This study reviewed the current status of the use of outcome indicators in randomized controlled trial(RCT) on traditional Chinese medicine(TCM) treatment of microvascular angina(MVA) and analyzed the existing problems and possible solutions, aiming to provide a basis for the design of high-quality RCT and the establishment of core outcome sets for MVA. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries were searched for the RCT on TCM treatment of MVA according to pre-defined criteria. The Cochrane's risk of bias assessment tool was used to evaluate the methodological quality of the included RCT and the use of outcome indicators was summarized. A total of 69 RCTs were included, from which 100 outcome indicators were extracted, with the frequency of 430. The extracted outcome indicators belonged to 8 domains: response rate, symptoms and signs, physical and chemical examinations, TCM efficacy, safety, quality of life, economic evaluation, and long-term prognosis. The indicators of physical and chemical examinations were the most(70 indicators with the frequency of 211), followed by those of response rate(7 indicators with the frequency of 73) and symptoms and signs(7 indicators with the frequency of 54). The outcome indicators with higher frequency were adverse reactions, angina attack frequency, clinical efficacy, endothelin-1, total duration of treadmill exercise, and hypersensitive C-reactive protein. The RCT on TCM treatment of MVA had the following problems: irregular reporting of adverse reactions, diverse indicators with low frequency, lack of attention to the application of endpoint indicators, insufficient use of TCM differentiation and efficacy indicators, non-standard evaluation criteria and failure to reflect the basic characteristics of TCM. A unified MVA syndrome differentiation standard should be established, on the basis of which an MVA treatment efficacy evaluation system and core outcome indicator set that highlights the characteristics of TCM with patient-reported outcomes as the starting point should be established to improve the clinical research and research value.
Humans ; Medicine, Chinese Traditional ; Drugs, Chinese Herbal/adverse effects* ; Microvascular Angina/drug therapy* ; Quality of Life ; Phytotherapy ; Treatment Outcome

OBJECTIVETo evaluate the clinical effect of Liqi Kuanxiong Huoxue method LKH, traditional Chinese medicine, TCM therapeutic method for regulating qi, relieving chest stuffiness and promoting blood circulation) in treating patients with cardiac syndrome X (CSX).

METHODSThe prospective, non-randomized controlled study was conducted on 51 selected patients with CSX, who were non-randomly assigned to 2 groups, the treated group treated with LKH in addition to the conventional treatment (32 patients), and the control group treated with conventional treatment (19 patients) like nitrate, diltiazem hydrochloride, etc. The treatment course was 14 days. The changes of such symptoms as angina pectoris, TCM syndrome and indexes of treadmill exercise test before and after treatment were observed.

RESULTSAfter treatment, such symptoms as chest pain and stuffy feeling and palpitation in the treated group were improved more than those in the control group (P<0.05); the total effective rate on angina pectoris and TCM syndrome in the treated group was better than that in the control group (P<0.05). The treadmill exercise test showed that the maximal metabolic equivalent (Max MET), the time of angina onset and ST segment depression by 0.1 mV were obviously improved after treatment in both groups, but the improvement in the treated group was better than that in the control group respectively (P<0.05).

CONCLUSIONThe LKH method could reduce the frequency of angina attacks and improve the clinical condition of patients with CSX.

Blood Circulation ; Drug Combinations ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Exercise Test ; Female ; Humans ; Male ; Microvascular Angina ; diagnosis ; physiopathology ; therapy ; Middle Aged ; Qi ; Thorax ; physiopathology ; Treatment Outcome

In women receiving evaluation for suspected ischemic symptoms, a "normal" diagnosis is five times more common than it is in men. These women are often labeled as having cardiac syndrome X, also known as microvascular angina (MVA). MVA is defined as angina pectoris caused by abnormalities of the small coronary arteries, and is characterized by effort chest pain and evidence of myocardial ischemia with a non-invasive stress test, although the coronary arteries can appear normal or near normal by angiography. MVA patients are often neglected due to the assumption of a good prognosis. However, MVA has important prognostic implications and a proper diagnosis is necessary in order to relieve the patients' symptoms and improve clinical outcomes. The coronary microvasculature cannot be directly imaged using coronary angiography, due to the small diameter of the vessels; therefore, the coronary microvascular must be assessed functionally. Treatment of MVA initially includes standard anti-ischemic drugs (beta-blockers, calcium antagonists, and nitrates), although control of symptoms is often insufficient. In this review, we discuss the pathophysiology, diagnosis, and treatment of MVA.
Cardiovascular Agents/therapeutic use ; Coronary Circulation ; Coronary Vessels/physiopathology ; Female ; Heart Function Tests ; Humans ; Male ; Microcirculation ; Microvascular Angina/diagnosis/drug therapy/*epidemiology/physiopathology ; Predictive Value of Tests ; Risk Factors ; Sex Distribution ; Sex Factors ; Treatment Outcome

OBJECTIVE: To determine the therapeutic effect of simvastatin combined with traditional medicine on patients with X-syndrome, and on the reserve of heart function and endothelial function. METHODS: Forty patients with X-syndrome were recruited from September 2006 to September 2007 and randomly divided into 2 groups (a simvastatin group and a control group). The control group received routine treatment including beta receptor blocker, calcium-channel blocker (CCB) and long active nitrate. The simvastatin group received simvastatin and the routine treatment. The clinical condition and exercise test (TET) were performed before and after the treatment.The levels of triglyeride (TG), total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C), endothelin-1 (ET-1) and nitric oxide (NO) were measured. RESULTS: The frequencies of chest pain in the simvastatin group were lower than those in the control group. The levels of ET-1, ET-1/NO, TG, TC, and LDL-C were significantly decreased in the simvastatin group as compared with the control group after the treatment. The levels of HDL-C and NO were significantly increased in the simvastatin group as compared with the control group after the treatment. The time in TET was significantly increased in the simvastatin group as compared with the control group. The frequencies of chest pain were positively related to the level of ET-1/NO and negatively related to the time in TET. CONCLUSION Simvastatin is effective for patients with X-syndrome and may improve the endothelial function and the reserve of heart function.
Anticholesteremic Agents ; therapeutic use ; Cholesterol, HDL ; blood ; Endothelin-1 ; blood ; Endothelium, Vascular ; physiopathology ; Exercise Test ; Female ; Humans ; Male ; Microvascular Angina ; drug therapy ; physiopathology ; Nitric Oxide ; blood ; Simvastatin ; therapeutic use