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JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study.
Zhang, J, Che, H, Zhang, B, Zhang, C, Zhou, B, Ji, H, Xie, J, Shi, X, Li, X, Wang, F, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153584
Abstract
BACKGROUND Proton pump inhibitors (PPIs) play an important role in the treatment of nonerosive reflux disease (NERD), but their long-term and excessive uses have been associated with safety concerns. Chinese herbal medicine (CHM) has become a popular alternative treatment for this condition. METHODS A total of 204 patients were randomly assigned to the combination group or PPI group (1:1 ratio). They were given JianpiQinghua (JQ) granules (34.8 g) plus omeprazole (10 mg) plus dummy omeprazole (10 mg) or dummy JQ granules (34.8 g) plus omeprazole (20 mg) daily for 4 weeks. The primary endpoints were the rate of sufficient relief and complete resolution of GERD Q at week 4. Metabonomics and the gut microbiota were also assessed. RESULTS Complete resolution was observed in 40.8% of patients in the combination group and 26.8% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.88; 95% CI, 1.03-3.44; p = 0.039). Sufficient relief was observed in 50% of patients in the combination group and 43.30% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.31; 95% CI, 0.74-2.30; p = 0.35). Three patients had liver dysfunction, one of whom had a mild case and 2 of whom had moderate-to-severe cases in the combination group. Patients in the combination group showed a significant increase in richness and diversity of their gut microbiota compared with those in the PPI group. Metabonomics showed that the combination therapy could correct the glutamate metabolism pathway. CONCLUSION Our findings demonstrate the superior efficacy of JQ granules combined with omeprazole (10 mg) vs. omeprazole (20 mg) in terms of symptom relief in patients with NERD. TRIAL REGISTRATION ClinicalTrials.gov number NCT02892357. Registered on 14 February 2019.
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Clinical Yi-guan decoction for liver cirrhosis: A protocol for systematic review and meta analysis.
Hu, X, Shang, G, Zhang, J, Chen, Z, Fu, L, Li, J, Lu, X
Medicine. 2021;(13):e24530
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BACKGROUND At present, Liver Cirrhosis (LC) is common in most later liver and gallbladder diseases that its morbidity and mortality seriously affect human health. The limitation and effectiveness of western medicine on LC have become a huge clinical challenge. However, a large number of clinical studies have shown that Yi-guan decoction has become a complementary treatment for LC. Therefore, this systematic review will aim to explore the safety and feasibility of Yi-guan decoction in the treatment of LC. METHODS We will conduct a comprehensive literature search in Medline, PubMed, Cochrane Database of Systematic Reviews, Embase, Chinese Biomedical Literatures Database, China National Knowledge Infrastructure, Wang Fang Database, Chinese Scientific Journal Database from inception to December 2020 without any language restriction, In addition, relevant literature will be searched manually. The main subject terms searched: "Yi-guan decoction" "cirrhosis" "LC". Data entry will be performed by 2 researchers separately. Primary outcomes will be concluded: Liver function indicators: Total bilirubin, Alanine transaminase, Aspartate aminotransferase, etc. Secondary outcome indicators: Total effective rate, Nutrition index, Survival analysis, Adverse events; All randomized controlled trials collected in this study will be evaluated and rated using the Cochrane risk-of-biasassessment tool. Meta-analysis will be performed using RevMan 5.4.0 software. The heterogeneity test will be conducted between the studies, P < .1 and I2 > 50% are the thresholds for the tests. Using solid effect model or random effect model will be based on its heterogeneity value. RESULTS This systematic review provides a theoretical basis for Yi-guan decoction to treat LC, we will report this result soon. CONCLUSION This study will explore Yi-guan decoction can will be used as one of the non drug therapies to prevent or treat LC. TRIAL REGISTRATION NUMBER INPLASY2020120114.
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China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial.
Xu, Y, Li, X, Zhang, H, Wu, Y, Zhang, J, Li, J, Dou, K, Yan, H, You, S, Yang, Y, et al
American heart journal. 2020;:47-55
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Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.
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Effectiveness of Chinese herbal medicine for primary Raynaud's phenomenon: a systematic review and Meta-analysis of randomized controlled trials.
Zhang, J, Hu, J, He, X, Meng, Y, Chen, G, Chen, Z, Lü, J, Li, P
Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan. 2020;(4):509-517
Abstract
OBJECTIVE To evaluate the effectiveness of Chinese herbal medicine for primary Raynaud's phenomenon (PRP). METHODS The Cochrane Central Register of Controlled Trials, PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database were searched up to February 13, 2018. Randomized controlled trials (RCTs) on treatment of PRP with Chinese herbal medicine compared with placebo, blank control, lifestyle changes, or calcium antagonists were identified and reviewed. The quality of included trials was assessed using a risk of bias tool. RESULTS Eight RCTs involving 674 participants were included. The methodological quality of the included trials was generally poor. Meta-analysis of two trials showed that Buyang Huanwu Tang plus Danggui Sini Tang produced greater improvement in global symptoms than nifedipine. One trial showed that Danggui Sini Tang and a self-composed Chinese herbal medicine decoction, respectively, produced greater improvement in global symptoms than nifedipine alone. In one trial, modified Danggui Sini Tang showed greater improvement in global symptoms and arterial peak systolic velocity compared with nifedipine. One trial showed that Jiejing Tongmi Tang produced greater improvement in global symptoms, plasma endothelin, and plasma nitric oxide than cinepazide maleate injection. However, Jiejing Tongmi Tang did not produce a significant difference in skin temperature and peripheral artery blood stream drawing after cold pressor testing compared with cinepazide maleate injection. None of the trials reported frequency of attacks, duration of attacks, participant preference scores, or adverse events. CONCLUSION Chinese herbal medicine may have a positive effective on PRP. However, owing to weak methodology, the benefits of Chinese herbal medicine for PRP are inconclusive. More rigorously designed studies are needed to confirm these findings.
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Probiotics, prebiotics, antibiotic, Chinese herbal medicine, and fecal microbiota transplantation in irritable bowel syndrome: Protocol for a systematic review and network meta-analysis.
He, Y, Xu, R, Wang, W, Zhang, J, Hu, X
Medicine. 2020;(32):e21502
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BACKGROUND Irritable bowel syndrome (IBS) is a functional gastrointestinal disease, with a high global incidence, which seriously influences the quality of life and work efficiency of patients. Extensive research showed that IBS is related to changes in the intestinal microenvironment. The novel treatment strategy targeting the gut microbiota is being actively implemented. Probiotics, antibiotics, prebiotics, fecal microbiota transplantation, and Chinese Herbal Medicine have been proven to be effective in the treatment of IBS, and all have an impact on the intestinal flora of patients. However, these 5 treatments have their own pros and cons and have not been systematically evaluated and compared. Therefore, this study will indirectly compare the safety and effectiveness of these 5 methods in the treatment of IBS through network meta-analysis. METHODS The following databases including Embase, Pubmed, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, WHO International Clinical Trials Registry Platform and ClinicalTrials.gov will be retrieved from inception to June 2020 without language restrictions. Literature selection, data extraction, and bias analysis will be done by 2 researchers. The primary outcome is global symptoms improvement. The secondary outcomes will include individual IBS symptom scores, emotional response, and adverse events. The conventional pair-wise meta-analysis will be performed using Stata V.14.0 and be pooled using a random-effects model. We will use WinBUGS V.1.4.3 (Cambridge, United Kingdom) with a Bayesian hierarchical random-effects model to conduct the network meta-analysis. RESULTS This study will provide systematic reviews and indirect network comparison results about treatments of IBS. CONCLUSIONS This study will systematically evaluate and compare 5 intestinal flora-related therapies for IBS and to provide an evidence-based medical decision-making basis for clinicians. TRIAL REGISTRATION NUMBER INPLASY202050047.
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Tripterygium wilfordii multiglycosides combined with prednisone in the treatment of idiopathic membranous nephropathy: A protocol for a systematic review and meta-analysis.
Jin, Y, Zhang, J, Wang, Y, Xiao, X, Zhang, Q
Medicine. 2020;(5):e18970
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AIM: The aim of this review is to assess the efficacy and safety of tripterygium wilfordii multiglycosides combined with prednisone in the treatment of idiopathic membranous nephropathy. BACKGROUND Tripterygium wilfordii multiglycosides, a Chinese patent medicine, is widely in-depth research in China, and is proved to have anti-inflammatory and immunosuppressive effect. It has been extensively used in China for the treatment of autoimmune diseases, such as idiopathic membranous nephropathy (IMN). However, there has no relevant systematic review studied on its effects and safety been reported. We plan to perform a systematically reviewing to assess the efficacy and safety of tripterygium wilfordii multiglycosides combined with hormones in the treatment of IMN. METHODS Seven electronic databases will be searched to identify eligible trials. Randomized controlled trials (RCTs) that compared tripterygium wilfordii multiglycosides combined with prednisone versus standard therapy are included. Methodological quality is assessed using the Cochrane Collaboration Risk of Bias tool. A random- or fixed-effect model is used to analyze outcomes that are expressed as risk ratios (RRs) or mean differences (MD), and the I statistic is used to assess heterogeneity. RESULTS A high-quality synthesis of current evidence of tripterygium wilfordii multiglycosides combined with prednisone in the treatment of idiopathic membranous nephropathy will be provided in this study. CONCLUSION This systematic review will provide evidence of whether tripterygium wilfordii multiglycosides is an effective intervention for idiopathic membranous nephropathy.PROSPERO registration number: No.CRD42018118179.
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Effect of ingredients from Chinese herbs on enterovirus D68 production.
Meng, X, Yu, X, Liu, C, Wang, Y, Song, F, Huan, C, Huo, W, Zhang, S, Li, Z, Zhang, J, et al
Phytotherapy research : PTR. 2019;(1):174-186
Abstract
Human enterovirus 68 (EVD68) is a primary causative agent for respiratory illness worldwide. Until now, there has been no available medication for treating EVD68-related diseases. Rheum emodin, artemisinin, astragaloside, pseudolaric acid B, oridonin, and erianin are natural extracts from Chinese herbs that have traditionally been used for the treatment and prevention of epidemic diseases. Our results showed that pseudolaric acid B protected cells from EVD68-induced cytopathic effects and decreased viral production. However, the same effects were not observed with rheum emodin, astragaloside, or artemisinin. Pseudolaric acid B inhibited EVD68 production by manipulating the host cell cycle in G2/M phase. Further, either oridonin or erianin related G2/M arrest also inhibited viral production. Due to inducing G2/M phase arrest, pseudolaric acid B, oridonin, and erianin might be good candidates for inhibiting EVD68 production, and Chinese herbs with natural compounds inducing G2/M arrest should be considered for the treatment of EVD68-related diseases.
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Chinese herbal injections for heart failure: A protocol for systematic review and network meta-analyses.
Yang, F, Zou, J, Ge, L, Tian, J, Lee, MS, Jun, JH, Zhang, J
Medicine. 2018;(8):e9973
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BACKGROUND Chinese herbal injections (CHIs) are commonly used for the treatment of heart failure in China. Due to the variety of CHIs used in clinic, selecting a suitable CHI for patients with heart failure is vital. This study aims to assess and compare the effect of different CHIs for heart failure using network meta-analysis (NMA). METHODS Six electronic databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, China National Knowledge Infrastructure, Wanfang, and Chinese Biomedical Literature Database will be search from inception to January 2018. Randomized controlled trial (RCT) comparing CHI with another CHI will be included. The primary outcome will be changes in heart function classification and left ventricular ejection fraction. Risk of bias assessment of the included RCTs will be conducted according to the Cochrane Handbook 5.1.0. A Bayesian NMA will be performed using WinBUGS 14 software and the result figures will be generated using Stata 13 software. GRADE will be used to explore the quality of evidence. RESULTS The results of this NMA will be published in a peer-reviewed journal. CONCLUSION Our study will generate evidence of CHIs for patients with heart failure and provide suggestions for Chinese medicine clinical practice or guideline. ETHICS AND DISSEMINATION Ethics approval and patient consent are not required because this study is an NMA based solely on the published literature. The results of this NMA will be submitted to a peer-reviewed journal. PROTOCOL REGISTRATION NUMBER PROSPERO CRD 42018086740.
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Herbal medicine (Danggui Liuhuang decoction) for managing menopausal symptoms: A protocol of systematic review of randomized clinical trials.
Jun, JH, Lee, HW, Zhang, J, Yang, F, Lee, MS
Medicine. 2018;(4):e9735
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BACKGROUND Danggui Liuhuang (DLH) decoction is a traditional herbal medicine that is widely used in East Asia to treat menopausal symptoms. Most of the available clinical trials that investigated DLH decoction have been included in this review. The objectives of this protocol are to provide the information of how to evaluate the effectiveness and safety of DLH decoction for the treatment of menopausal symptoms. METHODS AND ANALYSIS Fourteen databases will be searched from inception until February 2018. We will include randomized controlled trials (RCTs) testing any type of DLH decoction. All RCTs investigating DLH decoction or modified DLH decoction will be included. The methodological quality of the RCTs will be evaluated using the Cochrane's risk of bias assessment tool. ETHICS AND DISSEMINATION The full systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. Updates of the review will be conducted to inform and guide healthcare practice and policy. TRIAL REGISTRATION NUMBER PROSPERO 2017 CRD42017079189.
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Network meta-analysis of Chinese herb injections combined with FOLFOX chemotherapy in the treatment of advanced colorectal cancer.
Ge, L, Wang, YF, Tian, JH, Mao, L, Zhang, J, Zhang, JH, Shen, XP, Yang, KH
Journal of clinical pharmacy and therapeutics. 2016;(4):383-91
Abstract
WHAT IS KNOWN AND OBJECTIVE Research has indicated that some Chinese herb injections (CHIs) might be beneficial in combination with chemotherapy, including remedies that might be used as effective chemosensitizers and radiosensitizers, or as palliative therapy. Here, we carried out a network meta-analysis to assess the clinical efficacy and safety of CHIs combined with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) for advanced colorectal cancer (CRC). METHODS PubMed, EMBASE.com, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), Wanfang Database and Chinese Journal Full-text Database were searched from inception to 31 December 2014, to identify relevant randomized controlled trails (RCTs). The risk of bias in included RCTs was evaluated according to the Cochrane Handbook version 5.1.0. Standard pairwise meta-analysis and Bayesian network meta-analysis were performed to compare the efficacy and safety of different CHIs combined with FOLFOX. Data were analysed using STATA 12.0 and WinBUGS1.4 software. RESULTS AND DISCUSSION We identified 63 eligible studies (with 4837 patients in total), involving 9 CHIs. Pairwise meta-analysis showed that compared with FOLFOX alone, combinations with Aidi injection and compound matrine injection could significantly improve the overall response rate and quality of life and reduce the incidence of nausea and vomiting (III-IV), diarrhoea (III-IV), thrombocytopenia (III-IV), leukopenia (III-IV) and peripheral neurotoxicity (III-IV). According to results of indirect comparison, there were no statistically significant differences for most of comparison groups. Aidi+FOLFOX, shenqifuzheng+FOLFOX and compound matrine+FOLFOX had the greatest probability of being the best treatment in clinical efficacy and safety, considering the small sample size. WHAT IS NEW AND CONCLUSIONS Most of the included studies were of low quality, and there was a scarcity of eligible trials and numbers of participants. Based on currently limited evidence, aidi, shenqifuzheng and compound matrine were superior to other CHIs in patients receiving FOLFOX chemotherapy for advanced CRC. More studies are required to confirm the efficacy of CHIs in combination with FOLFOX for advanced CRC.