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重度のうつ病の研究におけるプラセボ反応:変数,実質的,および増加
B Timothy Walsh1, Stuart N Seidman, Robyn Sysko
1Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 1051 Riverside Dr, Unit 98, New York, NY 10032, USA.
JAMA
|April 10, 2002
まとめ
メジャーうつ病 (MDD) 試験におけるプラセボに対する反応率は,時間の経過とともに著しく増加し,薬物への反応の傾向を反映しています. これは,抗うつ薬の研究におけるプラセボグループの科学的重要性を強調しています.
科学分野:
- 精神科医は精神病を患っている.
- クリニック・トライアル 臨床試験
- 薬理学 薬理学とは
背景:
- 大型うつ病 (MDD) 薬の臨床試験におけるプラセボ対照群の必要性について議論がある.
- 効果的な抗うつ薬の利用により倫理的な懸念が生じ,新しい試験でプラセボ群の必要性を疑問視しています.
研究 の 目的:
- 抗うつ薬試験におけるプラセボ対照群の特徴の変化を時間とともに分析する.
主な方法:
- MEDLINEとPsychLitの体系的な検索は,1981年から2000年の間に出版された,MDDを患っている成人患者を含む臨床試験について行われました.
- 含有基準を満たす75件の試験を分析し,データを抽出し,複数の著者によって不一致を解決しました.
主要な成果:
- プラセボに対する平均応答率は29.7%で,活性薬に対する平均応答率は50.1%でした.
- プラセボと薬剤の両方の反応率は,出版年との有意な正の相関を示しました.
- 出版年数と応答率の相関は,薬剤よりもプラセボで強く見られた.
結論:
- MDD試験におけるプラセボに対する反応は変数的で,しばしば実質的であり,近年,薬剤への反応と同様に,著しく増加しています.
- この発見は,抗うつ薬試験にプラセボ群を含める科学的重要性を強調しています.
- リスクを最小限に抑え,プラセボ群での試験を倫理的に実施するために,継続的な努力が必要である.
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