Decoding the impact of the placebo response in clinical trials for chronic cough.

IF 4.3 3区 医学 Q1 RESPIRATORY SYSTEM ERJ Open Research Pub Date : 2024-10-28 eCollection Date: 2024-09-01 DOI:10.1183/23120541.00335-2024
Mengru Zhang, Bangyu Zhang, Alyn H Morice
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Abstract

Chronic cough is a prevalent and challenging condition, with limited treatment options available. The interpretation of clinical trial results for antitussive drugs is complicated by the presence of the placebo response, which can confound outcomes and impede regulatory approval. This review aims to explore the impact of the placebo response on clinical trials for cough medications and elucidate the underlying mechanisms involved. The multifaceted nature of antitussive effects, including pharmacological, psychological/neurobiological and nonspecific effects, is discussed. Additionally, potential solutions to address the placebo response in future cough medication development, such as strategic study design, appropriate choice of end-points and meticulous patient selection, are proposed. More progress to harness this issue is urgently needed.

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解码慢性咳嗽临床试验中安慰剂反应的影响。
慢性咳嗽是一种普遍且具有挑战性的疾病,可供选择的治疗方法有限。由于安慰剂反应的存在,止咳药临床试验结果的解释变得复杂,安慰剂反应可能会混淆结果并阻碍监管部门的审批。本综述旨在探讨安慰剂反应对止咳药临床试验的影响,并阐明其中的内在机制。文章讨论了止咳效果的多面性,包括药理、心理/神经生物学和非特异性效果。此外,还提出了在未来的止咳药研发中解决安慰剂反应的潜在解决方案,如战略性研究设计、终点的适当选择和患者的精心挑选。我们迫切需要在解决这一问题方面取得更多进展。
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来源期刊
ERJ Open Research
ERJ Open Research Medicine-Pulmonary and Respiratory Medicine
CiteScore
6.20
自引率
4.30%
发文量
273
审稿时长
8 weeks
期刊介绍: ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.
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