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1.
Medicine (Baltimore) ; 100(39): e27323, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34596133

RESUMO

BACKGROUND: Mild cognitive impairment (MCI), as a common neurodegenerative aging disease representing an intermediate stage between normal cognitive functioning and dementia, poses an excessive burden on health care. The clinical benefit of Chinese herbal medicines (CHMs) for MCI remains inconclusive. This study is aimed at evaluating the efficacy and acceptability of CHMs through meta-analysis and trial sequential analysis (TSA). METHODS: We applied extensive strategies on preliminary literature screening to identify relevant randomized controlled trials which meticulously compare any of CHMs interventions with placebo groups as monotherapy for MCI. The primary outcome of this study is the change of global cognitive function, and the secondary outcomes include assessments of activities of daily living, mood, and adverse events. Data synthesis, risk of bias assessment, sensitivity and subgroup analyses, and TSA will be conducted with application of Review Manager, Stata, and TSA software. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. INPLASY registration number: INPLASY202190006 (https://inplasy.com/inplasy-2021-9-0006/). RESULTS: This study will confirm the clinical efficacy and safety of CHMs when used in the treatment of patients with MCI. CONCLUSION: This study will provide reliable evidence and references for the selection of CHMs in therapy and future clinical research of MCI.


Assuntos
Disfunção Cognitiva/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Atividades Cotidianas , Afeto/efeitos dos fármacos , China , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
2.
Medicine (Baltimore) ; 100(40): e27372, 2021 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-34622839

RESUMO

BACKGROUND: Coronavirus disease 2019 (COVID-19) in many countries is still very serious. At present, there is no specific and effective drug for this disease. Traditional Chinese medicine (TCM) has played a great role in fighting against COVID-19. However, their effectiveness and safety are still obscure and deserve further investigation. The aim of the study was to evaluate the efficacy and safety of TCM assisted in conventional treatment in the treatment of mild and common COVID-19. METHODS: PubMed, EMbase, MEDLINE, China National Knowledge Infrastructure Database, WANFANG DATA, and VIP Chinese Science and Technology Periodical Database were searched for randomized controlled trials (RCTs) and non-randomized controlled trials of TCM assisted in conventional treatment. The RCT research quality was evaluated by Cochrane 5.1.0 bias risk scale and the non-randomized controlled trial research quality was evaluated by Newcastle Ottawa scale, and the statistical analysis was conducted by Revman 5.3 and R software. The bias and sensitivity of the statistical results were analyzed by STATA 14.0. Registration number: CRD42020210619. RESULTS: Fifteen studies were included with 7 RCT studies and 8 retrospective cohort studies, involving a total of 1623 patients. Compared with the control group, TCM can improve the main index clinical effective rate (odds ratio [OR] = 2.64, 95% Confidence interval (CI) [1.94,3.59], P < .00001). The results of Begg test (Pr > z = 0.266) and sensitivity analysis showed that the results were relatively stable. Toujie Quwen (OR = 4.9, 95%CI [1.9,14.0]), Shufeng Jiedu (OR = 2.9, 95%CI [1.5,5.7]), and Lianhua Qingwen (OR = 2.4, 95%CI [1.6,3.6]) were with the best. It can also improve the main clinical symptoms (fever, cough, fatigue, and the regression time of the 3 symptoms), severe conversion rate, and computed tomography improvement rate. Its safety was not significantly compared with conventional treatment. However, in terms of safety of a single TCM, Shufeng Jiedu (OR = -0.86, 95%CI [-1.89,0.09]) and Lianhua Qingwen (OR = -0.49, 95%CI[-0.94,-0.05]) were lower than those of conventional treatment. CONCLUSION: TCM as an adjuvant therapy combined with conventional treatment has good curative effect on mild and common type of COVID-19 patients. Its advantages lie in clinical efficacy and improvement of symptom group, and can prevent patients from transforming to severe disease. In terms of clinical efficacy and safety, Shufeng Jiedu and Lianhua Qingwen have obvious advantages, which are worthy of clinical promotion.


Assuntos
COVID-19/terapia , Medicamentos de Ervas Chinesas/uso terapêutico , Terapia Combinada , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Índice de Gravidade de Doença
3.
Medicine (Baltimore) ; 100(40): e27497, 2021 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-34622883

RESUMO

BACKGROUND: Primary liver cancer (PLC) is a common cancer, and its morbidity and mortality are ranked 6th and 3rd in the world for malignant tumors, respectively. And this number is still on the rise, seriously endangering people's health. In recent years, acupuncture combined with Chinese herbal medicine have been widely used in the treatment of PLC, and there are few restrictions. However, we have not found a meta-analysis of their synergistic effects. Therefore, this systematic review and meta-analysis will evaluate the efficacy and acupuncture combined with Chinese herbal medicine in the treatment of primary liver cancer. METHOD: We will search the following databases from inception up to August 20, 2021: PubMed, Web of Science, Embase, AMED, Cochrane Library, CNKI, VIP, CBM, and Wanfang. There will be no restrictions regarding publication date or language. We will apply a combination of medical keywords and words, including "acupuncture," "Chinese herbal medicine" and "primary liver cancer". Additionally, we will manually search all reference lists from relevant systematic reviews to find other eligible studies. We will use the random effects model in REVMAN v5.3 for meta-analysis. The study for acupuncture combined with Chinese herbal medicine in the treatment of PLC was a randomized controlled study. Two researchers will independently review the research selection, data extraction, and research quality assessments. Finally, we will observe the outcome measures. RESULTS: This study will provide evidence-based medical evidence for the treatment of PLC with a combination of acupuncture and Chinese herbal medicine, and provide new ideas and methods for the treatment of PLC.Registration number: INPLASY202180103.


Assuntos
Terapia por Acupuntura/métodos , Medicamentos de Ervas Chinesas/uso terapêutico , Neoplasias Hepáticas/terapia , Terapia por Acupuntura/efeitos adversos , Terapia Combinada , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Neoplasias Hepáticas/mortalidade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Análise de Sobrevida
4.
Ann Palliat Med ; 10(9): 9523-9534, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34628878

RESUMO

BACKGROUND: Due to constantly emerging new studies on Xuesaitong injection (XST) agent, it is necessary to summarize and analyze the latest published clinical research data to re-evaluate the clinical efficacy and safety of XST. This study mainly aimed to evaluate the clinical efficacy and safety of XST combined with western medicines (WM) for ischemic stroke treatment. METHODS: The related databases were searched to collect all randomized controlled trials (RCTs) comparing the combination of XST and WM with WM alone for the treatment of patients with ischemic stroke. Participant, intervention, comparison, outcome and study type (PICOS) was the inclusion criteria of all studies. The search for and data extraction of the included studies was performed by 2 researchers, who then conducted quality evaluation. The Cochrane Collaboration's risk of bias tool was used for the article evaluation. The software RevMan 5.3 and Stata 15.0 were used for pooled analysis. RESULTS: A total of 12 RCTs were included involving 1,769 patients with ischemic stroke, which combined XST with WM therapy. Moreover, the funnel plot showed that there was no obvious publication bias in the included studies. Meta-analysis showed that the total effective rate in the XST combined with WM group was higher than that in the WM alone group [odds ratio (OR) =4.04, 95% confidence interval (CI): 2.86 to 5.73, P<0.001]. The National Institutes of Health Stroke Scale (NIHSS) score in the XST combined with WM group was significantly lower than that in the WM alone group [weighted mean difference (WMD) =-3.17, 95% CI: -4.14 to -2.20, P<0.001]. In addition, XST combined with WM significantly reduced the plasma viscosity, fibrinogen level, whole blood high shear viscosity, and whole blood low shear viscosity in patients with ischemic stroke (P<0.01). For the comparison of adverse reactions, the results showed that the adverse reactions among patients with ischemic stroke in the XST combined with WM group and in the WM group did not differ significantly. DISCUSSION: Compared with single WM medication, XST combined with WM improves the total clinical effective rate, promotes the recovery of patients' neurological function, and has few adverse reactions and high safety in clinical application.


Assuntos
Medicamentos de Ervas Chinesas , AVC Isquêmico , Saponinas , Acidente Vascular Cerebral , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Acidente Vascular Cerebral/tratamento farmacológico , Estados Unidos
5.
Trials ; 22(1): 701, 2021 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-34649610

RESUMO

INTRODUCTION: Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional Chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aims to test the integrative medicine (Chinese medicine plus antiviral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis-related compensated liver cirrhosis. METHODS AND ANALYSIS: This is a multi-center randomized controlled trial, and a total of 5 hospitals and 802 patients will be involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction (YQSHD) group (n = 401) or the placebo group (n = 401). The YQSHD group receives YQSHD granule with entecavir (ETV), and the placebo group receives YQSHD placebo with ETV. The treatment period will last for 52 weeks, and the follow-up period for 52 ± 2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. The objective of this trial is "the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%." ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethics Committee of Guang'anmen Hospital, China (No.2019-006-KY), and the other centers in the trial will not begin recruiting until the local ethical approval has been obtained. Trial final results will be disseminated via publication. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900021532 . Registered on February 26, 2019.


Assuntos
Carcinoma Hepatocelular , Medicamentos de Ervas Chinesas , Hepatite B , Neoplasias Hepáticas , Antivirais/efeitos adversos , Carcinoma Hepatocelular/tratamento farmacológico , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Hepatite B/diagnóstico , Hepatite B/tratamento farmacológico , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
6.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2984-2994, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467688

RESUMO

To systematically review the efficacy and safety of Naoxueshu Oral Liquid in treatment of hypertensive intracerebral hemorrhage, four Chinese databases, four English databases, clinical trials registration center(ClinicalTrials.gov) and Chinese clinical trial registry were retrieved. The retrieval time was from the establishment of each database to September 9, 2020. According to the set criteria, the randomized controlled trial(RCT) of Naoxueshu Oral Liquid combined with conventional Western medicine was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.4.1 was used to conduct Meta-analysis of the included studies and GRADE system was used to evaluate the evidence quality of the outcome indicators. Eleven studies were finally included, with a total sample size of 1 221 cases, 612 cases in the treatment group and 609 cases in the control group. Meta-analysis showed that Naoxueshu Oral Liquid combined with conventional Western medicine had no significant difference compare with conventional Western medicine in reducing National Institute of health stroke scale(NIHSS) after 2 weeks of treatment for hypertensive intracerebral hemorrhage(MD=-1.59,95%CI[-3.46,0.29],P=0.10), but was superior to conventional Western medicine after 30 d of treatment(MD=-1.16,95%CI [-1.39,-0.94],P<0.000 01). Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine in improving Glasgow coma scale(MD=1.00,95%CI[0,2.00],P=0.05) and reducing the incidence of secondary brain insults(RR=0.38,95%CI[0.24,0.59],P<0.000 1), but there was no significant difference in increasing Barthel index(MD=1.00,95%CI[-0.30,2.30],P=0.13). In terms of effective rate, studies using Guideline for clinical trials of new patent Chinese medicines, NHISS or Glasgow outcome scale(GOS) had shown that Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine(RR_(Guideline for clinical trials of new patent Chinese medicines)=1.27,95%CI[1.10,1.46],P=0.001;RR_(NHISS)=1.26,95%CI[1.13,1.40],P<0.000 1;RR_(GOS)=1.54,95%CI[1.22,1.93],P=0.000 2). In reduction of hematoma volume, Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine after 2 and 4 weeks of treatment(MD_(2 week)=-2.31,95%CI[-3.12,-1.49],P<0.000 01;MD_(4 week)=-2.04,95%CI[-2.41,-1.68],P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. In terms of adverse reactions, two of the included studies reported mild adverse reactions, and the rest of studies were not mentioned, so this study was not able to make a positive evaluation of the safety of Naoxueshu Oral Liquid. This study showed that compared with conventional Western medicine, combined Naoxueshu Oral Liquid may be better for hypertensive intracerebral hemorrhage. However, due to the high bias risk in the included studies, more large-sample and high-quality RCTs are still needed in the future.


Assuntos
Medicamentos de Ervas Chinesas , Hemorragia Intracraniana Hipertensiva , Acidente Vascular Cerebral , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Hemorragia Intracraniana Hipertensiva/tratamento farmacológico , Medicamentos sem Prescrição
7.
Zhongguo Zhong Yao Za Zhi ; 46(15): 3990-3997, 2021 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-34472276

RESUMO

To systematically evaluate the efficacy and safety of Gongxuening Capsules in the treatment of abnormal vaginal bleeding after medical abortion. CNKI, Wanfang, SinoMed, VIP, PubMed, Cochrane Library and EMbase databases were retrieved to comprehensively collect the clinical randomized controlled trials(RCTs) of Gongxuening Capsules for treatment of abnormal vaginal bleeding after medical abortion from the establishment of the databases to October 10, 2020. Literature screening, data extraction and quality evaluation were conducted independently by two system reviewers according to the inclusion and exclusion criteria. Cochrane Handbook bias risk assessment tool was used for the literature methodology quality evaluation, RevMan 5.3 software was used for Meta-analysis, and the evidence quality of outcomes was evaluated by the evidence quality grading system(GRADE). A total of 16 RCTs were inclu-ded. The results of Meta-analysis showed that as compared with the western medicine treatment alone, the addition of Gongxuening Capsules to the western medicine treatment can reduce the amount of vaginal bleeding(RR=1.23, 95%CI[1.19, 1.27], P<0.000 01), shorten vaginal bleeding time(RR_(≤15 d number of people)=1.39, 95%CI[1.31, 1.48], P<0.000 01; MD_(number ofdays)=-1.20, 95%CI[-1.66,-0.74],P<0.000 01). However, there was no obvious advantage in abortion effect(RR=1.02, 95%CI[0.99, 1.06], P=0.14) and menstrual recovery(MD=-0.35, 95%CI[-0.96, 0.25], P=0.25). The results of GRADE showed that the grading level was low for vaginal bleeding volume and vaginal bleeding time, and extremely low for abortion effect and mens-trual recovery. In terms of safety, 16 studies reported adverse events. Only one study showed no adverse events and the rest showed transient nausea, vomiting, stomach burning, upper abdominal discomfort and other gastrointestinal symptoms. The results show that the addition of Gongxuening Capsules to the application of western medicine in treatment of drug abortion can reduce the amount of vaginal bleeding and shorten vaginal bleeding time, but the abortion effect and menstrual recovery have no obvious advantages. The use of Gongxuening Capsules helps to achieve less adverse reactions and higher safety. Due to the small sample size of the included studies and many methodological quality problems, no conclusions with clinical guidance value can be obtained. Large sample-zise, high-qua-lity randomized controlled trials are still needed for further verification.


Assuntos
Aborto Induzido , Medicamentos de Ervas Chinesas , Aborto Induzido/efeitos adversos , Cápsulas , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Masculino , Gravidez , Hemorragia Uterina
8.
Zhongguo Zhong Yao Za Zhi ; 46(17): 4581-4584, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581065

RESUMO

Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.


Assuntos
Ensaios Clínicos como Assunto , Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Medicamentos de Ervas Chinesas/efeitos adversos
9.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4615-4622, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581069

RESUMO

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.


Assuntos
Medicamentos de Ervas Chinesas , Cefaleia do Tipo Tensional , Adulto , Álcoois Benzílicos/uso terapêutico , Medicamentos de Ervas Chinesas/efeitos adversos , Glucosídeos , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
10.
Trials ; 22(1): 566, 2021 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-34521466

RESUMO

BACKGROUND: Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. At present, the targeted therapy of intestinal microbes for NAFLD is highly valued. Lycium barbarum polysaccharide (LBP), as the main active ingredient of Lycium barbarum, is considered to be a new type of prebiotic substance, which can improve NAFLD by regulating the gut microbiota. The purpose of this study is to evaluate the safety and efficacy of LBP supplementation in modulating gut microbiota for NAFLD patients. METHODS: This randomized, double-blind, placebo-control study will be conducted in the physical examination center of the Ningxia Hui Autonomous Region People's Hospital. A total of 50 patients with NAFLD confirmed by abdominal ultrasound, laboratory tests, and questionnaire surveys will be recruited and randomly assigned into the control group (maltodextrin placebo capsules) and the intervention group (LBP supplementation capsules) for 3 months. Neither patients, nor investigators, nor data collectors will know the contents in each capsule and the randomization list. The primary outcome measure is the level of ALT concentration relief after the intervention. Secondary outcomes include gut microbiota abundance and diversity, intestinal permeability, patient's characteristic demographic data and body composition, adverse effects, and compliance from patients. DISCUSSION: LBPs are potential prebiotics with the property of regulating host gut microbiota. Our previous studies have documented that LBP supplement can improve the liver damage and the gut microflora dysbiosis in NAFLD rats. This treatment would provide a more in-depth understanding of the effect of this LBP supplementation. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2000034740 . Registered on 17 July 2020.


Assuntos
Medicamentos de Ervas Chinesas , Microbioma Gastrointestinal , Hepatopatia Gordurosa não Alcoólica , Animais , Suplementos Nutricionais , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Ratos
11.
Trials ; 22(1): 545, 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34407832

RESUMO

BACKGROUND: Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chinese medicine (TCM) can relieve the symptoms of reflux and improve the quality of life. The purpose of this study is to evaluate the safety and efficacy of Hewei Jiangni recipe (HWJNR) in the treatment of NERD with cold-heat complex syndrome, and clarify the mechanism of HWJNR on NERD based on the correlation analysis of intestinal flora and metabolites. METHODS: This is a single-center, randomized controlled, double-blind, placebo-controlled clinical trial in which 72 eligible participants with NERD and TCM syndrome of intermingled heat and cold will be randomly allocated in the ratio of 1:1 to two groups: TCM group and western medicine group. The TCM group will receive HWJNR with omeprazole enteric-coated tablets placebo, while the western medicine group will receive omeprazole enteric-coated tablets with HWJNR placebo. Each group will be treated for 8 weeks. The primary outcome is the score of gastroesophageal reflux disease (GERD) health-related quality of life questionnaire (GERD-Q). Secondary outcomes include SF-36 quality of life scale (SF-36), patient-reported outcomes (PRO) self-rating scale score, syndrome score of TCM, and adverse events. Mechanistic outcome is the correlation analysis of intestinal flora and metabolites from healthy individuals and NERD participants before and after the treatment respectively. DISCUSSION: The goal of this trial is to investigate the efficacy and safety of HWJNR in the treatment of NERD with cold-heat complex syndrome, and to study the composition structure and metabolite expression profile of intestinal flora in patients with NERD through 16SrRNA sequencing and metabolomic correlation analysis of fecal flora, which makes us identify the dominant links of treatment and reveal the potential mechanism of HWJNR. ChiCTR2000041225 . Registered on 22 December 2020.


Assuntos
Medicamentos de Ervas Chinesas , Qualidade de Vida , China , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Temperatura Alta , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
12.
PLoS One ; 16(8): e0256429, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34415962

RESUMO

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has emerged as a global pandemic since its outbreak in Wuhan, China. It is an urgent task to prevent and treat COVID-19 effectively early. In China's experience combating the COVID-19 pandemic, Chinese herbal medicine (CHM) has played an indispensable role. A large number of epidemiological investigations have shown that mild to moderate COVID-19 accounts for the largest proportion of cases. It is of great importance to treat such COVID-19 cases, which can help control epidemic progression. Many trials have shown that CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 was superior to conventional therapy alone. This review was designed to evaluate the add-on effect of CHM in the treatment of mild to moderate COVID-19. METHODS: Eight electronic databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the Clinical Trials.gov website, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Database and China Biology Medicine (CBM) were searched from December 2019 to March 2021 without language restrictions. Two reviewers searched and selected studies, and extracted data according to inclusion and exclusion criteria independently. Cochrane Risk of Bias (ROB) tool was used to assess the methodological quality of the included RCTs. Review Manager 5.3.0 software was used for statistical analysis. RESULTS: Twelve eligible RCTs including 1393 participants were included in this meta-analysis. Our meta-analyses found that lung CT parameters [RR = 1.26, 95% CI (1.15, 1.38), P<0.00001] and the clinical cure rate [RR = 1.26, 95%CI (1.16, 1.38), P<0.00001] of CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 were better than those of conventional therapy. The rate of conversion to severe cases [RR = 0.48, 95%CI (0.32, 0.73), P = 0.0005], TCM symptom score of fever [MD = -0.62, 95%CI (-0.79, -0.45), P<0.00001], cough cases [RR = 1.43, 95%CI (1.16, 1.75), P = 0.0006], TCM symptom score of cough[MD = -1.07, 95%CI (-1.29, -0.85), P<0.00001], TCM symptom score of fatigue[MD = -0.66, 95%CI (-1.05, -0.28), P = 0.0007], and CRP[MD = -5.46, 95%CI (-8.19, -2.72), P<0.0001] of combination therapy was significantly lower than that of conventional therapy. The WBC count was significantly higher than that of conventional therapy[MD = 0.38, 95%CI (0.31, 0.44), P<0.00001]. Our meta-analysis results were robust through sensitivity analysis. CONCLUSION: Chinese herbal medicine combined with conventional therapy may be effective and safe in the treatment of mild to moderate COVID-19. More high-quality RCTs are needed in the future.


Assuntos
COVID-19/tratamento farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , COVID-19/diagnóstico por imagem , COVID-19/etiologia , Tosse/tratamento farmacológico , Tosse/virologia , Diarreia/induzido quimicamente , Medicamentos de Ervas Chinesas/química , Febre/tratamento farmacológico , Febre/virologia , Humanos , Pulmão/diagnóstico por imagem , Pulmão/virologia , Náusea/induzido quimicamente , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Vômito/induzido quimicamente
13.
Medicine (Baltimore) ; 100(29): e26671, 2021 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-34398031

RESUMO

BACKGROUND: Knee osteoarthritis (OA) is a major public health concern causing chronic disability as well as a substantial burden on health care and the economy. However, effective treatments for knee OA were still not available. Numerous clinical studies have suggested that Chinese herbal medicine (CHM) seems to be clinically effective in treating knee OA. Thus, this study aims to evaluate the efficacy and safety of CHM in the treatment of knee OA through a systematic review and network meta-analysis. METHODS: A comprehensive search will be performed in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, Chinese Biomedical Database, and 3 clinical trials registration websites, from the database inception to May 2021. Randomized controlled trials meeting the eligible criteria based on the PICOS framework will be included. All studies fulfilling the eligible criteria will be assessed for risk of bias using the Cochrane Collaboration's tool. The primary outcome will be the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index, and total effective rate. The secondary outcome is the incidence of adverse events. Data analysis will be performed using Stata, Addis, and WinBUGS. DISCUSSION: This study will provide a reliable evidence to assess effectiveness and safety of CHM for knee OA, which may provide guidance for clinical practice. SYSTEMATIC REVIEW REGISTRATION: This study protocol has been registered on INPLASY202160060.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Osteoartrite do Joelho/tratamento farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Fitoterapia , Projetos de Pesquisa
14.
Medicine (Baltimore) ; 100(34): e27120, 2021 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-34449516

RESUMO

BACKGROUND: Acute ischemic stroke (AIS) is one of the most common causes of mortality and disability worldwide, which has become a global health concern due to the high prevalence, mortality, and disability rate. Naoxintong capsule is an oral Chinese patent preparation used extensively to treat AIS in China. However, the systematic evaluation on the clinical efficacy and safety of Naoxintong capsule is still absent. Therefore, we attempt to perform a systematic review and meta-analysis based on the existing evidence, in order to provide solid support for the clinical practice of Naoxintong capsule in the treatment of AIS. METHODS: We will search both English and Chinese databases, including Scopus, EMBASE, PubMed, Cochrane library, Google Scholar, Web of Science, CNKI, VIP, Wanfang, and Chinese Biomedical Literature Database, for randomized controlled trials which focus on Naoxintong capsule treating AIS. The retrieving time was from inception to August 2021. According to eligibility criteria, 2 researchers will independently screen information and assess the quality of selected articles. The RevMan 5.3 (Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration) software will be used for meta-analysis. RESULTS: The clinical efficacy and safety of Naoxintong capsule in the treatment of AIS will be systematically evaluated or descriptive analyzed. CONCLUSION: The study will provide rigorous evidence to identify whether the application of Naoxintong capsule for treating AIS appeared to be adequate reliability regarding on the efficacy and safety. INPLASY REGISTRATION NUMBER: INPLASY202180052.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , AVC Isquêmico/tratamento farmacológico , Doença Aguda , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
15.
Zhongguo Zhong Yao Za Zhi ; 46(13): 3446-3454, 2021 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-34396765

RESUMO

Qingkailing Injection is one of the most commonly used traditional Chinese medicine injections with significant clinical application for the treatment of multiple diseases. This study aims to analyze the systematic reviews( SRs) of Qingkailing Injection,in order to provide reference for the clinical application of Qingkailing Injection and the development of relevant clinical practice guidelines. We searched CNKI,CBM,Wanfang,VIP,Pub Med,Cochrane Library and EMbase to collect SRs from the time of database establishment to August 2020. The eligible SRs were included according to the inclusion and exclusion criteria. AMSTAR 2 was used to assess the methodological quality. The diseases,drugs in combinations and results were extracted and analyzed. A total of 24 SRs were selected,including 10 for the treatment of acute cerebrovascular diseases,9 for respiratory infections,2 for viral hepatitis,1 for chronic obstructive pulmonary disease,and two for the adverse effects of Qingkailing Injection. Only three entries of AMSTAR 2 item were fully reported by over 70%,and the rest were reported by less than 70%,with no report about item 2,3 and 10. Twenty-nine outcome indicators were correlated with the included SRs,of which three mostly frequent outcomes were effectiveness,adverse reaction,and neurological deficit scores,showing a good efficacy of Qingkailing Injection. The common severe adverse reaction was anaphylaxis,and mild adverse reactions were skin and mucous membrane reactions. The most frequently combined drug was antibiotics,mainly Penicillin and Penicillin+Pioneeromycin. The existing evidences showed that the methodological quality of SRs of Qingkailing Injection needed to be improved and Qingkailing Injection had an obvious efficacy. However,the selection of outcome indicators for clinical trials and SRs shall be standardized,and the reporting of basic information,such as drug combination,shall be strengthened to provide more powerful clinical services.


Assuntos
Medicamentos de Ervas Chinesas , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Injeções , Medicina Tradicional Chinesa , Revisões Sistemáticas como Assunto
16.
World J Gastroenterol ; 27(28): 4710-4721, 2021 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-34366631

RESUMO

BACKGROUND: Gastroesophageal reflux disease (GERD) has a high prevalence worldwide, and its incidence is increasing annually. Modified Xiaochaihu Decoction (MXD) could relieve the symptoms of GERD, but the effects of MXD on GERD manifestations and relapse prevention need to be further explained. Therefore, we performed a prospective, double-blind, and double-simulation study. AIM: To verify the efficacy of MXD for GERD and its effect on esophageal motility. METHODS: Using randomization, double-blinding, and a simulation design, 288 participants with GERD were randomized to the treatment group and control group and received herbs (MXD) plus omeprazole simulation and omeprazole plus herbs simulation, respectively, for 4 wk. The GERD-Q scale score and esophageal manometry were measured at baseline, after treatment, and at 1 mo and 3 mo follow-up visits when medication was complete to evaluate recurrence indicators. RESULTS: The GERD-Q scale score in both groups decreased significantly compared to those before treatment (P < 0.01). However, no significant difference was observed between the two groups (P > 0.05). Esophageal manometry showed that participants with lower esophageal sphincter pressure reduction and the proportion of ineffective swallowing (more than 50%) improved in both groups from baseline (P < 0.01), especially in the treatment group (P < 0.05). The percentage of small intermittent contractions, large intermittent contractions, and increased pre-phase contractions in the treatment group significantly improved compared with baseline (P < 0.05) but did not improve in the control group (P > 0.05). There was no significant difference between the groups after treatment (P > 0.05). The percentage of weak esophageal contractility (distal contractile integral < 450 mmHg·s·cm), improved in both groups (P < 0.01), but no significant difference was observed between the groups after treatment (P > 0.05). The relapse rate in the treatment group was lower than that in the control group at the 1 mo (P < 0.01) and 3 mo follow-up (P < 0.05). CONCLUSION: MXD has a similar therapeutic effect to omeprazole in mild-to-moderate GERD. The therapeutic effect may be related to increased pressure in the lower esophageal sphincter and reduced ineffective swallowing.


Assuntos
Medicamentos de Ervas Chinesas , Refluxo Gastroesofágico , Medicamentos de Ervas Chinesas/efeitos adversos , Esfíncter Esofágico Inferior , Refluxo Gastroesofágico/tratamento farmacológico , Humanos , Manometria , Estudos Prospectivos
17.
Trials ; 22(1): 553, 2021 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-34419124

RESUMO

BACKGROUND: With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA. METHODS/DESIGN: This is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks and follow-up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of traditional Chinese medicine (TCM) efficacy. Secondary indicators are the Seattle Angina Scale score, serum lipid levels, electrocardiogram, and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial. DISCUSSION: Integrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX based on standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027015 . Registered on 28 October 2019.


Assuntos
Medicamentos de Ervas Chinesas , Angina Microvascular , Medicamentos de Ervas Chinesas/efeitos adversos , Coração , Humanos , Medicina Tradicional Chinesa , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Rev Assoc Med Bras (1992) ; 67(2): 190-194, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34287475

RESUMO

OBJECTIVE: To observe the effects of Dengzhan Shengmai capsule combined with donepezil hydrochloride on cognitive function, daily living ability, and safety in patients with Alzheimer's disease. METHODS: A total of 294 patients with Alzheimer's disease were randomly divided into a treatment group and a control group, 147 cases each group. The control group was given oral donepezil hydrochloride 5 mg once a day, and the treatment group was given oral Dengzhan Shengmai capsule 0.36 g three times a day, based on the control group. RESULTS: At 3 and 6 months of treatment, the ADAS-cog score of the treatment group was 48.69±6.23 and 44.24±5.53; for the control group, 45.48±5.94 and 41.57±5.10. The difference between the two groups is statistically significant (p<0.05). At 3 and 6 months of treatment, the NO level in the treatment group was (46.28±6.68) umol/l, (43.55±7.92) umol/l, and the control group was (42.95±7.92) umol/l, (38.89±5.93) umol/l. The differences between both groups were statistically significant (p<0.05). At 3 and 6 months of treatment, ET levels in the treatment group were (156.08±17.39) ng/l, (144.91±17.60) ng/l, and the control group was (150.48±22.94) ng/l, (135.04±10.08) ng/l. Correlation analysis showed that ADAS-cog score was negatively correlated with NO and ET (p<0.001). CONCLUSIONS: Dengzhan Shengmai capsule combined with donepezil hydrochloride can improve cognitive function and the living capacity of patients with Alzheimer's disease, reduce the production of neurotoxic substances NO and ET, and provide higher safety.


Assuntos
Doença de Alzheimer , Medicamentos de Ervas Chinesas , Doença de Alzheimer/tratamento farmacológico , Inibidores da Colinesterase , Cognição , Donepezila , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos
19.
Biomed Res Int ; 2021: 9935752, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34307676

RESUMO

Objectives: To investigate the clinical efficacy and safety of Shenxiong glucose injection combined with edaravone in the treatment of acute large-area cerebral infarction. Methods: 156 patients with acute large-area cerebral infarction admitted to our hospital from July 2015 to January 2017 were included in the analysis. The patients were randomly divided into experimental (78 cases) and control (78 cases) groups. Patients in the experimental group were given a 30 mg injection of edaravone in 100 ml of 0.9% sodium chloride solution by intravenous drip, twice a day within 30 minutes and a daily 200 ml injection of Shenxiong glucose by intravenous drip. Patients in the control group were given a 30 mg edaravone injection in 100 ml of 0.9% sodium chloride solution by intravenous drip, twice a day, and the drip was completed within 30 minutes. Patients in both groups were treated for 2 weeks. The levels of fibrinogen (FIB), D-dimer, interleukin 6 (IL-6), P-selectin (CD62P), and hypersensitive C-reactive protein (hs-CRP) were evaluated in the two groups of patients. Neurological disability was evaluated using the modified Rankin scale (mRS) and the neurological deficit score (National Institute of Health Stroke Scale, NIHSS). Adverse reactions to the treatments were also recorded. Results: No significant differences in age, gender, medical histories, and blood biochemical indices were observed between the two groups before treatment (P > 0.05). After treatment, the levels of FIB, D-dimer, IL-6, CD62P, and hs-CRP were significantly lower following treatment and compared to the control group (P < 0.05). Also, the mRS and NIHSS scores were significantly lower after treatment and compared with the control group (P < 0.05). The total effective rate of the treatment in the experimental group was significantly higher compared to the control group (P < 0.05). During the treatment period, no obvious adverse reactions were observed in the two groups of patients. Conclusions: In addition to the routine basic treatment of acute large-area cerebral infarction, the addition of Shenxiong glucose injection combined with edaravone injection can improve platelet aggregation and reduce inflammation by affecting P-selectin, D-dimer, and FIB. This treatment approach promotes the recovery of nerve defect function without obvious adverse reactions in patients with acute large-area cerebral infarction.


Assuntos
Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/uso terapêutico , Edaravone/uso terapêutico , Doença Aguda , Proteína C-Reativa/metabolismo , Infarto Cerebral/sangue , Infarto Cerebral/patologia , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/efeitos adversos , Edaravone/efeitos adversos , Edaravone/farmacologia , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Selectina-P/sangue , Selectina-P/metabolismo , Resultado do Tratamento
20.
Biosci Trends ; 15(4): 201-204, 2021 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-34193750

RESUMO

Traditional Chinese medicine (TCM) is a valuable form of medicine with a long history in China. It has played a significant role in the control and prevention of infectious diseases including SARS and H7N9 flu. After the outbreak of COVID-19, China's National Health Commission included TCM in the Diagnosis and Treatment Protocol for COVID-19. During the COVID-19 pandemic, three traditional Chinese medicines (Jinhua Qinggan granules, Lianhua Qingwen medicine, and a Xuebijing Injection) and three TCM preparations (a Qingfei Paidu decoction, a Huashi Baidu decoction, and a Xuanfei Baidu decoction) have been screened for their efficacy against COVID-19. More than 150 trials involving TCMs are registered in the Chinese Clinical Trial Registry (ChiCTR), and those trials cover prevention, treatment, recovery, and illnesses diagnosed in accordance with TCM principles. TCM can effectively alleviate the symptoms of patients with COVID-19, delay the disease's progression from mild to severe or critical, and reduce severe and critical all-cause mortality. The underlying mechanisms of TCM mainly involve action against SARS-CoV-2, anti-inflammatory and immunomodulatory action, and organ protection. The current work provides a brief description of the current status of and issues with TCM to treat this novel infectious disease. The hope is that TCM can help considerably to control this global epidemic.


Assuntos
COVID-19/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/uso terapêutico , Antivirais/efeitos adversos , Antivirais/uso terapêutico , China , Ensaios Clínicos como Assunto , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Medicina Tradicional Chinesa
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