Effect of Shenzhu Guanxin Recipe () on patients with angina pectoris after percutaneous coronary intervention: A prospective, randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of a combination therapy using Chinese medicine (CM) Shenzhu Guanxin Recipe (, SGR) and standard Western medicine treatment (SWMT) in patients with angina pectoris after percutaneous coronary intervention (PCI). METHODS: Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment (SGR) and control (placebo) groups. Outcome measures including angina pectoris score (APS), CM symptom score, and Seattle Angina Questionnaire (SAQ) score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis. RESULTS: In the treatment group, a larger within-treatment effect size (d=1.74) was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group (d=0.83, 53.8% symptom reduction); betweentreatment (BT) effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group (d=0.46), and a 16.1% decrease in the control group (d=0.31); d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group (d=0.63), followed by the level of body limitation of activity (d=0.62), condition of angina pectoris attacks (d=0.55), satisfaction level of treatments (d=0.31), and steady state of angina pectoris (d=0.30). Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event (including death toll, frequency of cardiovascular hospitalization or emergency room visits) was found between the two groups. CONCLUSION: The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.

A multicentre randomized clinical trial on efficacy and safety of huxin formula in patients undergoing percutaneous coronary intervention.

Percutaneous coronary intervention (PCI) is widely used in clinical treatment of coronary artery disease. However, the effects of PCI on preventing restenosis after revascularization and improving the quality of life were not satisfying. Huxin Formula is formulated by modifying an experienced Chinese medicine formula and has been widely used in clinical practice due to its marked effects on coronary heart disease. A multicentre double-blind randomized controlled clinical trial was designed to evaluate the effects and safety of Huxin Formula in patients undergoing PCI. Our results showed that there was no significant difference between the two groups in main outcomes. For patients with ejection fraction (EF) >50%, score of the quality of life scale was higher in treatment group compared with control group. For patients with unstable angina, score of the quality of life scale in 360 days was significantly higher in treatment group compared with control group (P < 0.05). No obvious adverse reaction was found in the use of Huxin Formula. In conclusion, Huxin Formula, believed to be a safe treatment for patients after PCI, has benefits in improving the quality of life in patients with unstable angina though it failed to show superiority in primary and secondary outcomes.

[Effect of clinical pathways based on integrative medicine for patients with chronic heart failure: a multi-center research].

OBJECTIVE: To assess a multi-center study effectiveness of clinical pathways based on integrative medicine (IM) for chronic heart failure (CHF) patients. METHODS: A combined method of historical control study and clinical study on concurrent control was used. After the standard management for clinical pathways was carried out in four hospitals at home, the effects on hospitalization days, medical expenses, clinical efficacy, patient satisfaction, and quality of life were assessed. RESULTS: Results of non-concurrent historical control study showed that: the hospital stay was significantly shorter in the pathways group than in the retrospective group (12.59 days vs 18.44 days), and the total cost of hospitalization was significantly reduced in the pathways group (yen 9 051.90 vs yen 11 978.40), showing statistical difference (P < 0.01). Moreover, the effect on the heart function was better in the pathways group than in the retrospective group (the markedly effective rate: 45.60% vs 21.90%; the total effective rate: 96.80% vs 86.10%), showing statistical difference (P < 0.01). Results of clinical study on concurrent control showed that the hospital stay was significantly shorter in the pathways group than in the control group (11.19 days vs 13.21 days), showing statistical difference (P < 0.05). The average total cost of hospitalization was significantly lower in the pathways group than in the control group (yen 8 656.80 vs yen 11 609.70), showing statistical difference (P < 0.01). As for clinical efficacy of Chinese medical syndrome, the total effective rate was higher in the pathways group than in the control group (97.10% vs 93.62%), showing statistical difference (P < 0.05). The markedly effective rate of heart function was better in the pathways group than in the control group, showing statistical difference (49.30% vs 38.30%, P < 0.05). The overall satisfaction was higher in the pathways group than in the conventional group (P < 0.01). There was no statistical difference in the mortality within 3 months after discharge from hospital, and the readmission rate due to heart failure between the two groups (P > 0.05). But there was statistical difference in the quality of life (P < 0.05). CONCLUSION: The pathway could shorten the hospitalization time, decrease the cost of hospitalization, improve the clinical efficacy, improve patients' quality of life and satisfaction, therefore, it could be spread nationwide.

[Clinical epidemiologic investigation on Chinese medicine syndrome laws in patients with chronic heart failure].

OBJECTIVE: To study the distribution laws of Chinese medicine syndromes in patients with chronic heart failure (CHF) by clinical epidemiologic investigation. METHODS: 512 CHF patients were studied, including 168 items of symptoms and 48 items of tongue and pulse pictures. A database of Chinese medicine syndromes was established, and 9 disease nature elements and 5 disease location elements were extracted. Frequency analysis was performed on all symptoms, tongue and pulse pictures. The variables with frequency constituent ratio less than 10.0% were deleted. Then the features of clinical epidemiology, syndrome patterns, syndrome elements, main symptoms, as well as tongue and pulse pictures were analyzed. RESULTS: (1) The disease nature elements of CHF covered qi deficiency, yin deficiency, and yang deficiency (categorized as the essential deficiency), as well as blood stasis, turbid phlegm, and the retained fluid (categorized to the superficiality excess). Among them, frequencies of qi deficiency and blood stasis (both more than 85.0%) were the highest. The disease location elements of CHF were ordered in frequency as Xin (97.9%), Pi (88.1%), followed by Shen (43.0%), Fei (30. 1%), and Gan (7.0%). (2) In the distribution of syndrome patterns in CHF patients, qi deficiency phlegm-stasis syndrome was the most (59.2%), followed by qi-yin deficiency with phlegm-stasis intermingle syndrome (20.3%), Xin-yang decline with phlegm-stasis obstruction syndrome (7.0%), and yang-deficiency with water overflowing syndrome (5.5%). (3) Patients with heart function grade II, III, and IV mainly manifested as qi-deficiency with phlegm-stasis syndrome. Besides, qi-yin deficiency with phlegm-stasis intermingle syndrome could be often seen in those with grade III. And Xin-yang decline with phlegm-stasis obstruction syndrome and yang-deficiency with water overflowing syndrome could often be seen in those with grade IV. CONCLUSIONS: The pathogenesis of CHF is essential deficiency and superficiality excess. The essentiality consists of qi deficiency, yin deficiency, and yang deficiency, and the superficiality consists of blood stasis, turbid phlegm, and retained fluid. The disease was located at the five zang-organs, mainly dominated at Xin and Pi, and associated with Fei, Shen, and Gan. Qi deficiency phlegm-stasis syndrome was dominated in Chinese medicine syndrome patterns. Along with the aggravation of CHF, Chinese medicine syndrome pattern shows certain development laws.

[Double blinded randomized and controlled study on treatment of chronic heart failure by nuanxin capsule].

OBJECTIVE: To evaluate the effect and safety of Nuanxin Capsule (NXC) in treating patients with chronic heart failure (CHF). METHODS: Adopting the randomized, positive controlled, double-blinded design, 150 CHF patients were assigned to the treatment group and the control group equally, they were treated with optimal western medical therapeutic scheme in combining respectively with NXC and placebo for 24 weeks. The indices for effectiveness and safety evaluation, such as Chinese medicine syndrome, grade of heart function, myocardial contraction, as well as the re-hospitalization rate and mortality, were observed. RESULTS: The total effective rate on heart function in the treatment group and the control group was 78.87% and 64.38% respectively, that on Chinese medicine syndrome was 85.9% and 63.0% respectively, comparisons of the two indices between the two groups all showed significant difference (P < 0.05, P < 0.01). And a better efficacy for improving patients' cardiac contraction function and quality of life was shown in the treatment group (P < 0.05, P < 0.01). The re-hospitalization rates in them were 23.9% and 53.4% respectively (P < 0.05), and 22.54% and 42.5% of the re-hospitalized patients had attack of acute heart failure, a significant difference was found between the two groups (P < 0.05). The mortality in them was 2.90% and 8.95% respectively, showing no significant difference between groups (P > 0.05). No obvious adverse effect was found in both groups. CONCLUSIONS: NXC could improve the heart function of patients, it has obvious curative effect and good safety in treating chronic heart failure.