (Direct Cost: ¥2,100,000、Indirect Cost: ¥630,000)
Fiscal Year 2019: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2017: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
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| Keywords | 代替医療 / 機能性表示食品 / 鍼治療 / 臨床試験 / システマティック・レビュー / 質の評価 / 研究倫理 / リサーチ・インテグリティー / 臨床研究 / 研究方法論的質 / 鍼 / 重複出版 / 診療ガイドライン / 論文の質評価 / 利益相反 / リサーチ・インテグリティ / 研究方法論 |
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| Outline of Final Research Achievements |
We evaluated whether clinical research activities and dissemination of evidence were fairly and properly conducted in the field of complementary and alternative therapies in Japan.
With regard to foods with function claims, there were methodological flaws in clinical trials and literature reviews submitted to Consumer Affairs Agency, and misleading statements in some evidence summary abstracts for consumers were found. As for clinical practice guidelines (CPGs) that include recommendations for acupuncture, the quality was not necessarily high, some of the CPGs contained serious errors of data extraction/input and failure to comply with predefined procedures, and some of the important qualitative problems were not detected by the CPG assessment tool “AGREE II”. As for clinical trials on acupuncture, there have been at least 15 duplicate publications, which might become a confusing factor in conducting meta-analyses.
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| Academic Significance and Societal Importance of the Research Achievements |
機能性表示食品のエビデンス情報発信の質は商品・企業によって差があり、必ずしも公正・誠実でないものがあることがわかった。消費者の誤解や過信を避けるため、科学的根拠の質の評価、記載の適正性の監視、改善指導などが必要である。
診療ガイドラインについては、少なくとも鍼治療の記述に関して正確・公正とはいえないものがあり、医療者と患者が適切な決断を行うためには出版前・後ともに情報の適正性について評価し改善を促す必要がある。また、鍼治療のエビデンス検証のためのメタアナリシスでは、組み入れ臨床試験の慎重な照合・重複除外作業を行うとともに、鍼灸臨床研究者の研究倫理教育を継続徹底する必要性が示唆された。
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