The International Journal Of Risk & Safety In Medicine[JOURNAL]
Sun
200 papers
The effect of nebivolol on erectile function in the cases with coronary artery bypass surgery: A protocol for a systematic review and meta-analysis of randomized controlled trials.
Yang Y, Yong S, Li F … +2 more , Dong L, Chang D
Medicine (Baltimore) · 2020 Aug · PMID 32769911 · Full text
BACKGROUND: Erectile dysfunction is a common disease. It affects the quality of life of both husband and wife and its prevalence is higher in patients with overt cardiovascular disease or cardiovascular risk factors. In...
BACKGROUND: Erectile dysfunction is a common disease. It affects the quality of life of both husband and wife and its prevalence is higher in patients with overt cardiovascular disease or cardiovascular risk factors. In recent years, multiple studies confirm that nebivolol exerts protective effects on erectile function against the disruptive effects of cardiopulmonary bypass in patients undergoing coronary artery bypass grafting, but its quality and efficacy have not been systematically evaluated. Therefore, it is necessary to carry out a systematic review and meta-analysis to fully evaluate the efficacy and safety of nebivolol on erectile function in the cases with coronary artery bypass grafting. METHODS AND ANALYSIS: Chinese and English literature of nebivolol on erectile function in the cases with coronary artery bypass surgery published before August 31, 2020 will be comprehensive searched in PubMed, Cochrane Library, EMBASE, WANFANG, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journal Database, Chinese biomedical document service system, and Clinicaltrials.gov. Only randomized controlled trials that meet the eligibility criteria will be included. Two researchers will independently complete literature screening, data extraction and assess the risk of bias, and the third investigator will handle disagreements. Our main evaluation includes 2 outcome indicators including the international index of erectile function 5 score and adverse events. RevMan 5.3 and Stata 14.0 will be used to conduct this systematic review. The preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) statement is followed in this protocol and the PRISMA statement will be followed in the completed systematic review. CONCLUSION AND DISSEMINATION: The efficacy and safety of nebivolol on erectile function in the cases with coronary artery bypass grafting will be evaluated. We will publish the results of this systematic review in peer-reviewed journals to provide new evidence to clinicians. ETHICS AND DISSEMINATION: Ethical approval is not required as the review is a secondary study based on published literature. The results will be published in a public issue journal to provide evidence-based medical evidence for urologists and andrologists to make better clinical decisions. REGISTRATION INFORMATION: INPLASY202060110.
A comparison of the efficacy and safety of complementary and alternative therapies for premature ovarian insufficiency: A protocol for network meta-analysis.
Zhang L, Li H, Zhang J … +4 more , Kong X, Wu Z, Dong S, Qin X
Medicine (Baltimore) · 2020 Jul · PMID 32756205 · Full text
BACKGROUND: With the increase in the incidence of premature ovarian insufficiency (POI) over the years, the ovarian function has become one of the integral aspects of research in reproductive medicine today. POI seriousl...
BACKGROUND: With the increase in the incidence of premature ovarian insufficiency (POI) over the years, the ovarian function has become one of the integral aspects of research in reproductive medicine today. POI seriously affects the physical and mental health of women, especially reproductive health. Studies show both complementary and alternative therapies to be effective in treating POIs. However, consistency in conclusions is still far-fetched. In light of this, we will carry out a study to evaluate the effectiveness and safety of complementary and alternative therapies for POIs. We therefore develop a study protocol for a proposed network meta-analysis (NMA) and systematic review on POI. METHODS: The following electronic bibliographic database will be searched: VIP database, Wanfang database, Chinese National Knowledge Infrastructure (CNKI), The Cochrane Library, PubMed, EMBASE and Web of Science from inception till 31 December 2019. A search at the World Health Organization (WHO) International Clinical Trials Registry Platform will also be done. Subsequently, the searched data will undergo independent screening, retrieving, and risk of bias assessment by 2 reviewers. Analysis will be performed on included studies using the NMA technique. Next, the primary outcomes will be compared using ADDIS 1.16.5 and Stata 15.0. RESULTS: The safety and effectiveness of alternative and complementary therapies used in the treatment of POI will be compared and evaluated. CONCLUSION: This work will provide high-quality evidence for clinicians in the field to build on for best practices in effective interventions (complementary and alternative therapies) for POI. ETHICS AND DISSEMINATION: This NMA is a secondary research which based on some previously published data. Therefore, the ethical approval was not necessary. PROSPERO REGISTRATION NUMBER: CRD42020163873.
Efficacy and safety of acupuncture combined with western medicine for anxiety: A systematic review protocol.
Tan A, Wang M, Liu J … +5 more , Huang K, Dai D, Li L, Shi H, Wang P
Medicine (Baltimore) · 2020 Jul · PMID 32756161 · Full text
BACKGROUND: As a common clinical mental disorder, the prevalence rate of anxiety disorder increased yearly, devastating both physical health and social-economic prospect. The most common treatment relied on the use of we...
BACKGROUND: As a common clinical mental disorder, the prevalence rate of anxiety disorder increased yearly, devastating both physical health and social-economic prospect. The most common treatment relied on the use of western medications which is yet to fulfill ideal performance. While acupuncture is adopted as a treatment for anxiety disorders, the combination treatment of acupuncture and western medicines becomes more acknowledged. Albeit a spike in related literatures, the curative effect and safety of the treatment are still in lack of evidence. Therefore, this systematic review and meta-analysis protocol is planned to evaluate the efficacy and safety of the combination treatment of acupuncture and western medications. METHODS: Six English databases (PubMed, Web of science, Medline, EBASE, Springer Cochrane Library and WHO International Clinical Trials Registry Platform) and four Chinese databases (Wan fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database (CNKI) and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to June 1, 2020. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on the Hamilton Anxiety Scale (HANA) and the self-rating anxiety scale (SAS) will be used as the main outcome measure, quality of life scale (SF-36), changes of symptoms in TCM, hormone levels and clinical global impression (CGI) as the secondary outcome. treatment emergent symptom scale (TESS), general physical examination(temperature, pulse, respiration, blood pressure), Routine examination of blood, urine and stool, Electrocardiogram, Liver and kidney function examination as the security indexes. RevMan 5.3.5 will be used for meta-analysis. RESULTS: This study will provide high-quality evidence to assess the effectiveness and safety of acupuncture combined with western medicine for anxiety. CONCLUSION: This systematic review will explore whether acupuncture combined with western medicine is an effective and safe intervention for anxiety. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and will be shared on social media platforms. This review will be disseminated in a peer-reviewed journal or conference presentation. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020149746.
Eunkyosan for the common cold: A PRISMA-compliment systematic review of randomised, controlled trials.
Lee H, Kang B, Hong M … +3 more , Lee HL, Choi JY, Lee JA
Medicine (Baltimore) · 2020 Jul · PMID 32756141 · Full text
BACKGROUND: Eunkyosan (EKS), also known as the Yinqiaosan formula, is widely applied for the common cold in East Asia. Many clinical trials have reported the efficacy and safety of the EKS formula for the treatment of th...
BACKGROUND: Eunkyosan (EKS), also known as the Yinqiaosan formula, is widely applied for the common cold in East Asia. Many clinical trials have reported the efficacy and safety of the EKS formula for the treatment of the common cold. OBJECTIVES: This study aimed to assess the clinical evidence for and against the use of EKS formula as a treatment for the common cold. DATA SOURCES: The following databases were searched from inception to the present: MEDINLE, EMBASE, CENTRAL, AMED CINAHL for English articles; OASIS, the Korean Traditional Knowledge Portal, the Korean Studies Information Service System, KoreaMed, the Korean Medical Database and DBPIA); and 3 Chinese databases, including CNKI (i.e., the China Academic Journal, the China Doctoral Dissertations and Master's Theses Full-text Database, the China Proceedings of Conference Full-Text Database and the Century Journal Project), Wanfang and VIP. In addition, we searched a Japanese database and conduct non-electronic searches of conference proceedings. STUDY ELIGIBILITY CRITERIA: Prospective randomised controlled trials (RCTs) evaluating the effectiveness of EKS for the common cold were included in this review. PARTICIPANTS: All types of common colds were eligible for inclusion. Participants who had both the common cold and other conditions were excluded. There were no restrictions based on other factors, such as age, sex, or symptom severity. INTERVENTIONS: Studies that evaluated any type of formulation (ie, decoction, tablet, pill, powder) of EKS were eligible for inclusion. STUDY APPRAISAL AND SYNTHESIS METHODS: Differences between intervention and control groups were assessed. Mean differences with 95% confidence intervals (CIs) were used to measure the effects of treatment for continuous data. METHODS AND ANALYSIS: Fourteen databases were searched in March 2018. We included RCTs examining EKS decoctions for any type of common cold. All RCTs of decoctions or modified decoctions were included. The methodological qualities of the RCTs were assessed using the Cochrane Collaboration tool for assessing risk of bias; confidence in the cumulative evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. RESULTS: A total of 315 potentially relevant studies were identified, and 4 RCTs met our inclusion criteria. Four RCTs tested the effects of EKS on the common cold, and all RCTs showed that EKS was superior regarding the treatment effect. LIMITATIONS: All RCTs were conducted in China, and the generalisation of these results to other countries might be limited. Most trials did not use internationally recognised reliability and validity outcome measurements. Moreover, the result of the response rate can be distorted by the practitioner. Future trials in compliance with international standards in the evaluation of treatment effects may resolve this issue. CONCLUSION: Our systemic review and meta-analysis provides suggestive evidence of the superiority of EKS over other therapies for treating the common cold. The level of evidence is low because of the high risk of bias. IMPLICATIONS OF KEY FINDINGS: The results of this systematic review and meta-analysis provide suggestive evidence of the superiority of EKS alone or combined with conventional drugs. REGISTRATION NUMBER: CRD42018087694.
Stopping renin-angiotensin system blockers after acute kidney injury and risk of adverse outcomes: parallel population-based cohort studies in English and Swedish routine care.
Bidulka P, Fu EL, Leyrat C … +12 more , Kalogirou F, McAllister KSL, Kingdon EJ, Mansfield KE, Iwagami M, Smeeth L, Clase CM, Bhaskaran K, van Diepen M, Carrero JJ, Nitsch D, Tomlinson LA
BMC Med · 2020 Jul · PMID 32723383 · Full text
BACKGROUND: The safety of restarting angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) after acute kidney injury (AKI) is unclear. There is concern that previous users do not resta...
BACKGROUND: The safety of restarting angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) after acute kidney injury (AKI) is unclear. There is concern that previous users do not restart ACEI/ARB despite ongoing indications. We sought to determine the risk of adverse events after an episode of AKI, comparing prior ACEI/ARB users who stop treatment to those who continue. METHODS: We conducted two parallel cohort studies in English and Swedish primary and secondary care, 2006-2016. We used multivariable Cox regression to estimate hazard ratios (HR) for hospital admission with heart failure (primary analysis), AKI, stroke, or death within 2 years after hospital discharge following a first AKI episode. We compared risks of admission between people who stopped ACEI/ARB treatment to those who were prescribed ACEI/ARB within 30 days of AKI discharge. We undertook sensitivity analyses, including propensity score-matched samples, to explore the robustness of our results. RESULTS: In England, we included 7303 people with AKI hospitalisation following recent ACEI/ARB therapy for the primary analysis. Four thousand three (55%) were classified as stopping ACEI/ARB based on no prescription within 30 days of discharge. In Sweden, we included 1790 people, of whom 1235 (69%) stopped treatment. In England, no differences were seen in subsequent risk of heart failure (HR 1.10; 95% confidence intervals (CI) 0.93-1.30), AKI (HR 0.90; 95% CI 0.77-1.05), or stroke (HR 0.99; 95% CI 0.71-1.38), but there was an increased risk of death (HR 1.27; 95% CI 1.15-1.41) in those who stopped ACEI/ARB compared to those who continued. Results were similar in Sweden: no differences were seen in risk of heart failure (HR 0.91; 95% CI 0.73-1.13) or AKI (HR 0.81; 95% CI 0.54-1.21). However, no increased risk of death was seen (HR 0.94; 95% CI 0.78-1.13) and stroke was less common in people who stopped ACEI/ARB (HR 0.56; 95% CI 0.34-0.93). Results were similar across all sensitivity analyses. CONCLUSIONS: Previous ACEI/ARB users who continued treatment after an episode of AKI did not have an increased risk of heart failure or subsequent AKI compared to those who stopped the drugs.
The effectiveness and safety of acupuncture for allergic rhinitis: Protocol for an overview of systematic reviews and meta-analyses.
Yang J, Xiong J, Wang X … +6 more , Yuan T, Fu Y, Jiang Y, Zhou X, Liao K, Xu L
Medicine (Baltimore) · 2020 Jul · PMID 32702893 · Full text
BACKGROUND: Allergic rhinitis (AR) is one of the most common allergic disorders globally. Several systematic reviews and meta-analyses have reported the effectiveness of acupuncture for patients with AR. However, the evi...
BACKGROUND: Allergic rhinitis (AR) is one of the most common allergic disorders globally. Several systematic reviews and meta-analyses have reported the effectiveness of acupuncture for patients with AR. However, the evidence has not been systematically synthesized. This overview aims to map, synthesize, and assess the reliability of evidence generated from these systematic reviews (SRs) and meta-analyses of acupuncture for AR. METHODS: A Comprehensive literature search will be conducted through the PubMed, Embase, the Cochrane Library of Systematic Reviews, the China National Knowledge Infrastructure Database, Wanfang Database, Chinese Biomedical Literature Database, and Chinese Scientific Journal Database from inception until January 2020. Additionally, the PROSPERO database and the reference list of included studies will be searched for unpublished, ongoing, or recently completed SRs and meta-analyses. The reviewers will identify reviews independently and extract data according to the methodological guidelines for overviews provided by the Cochrane Collaboration. The risk of bias will be assessed based on the Risk of Bias in Systematic Reviews. The methodological and reporting quality of the included reviews will be assessed using the Assessing the Methodological Quality of Systematic Reviews (V.2) tool and the Preferred Reporting Items for Systematic Review and Meta-Analyses statement. The outcomes of interest include total nasal symptom score, rhinoconjunctivitis quality-of-life questionnaire, immunoglobulin E, visual analog scale, laboratory examination, and side effects. The quality of evidence of outcomes will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation. The evidence will be synthesized where appropriate based on patient subgroups and outcomes. ETHICS AND DISSEMINATION: Ethical approval is not required for overviews. We plan to publish results in peer-reviewed journals and present at international and national academic, clinical, and patient conferences. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSION: This overview will provide comprehensive evidence of acupuncture for patients with AR. PROSPERO REGISTRATION NUMBER: CRD42019140756.
Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: A systematic review and meta-analysis.
Cicero AFG, Fogacci F, Hernandez AV … +2 more , Banach M, Lipid and Blood Pressure Meta-Analysis Collaboration (LBPMC) Group and the International Lipid Expert Panel (ILEP)
PLoS Med · 2020 Jul · PMID 32673317 · Full text
BACKGROUND: Bempedoic acid is a first-in-class lipid-lowering drug recommended by guidelines for the treatment of hypercholesterolemia. Our objective was to estimate its average effect on plasma lipids in humans and its...
BACKGROUND: Bempedoic acid is a first-in-class lipid-lowering drug recommended by guidelines for the treatment of hypercholesterolemia. Our objective was to estimate its average effect on plasma lipids in humans and its safety profile. METHODS AND FINDINGS: We carried out a systematic review and meta-analysis of phase II and III randomized controlled trials on bempedoic acid (PROSPERO: CRD42019129687). PubMed (Medline), Scopus, Google Scholar, and Web of Science databases were searched, with no language restriction, from inception to 5 August 2019. We included 10 RCTs (n = 3,788) comprising 26 arms (active arm [n = 2,460]; control arm [n = 1,328]). Effect sizes for changes in lipids and high-sensitivity C-reactive protein (hsCRP) serum concentration were expressed as mean differences (MDs) and 95% confidence intervals (CIs). For safety analyses, odds ratios (ORs) and 95% CIs were calculated using the Mantel-Haenszel method. Bempedoic acid significantly reduced total cholesterol (MD -14.94%; 95% CI -17.31%, -12.57%; p < 0.001), non-high-density lipoprotein cholesterol (MD -18.17%; 95% CI -21.14%, -15.19%; p < 0.001), low-density lipoprotein cholesterol (MD -22.94%; 95% CI -26.63%, -19.25%; p < 0.001), low-density lipoprotein particle number (MD -20.67%; 95% CI -23.84%, -17.48%; p < 0.001), apolipoprotein B (MD -15.18%; 95% CI -17.41%, -12.95%; p < 0.001), high-density lipoprotein cholesterol (MD -5.83%; 95% CI -6.14%, -5.52%; p < 0.001), high-density lipoprotein particle number (MD -3.21%; 95% CI -6.40%, -0.02%; p = 0.049), and hsCRP (MD -27.03%; 95% CI -31.42%, -22.64%; p < 0.001). Bempedoic acid did not significantly modify triglyceride level (MD -1.51%; 95% CI -3.75%, 0.74%; p = 0.189), very-low-density lipoprotein particle number (MD 3.79%; 95% CI -9.81%, 17.39%; p = 0.585), and apolipoprotein A-1 (MD -1.83%; 95% CI -5.23%, 1.56%; p = 0.290). Treatment with bempedoic acid was positively associated with an increased risk of discontinuation of treatment (OR 1.37; 95% CI 1.06, 1.76; p = 0.015), elevated serum uric acid (OR 3.55; 95% CI 1.03, 12.27; p = 0.045), elevated liver enzymes (OR 4.28; 95% CI 1.34, 13.71; p = 0.014), and elevated creatine kinase (OR 3.79; 95% CI 1.06, 13.51; p = 0.04), though it was strongly associated with a decreased risk of new onset or worsening diabetes (OR 0.59; 95% CI 0.39, 0.90; p = 0.01). The main limitation of this meta-analysis is related to the relatively small number of individuals involved in the studies, which were often short or middle term in length. CONCLUSIONS: Our results show that bempedoic acid has favorable effects on lipid profile and hsCRP levels and an acceptable safety profile. Further well-designed studies are needed to explore its longer-term safety.
Safety of psychotropic medications in people with COVID-19: evidence review and practical recommendations.
Ostuzzi G, Papola D, Gastaldon C … +19 more , Schoretsanitis G, Bertolini F, Amaddeo F, Cuomo A, Emsley R, Fagiolini A, Imperadore G, Kishimoto T, Michencigh G, Nosé M, Purgato M, Dursun S, Stubbs B, Taylor D, Thornicroft G, Ward PB, Hiemke C, Correll CU, Barbui C
BMC Med · 2020 Jul · PMID 32664944 · Full text
BACKGROUND: The novel coronavirus pandemic calls for a rapid adaptation of conventional medical practices to meet the evolving needs of such vulnerable patients. People with coronavirus disease (COVID-19) may frequently...
BACKGROUND: The novel coronavirus pandemic calls for a rapid adaptation of conventional medical practices to meet the evolving needs of such vulnerable patients. People with coronavirus disease (COVID-19) may frequently require treatment with psychotropic medications, but are at the same time at higher risk for safety issues because of the complex underlying medical condition and the potential interaction with medical treatments. METHODS: In order to produce evidence-based practical recommendations on the optimal management of psychotropic medications in people with COVID-19, an international, multi-disciplinary working group was established. The methodology of the WHO Rapid Advice Guidelines in the context of a public health emergency and the principles of the AGREE statement were followed. Available evidence informing on the risk of respiratory, cardiovascular, infective, hemostatic, and consciousness alterations related to the use of psychotropic medications, and drug-drug interactions between psychotropic and medical treatments used in people with COVID-19, was reviewed and discussed by the working group. RESULTS: All classes of psychotropic medications showed potentially relevant safety risks for people with COVID-19. A set of practical recommendations was drawn in order to inform frontline clinicians on the assessment of the anticipated risk of psychotropic-related unfavorable events, and the possible actions to take in order to effectively manage this risk, such as when it is appropriate to avoid, withdraw, switch, or adjust the dose of the medication. CONCLUSIONS: The present evidence-based recommendations will improve the quality of psychiatric care in people with COVID-19, allowing an appropriate management of the medical condition without worsening the psychiatric condition and vice versa.
Association of early vertebroplasty with risk of hip replacement: A nationwide population-based cohort study in Taiwan.
Li CZ, Li CC, Tang CT … +11 more , Chung CH, Ou CY, Chen CL, Chen NF, Chung TT, Hueng DY, Ma HI, Liu MY, Chen YH, Chien WC, Ju DT
Medicine (Baltimore) · 2020 Jul · PMID 32629691 · Full text
Studies show that vertebral fractures could predict the risk of hip fractures. We aimed to evaluate the potential benefits of whether the timing of vertebroplasty (VP) for vertebral fracture associated with the risk of h...
Studies show that vertebral fractures could predict the risk of hip fractures. We aimed to evaluate the potential benefits of whether the timing of vertebroplasty (VP) for vertebral fracture associated with the risk of hip fracture for hip replacement.We identified 142,782 patients from the Taiwan National Health Insurance Database with thoracolumbar vertebral fracture (International Classification of Diseases, Ninth Revision, Clinical Modification:805.2-805.9) who were followed up from 2000 to 2013. These patients were divided into those who underwent VP (VP group) (International Classification of Diseases, Ninth Revision, Clinical Modification : 78.49) within 3 months and those who did not (non-VP group). After adjusting for the confounding factors, the Cox proportional hazards analysis was used to estimate the effect of early VP on reducing the risk of hip fracture. The difference in the risk of hip replacement, between the VP group and non-VP group was estimated using the Kaplan-Meier method with the log-rank test.In the 14-year follow-up, the cumulative incidence rate of hip replacement in the VP group was lower than that in the non-VP group (0.362% and 0.533%, respectively, long-rank P < .001). There was a significant difference between the 2 groups since the first-year follow-up.Our study showed that early VP performed to avoid progression of the kyphotic changes following thoracolumbar vertebral fracture may reduce the risk of hip fracture. These results, obtained from retrospective data, indicate that a prospective study is warranted.
Effect of acupuncture on chronic bronchitis: A protocol for systematic review and meta-analysis.
Mao D, Deng Y, Zhang L … +3 more , Zhao Y, Li Y, Wang F
Medicine (Baltimore) · 2020 Jun · PMID 32541514 · Full text
INTRODUCTION: Chronic bronchitis (CB) is a clinically common and recurrent respiratory disease. However, many trials have shown that acupuncture can effectively treat CB. There is currently no systematic review of this t...
INTRODUCTION: Chronic bronchitis (CB) is a clinically common and recurrent respiratory disease. However, many trials have shown that acupuncture can effectively treat CB. There is currently no systematic review of this therapy. The plan is to evaluate the effectiveness and safety of this treatment in patients with CB. METHODS AND ANALYSIS: This systematic evaluation will entail an electronic and manual search of all acupuncture for CB from inception to December 31, 2020, regardless of the publication status or language. Databases include PubMed, Embase, Springer, Web of Science, the Cochrane Library, the World Health Organization International Clinical Trial Registration Platform, the Chinese Medicine Database, the China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the China Science Journal Database, and the Wanfang Database. Other sources of information, including bibliographies and meeting minutes for identified publications, will also be searched. A manual search for grey literature, including unpublished conference articles will be performed. Additionally, any clinical randomized controlled trials related to acupuncture for CB, regardless of the publication status and language limitations, will be included in the study. Study selection, data extraction, and research quality assessments will be conducted independently by 2 researchers. The main result was the Change in cystic fibrosis transmembrane conductance regulator function as measured by sweat chloride analysis or treatment effect. Secondary outcomes included Quality of life (eg, SF-36), change in Breathlessness, Cough, and Sputum Scale score, follow-up relapse rate, and adverse events. The system searches for randomized controlled trials of this therapy for CB. Implement the Cochrane RevMan V5.3 bias assessment tool to assess bias risk, data integration risk, meta-analysis risk, and subgroup analysis risk (if conditions are met). Mean difference, standard mean deviation, and binary data will be used to represent continuous results. RESULTS: This study will provide a comprehensive review and evaluation of the available evidence for the treatment of CB using this therapy. CONCLUSION: This study will provide new evidence to evaluate the effectiveness and side effects of acupuncture on CB. Because the data are not personalized, no formal ethical approval is required. PROSPERO REGISTRATION NUMBER: CRD42020170287.
Effect of Chinese medicine prescription on nephrotic syndrome: A protocol for systematic review and meta-analysis.
Deng Y, Zhang L, Wen A … +9 more , Xu D, Wang W, Hou Y, Liu Z, Yang L, Shen T, Luo Q, Wu W, Ou Y
Medicine (Baltimore) · 2020 Jun · PMID 32502039 · Full text
BACKGROUND: Nephrotic syndrome (NS) is a common chronic recurrent kidney disease. Many trials have shown that Chinese medicine prescription (CMP) can effectively treat NS. The program aims to evaluate the efficacy and sa...
BACKGROUND: Nephrotic syndrome (NS) is a common chronic recurrent kidney disease. Many trials have shown that Chinese medicine prescription (CMP) can effectively treat NS. The program aims to evaluate the efficacy and safety of CMP for NS. METHODS: This systematic evaluation will entail an electronic and manual search of all CMP for NS from inception to February, 2020, regardless of the publication status or language. Databases include PubMed, Embase, Springer, Web of Science, the Cochrane Library, the World Health Organization International Clinical Trial Registration Platform, the Chinese Medicine Database, the China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the China Science Journal Database, and the Wanfang Database. Other sources of information, including bibliographies and meeting minutes for identified publications, will also be searched. A manual search for grey literature, including unpublished conference articles will be performed. Additionally, any clinical randomized controlled trials related to CMP for NS, regardless of the publication status and language limitations, will be included in the study. Study selection, data extraction, and research quality assessments will be conducted independently by 2 researchers. The main result was the total clinical efficacy rate or other validated scales after at least 2 weeks of treatment. Secondary outcomes included 24-hour urine protein quantification, blood urea nitrogen, serum creatinine, C-reactive protein, tumor necrosis factor-α, and interleukin 6, recurrence rates and adverse events during follow-up. Implement the Cochrane RevMan V5.3 bias assessment tool to assess bias risk, data integration risk, meta-analysis risk, and subgroup analysis risk (if conditions are met). Mean difference, standard mean deviation and binary data will be used to represent continuous results. RESULTS: This study will provide a comprehensive review and evaluation of CMP for the treatment of NS. CONCLUSION: This study will provide new evidence for evaluating the effectiveness and side effects of CMP on NS. Since the data is not personalized, formal ethical approval is not required. INPLASY REGISTRATION NUMBER: INPLASY202040181.
Acupuncture and manual therapy for rotator cuff tears: A protocol for systematic review and meta analysis.
Tang H, Luo F, Fan H … +6 more , Huang L, Liao S, Yu W, Chen Y, Qin X, Chen J
Medicine (Baltimore) · 2020 May · PMID 32481335 · Full text
BACKGROUND: The tears of rotator cuff is caused by the tears or aseptic inflammation of tendon tissue such as subscapular muscle, supraspinatus muscle, infraspinatus muscle, teres minor muscle, and so on, which make up t...
BACKGROUND: The tears of rotator cuff is caused by the tears or aseptic inflammation of tendon tissue such as subscapular muscle, supraspinatus muscle, infraspinatus muscle, teres minor muscle, and so on, which make up the rotator cuff. Managements of rotator cuff disease often include acupuncture and manual therapy, usually delivered together. The aim of this review is to assess the effectiveness and safety of such interventions in patients with pain and dysfunction caused by rotator cuff tears. METHODS: We will search the EMBASE, the Cochrane Library, Ovid MEDLINE, PubMed, Web of Science, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Wanfang Database, the Chongqing VIP, the US National Institute of Health, the NIH clinical registry Clinical Trials, the International Clinical Trials Registry Platform, the Australian New Zealand Clinical Trials Registry and the Chinese clinical registry, from their inception to April 1, 2020. Randomized controlled trials that include patients with rotator cuff tears receiving acupuncture and manual therapy versus a control group will be included. The selection of studies, data extraction and risk of bias assessment will be conducted by 2 independent researchers. A third review author will resolve disagreements. The dichotomous data will be presented as risk ratios with 95% CIs and the continuous data will be presented as weighted mean differences or standardized mean differences with 95% CIs. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. DISCUSSION: This systematic review will provide updated evidence of various types of acupuncture and manual therapy specifically focuses on its effectiveness and safety for patients' pain and dysfunction caused by rotator cuff tears. ETHICS AND DISSEMINATION: Ethical approval is not necessary as this review will not require data from individual patients. The results of this will be published through peer-reviewed journal articles or conference presentations. REGISTRATION: Open Science Framework Preregistration. Registration number 10.17605/OSF.IO/M3NKV.
Development and validation of a multivariable prediction model for infection-related complications in patients with common infections in UK primary care and the extent of risk-based prescribing of antibiotics.
Mistry C, Palin V, Li Y … +5 more , Martin GP, Jenkins D, Welfare W, Ashcroft DM, van Staa T
BMC Med · 2020 May · PMID 32434588 · Full text
BACKGROUND: Antimicrobial resistance is driven by the overuse of antibiotics. This study aimed to develop and validate clinical prediction models for the risk of infection-related hospital admission with upper respirator...
BACKGROUND: Antimicrobial resistance is driven by the overuse of antibiotics. This study aimed to develop and validate clinical prediction models for the risk of infection-related hospital admission with upper respiratory infection (URTI), lower respiratory infection (LRTI) and urinary tract infection (UTI). These models were used to investigate whether there is an association between the risk of an infection-related complication and the probability of receiving an antibiotic prescription. METHODS: The study used electronic health record data from general practices contributing to the Clinical Practice Research Datalink (CPRD GOLD) and Welsh Secure Anonymised Information Linkage (SAIL), both linked to hospital records. Patients who visited their general practitioner with an incidental URTI, LRTI or UTI were included and followed for 30 days for hospitalisation due to infection-related complications. Predictors included age, gender, clinical and medication risk factors, ethnicity and socioeconomic status. Cox proportional hazards regression models were used with predicted risks independently validated in SAIL. RESULTS: The derivation and validation cohorts included 8.1 and 2.7 million patients in CPRD and SAIL, respectively. A total of 7125 (0.09%) hospital admissions occurred in CPRD and 7685 (0.28%) in SAIL. Important predictors included age and measures of comorbidity. Initial attempts at validating in SAIL (i.e. transporting the models with no adjustment) indicated the need to recalibrate the models for age and underlying incidence of infections; internal bootstrap validation of these updated models yielded C-statistics of 0.63 (LRTI), 0.69 (URTI) and 0.73 (UTI) indicating good calibration. For all three infection types, the rate of antibiotic prescribing was not associated with patients' risk of infection-related hospital admissions. CONCLUSION: The risk for infection-related hospital admissions varied substantially between patients, but prescribing of antibiotics in primary care was not associated with risk of hospitalisation due to infection-related complications. Our findings highlight the potential role of clinical prediction models to help inform decisions of prescribing of antibiotics in primary care.
Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial.
Murray LK, Kane JC, Glass N … +8 more , Skavenski van Wyk S, Melendez F, Paul R, Kmett Danielson C, Murray SM, Mayeya J, Simenda F, Bolton P
PLoS Med · 2020 Apr · PMID 32302308 · Full text
BACKGROUND: Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to add...
BACKGROUND: Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia. METHODS AND FINDINGS: This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (-4.5, 95% CI -6.9 to -2.2, p < 0.001, Cohen's d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes. CONCLUSIONS: Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT02790827).
Effect of auriculotherapy on chronic low back pain: A protocol for systematic review and meta-analysis.
Zhang G, Zhang L, Deng Y … +3 more , Shen Y, Wang X, Yu Y
Medicine (Baltimore) · 2020 Apr · PMID 32243410 · Full text
BACKGROUND: Chronic low back pain (CLBP) is a clinically common and recurrent disease. However, many trials have shown that auriculotherapy (AT) can effectively treat CLBP. There are currently no systematic reviews of th...
BACKGROUND: Chronic low back pain (CLBP) is a clinically common and recurrent disease. However, many trials have shown that auriculotherapy (AT) can effectively treat CLBP. There are currently no systematic reviews of this therapy. The plan aims to evaluate the effectiveness and safety of this treatment in patients with CLBP. METHODS: This systematic evaluation will entail an electronic and manual search of all AT for CLBP from inception to January 31, 2020, regardless of the publication status or language. Databases include PubMed, Excerpt Medica Database, Springer, Web of Science, the Cochrane Library, the World Health Organization International Clinical Trial Registration Platform, the Chinese Medicine Database, the China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the China Science Journal Database, and the Wanfang Database. Other sources of information, including bibliographies and meeting minutes for identified publications, will also be searched. A manual search for grey literature, including unpublished conference articles will be performed. Additionally, any clinical randomized controlled trials related to AT for CLBP, regardless of the publication status and language limitations, will be included in the study. Study selection, data extraction, and research quality assessments will be conducted independently by 2 researchers. The main result was the use of a visual analog scale, a short pain scale, or other effective scale. Secondary outcomes included effectiveness, Oswestry dysfunction index, self-rating anxiety scale, self-depression rating scale, Pittsburgh sleep quality index, follow-up relapse rate, and adverse events. The system searches for randomized controlled trials of this therapy for CLBP. Implement the Cochrane RevMan V5.3 bias assessment tool to assess bias risk, data integration risk, meta-analysis risk, and subgroup analysis risk (if conditions are met). Mean difference, standard mean deviation, and binary data will be used to represent continuous results. RESULTS: This study will provide a comprehensive review and evaluation of the available evidence for the treatment of CLBP using this therapy. CONCLUSION: This study will provide new evidence to evaluate the effectiveness and side effects of AT on CLBP. Because the data is not personalized, no formal ethical approval is required. PROSPERO REGISTRATION NUMBER: CRD42020151584.
Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study.
Luo J, Zheng J, Shi C … +30 more , Fang J, Peng Z, Huang J, Sun J, Zhou G, Li T, Zhu D, Xu H, Hou Q, Ying S, Sun Z, Du H, Xie X, Cao G, Ji W, Han J, Gu W, Guo X, Shao G, Yu Z, Zhou J, Yu W, Zhang X, Li L, Hu H, Hu T, Wu X, Chen Y, Ji J, Hu W
Medicine (Baltimore) · 2020 Mar · PMID 32195932 · Full text
This study aimed to investigate the efficacy and safety of drug-eluting beads (DEB) transarterial chemoembolization (TACE) treatment in Chinese intrahepatic cholangiocarcinoma (ICC) patients.37 ICC patients underwent DEB...
This study aimed to investigate the efficacy and safety of drug-eluting beads (DEB) transarterial chemoembolization (TACE) treatment in Chinese intrahepatic cholangiocarcinoma (ICC) patients.37 ICC patients underwent DEB-TACE treatment in CTILC study (registered on clinicaltrials.gov with registry No. NCT03317483) were included in this present study. Treatment response was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Overall survival (OS) was calculated from the time of DEB-TACE operation until the date of death from any causes. Liver function change and adverse events (AEs) were recorded during and after DEB-TACE operation.3 (8.1%) patients achieved complete response (CR) and 22 (59.5%) patients achieved partial response (PR), with objective response rate (ORR) of 67.6%. After DEB-TACE treatment, mean OS was 376 days (95%CI: 341-412 days). Multivariate logistic regression analysis revealed that Bilobar disease (P = .040, OR: 0.105, 95% CI: 0.012-0.898) and portal vein invasion (P = .038, OR: 0.104, 95% CI: 0.012-0.881) could independently predict less possibility of ORR. Patients with ALB abnormal, TP abnormal, ALT abnormal and AST abnormal were increased at 1-week post DEB-TACE treatment (P = .034, P = .001, P < .001, P = .006, respectively), while returned to the levels at baseline after 1 to 3 months (all P > .050). Besides, most of the AEs were mild including pain, fever, vomiting, and nausea in this study.DEB-TACE was effective and well tolerated in treating ICC patients, and bilobar disease as well as portal vein invasion were independently correlated with less probability of ORR achievement.
Effectiveness and safety of acupuncture in post-stroke depression (PSD): Protocol for a Bayesian analysis.
Chen B, Zhao M, Chen B … +4 more , Yang Z, Yu X, Lin X, Fan C
Medicine (Baltimore) · 2020 Mar · PMID 32195928 · Full text
BACKGROUND: Post-stroke depression (PSD) is the most common emotional problem after stroke. It can lower the quality of life and increase the recurrence and mortality. Pharmacological agents have been shown to treat PSD....
BACKGROUND: Post-stroke depression (PSD) is the most common emotional problem after stroke. It can lower the quality of life and increase the recurrence and mortality. Pharmacological agents have been shown to treat PSD. However, the benefits of pharmacotherapy are debatable and the side-effects are significant. More and more clinical trials suggest that acupuncture plays an important role in patients with PSD. The primary purposes of the study are to conduct a Bayesian analysis of randomized trials to determine the effect of acupuncture and investigate the effect of several acupuncture therapies on PSD. METHODS: We will retrieve articles from 5 English databases [PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials, and WHO International Clinical Trials Registry (TCTRP)] and 4 Chinese databases [Chinese National Knowledge Infrastructure (CNKI), Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database (CBM)]. The publication period will be from inception to January 2019. All randomized controlled trials that evaluate the safety and efficacy of acupuncture on PSD will be included. The primary outcomes will be the change in the degree of depression as measured by the Hamilton Depression Scale and Beck Depression Inventory. Two reviewers will separately extract the data and assess the risk of bias by using the Cochrane Collaboration's risk of bias tool. Bayesian analysis will be conducted to pool the effects of several acupunctures. The ranking probabilities for several acupunctures (simple acupuncture, fire needle, warm acupuncture, auriculo-acupuncture, or electroacupuncture) will be estimated by the surface under the cumulative ranking curve. RESULT: This study will provide reliable evidence for acupuncture on PSD. CONCLUSION: The results of this review will introduce a safe and effective treatment and provide reliable evidence to evaluate the effectiveness of several acupuncture therapies on PSD. TRIAL REGISTRATION NUMBER: CRD42019132725.
Platelet-rich plasma versus hyaluronic acid in the treatment of knee osteoarthritis: A meta-analysis.
Chen Z, Wang C, You D … +3 more , Zhao S, Zhu Z, Xu M
Medicine (Baltimore) · 2020 Mar · PMID 32176063 · Full text
BACKGROUND: This meta-analysis focuses on the controversial efficacy and safety of platelet-rich plasma (PRP) as compared with hyaluronic acid (HA) in the clinical treatment of knee osteoarthritis. We have attempted to p...
BACKGROUND: This meta-analysis focuses on the controversial efficacy and safety of platelet-rich plasma (PRP) as compared with hyaluronic acid (HA) in the clinical treatment of knee osteoarthritis. We have attempted to provide an evidence-based medicine protocol for the conservative treatment of knee osteoarthritis. In addition, we included the latest relevant literature in this meta-analysis, and a staging study was conducted to compare the therapeutic effects of PRP and HA for knee osteoarthritis over different time periods. METHODS: An online computer search with "platelet-rich plasma" and "knee osteoarthritis" as search terms was conducted in the PubMed, EMBASE, and Cochrane Library databases. We conducted a quality assessment of the retrieved literature and extracted the following indicators: visual analog scale (VAS) score, subjective International Knee Documentation Committee (IKDC) score, Western Ontario and McMaster Universities (WOMAC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), and adverse events. RevMan5.3 software was used to determine the effect sizes, and indicators were compared across studies at three different time points from the administration of treatment. RESULTS: A total of 14 randomized controlled trials (RCTs) involving 1350 patients were included. Long-term VAS, IKDC, WOMAC-Pain, WOMAC-Stiffness, WOMAC-Physical Function, and WOMAC-Total scores at each time point were higher in the PRP group than in the HA group. There were no significant differences in the remaining indicators between the two groups. CONCLUSION: Compared with HA, PRP offers obvious advantages in the conservative treatment of knee osteoarthritis. Treatment with PRP can reduce long-term pain and improve knee joint function with no additional risks. Therefore, PRP can be widely used for the conservative treatment of knee osteoarthritis.
Apatinib combined with chemotherapy or concurrent chemo-brachytherapy in patients with recurrent or advanced cervical cancer: A phase 2, randomized controlled, prospective study.
Guo Q, Sun Y, Kong E … +7 more , Rao L, Chen J, Wu Q, Zhang T, Liu N, Li M, Sun L
Medicine (Baltimore) · 2020 Mar · PMID 32176061 · Full text
OBJECTIVE: Apatinib mesylate is a novel vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor, which has exhibited good safety and efficacy in several types of solid tumors. The present study aimed to assess...
OBJECTIVE: Apatinib mesylate is a novel vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor, which has exhibited good safety and efficacy in several types of solid tumors. The present study aimed to assess the clinical efficacy and safety of apatinib combined with chemotherapy and concurrent chemo-brachytherapy (CCBT) in patients with recurrent and advanced cervical cancer. METHODS: A total of 52 patients with first diagnosed recurrent or untreated International Federation of Gynecology and Obstetrics stage IVB cervical cancer admitted at Shandong Cancer Hospital and Institute between July 2016 and May 2018 were analyzed in the current randomized controlled trial. The patients were randomly divided into 2 groups: the apatinib-treated group and the control group. Patients with recurrent cervical cancer in the apatinib-treated group were administered apatinib and carboplatin-paclitaxel as first-line chemotherapy. Patients with advanced cervical cancer were administered apatinib in combination with CCBT. In control group, patients with recurrent cervical cancer were treated with chemotherapy alone while patients with advanced cervical cancer received CCBT. RESULTS: The progression-free survival was significantly prolonged in apatinib group compared with control group (10.1 months; 95% confidence interval (CI), 8.42-11.79 vs 6.4 months; 95% CI, 3.88-8.92; P < .01; hazard ratio (HR), 0.44; 95% CI, 0.25-0.78; P < .01). The objective response rate in apatinib group was obviously higher than that in control group (64.3% vs 33.3%, P < .05). Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group. Apatinib did not obviously aggravate other radiotherapy or chemotherapy side effects. CONCLUSION: Apatinib exhibited promising clinical efficacy in cervical cancer patients, resulting in an improved response rate and prolonged progression-free survival compared with the control group, and had manageable side effects. Our study revealed that apatinib combination therapy, adenocarcinoma, and bone metastasis.
Tuina for periarthritis of shoulder: A systematic review protocol.
Ai J, Dong Y, Tian Q … +2 more , Wang C, Fang M
Medicine (Baltimore) · 2020 Mar · PMID 32176055 · Full text
BACKGROUND: Periarthritis of shoulder (PAS) symptom is one of the leading causes prompting many patients to seek treatment. Tuina is a common treatment for PAS in China. But at present, there is no systematic evaluation...
BACKGROUND: Periarthritis of shoulder (PAS) symptom is one of the leading causes prompting many patients to seek treatment. Tuina is a common treatment for PAS in China. But at present, there is no systematic evaluation report on its therapeutic effectiveness and safety. This protocol aims to reveal the efficacy and safety of Tuina for treating PAS. METHODS: The following databases will be searched by electronic methods: PubMed, EBASE, WHO International Clinical Trials Registry Platform, Embase, the Chinese Biomedical Literature Database (CBM), Wan-fang Data (WANFANG), the China National Knowledge Infrastructure (CNKI), and other sources from inception to December 2019. Bias risk, subgroup analysis, data synthesis, and meta-analyses will be assessed with RevMan V.5.3 software if the data is met inclusion conditions. RESULTS: This study will present a quality evidence of Tuina for the treatment of PAS patients. CONCLUSION: The systematic review will present reliable evidence to judge whether or not Tuina is a safe and effective intervention for PAS patients. PROSPERO REGISTRATION NUMBER: CRD42019147445.
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