Abstract

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.

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