Hua Bin, Abbas Estelle, Hayes Alan, Ryan Peter F, Nelson Lisa, O'Brien Kylie
1 School of Biomedical and Health Sciences, Victoria University , Melbourne, Australia .
J Altern Complement Med. 2012 Aug 21. doi: 10.1089/acm.2011.0726.
Abstract Background: A Chinese medicine (CM) "Syndrome" or "pattern of disharmony" is a diagnostic subcategory of a disease/disorder or symptom, characterized by particular symptoms and signs, and indicative of the etiology and the state of pathogenesis at that point in time. In CM, treatment is aimed at addressing the disease/disorder and the underlying CM Syndrome. A few studies have assessed reliability of CM Syndrome diagnosis according to one of the major CM theories, Zang-Fu theory, but only 1 study has investigated the reliability of diagnosis according to a fundamental theory, that of the Eight Guiding Principles. Given that treatment follows diagnosis, if diagnosis is not reliable there will be lower confidence that optimal treatment is received. There have not yet been any reliability studies in osteoarthritis (OA). Little is known about the characteristics or Syndromes of OA with respect to the Eight Guiding Principles and Zang-Fu theory. Objectives: The objectives of this study were to characterize diagnostic subcategories of OA according to the Eight Guiding Principles and Zang-Fu theory and to investigate the inter-rater reliability of CM diagnosis according to these two theories. Methods: An inter-rater reliability study was conducted as a substudy of a clinical trial investigating the treatment of knee OA with Chinese herbal medicine. Two (2) experienced CM practitioners conducted a CM examination separately, within 2 hours of each other, of 40 participants. A CM assessment form was utilized to record the diagnostic data. Cohen's κ coefficient was used as a measure of reliability. Results: Results support the concept that knee OA is more likely a disease with characteristics of Interior, Deficiency, and Yin according to the Eight Guiding Principles. There was no clear agreement on CM Syndromes of knee OA according to Zang-Fu theory. The main Zang Organs involved were broadly agreed on; they were Kidney, Liver, and Spleen. Conclusions: Results lend some empirical evidence to support to the argument that OA of the knee is an Internal disease with the manifestations of Deficient symptoms according to CM theories. To establish if Syndrome diagnosis is reliable, more studies should be conducted for different clinical conditions.
摘要 背景：中医的“证”是疾病或病症或症状的一种诊断亚类，其特征为特定的症状和体征，并指示当时的病因和发病机制状态。在中医中，治疗旨在针对疾病/病症以及潜在的中医证型。一些研究根据中医主要理论之一的脏腑理论评估了中医证型诊断的可靠性，但仅有一项研究根据基本理论八纲辨证研究了诊断的可靠性。鉴于治疗基于诊断，如果诊断不可靠，那么对于接受最佳治疗的信心就会降低。骨关节炎（OA）方面尚未有可靠性研究。关于OA在八纲辨证和脏腑理论方面的特征或证型知之甚少。目的：本研究的目的是根据八纲辨证和脏腑理论对OA的诊断亚类进行特征描述，并研究根据这两种理论进行中医诊断的评分者间信度。方法：作为一项用中药治疗膝骨关节炎临床试验的子研究，开展了一项评分者间信度研究。两名经验丰富的中医师在彼此间隔2小时内分别对40名参与者进行中医检查。使用一份中医评估表记录诊断数据。采用Cohen's κ系数作为信度指标。结果：结果支持这样一种观点，即根据八纲辨证，膝骨关节炎更可能是一种具有里、虚、阴特征的疾病。根据脏腑理论，对于膝骨关节炎的中医证型没有明确的一致性意见。对于主要涉及的脏器官大致达成了共识；它们是肾、肝和脾。结论：结果提供了一些实证证据，支持根据中医理论膝骨关节炎是一种具有虚证表现的内科疾病这一观点。为确定证型诊断是否可靠，应针对不同临床情况开展更多研究。
