Efficacy and Safety of Jinshuibao Capsule in Diabetic Nephropathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Objective: This systematic review was able to evaluate the clinical evidence of JSBC in the randomized controlled trial (RCT) of diabetic nephropathy. Methods: The Chinese and English literatures published in PubMed, Cochrane Library, VIP, Wanfang Data, CNKI, and CBM before July 30, 2019, were retrieved. This study includes only randomized controlled trials of treatments related to diabetic nephropathy. We assessed the methodological quality of the subjects involved according to the assessment criteria in 5.3.3 of the Cochrane Assessment Manual. RevMan 3.5.5 software was used to analyze the relevant data, meta-analysis, and inverted funnel analysis chart. Results: This study included 26 RCTs, including 4676 patients in total (2342 cases in the experimental group and 2334 cases in the control group). The results of 8 randomized controlled trials showed that urinary microprotein excretion rate (UAER) significantly decreased (P < 0.0001) before and after treatment of diabetic nephropathy. Conclusion: The available clinical evidence has suggested that JSBC combined with western drugs is differentially effective in the treatment of diabetic nephropathy. The combination of JSBC with western medicine is more effective. However, due to the small amount and low quality of the included literatures, the current evidence is not certain to be fully clinically applicable.

Comparison of the Efficacy of Danhong Injections at Different Time-points During the Perioperative Period of Acute Myocardial Infarction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Objectives: Danhong injections (DHI) are widely used in the treatment of acute myocardial infarction (AMI). As there are no guidelines for the timing of DHI in the peri-percutaneous coronary intervention (PCI) period for AMI, we investigated the effects of DHI timing. Methods: We reviewed reports published before September 30, 2020 in PubMed, embase, the Cochrane Central Register of Controlled Trials, the Chinese BioMedical database, Chinese VIP database, Wanfang database, and Chinese National Knowledge Infrastructure database. Only randomized controlled trials of DHI with percutaneous coronary intervention for AMI were included. Methodological quality was assessed using the Cochrane evaluation manual 5.3.3 criteria. A meta-analysis was performed, and forest plots were drawn. Results: We included 23 studies which all revealed that patients in DHI groups had better efficacy than control groups. Subgroup analysis revealed that DHI administered intraoperatively and continued postoperatively was more effective in increasing left ventricular ejection fraction when compared to other time-points (p < 0.001). The pre- and intraoperative use of DHI could improve reflow more effectively than conventional treatment, while the effect was not significant in the postoperative intervention study (p = 0.654). The 16 postoperative interventions revealed that the effect of DHI at 14 days was better than that at 7 and 10 days for hs-CRP (p = 0.013), the 10-days treatment produced better results for CK-MB than for the other treatments (p < 0.001) and a dosage of 30 ml proved most effective for IL-6 (p < 0.001). Conclusion: DHI proved to be superior to conventional Western medicine in reducing the incidence of adverse cardiac events, promoting reperfusion, improving cardiac function, reducing inflammatory factors, and protecting the myocardium. DHI should be administered early in the perioperative period and continued postoperatively because of its ability to improve cardiac function. Furthermore, in the PCI postoperative, 30 ml is recommended to inhibit IL-6 levels, for patients with high hs-CRP, a course of 14 days is most effective, for patients with obvious abnormalities of CK-MB, a 10-days course of treatment is recommended. However, due to the limited number and quality of the original randomized controlled trials, our conclusions need large, multi-centre RCTs to validation.

Yiqi Fumai Injection as an Adjuvant Therapy in Treating Chronic Heart Failure: A Meta-Analysis of 33 Randomized Controlled Trials.

BACKGROUND: Yiqi Fumai injection (YQFM) is a traditional Chinese medicine widely used for cardiovascular diseases in China. This systematic review aimed to evaluate whether YQFM could be an effective and safe complementary therapy for chronic heart failure (CHF). METHODS: Eight electronic literature databases were searched up to March 31, 2020. Randomized controlled trials (RCTs) comparing YQFM + conventional treatment with conventional treatment alone for CHF were included. The primary outcome was response to treatment, which was graded by improvements in heart function based on the New York Heart Association (NYHA) criteria, while the secondary outcomes included the left ventricular ejection fraction (LVEF), cardiac output, left ventricular end-systolic diameter (LVESD), amino-terminal pro-brain natriuretic peptide (NT-proBNP), 6-minute walk test performance (6MWT), quality of life (QoL) as assessed by the Minnesota Living with Heart Failure questionnaire, and adverse reactions. Data from individual RCTs were pooled by a random-effects meta-analysis with effect measures of proportional odds ratios (pORs) and 95% confidence intervals (95% CIs) for the ordinal outcomes and the mean difference (MD) and 95% CI for the continuous outcomes. RESULTS: In total, 33 RCTs involving 3070 patients with an overall moderate-to-high risk of bias were selected. The meta-analysis showed that compared with conventional treatment alone, YQFM plus conventional treatment had a significantly higher likelihood of improving the response to treatment (pOR 1.88, 95% CI 1.47 to 2.42, I 2 = 0%). YQFM also significantly improved the LVEF (MD 5.53%, 95% CI 4.73 to 6.33, I 2 = 82%), cardiac output (MD 0.32 L/min, 95% CI 0.19 to 0.45, I 2 = 47%), and LVESD (MD -3.73 mm, 95% CI -5.51 to -1.95, I 2 = 22%), reduced the NT-proBNP levels (MD -341.83 pg/mL, 95% CI -417.89 to -265.77, I 2 = 88%), and improved the 6MWT (MD 61.86 m, 95% CI 45.05 to 78.67, I 2 = 64%) and QoL (MD -9.82, 95% CI -14.17 to -5.46, I 2 = 81%). No serious adverse events related to YQFM were reported. CONCLUSION: Although limited by a moderate-to-high risk of bias, the current evidence suggests that YQFM as a complementary treatment significantly improves heart function and related indicators in patients with CHF. The clinical use of YQFM needs careful safety monitoring. Well-designed studies are still required to further evaluate the efficacy and safety of YQFM for CHF.

China's practice to prevent and control COVID-19 in the context of large population movement.

BACKGROUND: The emerging infectious disease, coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), poses a serious threat in China and worldwide. Challenged by this serious situation, China has taken many measures to contain its transmission. This study aims to systematically review and record these special and effective practices, in hope of benefiting for fighting against the ongoing worldwide pandemic. METHODS: The measures taken by the governments was tracked and sorted on a daily basis from the websites of governmental authorities (e.g. National Health Commission of the People's Republic of China). And the measures were reviewed and summarized by categorizations, figures and tables, showing an ever-changing process of combating with an emerging infectious disease. The population shift levels, daily local new diagnosed cases, daily mortality and daily local new cured cases were used for measuring the effect of the measures. RESULTS: The practices could be categorized into active case surveillance, rapid case diagnosis and management, strict follow-up and quarantine of persons with close contacts, and issuance of guidance to help the public understand and adhere to control measures, plus prompt and effective high-level policy decision, complete activation of the public health system, and full involvement of the society. Along with the measures, the population shift levels, daily local new diagnosed cases, and mortality were decreased, and the daily local new cured cases were increased in China. CONCLUSIONS: China's practices are effective in controlling transmission of SARS-CoV-2. Considering newly occurred situations (e.g. imported cases, work resumption), the control measures may be adjusted.

Acupuncture and related techniques for obesity and cardiovascular risk factors: a systematic review and meta-regression analysis.

OBJECTIVE: To assess how acupuncture and related techniques affect weight-related indicators and cardiovascular risk factors compared with non-acupuncture interventions in overweight and obese patients. METHODS: We searched PubMed, Embase and CENTRAL up to 19 April 2018 and included relevant randomised controlled trials (RCTs). Weighted mean differences (WMDs) and 95% confidence intervals (CI) were pooled using the inverse variance method with random-effects model. Prespecified hypotheses were tested in meta-regression to investigate the source of heterogeneity. Statistical software packages used were RevMan 5.3.5 and Stata 14.0. RESULTS: Thirty-three RCTs were included (n=2503 patients). Compared with non-acupuncture interventions, acupuncture produced a greater reduction in body weight (WMD -1.76 kg, 95% CI -2.22 to -1.30, I2=77%; moderate quality), body mass index (WMD -1.13 kg/m2, 95% CI -1.38 to -0.88, I2=85%; low quality) and waist circumference (WMD -2.42 cm, 95% CI -3.22 to -1.62, I2=75%; moderate quality). Acupuncture plus lifestyle intervention resulted in a greater reduction in body weight than acupuncture alone (MD -1.94 kg, 95% CI -3.17 to -0.70). Acupuncture also led to a greater reduction in total cholesterol (WMD -12.87 mg/dL, 95% CI -22.17 to -3.57, I2=87%; very low quality) and low-density lipoprotein cholesterol (WMD -13.52 mg/dL, 95% CI -21.47 to -5.58, I2=74%; low quality). The differences were not statistically significant for blood glucose or blood pressure. CONCLUSION: In the short term, acupuncture and related techniques may produce a small but statistically significant degree of weight loss based on moderate- to low-quality evidence, and improve serum lipid parameters based on low- to very-low-quality evidence. Their effects on blood glucose and blood pressure remain uncertain.

Efficacy and safety of Hou Gu Mi Xi for peptic ulcer diseases: Study protocol for a randomized controlled trial.

BACKGROUND: Peptic ulcer disease (PUD) is a major burden worldwide. Several challenges remain with standard Western treatment of PUD, such as persistent weakness, fatigue, and relapse. A dietary traditional Chinese medicine (TCM) formula, Hou Gu Mi Xi (HGMX), has been developed as a complementary treatment for PUD. AIMS: This multicenter, double-blind, randomized controlled trial will assess efficacy and safety of HGMX in patients with PUD. METHODS: Three hundred sixty eligible patients will be assigned to receive HGMX, placebo, HGMX + rabeprazole or placebo + rabeprazole for 4 weeks after 2 weeks of standard Western treatment. This first step, with a 2 × 2 factorial design, will focus on assessing the main and interaction effects of HGMX and rabeprazole on ulcer healing. Then, rabeprazole will be stopped, and HGMX will be continued for up to 1 year. The second step, with a placebo-controlled design, will compare the long-term effects of HGMX and placebo. Extended follow-up with no treatment will continue for up to 2 years. Independent and paired t tests, Pearson χ test and the rank-sum test will be used to compare between-group differences. The P value will be adjusted using the O'Brien & Fleming method for multiple comparisons. EXPECTED OUTCOMES: The primary outcomes are total efficacy rate of PUD treatment, quality of ulcer healing, and changes in spleen qi deficiency symptoms. The secondary outcomes include ulcer area, PUD recurrence, Helicobacter pylori eradication rate, gastric function, body weight, and body mass index. Adverse events (AEs), severe AEs, treatment-related AEs, and withdrawal owing to AEs will be recorded to assess treatment safety. DISCUSSION: The trial results will provide high-quality evidence for HGMX, as a complementary therapy, for the long-term management of PUD and will be valuable for the development of related guidelines and regulations. TRIAL REGISTRATION: The protocol of this trial was approved in all research hospitals and was registered in ClinicalTrials.gov at October 25, 2017(No. NCT03320538).

Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This study aims to evaluate the efficacy and safety of HGMX in patients with SQD who have undergone radical gastrectomy for gastric cancer. METHODS AND DESIGN: This study is a multicenter, randomized, double-blind, placebo-controlled trial. One hundred thirty patients with SQD who have undergone radical gastrectomy for gastric cancer will be assigned to receive either HGMX or placebo for 2 years. The main outcome will be changes in SQD symptoms assessed by the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale. The secondary outcomes will be changes in quality of life assessed by the Short Form 36 scale, performance status as assessed by the Eastern Cooperative Oncology Group Performance Status scale, body weight, and body mass index. Progression-free survival will also be assessed as a secondary outcome. Adverse events (AEs), severe AEs, and study withdrawal due to AEs will be recorded to evaluate the safety of HGMX. DISCUSSION: The results of this trial will provide initial evidence for the use of HGMX as an alternative and complementary intervention to manage chronic postoperative complications in patients who have undergone radical gastrectomy for gastric cancer. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03025152 . Registered on 17 January 2017.

Efficacy and safety of moxibustion in patients with chronic prostatitis/chronic pelvic pain syndrome: A systematic review protocol.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common urogenital disease. Moxibustion is a complementary treatment option for CP/CPPS. This systematic review will assess the efficacy and safety of moxibustion as a sole or add-on therapy for CP/CPPS. METHODS: We will retrieve randomized controlled trials (RCTs) of moxibustion for CP/CPPS from the following databases: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, VIP, Chinese Biomedical Database, China National Knowledge Infrastructure Database, Wanfang Data, Chinese Medicine Database System, Google Scholar, Clinicaltrials.gov, and China Clinical Trial Registry from their inception to March 9, 2019, without language restrictions. RCTs comparing moxibustion with active drugs or moxibustion + drugs with these same drugs alone will be included. Primary outcomes will be the change in the total score of the National Institutes of Health's Chronic Prostatic Inflammatory States Index (NIH-CPSI) after moxibustion treatment. Secondary outcomes will include the scores of the individual NIH-CPSI domains, response to treatment of CP/CPPS, leucocyte and phosphatidylcholine corpuscle count in prostatic fluid, incidence of adverse events (AEs), and incidence of moxibustion-related AEs. The Cochrane risk of bias tool will be used for evaluating the risk of bias of individual trials. Heterogeneity will be detected by the Cochran Q test and I-square test. A random-effects model will be used to pool data in the meta-analysis. Risk ratio and weighted or standardized mean difference will be used as the effect measures. Three sets of subgroup analyses will be performed to explore the sources of heterogeneity. Where appropriate, we will assess the likelihood of publication bias based on funnel plots and quantitative tests. RESULTS: This study will produce the systematic review evidence regarding moxibustion for treating CP/CPPS based on current RCTs. CONCLUSION: This study will provide a clear basis for understanding the efficacy and adverse reactions of moxibustion treatment for CP/CPPS. PROSPERO REGISTRATION NUMBER: CRD42019121338.

Acupuncture and related techniques for type 2 diabetes mellitus: A systematic review protocol.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major global health problem. As a complementary treatment, acupuncture and related techniques are widely used to treat metabolic and endocrine diseases, but their efficacy and safety for T2DM are yet to be established. This systematic review will qualitatively and quantitatively summarize the current randomized controlled trial (RCT) evidence regarding the efficacy and safety of acupuncture and related techniques in patients with T2DM. METHODS: Comprehensive literature searches will be performed on PubMed, Embase, Cochrane Central Register of Controlled Trials, and a trial registry "ClinicalTrials.gov" from inception to December 3, 2018. We will include RCTs for patients with T2DM that compared acupuncture with placebo, antidiabetic drugs, lifestyle interventions, or the combination. Primary outcomes are fasting blood glucose and hemoglobin A1c. Secondary outcomes include 2-hour blood glucose, fasting insulin, homeostatic model assessment for insulin resistance, incidence of diabetic complications, and acupuncture-related adverse events. The risk of bias of the RCTs included in the review will be examined using a revised Cochrane handbook tool. Heterogeneity will be detected using Cochran Q test and I statistics. With the use of random effects model, we will perform meta-analyses to pool results of RCTs. The effect measures will be weighted or standardized mean difference with 95% confidence intervals (CIs) for the continuous outcomes and risk ratio with 95% CIs for the dichotomous outcomes. Subgroup analyses and meta-regression with predefined effect modifiers will be performed to explore the sources of heterogeneity. Where appropriate, we will assess the possibility of reporting bias based on funnel plots and quantitative detection. We will appraise the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation system for each outcome. RESULTS: This study will provide accurate results and balanced inferences on the efficacy and safety of acupuncture and related techniques on T2DM. CONCLUSION: This well-designed systematic review will establish high-quality evidence of the efficacy and safety of acupuncture and related techniques for T2DM to facilitate the clinical practice and guideline development. PROSPERO REGISTRATION NUMBER: CRD42018115639.

Effects of Gua Sha therapy on perimenopausal syndrome: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: In East Asia, Gua Sha therapy is widely used in patients with perimenopausal syndrome. The goal of this systematic review was to evaluate the available evidence from randomized controlled trials (RCTs) of Gua Sha therapy for the treatment of patients with perimenopausal syndrome. METHODS: Databases searched from inception until June 2017 included: PubMed, Embase, the Cochrane Central Register of Controlled Trials and four Chinese databases [WanFang Med Database, Chinese BioMedical Database, Chinese WeiPu Database, and the China National Knowledge Infrastructure (CNKI)]. Only the RCTs related to the effects of Gua Sha therapy on perimenopausal syndrome were included in this systematic review. A quantitative analysis of RCTs was employed using RevMan 5.3 software. Study selection, data extraction, and validation were performed by two independent reviewers. Cochrane criteria for risk-of-bias were used to evaluate the methodological quality of the trials. RESULTS: A total of 6 RCTs met the inclusion criteria, and most were of low methodological quality. When compared with Western medicine therapy alone, meta-analysis of 5 RCTs indicated favorable statistically significant effects of Gua Sha therapy plus Western medicine on the Kupperman Menopausal Index (KMI) Score [mean difference (MD) = -4.57, 95% confidence interval (CI) (-5.37, -3.77), p < 0.01; heterogeneity: Chi2 = 29.57 p < 0.01, I2 = 86%]. Moreover, study participants who received Gua Sha therapy plus Western medicine therapy showed significantly greater improvements in serum levels of follicle-stimulating hormone (FSH) [MD = -5.00, 95% CI (-9.60, -0.40), p = 0.03], luteinizing hormone (LH) [MD = -4.00, 95% CI (-7.67, -0.33), p = 0.03], and E2 [MD = -6.60, 95% CI (-12.32, -0.88), p = 0.02] compared to participants in the Western medicine therapy group, with a low heterogeneity (Chi2 = 0.12, p = 0.94, I2 = 0% in FSH; Chi2 = 0.19 p = 0.91, I2 = 0% in LH; Chi2 = 0.93, p = 0.63, I2 = 0% in E2). In addition, the pooled results displayed favorable significant effects of Gua Sha therapy plus the Western medicine therapy on the MENQOL scale when compared with the Western medicine therapy alone [MD = -5.13, 95% CI (-7.45, -2.81), p < 0.01] with low heterogeneity (Chi2 = 0.66, p = 0.42, I2 = 0%). CONCLUSION: Preliminary evidence supported the hypothesis that Gua Sha therapy effectively improved the treatment efficacy in patients with perimenopausal syndrome. Additional studies will be required to elucidate optimal frequency and dosage of Gua Sha.

Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial.

BACKGROUND: There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases. Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs. OBJECTIVES: To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs. METHODS/DESIGN: This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years. All qualified subjects with NOGDs and SQD will be included. The study population will be divided into the HGMX and placebo groups. To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings. The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs. DISCUSSION: This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases. This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas. ETHICS: The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042).

Early outcome of early-goal directed therapy for patients with sepsis or septic shock: a systematic review and meta-analysis of randomized controlled trials.

Various trials and meta-analyses have reported conflicting results concerning the application of early goal-directed therapy (EGDT) for sepsis and septic shock. The aim of this study was to update the evidence by performing a systematic review and meta-analysis. Multiple databases were searched from initial through August, 2016 for randomized controlled trials (RCTs) which investigated the associations between the use of EGDT and mortality in patients with sepsis or septic shock. Meta-analysis was performed using random-effects model and heterogeneity was examined through subgroup analyses. The primary outcome of interest was patient all-cause mortality including hospital or ICU mortality. Seventeen RCTs including 6207 participants with 3234 in the EGDT group and 2973 in the control group were eligible for this study. Meta-analysis showed that EGDT did not significantly reduce hospital or intensive care unit (ICU) mortality (relative risk [RR] 0.89, 95% CI 0.78 to 1.02) compared with control group for patients with sepsis or septic shock. The findings of subgroup analyses stratified by study region, number of research center, year of enrollment, clinical setting, sample size, timing of EGDT almost remained constant with that of the primary analysis. Our findings provide evidence that EGDT offers neutral survival effects for patients with sepsis or septic shock. Further meta-analyses based on larger well-designed RCTs or individual patient data meta-analysis are required to explore the survival benefits of EDGT in patients with sepsis or septic shock.

[Discussing of influence mechanism of Chinese herbal monomer on physical stability of cream].

This study left flavonoids and alkaloids Chinese herbal monomer with common parent nucleus as cream base carriages drug respectively, cream base were prepared with stable span 60-tween 80 emulsification system. The near-infrared stability analysis technology was performed to quantitatively characterize the physical stability of cream. Base on the theory of gel network structure, theory of emulsification, theory of solubility parameter and theory of double layer, the influence mechanism of Chinese herbal monomer on physical stability of cream was discussed. The results showed that tetrahydropalmatine, matrine and naringenin had similar solubility parameter value with cream base material, creams prepared with those Chinese herbal monomer have higher Zeta potential value and stronger physical stability, and that those creams had similar microstructure information with cream base. However, a larger solubility parameter difference exists between baicalin, baicalein, berberine, palmatine and cream base material. Creams prepared with those Chinese herbal monomers had lower Zeta potential value and poorer physical stability, and that those creams had great different microstructure information with cream base.