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Background: Chinese medicine (CM) has its own diagnostic indicators that are used as evidence of change in a patient's condition. The majority of studies investigating efficacy of Chinese herbal medicine (CHM) have utilized biomedical diagnostic endpoints. For CM clinical diagnostic variables to be incorporated into clinical trial designs, there would need to be evidence that these diagnostic variables are reliable. Previous studies have indicated that the reliability of CM syndrome diagnosis is variable. Little information is known about where the variability stems from--the basic data collection level or the synthesis of diagnostic data, or both. No previous studies have investigated systematically the reliability of all four diagnostic methods used in the CM diagnostic process (Inquiry, Inspection, Auscultation/Olfaction, and Palpation). Objectives: The objective of this study was to assess the inter-rater reliability of data collected using the four diagnostic methods of CM in Australian patients with knee osteoarthritis (OA), in order to investigate if CM variables could be used with confidence as diagnostic endpoints in a clinical trial investigating the efficacy of a CHM in treating OA. 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, in 40 participants. A CM assessment form was utilized to record the diagnostic data. Cohen's κ coefficient was used as a measure of the level of agreement between 2 practitioners. Results: There was a relatively good level of agreement for Inquiry and Auscultation variables, and, in general, a low level of agreement for (visual) Inspection and Palpation variables. Conclusions: There was variation in the level of agreement between 2 practitioners on clinical information collected using the Four Diagnostic Methods of a CM examination. Some aspects of CM diagnosis appear to be reliable, while others are not. Based on these results, it was inappropriate to use CM diagnostic variables as diagnostic endpoints in the main study, which was an investigation of efficacy of CHM treatment of knee OA. [ABSTRACT FROM AUTHOR]

Background: Toyohari meridian therapy (TMT) is a Japanese system of acupuncture. Acupoint selection follows diagnosis of the primary and secondary patterns of disharmony ( sho) and disturbances in the yang channels. Pulse diagnosis and abdominal palpation diagnosis are the two main diagnostic methods used. Little is known about the reliability of pulse, abdominal, and pattern diagnosis in TMT. This is important since diagnosis of the sho determines acupoint treatment. If diagnosis is unreliable, there can be less confidence that the patient will receive optimal treatment. Objective: The objective of this study is to assess the level of agreement between two TMT practitioners on pulse diagnosis, abdominal diagnosis, and diagnosis of the primary and secondary sho. Methods: An inter-rater reliability study was conducted. Two (2) TMT practitioners separately conducted a TMT examination and completed an assessment form, choosing from a range of possible responses relating to pulse characteristics, abdominal diagnosis, and diagnosis of primary sho and secondary sho. The κ coefficient was used as a measure of inter-rater reliability of the outcome variables. Results: Sixty-two (62) Australians (22 males, 40 females) aged 20–65 years participated (mean age 49.2 ± 12.2 years). Level of agreement for pulse diagnosis was 57%, 61%, and 77% for pulse depth, speed, and strength, respectively. For abdominal diagnosis, the level of agreement for involvement of the Lung, Kidney, Spleen, and Liver abdominal regions was 58%, 53%, 35%, and 10%, respectively. The overall level of agreement on primary sho diagnosis was 48% and for secondary sho diagnosis, 44%. Conclusions: Overall, there was a reasonable level of agreement on basic pulse characteristics and on abdominal diagnosis for two of the abdominal regions. Level of agreement on primary and secondary sho diagnosis suggests room for improvement. Further studies are required in order to gain a greater understanding of the reliability of diagnosis in TMT. [ABSTRACT FROM AUTHOR]

The question of the objectivity of the clinical examination has been raised in relation to Western and non-Western medical systems. Western practitioners are often skeptical about Traditional Chinese Medicine (TCM), on the basis that its diagnostic variables and subcategories of disease appear subjective and not repeatable. We conducted a study investigating the reproducibility of individual diagnostic observations within three of the four diagnostic methods used in a TCM examination: inspection, palpation, and auscultation. Three TCM practitioners participated in the study, and examined 45 adults who had mild-to-moderate hypercholesterolemia but were otherwise healthy. Results indicated that while there are certain features of the TCM system that are highly objective and repeatable, such as detection of the presence of shen, character of breath sounds, and pulse speed, there are other features that are subjective and unreliable, such as color under the eyes and tongue body color. This poses a challenge for TCM practitioners to improve their clinical practice and demonstrates to Western medical practitioners that TCM does in part rest on a rigorous and objective empirical basis. [ABSTRACT FROM AUTHOR]