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1.
Medicine (Baltimore) ; 99(40): e22231, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019397

RESUMEN

BACKGROUND: There is a worldwide outbreak of coronavirus disease 2019 (COVID-19), at present, accumulative attention has been paid to COVID-19 due to its global prevalence. Acupuncture may play a beneficial role in patients who suffer from COVID-19. In China and East Asia, acupuncture has been widely used to treat diverse diseases for thousands of years, as an important method of treatment now, it plays an indispensable role in the treatment of respiratory diseases in China. This study is designed to determine the efficacy and safety of acupuncture in COVID-19. METHODS: We will search the following sources for the Randomized controlled trials (RCT): The Cochrane Library, PubMed, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science, and the Wanfang Database. All the above databases will be searched from the available date of inception until the latest issue. No language or publication restriction will be used. Primary outcomes will include chest CT and nucleic acid detection of respiratory samples. RESULTS: The results will provide a high-quality synthesis of current evidence for researchers in this subject area. CONCLUSION: The conclusion of our study will provide evidence to evaluate whether acupuncture is an effective treatments for patients suffering from COVID-19. PROSPERO REGISTRATION NUMBER: CRD42020180875.


Asunto(s)
Terapia por Acupuntura/métodos , Betacoronavirus , Infecciones por Coronavirus/terapia , Neumonía Viral/terapia , Femenino , Humanos , Masculino , Metaanálisis como Asunto , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
2.
Cochrane Database Syst Rev ; 10: CD008359, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-33001448

RESUMEN

This Cochrane review has been withdrawn. The Cochrane review is out of date and included a retracted article in the analysis. Withdrawn by Cochrane Colorectal Group. A new update is expected. The editorial group responsible for this previously published document have withdrawn it from publication.


Asunto(s)
Antibacterianos/uso terapéutico , Apendicectomía/métodos , Apendicitis/tratamiento farmacológico , Apendicitis/cirugía , Enfermedad Aguda , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
5.
Trials ; 21(1): 827, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33008479

RESUMEN

OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Antivirales/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Medicina Kampo , Neumonía Viral/tratamiento farmacológico , Antivirales/efectos adversos , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Interacciones Huésped-Patógeno , Humanos , Japón , Masculino , Estudios Multicéntricos como Asunto , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
6.
BMJ Open ; 10(10): e044566, 2020 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-33020111

RESUMEN

OBJECTIVES: To analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics. DESIGN: We analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials. SETTING: Interventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit. PARTICIPANTS: 2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included. MAIN OUTCOME MEASURES: Proportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers. RESULTS: Analysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials. CONCLUSIONS: Feasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.


Asunto(s)
Investigación Biomédica , Infecciones por Coronavirus , Pandemias , Selección de Paciente , Neumonía Viral , Ensayos Clínicos Controlados Aleatorios como Asunto , Betacoronavirus/aislamiento & purificación , Investigación Biomédica/organización & administración , Investigación Biomédica/estadística & datos numéricos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Determinación de la Elegibilidad , Femenino , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Neumonía Viral/epidemiología , Neumonía Viral/terapia , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Reino Unido
7.
Trials ; 21(1): 828, 2020 Oct 06.
Artículo en Inglés | MEDLINE | ID: mdl-33023671

RESUMEN

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Asunto(s)
Anticuerpos Antivirales/sangre , Betacoronavirus , Infecciones por Coronavirus , Pandemias , Plasma/inmunología , Neumonía Viral , Anciano , Betacoronavirus/inmunología , Betacoronavirus/aislamiento & purificación , Ensayos Clínicos Fase II como Asunto , Convalecencia , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/terapia , Femenino , Humanos , Inmunización Pasiva/métodos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Estudios Multicéntricos como Asunto , Neumonía Viral/diagnóstico , Neumonía Viral/inmunología , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Ajuste de Riesgo , Índice de Severidad de la Enfermedad
8.
Medicine (Baltimore) ; 99(40): e22542, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019463

RESUMEN

BACKGROUND: The goal of this study was to review relevant randomized controlled trials or case-control studies to determine the clinical efficacy of minodronate in the treatment of osteoporosis. METHOD: The relevant studies were identified on PubMed, Cochrane, and Embase databases using appropriate keywords. Pertinent sources in the literature were also reviewed, and all articles published through October 2019 were considered for inclusion. For each study, we assessed odds ratios, mean difference, and 95% confidence interval (95% CI) to evaluate and synthesize outcomes. RESULT: Thirteen studies comprising 3740 patients were included in this study. Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD]: -13.669, 95% confidence interval [CI]: -23.108 to -4.229), bone alkaline phosphatase (BAP) (WMD: -1.26, 95% CI: -2.04 to -0.47) and tartrate-resistant acid phosphatase 5b (WMD: -154.11, 95% CI: -277.85 to -30.37). Minodronate combined with other drugs would significantly decrease BAP (WMD: -3.10, 95% CI: -5.20 to -1.00) than minodronate. Minodronate-naïve would significantly decrease BAP (WMD: -3.00, 95% CI: -5.47 to 0.53) and tartrate-resistant acid phosphatase 5b (WMD: -128.20, 95% CI: -198.11 to -58.29) than minodronate-switch. The incidence of vertebral fracture was significantly decreased in the minodronate group than the other drugs (relative risk: 0.520, 95% CI: 0.363-0.744). CONCLUSION: Minodronate has better clinical efficacy in the treatment of osteoporosis than other drugs (alendronate, risedronate, raloxifene, or eldecalcitol).


Asunto(s)
Difosfonatos/uso terapéutico , Imidazoles/uso terapéutico , Osteoporosis/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Alendronato/uso terapéutico , Fosfatasa Alcalina/efectos de los fármacos , Conservadores de la Densidad Ósea/uso terapéutico , Estudios de Casos y Controles , Colágeno Tipo I/efectos de los fármacos , Creatinina , Quimioterapia Combinada/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Clorhidrato de Raloxifeno/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Ácido Risedrónico/uso terapéutico , Fracturas de la Columna Vertebral/epidemiología , Fosfatasa Ácida Tartratorresistente/efectos de los fármacos , Resultado del Tratamiento , Vitamina D/análogos & derivados , Vitamina D/uso terapéutico
9.
Medicine (Baltimore) ; 99(40): e22547, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019465

RESUMEN

BACKGROUND: chronic low back pain (CLBP) are common symptoms bothering people in daily life. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for CLBP. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis. METHODS: According to the strategy, The authors will retrieve a total of 7 electronic databases by September 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for CLBP. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. RESULTS: This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of CLBP. CONCLUSION: This study will generate evidence for different TCM nonpharmacological therapies for CLBP and provide a decision-making reference for clinical research. ETHICS AND DISSEMINATION: This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/4H3Y9.


Asunto(s)
Dolor de la Región Lumbar/terapia , Medicina China Tradicional/métodos , Metaanálisis en Red , Acupresión/métodos , Terapia por Acupuntura/métodos , Toma de Decisiones Clínicas , Terapia con Ventosas/métodos , Bases de Datos Factuales , Humanos , Dolor de la Región Lumbar/psicología , Medicina China Tradicional/efectos adversos , Medicina China Tradicional/tendencias , Moxibustión/métodos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Seguridad , Tai Ji/métodos , Resultado del Tratamiento
10.
Medicine (Baltimore) ; 99(40): e22564, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019468

RESUMEN

BACKGROUND: At present, the prevalence of type 2 diabetes mellitus (T2DM) has become a major public health issue throughout the world, especially in developing countries. Notably, traditional Chinese patent medicines (TCPMs) are of great significance in the treatment of T2DM combined with conventional Western medicine therapy. However, there is a lack of comparison among all the current common TCPMs for treating T2DM. Therefore, this study intends to explore the efficacy and safety of different TCPMs against T2DM through the Bayesian network meta-analysis (NMA). METHODS: We will conduct a comprehensive and systematic search for randomized controlled trials (RCTs) of TCPM for the treatment of T2DM in both Chinese and English databases published till August 2020. Two researchers will be responsible for screening eligible literature, extracting data, and assessing the risk of bias of included studies independently. Then, pairwise meta-analyses and Bayesian network meta-analyses will be conducted to assess all available evidence. In the end, data will be analyzed using STATA15.0 and WinBUGS1.4.3 software. CONCLUSION: This study will compare the efficacy and safety of different TCPMs against T2DM in detail. Our findings will provide a reliable evidence for selecting clinical treatment program and guideline development of T2DM.


Asunto(s)
Diabetes Mellitus Tipo 2/terapia , Medicina China Tradicional/métodos , Medicamentos sin Prescripción/efectos adversos , Teorema de Bayes , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Humanos , Masculino , Metaanálisis en Red , Medicamentos sin Prescripción/uso terapéutico , Prevalencia , Ensayos Clínicos Controlados Aleatorios como Asunto , Seguridad , Resultado del Tratamiento
11.
Medicine (Baltimore) ; 99(40): e22586, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019475

RESUMEN

BACKGROUND: Neurodermatitis is a common inflammatory and allergic disease, characterized by itching and lichenification plaque. Some studies have reported cupping therapy (CT) for the treatment of neurodermatitis. However, the effectiveness and safety are still uncertain. This study aims to evaluate the efficacy and safety of CT for the treatment of patients with neurodermatitis. METHODS: We will retrieve the following electronic databases systematically: Pubmed, Web of Science, Embase, the Cochrane Library, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, and Wanfang database from their inception to December 2020. Other literature resources will be manually searched. Published randomized controlled trials (RCTs) and quasi-randomized controlled trials (q-RCTs) on the topic will be retrieved by 2 investigators independently. We will apply a fixed-effect model or random effect model basis on the heterogeneity test and employ with RevMan 5.3 software for data synthesis. The total clinical effective rate will be selected as the primary outcome, skin disease quality of life index score, recurrence rate, and adverse events as secondary outcomes. RESULTS: This study will comprehensively summarize the high-quality trials to determine the efficacy and safety of CT for the treatment of patients with neurodermatitis. CONCLUSION: Our systematic review will present evidence for the efficacy and safety of CT to neurodermatitis patients. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/6DCM3.


Asunto(s)
Terapia con Ventosas/métodos , Medicina China Tradicional/métodos , Neurodermatitis/terapia , Prurito/etiología , Protocolos Clínicos , Terapia con Ventosas/efectos adversos , Femenino , Humanos , Erupciones Liquenoides/etiología , Erupciones Liquenoides/patología , Masculino , Medicina China Tradicional/efectos adversos , Neurodermatitis/patología , Neurodermatitis/psicología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Seguridad , Resultado del Tratamiento
12.
Medicine (Baltimore) ; 99(40): e22588, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019476

RESUMEN

BACKGROUND: The objective of this meta-analysis was to summarize and identify the available evidence from studies to estimate the clinical value of traditional Chinese medicine (TCM) in the treatment of recurrent aphthous stomatitis (RAS) and provides clinicians with evidence on which to base their clinical decision making. METHODS: This review will include all studies comparing clinical efficacy of TCM in the treatment of RAS. The search strategy will be performed in 9 databases. We will not establish any limitations to language and publication status, published from inception to the August 2020. Two reviewers will screen, select studies, extract data, and assess quality independently. Outcome is clinical efficacy, pain relief, duration of wound healing, effect on wound healing, rate of recurrence, adverse events, and safety. The methodological quality including the risk of bias of the included studies will be evaluated. We will carry out statistical analysis using RevMan 5.3 software. RESULTS: This study will summarize current evidence to assess the efficacy and safety of TCM in the treatment of RAS. CONCLUSION: The findings of this study will provide helpful evidence for the clinician, and will promote further studies, as well as studying the value of TCM. REGISTRATION NUMBER: INPLASY202080126 (DOI number: 10.37766/inplasy2020.8.0126).


Asunto(s)
Medicina China Tradicional/métodos , Dimensión del Dolor/estadística & datos numéricos , Estomatitis Aftosa/terapia , China/epidemiología , Toma de Decisiones Clínicas , Femenino , Humanos , Incidencia , Masculino , Medicina China Tradicional/efectos adversos , Estudios Observacionales como Asunto , Dimensión del Dolor/efectos de los fármacos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Seguridad , Estomatitis Aftosa/epidemiología , Resultado del Tratamiento , Cicatrización de Heridas/efectos de los fármacos
13.
Medicine (Baltimore) ; 99(40): e22589, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33019477

RESUMEN

BACKGROUND: Trigeminal neuralgia (TN) is a disease accompanied by severe facial pain, which seriously affects the daily life of patients. Acupuncture is widely used by Traditional Chinese Medicine doctors to treat various painful diseases. Acupuncture combined with the treatment of trigeminal neuralgia can increase the analgesic effect and reduce side effects. However, there is still a lack of more quality multi-center clinical controlled trials and comprehensive meta-analysis, and a lack of more comprehensive and stronger evidence-based medical evidence. METHODS: The 2 reviewers used the same search strategy to search CNKI, PubMed, Web of Science, Cochrane Library, Scopus, EBSCO, and the search date is until July 19, 2020. Two people read the retrieved literatures independently, and then delete duplications. Then, use the "risk of bias" tool in Cochrane Handbook 5.2 to score. Only documents with a score greater than 5 can be included. Make a table of literature characteristics, extract baseline patient data, research methods and possible risks of bias in the literature, interventions in treatment and control groups, outcome evaluation indicators (BNI, VAS, ER and AE), and research funding support. Use Review Manager 5.3.5 for meta-analysis, use Stata 15 for regression analysis to find the source of heterogeneity, and then perform subgroup analysis to resolve the heterogeneity based on the corresponding source. RESULTS: The analysis of BNI, VAS, ER and AE data can provide high-quality evidence for high-quality synthesis and/or descriptive analysis of the effectiveness and safety of acupuncture treatment of various causes of urinary retention. CONCLUSION: This study can provide more comprehensive and strong evidence to prove whether acupuncture is effective and safe in the treatment of TN patients. REGISTRATION: The research has been registered and approved on the PROSPERO website. The registration number is CRD42019119606.


Asunto(s)
Terapia por Acupuntura/métodos , Medicina China Tradicional/métodos , Neuralgia del Trigémino/terapia , Terapia por Acupuntura/efectos adversos , Estudios de Evaluación como Asunto , Dolor Facial/etiología , Dolor Facial/terapia , Femenino , Humanos , Masculino , Medicina China Tradicional/efectos adversos , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Seguridad , Resultado del Tratamiento , Neuralgia del Trigémino/patología , Retención Urinaria/etiología , Escala Visual Analógica
14.
Medicine (Baltimore) ; 99(41): e22318, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031270

RESUMEN

INTRODUCTION: The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called "NO-boosters," which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS). METHODS: This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters. DISCUSSION: The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.


Asunto(s)
Arginina/administración & dosificación , Citrulina/administración & dosificación , Músculo Esquelético/irrigación sanguínea , Músculo Esquelético/diagnóstico por imagen , , Ultrasonografía/métodos , Adolescente , Adulto , Medios de Contraste , Estudios Cruzados , Suplementos Dietéticos , Método Doble Ciego , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Vasodilatación
15.
Medicine (Baltimore) ; 99(41): e22347, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031271

RESUMEN

INTRODUCTION: Type 2 diabetic mellitus (T2DM) is a chronic disease. In 2013, the International Diabetes Federation showed that the total number of diabetic patients aged 20 to 79 years in China was 89 million, and it is expected to increase to 143 million by 2035. The incidence of T2DM and its complications in patients with blood glucose is gradually increasing, and there are low awareness rate, low diagnosis rate and high disability rate, which has become a global public health problem. Microcirculation Dysfunction in Type 2 diabetic mellitus (MDT2DM) plays an important role in the development of diabetic nephropathy, diabetic retinopathy, diabetic neuropathy and diabetic foot disease. It is 1 of the common etiological mechanisms of diabetic chronic complications. Patients with MDT2DM, serious complications, increase the quality of life of patients with social impact. Diabetic lower extremity microcirculation disease (dlemd) is the main cause of the occurrence, development and difficult healing of diabetic foot. Microvascular disease is microcirculation dysfunction. It has been proved that Shenqi compound prescription can treat T2DM macrovascular disease and microvascular dysfunction. However, due to the lack of evidence and no specific methods or suggestions, it is necessary to conduct a systematic evaluation of Shenqi compound prescription to provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to August 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure. PRIMARY OUTCOMES:: superoxide dismutase, malondialdehyde, C-reactiveprotein, HOMA-IR, advanced glycation end products , FPG, 2hBG, glycosylated hemoglobinA1c, fasting insulin ; ADDITIONAL OUTCOMES:: low density lipoprotein, high density lipoprotein, triglycerides, total serum cholesterol. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of Shenqi compound prescription in treating patients with MDT2DM CONCLUSION:: The systematic review of this study will summarize the current published evidence of Shenqi compound prescription in the treatment of MDT2DM, and further guide its popularization and application. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: August 24, 2020.osf.io/es6z7. (https://osf.io/es6z7).


Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Medicamentos Herbarios Chinos , Microcirculación/efectos de los fármacos , Proyectos de Investigación , Humanos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Revisiones Sistemáticas como Asunto
16.
Medicine (Baltimore) ; 99(41): e22402, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031275

RESUMEN

BACKGROUND: Sulindac has been used for treating colorectal polyps widely. However, the efficacy and safety of sulindac for colorectal polyps are unclear. This study aims to evaluate the efficacy and safety of sulindac for colorectal polyps. METHODS: Randomized controlled trials of sulindac in the treatment of colorectal polyps will be searched in PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), WanFang, the Chongqing VIP Chinese Science, and Technology Periodical Database, and China biomedical literature database (CBM) from inception to August, 2020. And Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain more relevant studies comprehensively. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: This study will summarize the present evidence by exploring the efficacy and safety of sulindac in the treatment of colorectal polyps. CONCLUSION: The findings of the study will provide helpful evidence for the efficacy and safety of sulindac in the treatment of colorectal polyps, facilitating clinical practice and further scientific studies. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/N5GDH.


Asunto(s)
Antineoplásicos/uso terapéutico , Pólipos del Colon/tratamiento farmacológico , Sulindac/uso terapéutico , Antineoplásicos/efectos adversos , Humanos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Recto , Proyectos de Investigación , Sulindac/efectos adversos , Revisiones Sistemáticas como Asunto
17.
Medicine (Baltimore) ; 99(41): e22454, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031277

RESUMEN

BACKGROUND: The combined therapy of Chinese herbal formula and western medicine against gastroesophageal reflux disease (GERD) could significantly improve the clinical effect, reduce the recurrence rate and the side effects of western medicine, and even reduce the dosage and course of treatment of western medicine. This study tried to systematically evaluate the efficacy and safety traditional Chinese herbal formula combined with western medicine in the treatment of GERD. METHODS: Randomized controlled trials of traditional Chinese herbal formula combined with western medicine for GERD patients will be systematically searched using the PubMed, Embase, Medline, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database, Chongqing VIP Chinese Science and Technology Periodical Database, and Chinese Biological and Medical database (CMB) until Aug. 28, 2020. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: This study will summarize the present evidence by exploring the efficacy and safety of traditional Chinese herbal formula combined with western medicine in the treatment of GERD. CONCLUSIONS: The findings of the study will help to determine potential benefits of traditional Chinese herbal formula combined with western medicine against GERD. ETHICS AND DISSEMINATION: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/RSAVF.


Asunto(s)
Antiácidos/uso terapéutico , Medicamentos Herbarios Chinos/uso terapéutico , Reflujo Gastroesofágico/tratamiento farmacológico , Antagonistas de los Receptores Histamínicos H2/uso terapéutico , Inhibidores de la Bomba de Protones/uso terapéutico , Antiácidos/efectos adversos , Quimioterapia Combinada , Medicamentos Herbarios Chinos/efectos adversos , Antagonistas de los Receptores Histamínicos H2/efectos adversos , Humanos , Metaanálisis como Asunto , Inhibidores de la Bomba de Protones/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto
18.
Medicine (Baltimore) ; 99(41): e22520, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031293

RESUMEN

BACKGROUND: There is no consensus in existing literature on the pulse power, application time, frequency and the dose of energy of laser therapy for the patients. Therefore, we conducted this research for the assessment of safety and efficiency of ultrasound and high-intensity laser therapy (HILT) in the lumbar disc herniation (LDH) patients. METHODS: Our present research was approved by the institutional review board in the West China-Guangan Hospital. All the participants would acquire the written informed consent. From December 2020 to December 2021, we will conduct a prospective evaluation via a senior surgeon for 1 hundred LDH patients who plan to undergo the conservative treatment at our hospital. In this research, the inclusion criteria contained: the patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities; and the patients with sufficient psychological ability to understand and then answer the questions raised in assessment scale. The participants were randomly divided into the control group or HILT group after performing the examination of baseline. The main outcome was the pain score of visual analog scale. The other results contained the adverse effects, back range of motion as well as functional scores. CONCLUSIONS: We assumed that the HILT is as effective as the ultrasound therapy in treating pain for LDH. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5975).


Asunto(s)
Desplazamiento del Disco Intervertebral/cirugía , Terapia por Láser/métodos , Humanos , Desplazamiento del Disco Intervertebral/complicaciones , Desplazamiento del Disco Intervertebral/fisiopatología , Desplazamiento del Disco Intervertebral/terapia , Terapia por Láser/efectos adversos , Dolor de la Región Lumbar/etiología , Vértebras Lumbares , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Rango del Movimiento Articular , Terapia por Ultrasonido/efectos adversos
19.
Medicine (Baltimore) ; 99(41): e22539, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031296

RESUMEN

BACKGROUND: Clinical treatment of plaque psoriasis typically involves a comprehensive therapy, which is expensive and unsatisfactory, and some medications have serious side effects. Moving cupping therapy has shown good clinical efficacy in the treatment of plaque psoriasis; it can significantly relieve skin inflammation and excessive thickening of plaque psoriasis and has fewer side effects. However, a comprehensive evaluation of the current clinical evidence regarding its use is lacking. METHODS: Several databases were systematically searched from inception to March 2, 2020, including PubMed, Embase, Cochrane Central Register of Controlled Trials, China Network Knowledge Infrastructure, and Wan Fang. This review included randomized controlled trials on plaque psoriasis treatment with the use of moving cupping and in combination with Chinese herbs or conventional Western medicine therapy. These trial findings were compared with the treatment results using placebo, pharmaceutical medications, or Chinese herbs. Moving cupping treatment frequency was also compared. RESULTS: Sixteen trials with 1164 participants met the inclusion criteria. Meta-analysis showed that the intervention group (moving cupping therapy) had a significant effect compared with the no-moving cupping therapy group (weighted mean difference = -1.22, 95% confidence interval [CI] [-1.58, -0.85], P < .00001 random model; I = 85%). Furthermore, moving cupping (weighted mean difference = -1.19, 95% CI [-1.98, -0.39], P = .003 random model; I = 85%) or combined with pharmaceutical medications (weighted mean difference = -1.55, 95% CI [-1.89, -1.20], P < .00001 random model; I = 0%) were better than pharmaceutical medications alone in treating plaque psoriasis. Cupping therapy significantly improved psoriasis recurrence rate (risk ratio = 0.33, 95% CI [0.16, 0.68], P = .003 fixed model; I = 28%). However, for the visual analogue score, moving cupping showed no obvious advantages (weighted mean difference = -0.27, 95% CI [-0.71, 0.17], P = .22 random model; I = 64%). Moreover, studies reported that moving cupping reduced serum tumor necrosis factor-α and vascular endothelial growth factor levels more significantly than pharmaceutical medications. Moving cupping was associated with few transient adverse reactions, such as redness, itching, and local skin burning. CONCLUSION: Moving cupping therapy could be an effective treatment either alone or as a combination therapy for plaque psoriasis. However, further large-scale, rigorously designed trials are needed to confirm these findings.


Asunto(s)
Terapia con Ventosas , Psoriasis/terapia , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
20.
Medicine (Baltimore) ; 99(41): e22585, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031310

RESUMEN

BACKGROUND: Acute chronic liver failure (ACLF) is the most common type of liver failure. The clinical symptoms are complex and changeable, the treatment is difficult and the fatality rate is high. It has become an urgent problem to actively seek effective treatment means and improve the clinical efficacy of ACLF patients. Studies have shown that decreased intestinal barrier function and bacterial endotoxin translocation in ACLF patients are considered to be the key causes of enterogenic endotoxemia, and traditional Chinese medicine enema has certain advantages in adjuvant treatment of this disease. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on Traditional Chinese medicine enema for ACLF and provide effective evidence for further research. METHODS: We will search the following electronic databases from their inception to July 2020: Electronic database includes PubMed, Embase, Cochrane Library, Chinese Biomedical Database WangFang, VIP medicine information, and China National Knowledge Infrastructure. Primary outcomes: survival rates, TCM syndrome score. SECONDARY OUTCOMES: liver function (alanine aminotransferase, aspartic acid amino transferase, total bilirubin), blood coagulation function (prothrombin activity), adverse events. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of Traditional Chinese medicine enema for ACLF. CONCLUSION: The systematic review of this study will summarize the currently published evidence of Traditional Chinese medicine enema for ACLF to further guide its promotion and application.


Asunto(s)
Insuficiencia Hepática Crónica Agudizada/terapia , Enema , Medicina China Tradicional , Proyectos de Investigación , Humanos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Revisiones Sistemáticas como Asunto
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