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Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial.
Han, K, Kwon, O, Jung, SY, Park, IH, Hwang, MS, Park, SY, Hwang, EH, Lee, JH
Trials. 2020;(1):211
Abstract
BACKGROUND Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strategies have been studied to help recovery after exercise. Jakyakgamcho-tang (JGT) is a widely prescribed herbal medicine to treat muscle pain and cramps in traditional Eastern medicine. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise. METHODS This study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4 days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as outcome measures. Blood tests and blood pressure will be measured as safety assessments. In addition, blood tests for muscle damage and inflammation markers, such as creatine kinase, interleukin-6, and C-reactive protein, will be analyzed. DISCUSSION This will be the first trial to assess the effect of JGT on exercise-induced muscle soreness. Our findings will provide valuable data to determine the clinical effects of JGT on DOMS. TRIAL REGISTRATION Clinical Research Information Sevice, KCT0003457. Registered on 29 January 2019.
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Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial.
Jang, S, Sung, HK, Ko, MM, Shin, SM, Go, HY, Jung, J
Trials. 2020;(1):193
Abstract
BACKGROUND Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment. METHODS/DESIGN This study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8-16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer. DISCUSSION The results of this pilot trial will be the bases for a full-scale clinical trial of GBH. TRIAL REGISTRATION Clinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.
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Herbal Medicine Treatment for Influenza: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Choi, M, Lee, SH, Chang, GT
The American journal of Chinese medicine. 2020;(7):1553-1576
Abstract
The aim of this research is to evaluate the clinical evidence of an herbal medicine (HM) treatment on influenza and describe the potential benefits and adverse events by reviewing all relevant randomized controlled trials. All papers published from 2010 to 2019 in all languages in six databases were searched, including all randomized controlled trials on adults and children, testing herbal medicine for treatment of influenza, alone or in combination with conventional antiviral therapy. The main outcome parameters of interest were total effective rate, time to resolution of fever, adverse events, complications, and duration of viral shedding. 25 trials of 3044 patients were included. Herbal medicine compared to placebo significantly reduced time to fever resolution by 4.96[Formula: see text]h (mean difference, [Formula: see text]4.96; 95% CI, [Formula: see text]7.11 to [Formula: see text]2.80; [Formula: see text]), herbal medicine compared to oseltamivir showed no significant difference (mean difference, [Formula: see text]1.82; 95% CI, [Formula: see text]6.08 to 2.44; [Formula: see text]), and herbal medicine plus oseltamivir combined treatment significantly reduced duration of fever by 7.84[Formula: see text]h compared to a single treatment with oseltamivir (mean difference, [Formula: see text]7.84; 95% CI, [Formula: see text]12.51 to [Formula: see text]3.17; [Formula: see text]). Herbal medicine compared to placebo showed a significantly better total effective rate (risk ratio, 1.90; 95% CI, 1.18 to 3.07; [Formula: see text]), herbal medicine compared to oseltamivir indicated significantly better effective rate (risk ratio, 1.15; 95% CI, 1.03 to 1.29; [Formula: see text]), and combined treatment showed a significantly better total effective rate compared to a single treatment with oseltamivir (risk ratio, 1.20; 95% CI, 1.06 to 1.36; [Formula: see text]). Regarding safety, no serious adverse events were reported in HM treatment. HM presented fewer adverse events compared to oseltamivir, but the difference was not significant (risk difference, [Formula: see text]0.04; 95% CI, [Formula: see text]0.09 to 0.00; [Formula: see text]), and the combined treatment did not increase adverse events compared to oseltamivir (risk difference, [Formula: see text]0.02; 95% CI, [Formula: see text]0.06 to 0.02; [Formula: see text]). Research findings show that herbal medicine treatments have beneficial therapeutic effects on influenza and could decrease duration of fever and improve total effective rate. In addition, herbal medicine plus oseltamivir combined therapy could increase the therapeutic effect compared to a single treatment with oseltamivir.
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Erchen decoction for hyperlipemia: Protocol for a systematic review and meta-analysis.
Luo, H, Xiong, M, Zhu, W, Shen, T
Medicine. 2020;(42):e22374
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BACKGROUND Hyperlipidemia is a metabolic disease characterized by elevated levels of blood lipids and lipoproteins and a major pathogenic factor of atherosclerosis. In China, Erchen decoction (ECD) has been widely used to treat hyperlipidemia. However, there is no systematic review found. In order to evaluate the efficacy and safety of ECD in the treatment of hyperlipidemia, we need to conduct a meta-analysis and systematic evaluation. METHODS We will enroll the randomized controlled trials (RCTs) evaluating the effectiveness and safety of ECD in the treatment of hyperlipidemia. Data come mainly from 4 Chinese databases (China national knowledge infrastructure, Wanfang, Chinese biomedical literature database, and VIP Database) and 4 English databases (Pubmed, Embase excerpt medica database, Cochrane Library, and Web of science). The enrollment of RCTs is from the starting date of database establishment till September 30, 2020. Low density lipoprotein cholesterol is considered as the main indicator of the dyslipidemia, while the serum concentrations of total cholesterol, triglyceride, high density lipoprotein cholesterol, apolipoprotein A, and apolipoprotein B are regarded as the secondary indicators. There are Safety indicators including liver enzyme, kidney function and fasting blood glucose. The work such as selection of literature, data collection, quality evaluation of included literature, and assessment of publication bias will be conducted by 2 independent researchers. Meta-analysis will be performed by RevMan 5.0 software. RESULTS This study will provide high-quality evidence for the effectiveness and safety of ECD in the treatment of hyperlipidemia. CONCLUSION The results of the study will help us determine whether ECD can effectively treat hyperlipidemia. ETHICS AND DISSEMINATION This study does not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal. OSF REGISTRATION NUMBER DOI 10.17605/OSF.IO/GZ69F.
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Efficacy of Chinese herbal injections combined with fluoropyrimidine and oxaliplatin-based chemotherapy for advanced colorectal cancer: A protocol for systematic review and meta-analysis of randomized controlled trials.
Wang, S, Wang, X, Zhang, Y, Zhou, T, Hu, S, Tian, P, Li, Z, Li, Y, Gui, Y, Dong, J, et al
Medicine. 2020;(52):e23550
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BACKGROUND Fluoropyrimidine combined with oxaliplatin-based chemotherapy have become the first-line treatment for advanced colorectal cancer (CRC). Chinese herbal injections (CHIs), as an important part of TCM, have been widely applied as adjunctive treatments to chemotherapy in patients with advanced CRC. However, the efficacy of this combination therapy has not been evaluated comprehensively. METHODS We will conduct this systematic review and meta-analysis in accordance with the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. 7 databases will be searched for related randomized controlled trials (RCTs) from their inception to August 31, 2020: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), SinoMED and Wanfang Database. Two researchers will perform study selection, data extraction, and assessment of risk of bias independently. The primary outcomes are the disease control rate (DCR) and the objective response rate (ORR), the secondary outcomes are progression-free survival (PFS), survival rate, quality of life (QoL) and adverse effects. Cochrane Review Manager (RevMan 5.3) software will be used to analyze the outcomes. RESULTS AND CONCLUSION This systematic review will evaluate the efficacy of CHIs and fluoropyrimidine and oxaliplatin-based chemotherapy for advanced CRC so as to provide valuable evidence to the application of CHIs in advanced CRC. SYSTEMATIC REVIEW REGISTRATION INPLASY registration number: INPLASY2020100050.
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The role of Chinese herbal medicine in the management of adverse drug reactions of leflunomide in treating rheumatoid arthritis.
Wang, W, Zhou, H, Liu, L
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2020;:153136
Abstract
BACKGROUND The high discontinuation rate in RA patients who use LEF might be attributed to their intolerance rather than irresponsibility. The concomitant administration of Leflunomide (LEF) with Chinese herbal medicine (CHM) provides a potential solution to preventing the adverse drug reactions (ADRs) induced by LEF during the treatment of rheumatoid arthritis (RA). PURPOSE To investigate whether co-administration of LEF with CHM could bring in both increased therapeutic outcomes and reduced ADRs due to the framework of treatment at the level of entire body. STUDY DESIGN The mechanism of LEF in RA treatment and the ADRs it induced was introduced based on recent papers. Reported clinical examples of CHM concurrent use with LEF was revealed to provide more evidence. The management of the ADRs caused by LEF was suggested by current researches on the concomitant therapy of CHM with LEF. RESULTS The active ingredients, compounds and medicinal herbs all demonstrated properties in relieving toxicities and reducing ADRs when used with LEF and reported in several clinical cases. The wide application of concurrent use of CHM with LEF is however hindered by the complex pathogenesis of RA which requires further scientific grounds for diagnosis and treatment. CONCLUSION This review introduced that the adoption of CHM is emerging as a novel strategy for the management of ADRs caused by LEF.
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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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Clinical practice guideline on treating influenza in adult patients with Chinese patent medicines.
Wu, L, Chen, Y, Ma, Y, Yang, Z, Yang, N, Deng, W, Chen, Y, Sun, Y, Li, Y, Lin, L
Pharmacological research. 2020;:105101
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Influenza is a major public health problem worldwide. Mutations and resistance development make the use of antiviral therapy challenging. Chinese patent medicines are often used to treat influenza in China and well tolerable. However, the misuse of Chinese patent medicines is common. We therefore aimed to develop an evidence-based guideline on treating influenza with Chinese patent medicines in adults to guide clinical practice. We formed a steering committee, a consensus panel, a consultants' group and an evidence synthesis team to guide the development of the guideline. We formulated the clinical questions through two rounds of survey, and finally selected five questions. We then systematically searched the related evidence and conducted meta-analyses, evidence summaries and GRADE decision tables to draft the recommendations, which the consensus panel then voted on using the Delphi method. Finally, we formulated six recommendations based on the evidence synthesis and experts' consensus. For treating mild influenza, we suggest either Lianhua Qingwen capsule, Jinhua Qinggan granule, Banlangen granule, Shufeng Jiedu capsule, or Jinfang Baidu pill, depending on the manifestations. For severe influenza, or mild influenza in patients at high risk of developing severe influenza, we suggest Lianhua Qingwen capsule in combination with antiviral medications and supportive therapy. The strength of all recommendations was weak. Traditional Chinese medicine has great potential to help in the fight against influenza worldwide, but more high-quality studies are still needed to strengthen the evidence.
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Efficacy and safety of Shenkang injection as adjuvant therapy in patients with diabetic nephropathy: A protocol for systematic review and meta-analysis.
Wang, Y, Li, M, Li, C, Xu, S, Wu, J, Zhang, G, Cai, Y
Medicine. 2020;(52):e23821
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BACKGROUND Diabetic nephropathy is a frequent microvascular complication of diabetes mellitus that causes end-stage renal disease most of the time. In China, Shenkang injection is one of widely used traditional Chinese medicine for treating chronic kidney disease, but its efficacy and safety have not yet been clarified. We will systematically review the current randomized controlled trial (RCT) evidence to summarize the efficacy and safety of Shenkang injection in treating diabetic nephropathy. METHODS We will search 7 literature databases including PubMed, EMBASE, Cochrane Library, Sinomed, Chinese National Knowledge Infrastructure, Wanfang, and VIP. Two trial registry platforms will also be searched. The time frame of the search will be from the inceptions of the databases to December 31, 2020. RCTs assessing Shenkang injection combined with basic treatments versus basic treatments alone for treating diabetic nephropathy will be included. The risk of bias within the individual RCTs will be evaluated using criteria proposed by the Cochrane Handbook 5.1.0. The primary outcomes to be investigated are glomerular filtration rate and serum creatinine; the secondary outcome will include 24-hour urine albumin excretion rate, blood urea nitrogen, fasting blood glucose, postprandial blood glucose, hemoglobin A1c, total cholesterol, triglyceride, response to treatment, and incidence of adverse events. The effect data of individual RCTs by performing random-effects model meta-analysis. Statistical heterogeneity will be measured by the Cochran Q test and I-squared statistics. Three subgroup analyses, set based on clinical experience, will be performed to explore the sources of heterogeneity. Sensitivity analyses excluding RCTs with high risk of bias and using fixed effect model will be done to test the robustness of the meta-analytic results. Publication bias across included RCTs will be evaluated by funnel plots and Egger test. RESULTS This study will provide systematic review on the efficacy and safety of Shenkang Injection as adjuvant therapy in patients with diabetic nephropathy by rigorous quality assessment and reasonable data synthesis. The results will be submitted to a peer-reviewed journal for publication. CONCLUSION This systematic review will provide the best evidence currently on Shenkang Injection as adjuvant therapy in patients with diabetic nephropathy. INPLASY REGISTRATION NUMBER INPLASY2020110014.
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[Research progress of effect of anxiolytic traditional Chinese medicines and formulas on neurotransmitters].
Xiong, TW, Wu, Q, Liu, J, Liu, B, Xu, YY, Wang, LN, Zhang, CC, Zhang, W, Shi, JS
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica. 2020;(1):14-19
Abstract
Anxiety disorders are a common mental illness that seriously endangered physical and mental health of human beings. The etiology of anxiety disorders is closely related to the abnormality of monoamines neurotransmitters, amino acids neurotransmitters and neuropeptides. The long-term use of anti-anxiety chemical drugs has some adverse effects, such as constipation, muscle relaxation, lethargy, tolerance and withdrawal symptoms. However, traditional Chinese medicines have advantages of multi-component, multi-target coordination, with less adverse reactions. Therefore, it is a promising prospect to develop novel anti-anxiety drugs from traditional Chinese medicines and formulas. This article reviewed some traditional Chinese medicines and formulas that can relieve anxiety symptoms. These include traditional Chinese medicines(Panax ginseng, Lycium ruthenium, Morus alba, Bupleurum plus dragon bone oyster soup, Chailong Jieyu Pills, and Naogongtai Formulas) with the effect on monoamine neurotransmitters, such as serotonin, dopamine, and norepinephrine; traditional Chinese medicines(Rehmannia glutinosa, Ziziphus jujuba Mill. var. spinosa, Jielv Anshen Decoction, Baixiangdan Capsules, Antianxietic Compound Prescription Capsules) with the effect on amino acid neurotransmitters, such as glutamic acid, γ-aminobutyrc acid; and traditional Chinese medicines(P. ginseng, Xiaoyao San, Shuyu Ningxin Decoction)with the effect on neuropeptide Y pathway, with the aim to provide theoretical basis for the further development of some novel and more effective anti-anxiety therapeutics from traditional Chinese medicine and formulas.