臨床試験における女性健康イニシアチブにおける更年期ホルモン療法のより大きな効果を明らかにした
Joshua Angrist1, Amanda E Kowalski2, Ljubica Ristovska3
1Massachusetts Institute of Technology.
まとめ
更年期ホルモン療法 (MHT) のリスクは,これまで考えられていたよりも大きい. 器用変数の方法では,MHTを遵守する女性の実際のリスクと利益は,以前に示された治療意図の分析よりも大幅に大きいことが示されています.
科学分野:
- 生殖 健康
- 臨床流行病学
- バイオ統計学
背景:
- 女性の健康イニシアティブ (WHI) 試験では,更年期ホルモン療法 (MHT) で乳がんと有害事象のリスクが増加したことが示されました.
- 最近の分析によると,MHTのリスクは最小限であり,主に治療意図 (ITT) 効果の推定に基づいています.
- ITTの分析は,介入群の不服従と対照群の治療開始により,MHTの真の影響を誤って表す可能性があります.
研究 の 目的:
- 更年期ホルモン療法 (MHT) のリスクと利益を再評価する.
- インストゥルメンタル変数 (IV) の方法を用いて,MHTの女性への因果的影響を推定する.
- IVの推定値と従来のITTの推定値を比較する.
主な方法:
- 女性の健康イニシアチブ (WHI) 試験からのアデレンスデータを組み込み,インストゥルメンタル変数 (IV) メソッドを使用した.
- 指定された治療法に従った女性に対してMHTの効果を推定した.
- これらのIV推定値と治療意図 (ITT) 効果の推定値を比較した.
主要な成果:
- 器用変数 (IV) の推定によると,更年期ホルモン療法 (MHT) に伴うリスクと利益は,以前報告されたものより大幅に大きい.
- 適合度調整した分析では,治療意図 (ITT) の結果と比較して,MHTの効果がより顕著であった.
- これは,実際に使用する女性に対するMHTの真の影響が,人口レベルのITTの推定値と著しく異なることを示唆しています.
結論:
- 更年期ホルモン療法 (MHT) の実際のリスクと利益は,従来の使用者にとって,治療意図 (ITT) 分析によって示唆されるよりもかなり大きい.
- インストゥルメンタル変数 (IV) の方法は,MHTの影響をより正確に推定し,アデレンスを検討することの重要性を強調します.
- 臨床ガイドラインと患者カウンセリングに潜在的に影響を与える,MHTの安全性と有効性の以前の解釈に挑戦します.
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