Clinical research in traditional medicine: Priorities and methods

Clinical research in traditional medicine: Priorities and methods
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DOI:
10.1016/j.ctim.2006.07.003
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发表时间:
2006-12-01
影响因子:
3.6
通讯作者:
Kronenberg, Fredi
Kronenberg, Fredi
中科院分区:
医学3区
文献类型:
--
作者:
Cardini, Francesco;Wade, Christine;Kronenberg, Fredi

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本文探讨了与传统医疗系统(TMS)产生的治疗评估相关的挑战和机遇。全球化和受消费者和工业驱动的市场力量促进了传统治疗、技术和技术的传播,但不一定确保其有用性或安全性。国际科学界有义务评估这些治疗方法的安全性和有效性,因为它们可能对全球公共卫生产生影响。然而,传统治疗的临床评价在方法和实践上面临着复杂的挑战,这取决于研究的目标和结果的受众(原产国;或新的东道国和新的患者群体)。为了应对这些挑战,作者提出了以下建议,以确定和优先考虑研究的治疗方法,以及如何设计研究方案。对传统疗法的评估最好首先通过合作的、国际的、务实的研究来解决。观察性、前瞻性、实用性试点研究(可行时随机对照)的方案应协同设计,并在原文化和新环境中同时执行。反过来,这可以决定更大的随机对照试验(rct)的可接受性、有用性和可行性。国际多中心随机对照试验将具有评估安全性和有效性以及评估传统治疗在不同社会和文化背景下的可转移性的潜在益处。(c) 2006 Elsevier Ltd.版权所有。
This paper explores the challenges and opportunities associated with the evaluation of treatments arising from traditional medical systems (TMS). Globalization and popular consumer-and industry-driven market forces contribute to the spread of traditional treatments, techniques and technologies, but do not necessarily ensure their usefulness or safety. The international scientific community is obliged to evaluate the safety and efficacy of these treatments because of their potential impact on global public health. Clinical evaluations of traditional treatments, however, have complex methodological and practical challenges, depending on the goals of the research and the audience for the results (country of origin; or new host countries and new patient populations). To address these challenges, the authors offer the following recommendations to identify and prioritize treatments to study and how to design study protocols. Evaluations of traditional treatments are best addressed first by collaborative, international, pragmatic studies. Protocols for observational, prospective, pragmatic pilot study (randomized and controlled, when feasible) should be designed collaboratively and executed simultaneously in the culture of origin and in new contexts. This, in turn, could determine the acceptability, usefulness and feasibility of larger randomized controlled trials (RCTs). International multicentre RCTs would have the potential benefits of evaluating safety and effectiveness and also assessing the transferability of a traditional treatment across social and cultural contexts. (c) 2006 Elsevier Ltd. All rights reserved.