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2023 Fiscal Year Final Research Report

Systematic review on heterogeneity of control groups hindering estimation of effect size of non-pharmacological therapies

Research Project

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Project/Area Number 20K10363
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 58010:Medical management and medical sociology-related
Research InstitutionMorinomiya University of Medical Sciences

Principal Investigator

Yamashita Hitoshi  森ノ宮医療大学, 医療技術学部, 教授 (10248750)

Co-Investigator(Kenkyū-buntansha) 増山 祥子  森ノ宮医療大学, 医療技術学部, 准教授 (10454688)
Project Period (FY) 2020-04-01 – 2024-03-31
Keywords対照群 / 非薬物療法 / 鍼治療 / ランダム化比較試験 / システマティック・レビュー / 偽鍼
Outline of Final Research Achievements

A systematic review of randomized controlled trials on acupuncture in Japan was conducted to analyze the types and trends of control groups by decade. A different acupuncture method or different point selection was the most dominant control setting before 1990, while sham needling/acupoints became the most dominant in the 2000s. In the 2010s, both types of sham needling/points and different acupuncture methods became equally dominant, each accounting for approximately one-third. Perhaps the view that sham acupuncture is not completely inert became widespread in the 2000s. The results suggest that in presenting effect size of treatments, it is necessary to specify the type of control used in the relevant trials.

Free Research Field

鍼灸研究方法論

Academic Significance and Societal Importance of the Research Achievements

本研究では鍼治療を例として、臨床試験で対照群が無治療・偽治療・通常治療など多様に設定されていること、そしてその傾向は試験が行われた年代によっても異なることを示した。この事実に関する認識がないまま各種治療法の効果量をメタアナリシスで算定して診療ガイドライン等で提示すると、臨床実践にあたって正しい判断を妨げてしまう恐れがある。特に非薬物療法の効果量の推定と提示にあたっては、異なる対照群ごとに効果量を算出して治療法間の公正な相互比較を行う必要があることが本研究によって確認された。

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Published: 2025-01-30  

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