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Combination of Hua Shi Bai Du granule (Q-14) and standard care in the treatment of patients with coronavirus disease 2019 (COVID-19): A single-center, open-label, randomized controlled trial.
Liu, J, Yang, W, Liu, Y, Lu, C, Ruan, L, Zhao, C, Huo, R, Shen, X, Miao, Q, Lv, W, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153671
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Abstract
OBJECTIVE To evaluate the efficacy and safety of Hua Shi Bai Du Granule (Q-14) plus standard care compared with standard care alone in adults with coronavirus disease (COVID-19). STUDY DESIGN A single-center, open-label, randomized controlled trial. SETTING Wuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020. PARTICIPANTS A total of 204 patients with laboratory-confirmed COVID-19 were randomized into the treatment group and control group, consisting of 102 patients in each group. INTERVENTIONS In the treatment group, Q-14 was administered at 10 g (granules) twice daily for 14 days, plus standard care. In the control group, patients were provided standard care alone for 14 days. MAIN OUTCOME MEASURE The primary outcome was the conversion time for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral assay. Adverse events were analyzed in the safety population. RESULTS Among the 204 patients, 195 were analyzed according to the intention-to-treat principle. A total of 149 patients (71 vs. 78 in the treatment and control groups, respectively) tested negative via the SARS-CoV-2 viral assay. There was no statistical significance in the conversion time between the treatment group and control group (Full analysis set: Median [interquartile range]: 10.00 [9.00-11.00] vs. 10.00 [9.00-11.00]; Mean rank: 67.92 vs. 81.44; P = 0.051). The recovery time for fever was shorter in the treatment group than in the control group. The disappearance rate of symptoms like cough, fatigue, and chest discomfort was significantly higher in the treatment group. In chest computed tomography (CT) examinations, the overall evaluation of chest CT examination after treatment compared with baseline showed that more patients improved in the treatment group. There were no significant differences in the other outcomes. CONCLUSION The combination of Q-14 and standard care for COVID-19 was useful for the improvement of symptoms (such as fever, cough, fatigue, and chest discomfort), but did not result in a significantly higher probability of negative conversion in the SARS-CoV-2 viral assay. No serious adverse events were observed. TRIAL REGISTRATION ChiCTR2000030288.
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[Mechanism of extract of Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma and Chuanxiong Rhizoma on SIRT1 autophagy pathway of endothelial cell senescence induced by hydrogen peroxide].
Xiu, CK, Fu, YK, Wang, Q, Wang, X, Hu, YH, Wu, Y, Yang, J, Lei, Y
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica. 2021;(23):6216-6223
Abstract
This study aims to explore the effect of extract of Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma, and Chuanxiong Rhizoma(hereinafter referred to as GNS) on the SIRT1-autophagy pathway of endothelial cell senescence induced by hydrogen peroxide(H_2O_2). To be specific, vascular endothelial cells were classified into the blank control group(control), model group(model), model + DMSO group(DMSO), resveratrol group(RESV), and GNS low-dose(GNS-L), medium-dose(GNS-M), and high-dose(GNS-H) groups. They were treated with H_2O_2 for senescence induction except the control. After intervention of cells in each group with corresponding drugs for 24 h, cell growth status was observed under an inverted microscope, and the formation of autophagosome under the transmission electron microscope. In addition, the changes of microtubule-associated protein 1 light chain 3β(LC3 B) were detected by immunofluorescence staining. The autophagy flux was tracked with the autophagy double-labeled adenovirus(mRFP-GFP-LC3) fusion protein. Dansylcadaverine(MDC) staining was employed to determine the autophagic vesicles, and Western blot the expression of sirtuin 1(SIRT1), ubiquitin-binding protein p62, and LC3Ⅱ. After H_2O_2 induction, cells demonstrated slow growth, decreased adhesion ability, raised number of SA-β-gal-stained blue ones, a certain number of autophagosomes with bilayer membrane and secondary lysosomes in the cytoplasm, and slight rise of autophagy flux level. Compared with the model group, GNS groups showed improved morphology, moderate adhesion ability, complete and smooth membrane, decreased SA-β-gal-stained blue cells, many autophagosomes, autophagic vesicles, and secondary lysosomes in the cytoplasm, increased autophagolysosomes, autophagy flux level, and fluorescence intensity of LC3 B and MDC, up-regulated expression of SIRT1 and LC3Ⅱ, and down-regulated expression of p62, suggesting the improvement of autophagy level. GNS can delay the senescence of vascular endothelial cells. After the intervention, the autophagy flux and related proteins SIRT1, LC3Ⅱand p62 changed significantly, and the autophagy level increased significantly. However, EX527 weakened the effect of Chinese medicine in delaying vascular senescence. GNS may delay the senescence of vascular endothelial cells through the SIRT1 autophagy pathway.
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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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Abstract
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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Efficacy and safety of Chinese herbal medicine Long Dan Xie Gan Tang in insomnia: A systematic review and meta-analysis.
Fan, X, Su, Z, Nie, S, Yang, J, Zhang, X, Tan, D, Xie, S, Xu, Y, Zhao, Y, Feng, L, et al
Medicine. 2020;(11):e19410
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BACKGROUND Insomnia is a global public problem, which has a significant negative impact on both physical and mental health, while increasing the economic burden placed on both sufferers and society. Western medicine has a fast treatment on sleep, but it leads to side effects and strong dependence. Long Dan Xie Gan Tang(LDXGT) is a representative Chinese herbal medicine for the treatment of insomnia especially which has a bad-tempered symptom, and its effectiveness and safety has been validated clinically. However, there is yet to be any evidence-based medicine. Therefore, the effectiveness and safety of LDXGT in the treatment of insomnia are studied and systematically evaluated in this study. It will provide a theoretical support for the treatment of insomnia compared to western medicine. OBJECTIVE The study is purposed to evaluate the effectiveness and safety of LDXGT for the treatment of insomnia. METHODS Search was conducted for various databases including Pubmed, Chinese Biomedicine Database(CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. Randomized-controlled trials (RCTs) were identified for insomnia treatment involving LDXGT and LDXGT combined with ordinary Western medicine. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bias. RevMan 5.3 software and STATA 12.0 software were applied to perform the meta-analysis. RESULTS Thirteen studies involving 1181 participants were identified in this systematic review. Few studies described the details of random principle. No placebo was involved in treatment. LDXGT was compared with ordinary Western medicine in 11 trials and with LDXGT combined with conventional Western medicine in 2 trials. The results of our meta-analysis showed the relative benefits in effective rates compared with conventional western medicine. (Odds Ratio [OR]= 4.32, I = 0%,95% confidence interval CI [3.05 to 6.13], P < .00001) and recovery rate was (Odds Ratio [OR] = 2.67, I = 0%,95% confidence interval CI [2.04 to 3.48], P < .00001). In two trials, adverse events were reported, but no serious adverse effects were reported. CONCLUSION Our systematic evaluation will provide evidence for the clinical effectiveness and safety of LDXGT in the treatment of insomnia, and the side effects of western medicine are addressed. Further trials are necessary to collect the evidence for the use of LDXGT.
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"Effects of extracts from Renshen (Radix Ginseng), Sanqi (Radix Notoginseng), and Chuanxiong (Rhizoma Chuanxiong) on F-actin in senescent microvascular endothelial cells".
Wang, Q, Yang, J, Lei, Y, Xiu, C, Huo, Y, Shi, H
Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan. 2020;(3):376-385
Abstract
OBJECTIVE To investigate the effects of extracts from Renshen (Radix Ginseng), Sanqi (Radix Notoginseng), and Chuanxiong (Rhizoma Chuanxiong) on the endothelial actin cytoskeleton in senescent human cardiac microvascular endothelial cells (HCMECs), and to propose the possible mechanism underlying the actions. METHODS Lentiviral mediated RNA interference was applied to a replicative senescent HCMEC model by knocking down heat shock protein 27 (HSP27) gene. Cells were treated with extracts from Renshen (Radix Ginseng), Sanqi (Radix Notoginseng), and Chuanxiong (Rhizoma Chuanxiong) at final concentrations of 50, 100, and 200 mg/L, respectively and with 10 μM resveratrol for 48 h. Untreated cells were used as controls. Senescence was detected by senescence β-galactosidase staining and cell proliferation was analyzed by cell counting kit-8 assays. Secreted nitric oxide levels were detected by nitrate reductase. Morphological changes of F-actin and G-actin were observed by laser scanning confocal microscopy. Protein and gene expression of F- actin and HSP27 was detected by western blotting. RESULTS Compared with the control group, the proportion of senescent HSP27 shRNA cells treated with the extracts was decreased and their proliferation was increased. In the extract intervention group, F-actin around the cell periphery became irregular and jagged fractures formed gradually and then dissipated. Moreover, some dynamic actin stress fiber filaments appeared. The G-actin stretched to the cell periphery and punctate staining was scattered in the cytoplasm. In addition, the mean optical density value of F/G-actin was decreased significantly and the protein expression of F-actin was downregulated. CONCLUSION The extracts delayed microvascular endothelial cell senescence by downregulating the expression of F-actin through HSP27.
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Meta-Analysis of Efficacy of Sijunzi Decoction Combined with Enteral Nutrition for the Treatment of Gastric Cancer.
Chen, X, Yang, K, Yang, J, Li, K
Nutrition and cancer. 2020;(5):723-733
Abstract
Objective: Whether to conduct Sijunzi decoction combined with enteral nutrition (SJZD/EN) in patients with gastric cancer (GC) remains controversial. This study was aimed to systematically analyze the efficacy and safety of SJZD/EN in patients with gastric cancer.Methods: We performed searches in PubMed, MEDLINE, EMBASE, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Wanfang database, and Chinese Biomedicine Literature Database (SinoMed) to identify relevant literature comparing SJZD/EN with conventional EN for GC patients. The analysis was carried out with RevMan 5.3.Results: A total of 10 randomized controlled trials (688 patients) were included. Meta-analysis showed a significantly shorter time to flatus (t/h) (MD, -9.45; 95% CI, -10.76 to -8.13; p < 0.00001), a shorter length of hospital stay (t/d) (MD, -5.22; 95% CI, -7.46 to -2.99; p < 0.00001), and a lower incidence of postoperative complications (%) (OR, 0.14; 95% CI, 0.03-0.64; p = 0.01) in the SJZD/EN group than the EN group. Compared with the EN, the SJZD/EN group had a higher level of albumin(g/L) (MD, 2.59; 95% CI, 1.90-3.28; p < 0.00001), prealbumin (mg/L) (MD, 36.81; 95% CI, 13.41-60.20; p = 0.002), transferrin (g/L) (MD, 0.19; 95% CI, 0.10-0.28; p < 0.0001), immunoglobulin G (g/L) (MD, 2.61; 95% CI, 2.12-3.09; p < 0.00001), immunoglobulin A (g/L) (MD, 0.38; 95% CI, 0.31-0.45, p < 0.00001), immunoglobulin M (g/L) (MD, 0.31; 95% CI, 0.22-0.41; p < 0.00001), CD3+ (%) (MD, 6.73; 95% CI, 3.48-9.98; p < 0.0001), CD4+ (%) (MD, 4.32; 95% CI, 3.30-5.33; p < 0.00001), and CD4+/CD8+ (MD, 0.20; 95% CI, 0.11-0.28; p < 0.00001).Conclusions: Sijunzi decoction combined with enteral nutrition appears to have efficacy and safety for gastric cancer.
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Traditional Chinese medicine in cancer care: a review of controlled clinical studies published in chinese.
Li, X, Yang, G, Li, X, Zhang, Y, Yang, J, Chang, J, Sun, X, Zhou, X, Guo, Y, Xu, Y, et al
PloS one. 2013;(4):e60338
Abstract
BACKGROUND Traditional Chinese medicine (TCM) has been widely applied for cancer care in China. There have been a large number of controlled clinical studies published in Chinese literature, yet no systematic searching and analysis has been done. This study summarizes the current evidence of controlled clinical studies of TCM for cancer. METHODS We searched all the controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases from their inception to November 2011. We bibliometrically analyzed the included studies and assessed the reporting quality. RESULTS A total of 2964 reports (involving 253,434 cancer patients) including 2385 randomized controlled trials and 579 non-randomized controlled studies were included. The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer by both study numbers and case numbers. The majority of studies (72%) applied TCM therapy combined with conventional treatment, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently applied TCM therapy (2677 studies, 90.32%). The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumor size (869 studies, 29.32%) and safety (547 studies, 18.45%). Completeness and adequacy of reporting appeared to improve with time. CONCLUSIONS Data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.
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A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure.
Li, X, Zhang, J, Huang, J, Ma, A, Yang, J, Li, W, Wu, Z, Yao, C, Zhang, Y, Yao, W, et al
Journal of the American College of Cardiology. 2013;(12):1065-1072
Abstract
OBJECTIVES The purpose of this study was to assess the effects of qili qiangxin capsules in patients with chronic heart failure (CHF). BACKGROUND Qili qiangxin capsules are a traditional Chinese medicine that has been approved in China for the treatment of CHF, but the evidence supporting its efficacy remains unclear. METHODS A total of 512 patients with CHF were enrolled and randomly assigned to receive the placebo or qili qiangxin capsules in addition to their standard medications for the treatment of CHF. The primary endpoint was the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level during 12 weeks of treatment. RESULTS At the 12-week follow-up, a significant reduction in the NT-proBNP level from baseline was observed in both groups, but the qili qiangxin capsule group demonstrated a significantly greater reduction than the placebo group (p = 0.002); 47.95% of patients in the qili qiangxin capsule group demonstrated reductions in NT-proBNP levels of at least 30% compared with 31.98% of patients in the placebo group (p < 0.001). Treatment with qili qiangxin capsules also demonstrated superior performance in comparison to the placebo with respect to New York Heart Association functional classification, left ventricular ejection fraction, 6-min walking distance, and quality of life. CONCLUSIONS On a background of standard treatment, qili qiangxin capsules further reduced the levels of NT-proBNP. Together, our data suggest that qili qiangxin capsules could be used in combination therapy for CHF.
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[Treating menopause syndrome by kuntal capsule and hormone replacement therapy: a meta-analysis of efficacy and safety comparison].
Li, CC, Wang, JJ, Chen, C, Li, YF, Zheng, QS, Yang, J, Liu, HX
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2013;(9):1183-90
Abstract
OBJECTIVE To evaluate the efficacy and safety of Kuntai Capsule (KC) and hormone replacement therapy (HRT) in treating menopause syndrome by Meta-analysis. METHODS Randomized controlled trials were electronically retrieved from PubMed, EMbase, The Cochrane Library, CBM, CNKI, Chinese Doctoral Dissertation Full Text Database, Chinese Outstanding Masters' Dissertation Full Text Database, and VIP database, Wanfang Database, and some other related papers were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of interventions and then effective data were analyzed by RevMan 5.0.2 Software. RESULTS Eight randomized control trials involving 675 patients were included. Results of Meta-analysis showed that there was no statistical difference in the Kupperman Menopausal Scores [MD = 1.91, 95% CI (-0.31, 4.12)] and the effective rate of Kupperman Menopausal Scores [OR = 1.37, 95% CI (0.66, 2.85)] between the KC group and the estrogen replacement therapy group (P > 0.05). Compared with the KC group, the E2 level [MD = -12.8, 95% CI (-22.85, -2.76)] and the FSH level [MD = 17.96, 95% CI (3.03, 32.88)] could be significantly improved in the estrogen replacement therapy group. Compared with the estrogen replacement group, KC could significantly reduce the total incidence of adverse reactions [OR = 0.41, 95% CI (0.24, 0.73)], the incidence of breast distending pain [OR = 0.65, 95% CI (0.42, 1.00)], and the incidence of vaginal bleeding [OR = 0.26, 95% CI (0.17, 0.40) ] (P < 0.05). CONCLUSIONS The current limited evidence showed that, when compared with the estrogen replacement therapy group, KC could also improve climacteric symptoms. It was inferior to the estrogen replacement therapy group in improving in vivo hormone levels. But it was superior in reducing the incidence of adverse reactions, breast distending pain, and vaginal bleeding.
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[Clinical observation on treatment of premature ovarian failure patients of shen deficiency gan stagnation syndrome by combination of bushui roumu recipe and medroxyprogesterone acetate tablet HUA].
Hua, FF, Xia, YH, Yang, J
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2012;(8):1028-31
Abstract
OBJECTIVE To study the therapeutic efficacy of bushui roumu recipe (BRR) combined medroxyprogesterone acetate tablet (MAT) in treating premature ovarian failure (POF). METHODS Totally 90 POF patients of Shen deficiency Gan stagnation syndrome were assigned to 3 groups by random number table, 30 in each group. Patients in the treatment group were treated with BRR and MAT, those in the Chinese medicine group were treated with BRR, and those in the Western medicine group were treated with artificial period method. All patients were treated for 3 months. The menstrual improvement was observed before and after treatment. The therapeutic efficacy was assessed using modified Kupperman scoring standard. The serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) were observed before and after treatment. RESULTS (1) In aspect of the menstrual improvement: In the treatment group 20 patients had menstrual onset during the treatment course. Ten had normal menstruation after discontinued medication. Of them one got pregnancy one month after treatment. In the Chinese medicine group 6 patients had menstrual onset during the treatment course. Two had normal menstruation after discontinued medication. In the Western medicine group 26 patients had menstrual onset during the treatment course. Twelve had normal menstruation after discontinued medication. Better effects on the menstrual improvement were obtained in the treatment group than in the Chinese medicine group (P < 0.01), but with no statistical difference when compared with the Western medicine group (P > 0.05). (2) There was statistical difference in modified Kupperman scores of the 3 groups between before and after treatment (P < 0.01). The improvement of total modified Kupperman score was better in the treatment group than in the other two groups (P < 0.01). The improvement of palpitation was better in the treatment group than in the other two groups (P < 0.05). The improvement of tidal fever and sweat was better in the treatment group and the Chinese medicine group than in the Western medicine group (P < 0.05). (3) After treatment all patients' serum E2 was higher than before treatment, serum levels of FSH and LH were lower than before treatment. Compared pre- and post-treatment, there was statistical difference (P < 0.01). The serum E2 level in the 3 groups was higher after treatment than before treatment with statistical difference (P < 0.01). The levels of FSH and LH were lower in the 3 groups after treatment than before treatment with statistical difference (P < 0.01). The improvement of E2 was better in the treatment group than in the Chinese medicine group (P < 0.05). The improvement of FSH and LH was better in the treatment group than in the Western medicine group (P < 0.05). CONCLUSION Combination of BRR and MAT could improve the clinical symptoms, menstruation, and serum reproductive hormones in POF patients of Shen deficiency Gan stagnation syndrome.