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ABSTRACT: T89 (Dantonic) is a modern herbal medicine currently used in Chinese hospitals for the management of ischemic heart disease. This dose-escalation clinical trial aims to assess tolerability of Western people to T89. Healthy Australian adults of non-Asian background orally took a single dosage of 6, 8, 10, 12, 13, 14, 15, or 16 T89 capsules (6 people for each dose) and were assessed with respect to symptoms and physical signs, electrocardiogram, hematology, plasma biochemistry, and urinalysis. Secondary objectives were to determine the dose-limiting toxicity and maximum-tolerated dose. It found that a single dose of T89 up to 16 capsules was not associated with significant adverse events or abnormalities in clinical laboratory tests and electrocardiogram parameters, except minor symptoms reported included mild and transient dizziness, stomach discomfort, diarrhea, and involuntary muscular contraction. The incident rate of these symptoms was generally low (1/30, 3.3%) but increased (7/18, 38.9%) in higher dose (≥14 capsules) groups. No defined dose-limiting toxicity events occurred; so the study could not define the maximum-tolerated dose. In conclusion, a single dose of T89 up to 13 capsules, 4 times of a regular therapeutic dosage, is generally safe and tolerated by individuals of non-Asian background.
Journal of cardiovascular pharmacology 12/2012; 60(6):513-9. · 2.83 Impact Factor
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ABSTRACT: 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.
Journal of alternative and complementary medicine (New York, N.Y.) 07/2009; 15(7):727-34. · 1.69 Impact Factor
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ABSTRACT: Chinese medicine distinguishes itself from Western medicine in the differentiation of diseases according to underlying patterns of disharmony, or Chinese medicine (CM) syndromes. CM has its own clinical endpoints that are used as evidence of change in the body. Yet, relatively little is known about the reliability of CM diagnostic techniques, the final diagnosis of a CM syndrome, or the organizing principles used to reach a CM diagnosis such as the Eight Guiding Principles. Information about reliability of CM diagnosis has important implications for clinical practice and research, particularly if CM diagnostic variables or CM syndromes are to be incorporated into study designs.
An inter-rater reliability study was conducted with three CM practitioners to investigate the reproducibility of CM diagnosis according to the Eight Guiding Principles and Zang-Fu Theory. Forty-five (45) adults with mild hypercholesterolemia but who were otherwise healthy participated in the study.
Our results suggest that there is a reasonably good level of agreement between at least two practitioners on the dimensions of the Eight Guiding Principles. Level of agreement between at least two practitioners on CM syndrome diagnosis according to Zang-Fu Theory was very good for one syndrome only, that of Spleen qi deficiency.
Further investigations are needed into the reliability of the CM diagnostic processes from the initial stage of data collection to the final CM syndrome diagnosis.
Journal of alternative and complementary medicine (New York, N.Y.) 03/2009; 15(3):259-66. · 1.69 Impact Factor
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ABSTRACT: Circulating adhesion molecules (CAMs), surface proteins expressed in the vascular endothelium, have emerged as risk factors for cardiovascular disease (CVD). CAMs are involved in intercellular communication that are believed to play a role in atherosclerosis. A Chinese medicine, the "Dantonic Pill" (DP) (also known as the "Cardiotonic Pill"), containing three Chinese herbal material medica, Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, has been used in China for the prevention and management of CVD. Previous laboratory and animal studies have suggested that this preparation reduces both atherogenesis and adhesion molecule expression. A parallel double blind randomized placebo-controlled study was conducted to assess the effects of the DP on three species of CAM (intercellular cell adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 and endothelial cell selectin (E-selectin)) in participants with mild-moderate hypercholesterolemia. Secondary endpoints included biochemical and hematological variables and clinical effects. Forty participants were randomized to either treatment or control for 12 weeks. Treatment with DP was associated with a statistically significant decrease in ICAM-1 (9% decrease, P = .03) and E-Selectin (15% decrease, P = .004). There was no significant change in renal function tests, liver function tests, glucose, lipids or C-reactive protein levels and clinical adverse effects did not differ between the active and the control groups. There were no relevant changes in participants receiving placebo. These results suggest that this herbal medicine may contribute to the development of a novel approach to cardiovascular risk reduction.
Evidence-based Complementary and Alternative Medicine 10/2008; 2011:790784. · 4.77 Impact Factor
