Division of Epidemiology, The JC School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.
Evid Based Complement Alternat Med. 2013;2013:128030. doi: 10.1155/2013/128030. Epub 2013 Aug 20.
Four phases of trial are widely used in testing drugs, surgery, and diagnosis in Western medicine (WM). The staged testing process helps protect patients from unnecessary harms and control costs while assessing safety and efficacy. In this paper we adapt the four phase trials for traditional Chinese medicine (TCM). As TCM has been used in humans for thousands of years and there has been good preliminary clinical evidence on safety and efficacy for many of its therapies, in most cases its evaluation can start directly in humans, and preclinical laboratory research can be conducted in phase 4 trials after the efficacy is firmly demonstrated. Furthermore, unlike investigational drugs, TCM therapies are various in the certainty of their safety and efficacy and thus should not enter the evaluation process at the same stage. Unlike in WM, clarifying and refining PICO (patients, intervention, comparator, and outcome) are an important part of evaluation of newly designed TCM therapies. The incommensurability between WM and TCM causes additional difficulties in TCM trials regarding defining and choosing PICO, for which some suggestions are made. Observational studies seem to have a greater role in evaluation for TCM although the efficacy must be confirmed with randomized trials.
四期临床试验广泛应用于西医的药物、手术和诊断测试。分期测试过程有助于保护患者免受不必要的伤害和控制成本，同时评估安全性和疗效。在本文中，我们将四期临床试验方法应用于中医（TCM）。由于中医在人类中已经使用了数千年，并且其许多疗法的安全性和疗效已经有了很好的初步临床证据，因此在大多数情况下，可以直接在人体中进行评估，并且在疗效得到充分证实后，可以在第四阶段临床试验中进行临床前实验室研究。此外，与研究性药物不同，中医治疗方法在安全性和疗效方面的确定性各不相同，因此不应在同一阶段进入评估过程。与西医不同，明确和细化 PICO（患者、干预、对照和结局）是新设计的中医治疗方法评估的重要组成部分。由于 WM 和 TCM 之间的不可通约性，在定义和选择 PICO 方面，中医试验会带来额外的困难，针对这些问题提出了一些建议。虽然必须通过随机试验来确认疗效，但观察性研究似乎在中医评估中具有更大的作用。
