阿尔普拉佐拉姆XR未发表的试验及其对其在恐慌障碍治疗中明显有效性的影响
Rosa Y Ahn-Horst1,2,3, Erick H Turner4,5
1Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Psychological medicine
|October 19, 2023
概括
出版偏见显著夸大了阿尔普拉佐拉姆的价值.
科学领域:
- 精神病学是一个精神病学.
- 药理学 药理学是指药理学的学科.
- 临床研究 临床研究
背景情况:
- 阿尔普拉佐拉姆是一种用于恐慌障碍的广泛处方的二.
- 出版偏见可能会影响药物的有效性.
研究的目的:
- 为了调查对恐慌障碍的阿尔普拉佐拉姆延长释放 (Xanax XR) 试验的出版偏差.
- 将美国食品和药物管理局 (FDA) 的试验结果与已发表的文献进行比较.
主要方法:
- 包括FDA的第2/3阶段疗效试验,用于治疗恐慌障碍的阿尔普拉佐拉姆XR.
- 在PubMed和谷歌学者中搜索了匹配的出版物.
- 将FDA试验结果和效果大小与已发表的数据进行比较.
主要成果:
- 美国食品和药物管理局的数据显示,只有20%的试验是阳性的,而已发表的文献显示了100%的阳性结果.
- 两项非阳性试验发表了积极结果;两项没有发表.
- 与FDA数据相比,当从已公布的数据计算时,阿尔普拉佐拉姆的效果大小比FDA数据高42%.
结论:
- 出版偏见大大膨胀了阿尔普拉佐拉姆XR的明显疗效.
- 发表的文献高估了阿尔普拉佐拉姆在恐慌症治疗中的有效性.
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