中草药临床研究的评价(英文)

Critical appraisal of clinical studies in Chinese herbal medicine

补充替代医学正被广泛应用,并呈现出良好的增长趋势。随着寻求补充替代医学疗法的人口比例的增长,无论是补充替代医学被单独使用,还是与传统的对抗疗法联合应用,对补充替代医学临床报告质量的研究变得日益迫切。大部分这种质量研究是针对那些主要目的在于为临床医师提供参考的临床研究报告,我们发现,在解释临床研究的结果及其意义时,人们不得不面对其方法学质量低劣的问题。如何解决这个问题,将是我们面临的巨大挑战。临床医师要有效地利用这些科学研究的文献,就必须熟悉循证医学的基本原则。本文的目的在于向临床医师介绍临床研究评价的概念,使他们在阅读研究论文时能带着评判的眼光,以便更好地评价论文中的研究结果,并将其合理地运用到自己的日常医疗实践中去。本文主要讨论了以下六个方面的问题:(1)循证医学的基本原理;(2)临床研究的类型;(3)证据的分级;(4)应用临床试验报告统一标准评价随机对照试验报告的质量;(5)随机对照试验方法学质量的评分;(6)中草药临床研究质量评价的有关问题。

The use of complementary and alternative medicine （CAM） is currently widespread and appears to be growing. As an increasing proportion of the population turns to CAM therapies, whether singly or in combination with allopathic medicine, the need for quality research in this area is reinforced. Much of this research consists of clinical studies aimed primarily at clinicians, yet challenges arising from poor methodological quality will occur when interpreting study findings and their implications. For clinicians to be effective consumers of the scientific literature, familiarization with the principles of evidence-based medicine （EBM） is essential. The goal of this review is to introduce clinicians to the concept of critical appraisal of clinical studies and foster critical thinking when reading research articles in order to best evaluate and incorporate study findings into their daily practice. Topics discussed in this article include： （1） fundamentals of EBM; （2） types of clinical studies; （3） hierarchy of evidence; （4） Consolidated Standard of Randomized Trials （CONSORT） statement to evaluate the quality of reporting in randomized controlled trials （RCTs）; （5） methodologic quality rating scales for RCTs; and （6） issues specific to evaluating studies of Chinese herbal medicine.