Chronic heart failure (CHF) is a clinical syndrome characterized by dyspnea, edema of both lower extremities and fatigue, and is the end-stage manifestation of cardiovascular disease and the main cause of death.
According to epidemiological reports, the incidence of CHF increases every year, and the mortality rate has increased sharply in recent years, with the case fatality rate reaching 20% within 1 year and as high as 53% within 5 years.
With the growing population of CHF, the research literature on how to reduce cardiovascular adverse events, improve quality of life, and prolong life in CHF patients has also increased year by year.
The 2022 AHA/ACC/HFCA Heart Failure Management Guidelines change the basic drugs of CHF to a "new quadruple" [5], including: renin-angiotensin system inhibitors (eg, sacubitril, valsartan, enalapril, etc.), β blockers (eg, bisoprolol, metoprolol succinate extended-release, etc.), mineralocorticoid receptor antagonists (eg, eplerenone, spironolactone, etc.), sodium-glucose co-transporter 2 inhibitors (recommended when CHF is symptomatic, Regardless of the presence or absence of type 2 diabetes (e.g., dapagliflozin, empagliflozin, etc.).
Traditional medicine classifies chronic heart failure as "wheezing", "heart water" and "edema" according to clinical manifestations.
The "Twelfth Five-Year Plan" textbook of "Internal Medicine of Traditional Chinese Medicine" added "heart failure disease" for the first time, and its pathogenesis is based on the false standard of heart qi and heart yang, and the tangible real and evil obstruction such as blood congestion, water drinking, phlegm turbidity and other tangible and evil obstruction is the target, so the clinical treatment method is to warm yang and invigorate qi, and activate blood and water.
Qianqiang Heart Capsules have the effect of invigorating temperature and yang, activating blood circulation, water and reducing swelling.
Studies have shown that Qianxin capsules contain active ingredients such as astragaloside IV, isoflavone glucoside and manganthocyanin, which can inhibit myocardial fibrosis, improve myocardial energy metabolism, regulate inflammatory response, control blood pressure, etc., and delay the development of CHF.
In this study, meta-analysis was used to collect the RCTs literature of Qianqiang Qiangxin capsules combined with Western medicine and Western medicine alone in the treatment of CHF, and the efficacy of the two was evaluated and compared, so as to provide evidence-based medical evidence that the combination of Qianxin Qiangxin Capsules can improve the quality of life, reduce rehospitalization, and reduce the mortality rate of CHF patients.
The existing RCTs published at home and abroad with Qiangxin capsules for the treatment of CHF were used as research objects.
Computer search for PubMed, Embase, Webofscience, CNKI, Wanfang, Weipu, China Biomedical Literature Database published literature, the time is set from the establishment of the library to 2023, the search adopts a combination of subject words and free words, and adjusts according to the specific database.
English search terms include: Heartfailure, qiliqiangxincapsule, randomizedcontrolledtrial, randomized, etc.; Chinese search terms include: heart failure, heart failure, chronic heart failure, chronic heart failure, chronic cardiac insufficiency, Qianqiang Qiangxin capsules, randomized control, randomized, RCT, etc.
For patients who meet the diagnosis of CHF, the diagnostic criteria refer to the "2022 AHA/ACC/HSSA Heart Failure Management Guidelines" issued by the United States, and the "Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine (2022)" issued by the Cardiovascular Disease Branch of the Mainland Chinese Association of Chinese Medicine in 2023, and include patients with cardiac function grade II.~IV. and left ventricular ejection fraction (LVEF) ≤ 50% according to the New York Heart Association's cardiac function classification (NYHA classification).
The control group was treated with conventional western medicine, and the treatment method was referred to the 2022 AHA/ACC/HHSA heart failure management guidelines.
The treatment group added Qianxin capsules to the conventional western medicine.
Evaluation of the efficacy of cardiac function (obvious: cardiac function increases grade II and above or reaches grade I, and the patient's symptoms basically disappear; Effective: cardiac function improves grade I, and the patient's symptoms are significantly reduced; Ineffective: patients with symptoms, cardiac function without improvement or even deterioration), left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), cardiac stroke volume (SV), 6 min walk test (6MWT), and N-terminal brain natriuretic peptide precursor (NT-proBNP).
- Literature that did not meet RCT requirements.
(2) Literature on experimental design that does not match or experimental design is not rigorous (e.g., in addition to adding Qianxin capsules on the basis of the control group, the treatment group also used other drugs or means to intervene; The general description of the sample is not clear, etc.).
(3) Duplicate publications or data with duplicates, systematic reviews, animal experiments, conferences and other literature.
(4) Literature with inconsistent efficacy indicators.
(5) Patients with acute heart failure and acute onset of chronic heart failure, acute myocardial infarction, cor pulmonale, hypertrophic cardiomyopathy, congenital heart disease, as well as patients with atrial fibrillation, sick sinus node syndrome, high atrioventricular block, diabetes, and severe liver and kidney dysfunction.
(6) Literature with less than 4 weeks of treatment and a sample size of less than 120 cases.
Two researchers independently screen and extract, exchange and check the extracted data after completion, and if there is any disagreement, ask a third researcher to discuss and make a decision.
The first step is to search the Chinese and English databases, download the documents that meet the requirements, import all the documents into NoteExpress to check the duplicates and remove the duplicate parts.
The second step is to read the title and abstract of the article for preliminary exclusion.
In the third step, the preliminary screening literature was read in full, and the literature with incomplete data and experimental design was eliminated and the reasons for the exclusion were recorded.
The fourth step is to extract the final included literature with Excel2010, including the name of the first author, the time of publication, the number of patients, interventions, treatment course, efficacy indicators and other information.
The quality of the final included studies was assessed using the RCT bias assessment tool recommended by CochraneHandbook 5.1.0.
The main aspects of the review were: method of randomization, concealment of allocation, blinding of participants, blinding of study results, data integrity, selective reporting, and other biases.
The quality of the literature was rated as "low risk of bias", "high risk of bias" and "unclear quality".
RevMan 5.4 and Stata17.0 software were used for analysis, the counting data were expressed using odds ratio (OR) and 95% confidence interval (95% CI), and the metric data were analyzed using weighted mean difference (WMD) and its 95% CI.
The Q test and I2 test were used to judge the heterogeneity of the included studies, and the fixed-effect model was used for analysis when I2 ≤50% and P>0.1, and vice versa.
When P<0.05 was statistically significant.
A total of 2920 relevant articles were obtained through preliminary computer search, and a total of 20 RCTs were finally included through screening, all of which were Chinese articles.
Finally, a total of 20 RCTs were included, including 2953 patients, including 1508 in the treatment group and 1445 in the control group.
| Included studies | Sample size/example | NYHA grading | LVEF | Course | Treatment group medication | Control group medication | Efficacy indicators |
| T/C | |||||||
| Li Xin 2022 | 61/61 | Class II.~IV | Not indicated | 4 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ②④⑥ |
| Li Gaoyu 2021 | 60/60 | Grade II.~III | Not indicated | 4 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ②③⑤ |
| Li Chongyao 2020 | 60/60 | Class II.~IV | Not indicated | 1 month | Control group + Qianxin capsule | Conventional Western medicine treatment | ② |
| Lee Sun-kyung 2020 | 92/92 | Class II.~IV | Not indicated | 1 month | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③④ |
| Tang Yong 2020 | 100/100 | Class II.~IV | ≤50% | 12 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ②③⑥ |
| Qin Mingming, 2020 | 100/100 | Class II.~IV | Not indicated | 3 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ②③⑥ |
| Yang Dongmei 2019 | 100/100 | Grade III.~IV | ≤50% | 6 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ②⑤ |
| Ren Hongjie, 2019 | 60/60 | Class II.~IV | ≤40% | 12 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②⑥ |
| Chen Miao, 2018 | 85/85 | Class II.~IV | Not indicated | 3 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③⑥ |
| Qiao Defeng 2018 | 61/61 | Grade III.~IV | Not indicated | 3 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③ |
| Yin Xiaoqian 2017 | 63/62 | Class II.~IV | Not indicated | 2 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②④⑥ |
| King Flower 2017 | 63/62 | Class II.~IV | Not indicated | 6 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③⑥ |
| Cheng Wenjun, 2016 | 88/84 | Class II.~IV | Not indicated | 12 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③⑥ |
| Li Zheng 2015 | 116/80 | Class II.~IV | ≤40% | 8 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③⑤⑥ |
| Sun Panli, 2014 | 60/60 | Class II.~IV | Not indicated | 8 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ②③⑥ |
| Wu Shuangping, 2014 | 70/60 | Grade II.~III | ≤40% | 4 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③⑥ |
| Li Tao, 2014 | 60/60 | Grade II.~III | Not indicated | 4 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②③ |
| Li Qiang, 2014 | 60/60 | Class II.~IV | ≤50% | 6 months | Control group + Qianxin capsule | Conventional Western medicine treatment | ②③⑤⑥ |
| Gao Jianbu 2011 | 89/78 | Grade II.~III | ≤40% | 4 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ②⑤⑥ |
| Li Guimin 2011 | 60/60 | Class II.~IV | Not indicated | 4 weeks | Control group + Qianxin capsule | Conventional Western medicine treatment | ①②④⑥ |
T: treatment group; C: control group; Efficacy indicators: (1) evaluation of cardiac function; ②LVEF； ③LVEDD； ④SV； ⑤6MWT； (6) NT-proBNP or BNP
Cochrane Handbook 5.1.0 was used for included RCTs, of which seven were not at any high risk.
In the random allocation scheme, 6 articles were allocated using the random number table method, 1 literature was randomly allocated according to the order of presentation, and the rest only mentioned the word "random" and did not describe the allocation method.
In terms of allocation concealment, one article gave the control group a control capsule with the same appearance as Qianxin capsules in the experiment.
In terms of completeness of the outcome data, one study reported that one case withdrew midway due to traumatic surgery during the study, and the rest of the literature did not fall out during the study.
After heterogeneity testing, I2=0%<50%, and Q test P=0.946>0.1, indicating that there was no heterogeneity between these 11 documents (heterogeneity was not statistically significant), so fixed-effect combined effect sizes were selected.
Results: There was a significant difference in efficacy evaluation between the two groups (OR=2.09, 95%CI: 1.71~2.55, P<0.001), suggesting that the efficacy of conventional Western medicine combined with Qianqiang Xin capsules in the treatment of CHF was significantly better than that of Western medicine alone.
| Author and year | Constituencies | Number of examples | Effect/example | Valid/Example | Invalid/Example |
| Lee Sun-kyung 2020 Ren Hongjie, 2019 Chen Miao, 2018 Qiao Defeng 2018 Yin Xiaoqian 2017 King Flower 2017 Cheng Wenjun, 2016 Li Zheng 2015 Wu Shuangping, 2014 Li Tao, 2014 Li Guimin 2011 | Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group Treatment group Control group | 92 92 60 60 85 85 61 61 63 62 63 62 88 84 116 80 60 60 60 60 60 60 | 59 50 25 19 26 19 22 16 45 33 29 20 28 18 22 11 32 10 36 26 39 32 | 20 16 31 26 48 40 33 31 13 14 27 25 49 39 85 56 30 36 20 16 16 15 | 13 26 4 15 10 26 6 12 5 15 7 17 11 27 7 10 8 14 4 18 4 9 |
A total of 20 studies reported LVEF, and after heterogeneity testing, the heterogeneity between studies was significant (P<0.1, I2=94%), and there was no significant reduction in heterogeneity after sensitivity analysis, so a random-effects model was used for meta-analysis.
The results showed that the LVEF of patients in the treatment group could be significantly improved, and the difference compared with the control group was statistically significant (WMD=7.05, 95%CI: 5.30~8.79, P<0.00001), suggesting that the combination of Qianqiang Qiangxin Capsules on the basis of conventional Western medicine treatment can effectively improve the cardiac function of CHF patients, and its effect is better than that of Western medicine alone.
A total of 13 studies reported LVEDD, with a total of 1979 cases, after heterogeneity testing, the heterogeneity between studies was significant (P<0.1, I2=87%), and after sensitivity analysis, none of the literature had a significant effect on heterogeneity, so a random-effects model was used for meta-analysis.