Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 NanXiaoJie, DongZhiMenNei, Dong Cheng District, Beijing 100700, China.
Evid Based Complement Alternat Med. 2013;2013:587234. doi: 10.1155/2013/587234. Epub 2013 Oct 28.
Background. The characteristics of treatment based on syndrome differentiation (TBSD) cause great challenges to evaluate the effectiveness of the clinical methods. Objectives. This paper aims to evaluate the influence of physician to personalized medicine in the process of TBSD. Methods. We performed a randomized, triple-blind trial involving patients of primary insomnia treated by 3 physicians individually and independently. The patients (n = 30) were randomly assigned to receive treatments by the 3 physicians for every visit. However, they always received the treatment, respectively, prescribed by the physician at the first visit. The primary outcome was evaluated, respectively, by the Pittsburgh Sleep Quality Index (PSQI) and the TCM symptoms measuring scale. The clinical practices of the physicians were recorded at every visit including diagnostic information, syndrome differentiation, treating principles, and prescriptions. Results. All patients in the 3 groups (30 patients) showed significant improvements (>66%) according to the PSQI and TCM symptoms measuring scale. Conclusion. The results indicate that although with comparable effectiveness, there exist significant differences in syndrome differentiation, the treating principles, and the prescriptions of the approaches used by the 3 physicians. This means that the physician should be considered as an important factor for individualized medicine and the related TCM clinical research.
背景。基于辨证论治（TBSD）的治疗特点对临床方法的疗效评估带来了巨大挑战。目的。本文旨在评估医生在 TBSD 过程中对个体化医学的影响。方法。我们进行了一项随机、三盲试验，涉及由 3 位医生分别独立治疗的原发性失眠患者。将患者（n=30）随机分配给每位医生每次就诊时接受治疗。然而，他们总是接受第一次就诊时医生开出的治疗。主要结局分别用匹兹堡睡眠质量指数（PSQI）和中医症状测量量表进行评估。每次就诊时记录医生的临床实践，包括诊断信息、辨证、治疗原则和处方。结果。所有 3 组（30 名患者）的 PSQI 和中医症状测量量表均显示出显著改善（>66%）。结论。结果表明，尽管疗效相当，但 3 位医生使用的辨证、治疗原则和处方存在显著差异。这意味着医生应该被视为个体化医学和相关中医临床研究的一个重要因素。
