BackgroundExperts in Traditional Chinese Medicine (TCM) have studied the TCM subject of the pathogenesis of heart failure (HF) for several decades. As a result, the general idea is ben deficiency and biao excess. However, the clinical evaluation system which combined the TCM and western medicine in HF has not been developed yet. The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods.MethodsNine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome.DiscussionBy putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index system which built in the study will be helpful for the clinical effect expression of HF by integrated medicine in future.Trial RegistrationChiCTR-TRC-00000059
Clinical reports on cardiac syndrome X (CSX) have been increasing in recent years. In general, CSX does not increase the cardiovascular mortality, but it can affect the patient's quality of life (QOL) and increase the incidence rates of cardiovascular and cerebrovascular events. Although a variety of drugs and therapies have been utilized in the clinical treatment, the management of CSX still represents a major challenge due to its unclear pathogenesis. It is necessary to explore more effective treatment programs. Many attempts have been made on trials of the Chinese medicine (CM) treatment for CSX and proved that CM has a certain advantage in efficacy to improve clinical symptoms and QOL. CM may provide a new approach for the effective treatment of CSX.
A good effect was achieved in the integration of Chinese and Western Medicines for CSX. The therapy is worthy to be applied further in clinical practice. On the other hand, more long-term and randomised controlled studies with large samples are still required to further determine the clinical efficacy and safety of the therapy.
Low-, medium- and high-dose SMI shows different effects on pharmacokinetics of digoxin and reveals a tendency to shorten T(1/2β) of digoxin. Low-dose SMI can accelerate the clearance of digoxin in blood.
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