Efficacy of Acupuncture in the Treatment of Essential Hypertension: An Overview of Systematic Reviews and Meta-Analyses.

Background: Acupuncture is widely used in the clinical treatment of essential hypertension (EH). This overview is aimed at summarizing current systematic reviews of acupuncture for EH and assessing the methodological bias and quality of evidence. Methods: Two researchers searched and extracted 7 databases for systematic reviews (SRs)/meta-analyses (MAs) and independently assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of randomized controlled trials (RCTs) included in the SRs/MAs. Tools used included the measurement tool to assess systematic reviews 2 (AMSTAR-2), the risk of bias in systematic (ROBIS) scale, the checklist of preferred reporting items for systematic reviews and meta-analyses (PRISMA), and the grading of recommendations assessment, development, and evaluation (GRADE) system. Results: This overview included 14 SRs/MAs that use quantitative calculations to comprehensively assess the various effects of acupuncture in essential hypertension interventions. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. According to the results of the AMSTAR-2 assessment, all SRs/MAs were of low or very low quality. According to the results of the ROBIS evaluation, a few SRs/MAs were assessed as low risk of bias. According to the results of the PRISMA checklist assessment, SRs/MAs that were not fully reported on the checklist accounted for the majority. According to the GRADE system, 86 outcomes were assessed under different interventions in SRs/MAs, and 2 were rated as moderate-quality evidence, 23 as low-quality evidence, and 61 as very low-quality evidence. Limitations of the included SRs/MAs included the lack of necessary items, such as not being registered in the protocol, not providing a list of excluded studies, and not analyzing and addressing the risk of bias. Conclusion: Currently, acupuncture may be an effective and safe treatment for EH, but the quality of evidence is low, and caution should be exercised when applying this evidence in clinical practice.

Effect of Shenmai Injection on Long-Term Prognosis of Patients with Chronic Heart Failure: A Multicenter, Large Sample Capacity, Long-Term Follow-Up Retrospective Cohort Study.

OBJECTIVE: To explore the effect of Shenmai Injection (SMI) on the long-term prognosis of patients with chronic heart failure (CHF). METHODS: The Hospital Information System was used to extract data of CHF patients, and the retrospective cohort study was conducted for analysis. In non-exposed group, standardized Western medicine treatment and Chinese patent medicine or decoction were applied without combination of SMI while in the exposed group, SMI were applied for more than 7 days. Evaluation indicators are followed with New York Heart Association functional classification (NYHA classification), left ventricular ejection fraction (LVEF), N-terminal brain natriuretic peptide precursor (NT-ProBNP), cardiogenic death and heart failure (HF) readmission. Statistical analysis includes Kaplan-Meier analysis and Cox regression which are used to explore the relationship between SMI and outcome events. RESULTS: A total of 1,211 eligible CHF patients were involved and finally 1,047 patients were followed up successfully. After treatment, the cases of NYHA classification decline in the exposed and non-exposed groups accounted for 64.30% and 43.45%, respectively; the improvement values of LVEF were 8.89% and 7.91%, respectively; the improvement values of NT-ProBNP were 909 pg/mL and 735 pg/mL, respectively. After exposure on SMI, the rates of cardiogenic death and HF readmission reduced from 15.43% to 10.18% and 38.93% to 32.37%. According to Kaplan-Meier analysis, the log-rank P value of SMI and cardiogenic death was 0.014, while the counterpart of SMI and HF readmission was 0.025. Cox regression analysis indicated that for cardiogenic death, age, cardiomyopathy, diabetes, and NYHA classification were risk factors while ß-blockers, aldosterone receptor antagonists, Chinese patent medicine/decoction and SMI were protective factors. Likewise, for HF readmission, age, cardiomyopathy, and NYHA classification were risk factors while SMI was a protective factor. CONCLUSION: Combination with SMI on the standardized Western medicine treatment can effectively reduce cardiogenic mortality and readmission rate in CHF patients, and thereby improve the long-term prognosis.

A 5-Year Survival Prediction Model for Chronic Heart Failure Patients Induced by Coronary Heart Disease with Traditional Chinese Medicine Intervention.

OBJECTIVE: This study aimed to construct a 5-year survival prediction model of coronary heart disease (CHD) induced chronic heart failure (CHF), which is supported by the traditional Chinese medicine (TCM) factor, and to verify the model. METHODS: Inpatients from January 1, 2012, to December 31, 2017, in seven hospitals in Shandong Province were studied. The random number table was used to randomly divide the seven hospitals into two groups (training set and verification set). In the training set, the least absolute shrinkage selection operator regression was first used to screen the independent variables. Logistic regression was then applied to construct a survival prediction model. The following nomogram visualizes the prediction model results. Finally, C-indices, calibration curves, and decision curves were used to discriminate and calibrate the established model and evaluate its practicability in the clinic. Bootstrap resampling and the verification set were used for internal and external verification, respectively. RESULTS: A total of 424 eligible patients were included in the model construction and verification. In this 5-year survival prediction model of patients with CHF induced by CHD, eight independent predictors were included. The series of C-indices for the training set, bootstrap resamples, and verification set was 0.885, 0.867, and 0.835, respectively, demonstrating the credibility of our model. Additionally, the receiver operating characteristic curve, calibration curve, and clinical decision curve analysis of the training and verification sets showed that this 5-year survival prediction model was good in discrimination, calibration, and clinical practicability. CONCLUSION: This work highlights eight independent factors affecting 5-year mortality in patients with CHF induced by CHD after discharge and further helps reallocate medical resources rationally by precisely identifying high-risk groups. The constructed prediction model not only plays a credible role in prediction but also demonstrates TCM intervention as a protective factor for the 5-year death of patients with CHF induced by CHD, thereby advancing the use of TCM in CHF.

Efficacy and safety of Shenfuqiangxin pills in complementary treatment of chronic heart failure: A protocol for systematic review and meta-analysis.

BACKGROUND: As the last link in the chain of cardiovascular events, chronic heart failure (CHF) has high morbidity, high mortality, and poor prognosis. It is one of the main causes of death and disability worldwide. Shenfuqiangxin Pills (SFQX) is widely used as a Chinese herbal medicine (CHM) prescription for CHF, but there is still a lack of strict evidence-based medical evidence. Therefore, we make a protocol for evaluating the efficacy and safety of SFQX for CHF. METHODS: According to the search strategy, randomized controlled trials (RCTs) of SFQX for CHF will be retrieved from 8 databases without limitation of publication date or language. First of all, the literature was screened according to the eligibility criteria, and use the Cochrane Collaboration's tool to assess the quality of the included literature. Then, using software for traditional meta-analysis. Finally, using GRADE method to assess the strength of recommendations. RESULTS: This study will evaluate the efficacy and safety of SFQX for CHF, thereby providing more evidence support for clinical decision-making in CHF. CONCLUSION: Our research will provide more references for the clinical medication of patients with CHF. PROTOCOL REGISTRATION NUMBER: INPLASY202110019.

Efficacy and safety of Qishen Yiqi dripping pills as a complementary treatment for Heart Failure: A protocol of updated systematic review and meta-analysis.

BACKGROUND: Heart failure (HF) has become a serious global public health issue due to its high incidence, high mortality and extremely low quality of life. According to several clinical trials, Qishen Yiqi Dripping pills (QSYQ) combined with routine western medicine treatment can further enhance the curative effect of HF patients. However, most of the trials are small in sample size and poor in quality, which can only provide limited evidence-based medicine. The existing systematic reviews of efficacy and safety has provided evidence for the clinical application of QSYQ to a certain extent, but there are still 3 major defects. Here, we will perform a systematic review and meta-analysis that include the randomized clinical trial (RCT) of CACT-IHF, apply meta-regression and subgroup analysis to cope with multiple confounding factors, and add the clinical efficacy standards of TCM, all-cause death and readmission rates as reliable efficacy evaluation indicators. The purpose of this study was to rigorously evaluate the clinical efficacy and safety of QSYQ in the complementary treatment of HF with a well-designed systematic review and meta-analysis. METHODS: Following the strict search strategy, 9 databases will be searched to ensure a comprehensive search. We search the database from the establishment until November 30, 2020. This study will include RCTs of QSYQ in HF patients' complementary treatment. Two searchers will independently draft and carry out the search strategy, and the third member will further complete it. Two members independently screen literature, extract data and cross-check, and solve different opinions through discussion or negotiation with the third member. The risk bias will be evaluated based on Cochrane tool of risk of bias. Meta-regression and subgroup analysis are used to check and deal with the heterogeneity. The data analysis will be conducted by the statistical software Stata 16.0. RESULTS: The results of this research will be delivered in a peer-reviewed journal. CONCLUSION: This study expects to provide credible and scientific evidence for the efficacy and safety of QSYQ in HF's complementary treatment, and at the same time provide a convenient and effective choice for decision-makers and patients. PROTOCOL REGISTRATION NUMBER: INPLASY 2020120106. ETHICAL APPROVAL: Since this study is on the basis of published or registered RCTs, ethical approval and informed consent of patients are not required.

Effect and safety of oral Chinese patent medicine for heart failure: A protocol for systematic review and network meta-analysis.

BACKGROUND: Heart failure (HF) is the terminal stage of various common cardiovascular diseases with quite a frequent readmission and a high mortality rate, and brings heavy financial burdens to families and society. Oral Chinese patent medicine (CPM) has been widely applied in the treatment of HF in China because of its simplicity, cheapness, convenience, and high efficiency. However, due to the large number and broad clinical selectivity of oral CPMs, there is a lack of uniformity and clinical application standardization. To choose more effective and safe medicine among so many oral CPMs is particularly essential for further improving the therapeutic effect. In this study, the efficacy and safety of different oral CPMs will be compared by a network meta-analysis (NMA), and the best CPM will be selected for the treatment of HF. METHODS: According to the search strategy, 4 English and 4 Chinese databases will be searched from the construction of the library to July 31, 2020. The NMA will include clinical randomized controlled trials (RCTs) of different oral CPMs in HF treatment. The methodological quality is assessed according to the bias risk assessment tool of Cochrane. The Bayesian NMA is performed by Aggregate Data Drug Information System (ADDIS), and the results are visualized using Stata 15.0 software. The GRADE approach is used to assess the quality of evidence and recommendation intensity. RESULTS: The NMA will identify the best oral CPM in the complementary treatment of HF. A peer-reviewed journal will publish the results of the study. CONCLUSION: This study can provide reliable evidence for the efficacy and safety of oral CPMs in the treatment of HF, and help decision-makers and patients to select more effective and safer oral CPM. PROTOCOL REGISTRATION NUMBER: INPLASY202090053.

Efficacy of Traditional Chinese Medicine in patients with acute myocardial infarction suffering from diabetes mellitus.

OBJECTIVE: To investigate the ""real world"" effectiveness of Traditional Chinese Medicine (TCM) in patients with acute myocardial infarction suffering from diabetes mellitus (AMI+DM patients). METHODS: This was a retrospective cohort study. During hospitalization, the ""exposure group"" was defined as patients who had a TCM injection for ≥ 7 d. During follow-up, the definition of the exposure group was application of a Chinese patent medicine or decoction of Chinese medicine for ≥ 28 d. General information (age, sex, contact details), TCM use and endpoint events of AMI+DM patients during hospitalization and follow-up were collected. The correlation between TCM and the end-point events of AMI + DM patients was analyzed using a multiple logistic regression method. RESULTS: A total of 479 AMI + DM patients were enrolled and 345 cases were followed up. During hospitalization, TCM, age, hypertension and use of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) were associated with cardiac death. During follow-up, TCM was associated with cardiac death. TCM was a relevant factor for a composite endpoint of re-infarction and stroke. TCM, anti-thrombotic therapy and lipid-lowering therapy were related to acute heart failure. TCM, anti-thrombotic therapy, anti-MI therapy and ACEI/ARB use exhibited a strong correlation with re-hospitalization due to cardiovascular disease. CONCLUSION: TCM reduced the prevalence of cardiac death during hospitalization, and cardiac death, a composite endpoint of re-infarction and stroke, acute heart failure and re-hospitalization due to cardiovascular disease during follow-up.

Tonifying Qi and activating blood circulation in terms of Traditional Chinese Medicine: their effects in patients with myocardial infarction.

OBJECTIVE: To investigate the effects of tonifying Qi and activating blood circulation (SQABC), a method in Traditional Chinese Medicine (TCM), on end-point events in patients with myocardial infarction (MI) in this retrospective cohort study. METHODS: Clinical data were obtained from the medical records of patients with acute MI (AMI), both during hospitalization and follow-up, and included general demographic information (age, gender, and contact information), TCM regimens used, and end-point events. RESULTS: A total of 1596 patients with AMI were enrolled to this study, but data of only 1210 cases are accessible till follow-up. We classified the patients based on the exposure levels of SQABC. When comparing the results between all exposure and non-exposure groups, significant differences were identified, both during hospitalization and follow-ups. During hospitalization, cardiac death (4.40% vs 21.55%, P < 0.05) and cardiac shock (3.04% vs 11.62%, P < 0.05) were significantly lower in the exposure group than the non-exposure group. Similarly, during the follow-up, cardiac death (12.04% vs 20.49%, P < 0.05), acute heart failure (7.27% vs 11.81%, P < 0.05), composite endpoint of reinfarction and stroke (9.11% vs 15.28%, P < 0.05), and rehospitalization due to angina (25.49% vs 34.38%, P < 0.05) were significantly lower in the exposure group than the non-exposure group. CONCLUSION: Our findings suggest that SQABC can significantly benefits the subjects in the management of high-risk AMI in them.

[Analysis on medication rules of modern traditional Chinese medicines in treating palpitations based on traditional Chinese medicine inheritance support system].

To analyze the prescription and medication rules of Chinese medicines in the treatment of palpitations in the Chinese journal full text database(CNKI) by using traditional Chinese medicine inheritance system, and provide a reference for further research and development of modern traditional Chinese medicines(TCMs) in treatment of palpitations. In order to give better guidance for clinical mediation, prescriptions used for treatment of palpitations in CNKI were collected, and then were input to the TCM inheritance support system for establishing a Chinese medicine prescription database for palpitations. The software's revised mutual information, complex system entropy clustering and other data mining methods were adopted to analyze the prescriptions according to the frequencies of herbs, "four natures", "five flavors" and "meridians" of the high-frequency medicines in the database, identify the core herbs and application characteristics, and analyze the prescription rules and medication experience. Totally, 545 prescriptions used for palpitation were included in this study and involved 247 Chinese herbs. The analysis results showed that the herbs in prescriptions for palpitation mostly had the warm property, and the herbs in heart and spleen meridian accounted for a larger proportion, indicating that the treatment was mainly to nourish heart and strengthen spleen. The top 11 herbs in usage frequency were consistent with the high-frequency medicines in medication patterns of common herbal pairs; therefore, we considered that these 11 herbs were the core herbs; the core herbal combination included Cassia Twig, Licorice, fossil fragments, Ostreae decoction, and evolved into 9 new prescriptions for treating palpitation. Our results objectively presented the prescription and medication rules for treating palpitation and provided extremely effective guidance for the clinical therapy.

Qi-Shen-Yi-Qi Dripping Pills Promote Angiogenesis of Ischemic Cardiac Microvascular Endothelial Cells by Regulating MicroRNA-223-3p Expression.

Traditional Chinese medicine (TCM) research shows that Qi-Shen-Yi-Qi Dripping Pills (QSYQ) can promote ischemic cardiac angiogenesis. Studies have shown that microRNAs (miRNAs) are the key component of gene regulation networks, which play a vital role in angiogenesis and cardiovascular disease. Mechanisms involving miRNA by which TCM promotes ischemic cardiac angiogenesis have not been reported. We found that microRNA-223-3p (mir-223-3p) was the core miRNA of angiogenesis of rats ischemic cardiac microvascular endothelial cells (CMECs) and inhibited angiogenesis by affecting RPS6KB1/HIF-1α signal pathway in previous study. Based on the results, we observed biological characteristics and optimal dosage for QSYQ intervening in rats ischemic CMECs angiogenesis and concluded that QSYQ low-dose group had the strongest ability to promote angiogenesis of ischemic myocardium. Using miRNA chip and real-time PCR techniques in this study, we identified mir-223-3p as the pivotal miRNA in QSYQ that regulated angiogenesis of ischemic CMECs. From real-time PCR and western blot analysis, research showed that gene and protein expression of factors located RPS6KB1/HIF-1α signaling pathway, including HIF-1α, VEGF, MAPK, PI3K, and AKT, were significantly upregulated by QSYQ to regulate angiogenesis of ischemic CMECs. This study showed that QSYQ promote ischemic cardiac angiogenesis by downregulating mir-223-3p expression in rats ischemic CMECs.

Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction: a randomised clinical trial.

Background. Several types of drugs have been recommended for the secondary prevention of myocardial infarction (MI). However, these conventional strategies have several limitations, such as low adherence, high cost, and side effects during long time use. Novel approaches to this problem are still needed. This trial aimed to test the effectiveness and safety of Qi-Shen-Yi-Qi Dripping Pills (QSYQ), a multi-ingredient Chinese patent medicine, for the secondary prevention of MI. Methods and Findings. A total of 3505 eligible patients were randomly assigned to QSYQ group (1746 patients) or aspirin group (1759). Patients took their treatments for 12 months. The final follow-up visit took place 6 months after the end of the trial drugs. The 12-month and 18-month estimated incidences of the primary outcome were 2.98% and 3.67%, respectively, in the QSYQ group. The figures were 2.96% and 3.81% in the aspirin group. No significant difference was identified between the groups. Conclusions. This trial did not show significant difference of primary and secondary outcomes between aspirin and QSYQ in patients who have had an MI. Though inconclusive, the result suggests that QSYQ has similar effects to aspirin in the secondary prevention of MI.

[Effects of rhynchophylla alkaloids on vascular adventitial fibroblast apoptosis and proliferation in the thoracic aorta of spontaneously hypertensive rats].

OBJECTIVE: To study the effects of rhynchophylline, isorhynchophylline, and rhynchophylla alkaloids on the vascular adventitial fibroblasts (VAF) apoptosis and proliferation in thoracic aorta of spontaneously hypertensive rats (SHR), and on the Bcl-2, Bax, c-Fos, c-Myc, laminin (LN), and fibronectin (FN). METHODS: Forty 8-week old male SHR were randomly divided into five groups, i. e., the model group, the captopril group (17.5 mg/kg), the isorhynchophylline group (5.0 mg/kg), the rhynchophylline group (5.0 mg/kg), and the rhynchophylla alkaloids group (50.0 mg/kg), 8 in each group. In addition, eight 8-week old male Wistar rats were selected as the normal group. Equal volume of normal saline was given to rats in the normal group and the model group by gastrogavage. Rats in the rest groups were perfused with isovolumic medication solution (10 mL/kg), six days per week for eight successive weeks. The dosage of drugs was adjusted according to the change of body weight. The VAF apoptosis rate of the thoracic aorta was measured by Annexin V-FITC combined with PI dyeing and flow cytometry. The protein expressions of thoracic aortic Bcl-2, Bax, c-Myc, c-Fos, FN, and LN were detected by immunohistochemical assay. The adventitial transforming growth factor beta1 (TGF-beta1) mRNA expression in the thoracic aorta was detected by in situ hybridization method. RESULTS: Compared with the model group, the tail arterial systolic pressure decreased, the VAF apoptosis and the protein expression of Bax increased, Bcl-2, c-Fos, FN, LN, and TGF-beta1 mRNA all decreased in the thoracic aorta of SHR in each treatment group after 4-and 8-week of intervention. Rhynchophylline, isorhynchophylline, and rhynchophylla alkaloids could inhibit the protein expression of c-Myc with statistical difference (P<0.05, P<0.01). Compared with the captopril group, there was no statistical difference in decreasing the tail arterial systolic pressure, the protein expression of c-Fos and the mRNA expression of TGF-beta1 among the rhynchophylline group, the isorhynchophylline group, and the rhynchophylla alkaloids group (P>0.05). There was statistical difference in increased VAF apoptosis and decreased protein expressions of Bcl-2, c-Myc, and LN (P<0.05, P<0.01). There was statistical difference in increased protein expression of Bax between the rhynchophylline group and the isorhynchophylline group (P<0.05, P<0.01). There was statistical difference in decreased protein expression of FN in the isorhynchophylline group (P<0.05). There was no significant difference among the rhynchophylline group, the isorhynchophylline group, or the rhynchophylla alkaloids group (P>0.05). CONCLUSIONS: Rhynchophylline, isorhynchophylline, and rhynchophylla alkaloids might promote the VAF apoptosis in the thoracic aorta of SHR by regulating the protein expressions of Bcl-2 and Bax. They might inhibit the VAF proliferation by restraining protein expressions of c-Fos, c-Myc, and TGF-beta1 mRNA. They also might improve the thoracic aorta wall reconstruction and decrease the tail arterial systolic pressure by down-regulating the protein expressions of FN and LN, and attenuating the deposition of extracellular matrix.

Influence of environment and substrate quality on the decomposition of wetland plant root in the Sanjiang Plain, Northeast China.

The litterbag method was used to study the decomposition of wetland plant root in three wetlands along a water level gradient in the Sanjiang Plain, Northeast China. These wetlands are Calamagrostis angustifolia (C.aa), Carex meyeriana (C.ma) and Carex lasiocarpa (C.la). The objective of our study is to evaluate the influence of environment and substrate quality on decomposition rates in the three wetlands. Calico material was used as a standard substrate to evaluate environmental influences. Roots native to each wetland were used to evaluate decomposition dynamics and substrate quality influences. Calico mass loss was statistically different among the three wetlands in the upper soil profile (0-10 cm) and in the lower depth range (10-20 cm). Hydrology, temperature and pH all influence calico decomposition rates in different ways at different depths of the soil profiles. The decomposition rates of native roots declined differentially with the increase of depth in the soil profiles. The mass loss of native roots showed a statistical decrease among the three wetlands in the upper soil profile (0-10 cm) and in the lower depth range (10-20 cm) as C.ma wetland > C.aa wetland > C.la wetland. Both the C:P ratio and N:P ratio were positively interrelated with decomposition rates. Decomposition rates were negatively related to initial P concentration in all three wetlands, indicating that P concentration seems to be an important factor controlling the litter loss.

[Application of central randomized system in project of clinical trial for secondary prevention of myocardial infarction by Qishen Yiqi Drop Pill].

Central randomized system (CRS) is actually a management system for actualizing process of clinical trial, which can not only reduce the factitious jamming during randomization to avoid bias, but also play an important role in drug supervision during long-term and large-scale clinical trials in which a large amount of drugs are applied. This article introduced the two main functions of the CRS, i. e. the randomization of testees and the management of drugs, as well as the key points and instructions for applying clinical research interactive voice responding system (CRIVRS) in operating the project of clinical trial for secondary prevention of myocardial infarction by Qishen Yiqi Drop Pill.

[Case recruitment in large-scale clinical trials of traditional Chinese medicine].

Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".

[Key points of protocol design on clinical therapeutic research of traditional Chinese medicine].

Therapeutic effect is the core in clinic medicine. Traditional Chinese medicine (TCM) has certain advantages on clinical efficacy, but is still lack of reliable evidence. With the rapid development of evidence based medicine (EBM), more and more attention is paid on scientific evaluation of clinical efficacy increasingly. To carry out TCM clinical therapeutic research and to scientifically evaluate its efficacy has become a very important task for TCM development. Scientific and precise protocol design is the precondition for progressing the research and obtaining high quality evidences. The article puts stress on how to design the clinical therapeutic program of research on TCM in combining with characteristics of TCM.

[Administration and quality control of large-scale clinical trials of traditional Chinese medicine].

Abstract: Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.