The add-on effect of Shufeng Jiedu capsule for treating COVID-19: A systematic review and meta-analysis.

Introduction: Shufeng Jiedu capsule (SFJD) is a commonly used Chinese patent medicine in China. Some studies have reported that SFJD has therapeutic effects in patients diagnosed with COVID-19. This systematic review aimed to critically evaluate the efficacy and safety of SFJD combined with western medicine (WM) for treating COVID-19. Methods: A literature search by using WHO COVID-19 database, PubMed, Embase, Cochrane Library, the Web of Science, CKNI, Wanfang, VIP, SinoMed, and clinical trial registries was conducted, up to 1 August 2022. Randomized controlled trials (RCTs), non-RCTs, cohort studies and case series of SFJD combined with WM for COVID-19 were included. Literature screening, data extraction, and quality assessment were performed independently by two reviewers in line with the same criteria. We used the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the certainty of evidence. Meta-analyses were performed with Revman 5.3 if possible. The descriptive analysis was conducted when the studies could not be meta-analyzed. Results: Totally 10 studies with 1,083 patients were included. Their methodological quality were moderate. The results demonstrated that compared to WM group, SFJD + WM group remarkably increased the nucleic acid negative conversion rate (RR = 1.40, 95%CI: 1.07-1.84), total effective rate (RR = 1.18, 95%CI: 1.07-1.31), cure rate (RR = 4.06, 95%CI: 2.19-7.53), and the chest CT improvement rate (RR = 1.19, 95%CI: 1.08-1.31), shorten nucleic acid negative conversion time (MD = -0.70, 95%CI: -1.14 to -0.26), reduced the clinical symptom disappearance time (fever, diarrhea, cough, fatigue, pharyngalgia, nasal congestion, and rhinorrhea), as well as improved the levels of laboratory outcomes (CRP, IL-6, Lym, and Neu). Additionally, the incidence of adverse reactions did not exhibit any statistically significant difference between SFJD + WM group and WM group. Conclusion: SFJD combined with WM seems more effective than WM alone for the treatment of COVID-19. However, more well-designed RCTs still are warranted. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022306307].

Development of a core outcome set on Traditional Chinese Medicine and Western Medicine for rheumatic heart disease: a study protocol.

INTRODUCTION: Globally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine are gradually increasing in China. However, because the outcomes of clinical trials are subject to heterogeneity and selective reporting, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, and diminishing the value of clinical trials. Therefore, there is an urgent need to design a TCM or integrated medicine core outcome set (COS) for RHD. METHODS AND ANALYSIS: The development of this study will take place in four stages under the direction of a multidisciplinary advisory board. (1) Establishing a comprehensive outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centres, patient's semistructured interviews, and clinician's questionnaire surveys; (2) Screen stakeholder groups from various fields to participate in the Delphi survey; (3) Two e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4) Hold a face-to-face consensus meeting to develop the COS-TCM-RHD. ETHICS AND DISSEMINATION: The ethical approval for this study has been obtained from the Tianjin University of Traditional Chinese Medicine Ethics Committee (TJUTCM-EC20210008). The findings will be disseminated in peer-reviewed journals and meetings. TRIAL REGISTRATION NUMBER: This study has been registered at the Core Outcome Measures in Effectiveness Trials (COMET) database (Registration #1743).

[Clinical trials and evaluation of Chinese patent medicine for influenza].

The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.

[Network Meta-analysis of efficacy and safety of oral Chinese patent medicines combined with conventional western medicine in treatment of hypertension].

This study aims to systematically evaluate the effect of oral Chinese patent medicines on hypertension with network Meta-analysis. Randomized controlled trials on the treatment of hypertension with oral Chinese patent medicine combined with conventional western medicine were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library(from establishment of the database to August 2021). Two researchers independently screened the articles, extracted the data, and evaluated article quality. Then R 4.1.0 was employed for data analysis. Finally, 195 eligible articles were screened out, involving 22 546 patients and 18 oral Chinese patent medicines. The results of the network Meta-analysis are as follows. In terms of reducing systolic blood pressure(SBP) and diastolic blood pressure(DBP), Xuesaitong, Qiangli Dingxuan Tablets, Songling Xuemaikang Capsules combined with conventional western medicine are superior. In improving blood lipids, the overall effects of Xinmaitong Capsules, Compound Xueshuantong Capsules, Ginkgo Folium preparations, Yindan Xinnaotong Soft Capsules, and Naoxintong Capsules combined with conventional western medicine are outstanding. In terms of regulating endothelial function, Yindan Xinnaotong Soft Capsules, Xinmaitong Capsules, Zhenju Jiangya Tablets, Compound Danshen Dripping Pills, Xuesaitong with conventional western medicine have certain advantages. As for the safety, the incidence of adverse reactions of conventional western medicine combined with oral Chinese patent medicines is lower than that of conventional western medicine alone. In summary, compared with conventional western medicine alone, the 18 oral Chinese patent medicines combined with conventional western medicine in the treatment of hypertension show advantages in improving blood pressure, blood lipids, and endothelial function. Among them, Xuesaitong, Qiangli Dingxuan Tablets, and Songling Xuemaikang Capsules may be the best oral Chinese patent medicines for lowering blood pressure. The conclusion needs to be further verified by more high-quality studies.

[Analysis of outcome indexes in randomized controlled trials of traditional Chinese medicine for rheumatic heart disease].

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of " surro-gate indexes", insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.

Chinese Medical Injections for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Network Meta-analysis.

BACKGROUND: The World Health Organization has indicated that chronic obstructive pulmonary disease (COPD) may become the third leading cause of death by 2030. Acute exacerbation of COPD (AECOPD) is an important process in clinical treatment. Recent studies have shown that Chinese medical injections (CMI) are effective against AECOPD, but the effective difference among different CMIs remains unclear. The aim of this network meta-analysis (NMA) is to compare the therapeutic effect of various CMIs. METHODS: We conducted an overall, systematic literature search in the China National Knowledge Infrastructure, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, and Web of Science databases to retrieve randomized controlled trials (RCTs) of CMIs for AECOPD published up to January 2021. The Cochrane risk of bias tool was used to assess the risk of bias. Stata 13.1 and WinBUGS 14.3 were used for data analyses. RESULTS: In total, 103 RCTs involving 8767 participants and 23 CMIs were included. The results indicated that among all treatments conventional Western medical therapy (WM) plus Dengzhanxixin injection (DZXX) led to the best improvement in the clinical efficacy and the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) (FEV1/FVC), with surface under the cumulative ranking curve (SUCRA)=80.47% and 98.55%, respectively. Moreover, Shenmai injection (SM) plus WM and Reduning injection (RDN) plus WM led to the best improvement in the FEV1 (SUCRA=80.18%) and the ratio of forced expiratory volume in one second to the predicted value (FEV1%, SUCRA=87.28%). Shengmai injection (SGM) plus WM led to the most considerable shortening in the length of hospital stay (SUCRA=94.70%). Cluster analysis revealed that WM+DZXX had the most favorable response for clinical efficacy and FEV1, as well as clinical efficacy and FEV1/FVC, WM+RDN had the most favorable response for clinical efficacy and FEV1%, WM+SGM had the most favorable response for clinical efficacy and length of hospital stay. CONCLUSION: WM+DZXX, WM+RDN, and WM+SGM were noted to be the optimum treatment regimens for improving in clinical efficacy, FEV1, FEV1/FVC, FEV1% and reducing the hospital stay length of AECOPD patients. Considering the limitations this NMA may have, the current results warrant further verification via additional high-quality studies.