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1.
Trials ; 20(1): 756, 2019 Dec 21.
Artículo en Inglés | MEDLINE | ID: mdl-31864393

RESUMEN

BACKGROUND: Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed that the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing microalbuminuria and macroalbuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD. METHODS/DESIGN: This trial is a 13-center, randomized, double-blind, placebo-controlled study. A total of 632 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus losartan) and a control group (placebo plus losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in the urine microalbumin-creatinine ratio from baseline to week 24. The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups. Safety in medication will also be evaluated. DISCUSSION: We hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03009864. Registered January 2017.


Asunto(s)
Albuminuria/tratamiento farmacológico , Nefropatías Diabéticas/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Proteinuria/tratamiento farmacológico , Adulto , Anciano , Antihipertensivos/uso terapéutico , Estudios de Casos y Controles , China/epidemiología , Nefropatías Diabéticas/epidemiología , Método Doble Ciego , Medicamentos Herbarios Chinos/efectos adversos , Diagnóstico Precoz , Femenino , Tasa de Filtración Glomerular/efectos de los fármacos , Humanos , Riñón/fisiopatología , Losartán/uso terapéutico , Masculino , Medicina China Tradicional , Persona de Mediana Edad , Placebos/administración & dosificación , Prevalencia , Resultado del Tratamiento
2.
Ann Palliat Med ; 8(5): 576-585, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31865721

RESUMEN

BACKGROUND: No systematic reviews of acupuncture as a treatment for myasthenia gravis (MG) have been published in English. The aim of our study is to evaluate the efficacy and safety of acupuncture as a treatment for MG. METHODS: We searched for randomized controlled trials (RCTs) in seven main electronic databases. Unpublished articles, including conference papers and Chinese doctoral and master's theses, were also included as supplementary sources. The primary outcome was the relative clinical score (RCS) response rate. We performed a meta-analysis using RR and MD with 95% CI. RESULTS: Thirteen RCTs involving a total of 775 participants were included. Most included trials had a high risk of bias in allocation concealment and blinding. Eleven RCTs used acupuncture as an adjuvant to medication, and this treatment showed a significant improvement in the RCS response rate compared to medication alone (RR: 1.42; 95% CI: 1.06-1.91; P=0.02). The subgroup analysis based on the treatment duration showed a significant effect on the RCS response rate when the treatment duration was longer than 12 weeks (RR: 2.02; 95% CI: 1.31-3.12; P=0.001). In contrast, there was no significant effect of treatment with a duration less than 8 weeks (RR: 1.14; 95% CI: 0.91-1.44; P=0.26). Four RCTs showed a significant difference in the absolute clinical score (ACS) (RR: 3.42; 95% CI: 1.23-5.61; P=0.002). The acupuncture group reported better outcomes. No severe adverse events corresponding to acupuncture were reported. CONCLUSIONS: This meta-analysis suggests that acupuncture as an integrative therapy has a significant positive effect in treating MG. Acupuncture may enhance the efficacy of medication in MG patients. The safety of acupuncture requires further investigation. The clinical significance of these changes needs to be investigated by further studies using rigorous designs and longer follow-up times.


Asunto(s)
Terapia por Acupuntura , Miastenia Gravis/terapia , Seguridad del Paciente , Humanos , Calidad de Vida
3.
Ann Surg ; 2019 Dec 10.
Artículo en Inglés | MEDLINE | ID: mdl-31850987

RESUMEN

OBJECTIVE: To identify preoperative sociodemographic and health-related factors that predict higher risk of nonfatal self-harm and suicide after bariatric surgery. BACKGROUND: Evidence is emerging that bariatric surgery is related to an increased risk of suicide and self-harm, but knowledge on whether certain preoperative characteristics further enhance the excess risk is scarce. METHODS: The nonrandomized, prospective, controlled Swedish Obese Subjects study was linked to 2 Nationwide Swedish registers. The bariatric surgery group (N = 2007, per-protocol) underwent gastric bypass, banding or vertical banded gastroplasty, and matched controls (N = 2040) received usual care. Participants were recruited from 1987 to 2001, and information on the outcome (a death by suicide or nonfatal self-harm event) was retrieved until the end of 2016. Subhazard ratios (sub-HR) were calculated using competing risk regression analysis. RESULTS: The risk for self-harm/suicide was almost twice as high in surgical patients compared to control patients both before and after adjusting for various baseline factors [adjusted sub-HR = 1.98, 95% confidence interval (CI) = 1.34-2.93]. Male sex, previous healthcare visits for self-harm or mental disorders, psychiatric drug use, and sleep difficulties predicted higher risk of self-harm/suicide in the multivariate models conducted in the surgery group. Interaction tests further indicated that the excess risk for self-harm/suicide related to bariatric surgery was stronger in men (sub-HR = 3.31, 95% CI = 1.73-6.31) than in women (sub-HR = 1.54, 95% CI = 1.02-2.32) (P = 0.007 for adjusted interaction). A simple-to-use score was developed to identify those at highest risk of these events in the surgery group. CONCLUSIONS: Our findings suggest that male sex, psychiatric disorder history, and sleep difficulties are important predictors for nonfatal self-harm and suicide in postbariatric patients. High-risk patients who undergo surgery might require regular postoperative psychosocial monitoring to reduce the risk for future self-harm behaviors.

4.
Health Technol Assess ; 23(63): 1-190, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31851608

RESUMEN

BACKGROUND: Thromboprophylaxis can reduce the risk of venous thromboembolism (VTE) during lower-limb immobilisation, but it is unclear whether or not this translates into meaningful health benefit, justifies the risk of bleeding or is cost-effective. Risk assessment models (RAMs) could select higher-risk individuals for thromboprophylaxis. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of different strategies for providing thromboprophylaxis to people with lower-limb immobilisation caused by injury and to identify priorities for future research. DATA SOURCES: Ten electronic databases and research registers (MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, the Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluation Database, Science Citation Index Expanded, ClinicalTrials.gov and the International Clinical Trials Registry Platform) were searched from inception to May 2017, and this was supplemented by hand-searching reference lists and contacting experts in the field. REVIEW METHODS: Systematic reviews were undertaken to determine the effectiveness of pharmacological thromboprophylaxis in lower-limb immobilisation and to identify any study of risk factors or RAMs for VTE in lower-limb immobilisation. Study quality was assessed using appropriate tools. A network meta-analysis was undertaken for each outcome in the effectiveness review and the results of risk-prediction studies were presented descriptively. A modified Delphi survey was undertaken to identify risk predictors supported by expert consensus. Decision-analytic modelling was used to estimate the incremental cost per quality-adjusted life-year (QALY) gained of different thromboprophylaxis strategies from the perspectives of the NHS and Personal Social Services. RESULTS: Data from 6857 participants across 13 trials were included in the meta-analysis. Thromboprophylaxis with low-molecular-weight heparin reduced the risk of any VTE [odds ratio (OR) 0.52, 95% credible interval (CrI) 0.37 to 0.71], clinically detected deep-vein thrombosis (DVT) (OR 0.40, 95% CrI 0.12 to 0.99) and pulmonary embolism (PE) (OR 0.17, 95% CrI 0.01 to 0.88). Thromboprophylaxis with fondaparinux (Arixtra®, Aspen Pharma Trading Ltd, Dublin, Ireland) reduced the risk of any VTE (OR 0.13, 95% CrI 0.05 to 0.30) and clinically detected DVT (OR 0.10, 95% CrI 0.01 to 0.94), but the effect on PE was inconclusive (OR 0.47, 95% CrI 0.01 to 9.54). Estimates of the risk of major bleeding with thromboprophylaxis were inconclusive owing to the small numbers of events. Fifteen studies of risk factors were identified, but only age (ORs 1.05 to 3.48), and injury type were consistently associated with VTE. Six studies of RAMs were identified, but only two reported prognostic accuracy data for VTE, based on small numbers of patients. Expert consensus was achieved for 13 risk predictors in lower-limb immobilisation due to injury. Modelling showed that thromboprophylaxis for all is effective (0.015 QALY gain, 95% CrI 0.004 to 0.029 QALYs) with a cost-effectiveness of £13,524 per QALY, compared with thromboprophylaxis for none. If risk-based strategies are included, it is potentially more cost-effective to limit thromboprophylaxis to patients with a Leiden thrombosis risk in plaster (cast) [L-TRiP(cast)] score of ≥ 9 (£20,000 per QALY threshold) or ≥ 8 (£30,000 per QALY threshold). An optimal threshold on the L-TRiP(cast) receiver operating characteristic curve would have sensitivity of 84-89% and specificity of 46-55%. LIMITATIONS: Estimates of RAM prognostic accuracy are based on weak evidence. People at risk of bleeding were excluded from trials and, by implication, from modelling. CONCLUSIONS: Thromboprophylaxis for lower-limb immobilisation due to injury is clinically effective and cost-effective compared with no thromboprophylaxis. Risk-based thromboprophylaxis is potentially optimal but the prognostic accuracy of existing RAMs is uncertain. FUTURE WORK: Research is required to determine whether or not an appropriate RAM can accurately select higher-risk patients for thromboprophylaxis. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017058688. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Asunto(s)
Anticoagulantes , Análisis Costo-Beneficio , Heparina de Bajo-Peso-Molecular , Extremidad Inferior/lesiones , Tromboembolia Venosa , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/administración & dosificación , Heparina de Bajo-Peso-Molecular/efectos adversos , Humanos , Años de Vida Ajustados por Calidad de Vida , Evaluación de la Tecnología Biomédica , Resultado del Tratamiento , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/prevención & control , Trombosis de la Vena/prevención & control
5.
PLoS One ; 14(12): e0225540, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31851666

RESUMEN

BACKGROUND: Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. OBJECTIVE: Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. DESIGN: 9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit). SETTING: Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. PARTICIPANTS: 159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. INTERVENTIONS: IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. MEASUREMENTS: Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. RESULTS: There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls. LIMITATIONS: Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. CONCLUSION: Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. TRIAL REGISTRATION: clinicaltrials.gov NCT02262377.


Asunto(s)
Dolor Crónico/terapia , Depresión/terapia , Medicina Integral/métodos , Atención Plena/métodos , Visita a Consultorio Médico , Centros Médicos Académicos/organización & administración , Adulto , Anciano , Anciano de 80 o más Años , Dolor Crónico/diagnóstico , Dolor Crónico/psicología , Centros Comunitarios de Salud/organización & administración , Depresión/diagnóstico , Depresión/psicología , Femenino , Humanos , Medicina Integral/organización & administración , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Cuestionario de Salud del Paciente , Atención Primaria de Salud/métodos , Atención Primaria de Salud/organización & administración , Proveedores de Redes de Seguridad/organización & administración , Índice de Severidad de la Enfermedad , Método Simple Ciego , Centros de Atención Terciaria/organización & administración , Resultado del Tratamiento , Adulto Joven
6.
Medicine (Baltimore) ; 98(50): e18326, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31852125

RESUMEN

BACKGROUND: Vascular dementia (VaD) is the second most common cause of dementia. The treatment of VaD still remains a challenge so far. Traditional Chinese Herbal medicine is a promising therapy due to their multiple components and targets. Shenmayizhi decoction (SMYZD), a Chinese Herbal prescription, has been reported its effective in alleviating cognitive dysfunction in clinical practice. However, strong clinical research of SMYZD in the treatment of VaD was lack. Therefore, we design this study to evaluate the adjuvant role of SMYZD in the treatment of VaD. METHODS: This is a multicenter, randomized, blind, controlled trial. A total of 196 eligible patients will be assigned to receive Ginkgo biloba extracts (GBEs) plus SMYZD granule or GBEs plus SMYZD mimetic granule in a 1:1 ratio. The duration of the trial will be 12 weeks, and a follow-up will be performed at the 24th week. The primary outcomes are the National Institute of Health stroke scale (NIHSS) and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcomes include the Mini-Mental State Examination (MMSE), the traditional Chinese Medicine (TCM) syndrome scale, Activities of Daily Living (ADL), concentrations of hypersensitive C-reactive protein (Hs-CRP), neuron-specific enolase (NSE) and homocysteine (HCY) in serum. Researchers will record any adverse events throughout the trial. DISCUSSION: This study will provide evidences to evaluate the efficacy and safety of SMYZD in combination with GBEs in treatment of VaD, as well as the adjuvant role of SMYZD in combination. TRIAL IS REGISTERED AT CHINESE CLINICAL TRIAL REGISTRY: ChiCTR1800017359.


Asunto(s)
Demencia Vascular/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Medicina China Tradicional/métodos , Actividades Cotidianas , Anciano , Quimioterapia Adyuvante/métodos , Femenino , Humanos , Masculino , Pruebas de Estado Mental y Demencia , Persona de Mediana Edad , Extractos Vegetales/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
7.
Medicine (Baltimore) ; 98(50): e18335, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31852128

RESUMEN

BACKGROUND: Many people with cough variant asthma use Traditional Chinese Patent Medicine-Suhuang anti-tussive capsule to help reduce symptoms. However there is no systematic reviews had promising its efficacy and safety for cough variant asthma. METHODS: Four English databases (PubMed, Web of science, EMBASE, and Springer Cochrane Library) and 4 Chinese databases (Wanfang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, and Chinese Biomedical Literature Database) were researched for the randomized controlled trials of Suhuang anti-tussive capsule for cough variant asthma. The search was limited to human studies, using the search keywords or free-text terms "cough," "cough variant asthma," "Suhuang Zhike capsul,""Suhuang anti-tussive capsul," and "randomized clinical trials." Two reviewers individually extracted data from the included randomized controlled trials (RCTs). Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. The primary outcomes include the frequency of asthma exacerbations during follow-up, asthmatic symptoms by validated instruments (including symptom scores, Likert scale, visual analogue scale). Lung function, serum immunoglobulin E, blood eosinophil count, phlegm eosinophil count, tumor necrosis factor-a, interleukin-1b, and adverse effects (numbers of participants experiencing each adverse events) will be assessed as the secondary outcome. Meta-analysis will be performed using RevMan5.3.5 software provided by the Cochrane Collaboration. RESULTS: This study will provide high-quality synthesis based on current evidence of Suhuang anti-tussive capsule treatment for cough variant asthma. CONCLUSION: This analysis will provide updated evidence for whether Suhuang anti-tussive capsule is an effective and safe intervention for cough variant asthma. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019139695.


Asunto(s)
Asma/tratamiento farmacológico , Tos/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Medicamentos sin Prescripción/uso terapéutico , Adulto , Asma/complicaciones , Cápsulas/uso terapéutico , Tos/etiología , Femenino , Humanos , Masculino , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
8.
Medicine (Baltimore) ; 98(50): e18346, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31852132

RESUMEN

BACKGROUND: Type 2 diabetes (T2D) is a significant health concern worldwide, and good glycemic control is the basis of avoiding disease progression. Herbal tea, as a convenient and effective medication method, has gained popularity among many diabetic patients. However, there are no systematic reviews or meta-analyses to evaluate the clinical efficacy of herbal tea on T2D. METHODS: Four English electronic databases and 4 Chinese electronic databases were searched for randomized controlled trials (RCTs) meeting inclusion criteria; Clinical trials were searched to explore the relevant unpublished data. Fasting blood glucose and glycated hemoglobin will be measured as primary outcomes. Secondary outcomes include 2-hour postprandial blood glucose, fasting insulin, and homeostasis model assessment-insulin resistance. The heterogeneity of data will be investigated by Chi-square and I test; subgroup analysis and sensitivity analysis will be conducted to explore the sources of heterogeneity; funnel plot will be used to evaluate publication bias; finally, we will use grading of recommendations assessment, development, and evaluate system method to evaluate the quality of evidence. Merging analysis of data will be performed using Rev Man 5.3 software. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSIONS: The systematic review will confirm whether herbal tea consumption is benefit to the glycemic control in patients with T2D. PROSPERO REGISTRATION NUMBER: CRD42019129863.


Asunto(s)
Glucemia/análisis , Diabetes Mellitus Tipo 2/sangre , Índice Glucémico , Tés de Hierbas , Diabetes Mellitus Tipo 2/dietoterapia , Ayuno , Hemoglobina A Glucada/análisis , Humanos , Insulina/sangre , Resistencia a la Insulina , Metaanálisis como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto
9.
BMC Med ; 17(1): 231, 2019 12 19.
Artículo en Inglés | MEDLINE | ID: mdl-31852455

RESUMEN

BACKGROUND: There are an estimated 800,000 suicides per year globally, and approximately 16,000,000 suicide attempts. Mobile apps may help address the unmet needs of people at risk. We assessed adherence of suicide prevention advice in depression management and suicide prevention apps to six evidence-based clinical guideline recommendations: mood and suicidal thought tracking, safety plan development, recommendation of activities to deter suicidal thoughts, information and education, access to support networks, and access to emergency counseling. METHODS: A systematic assessment of depression and suicide prevention apps available in Google Play and Apple's App Store was conducted. Apps were identified by searching 42matters in January 2019 for apps launched or updated since January 2017 using the terms "depression," "depressed," "depress," "mood disorders," "suicide," and "self-harm." General characteristics of apps, adherence with six suicide prevention strategies identified in evidence-based clinical guidelines using a 50-question checklist developed by the study team, and trustworthiness of the app based on HONcode principles were appraised and reported as a narrative review, using descriptive statistics. RESULTS: The initial search yielded 2690 potentially relevant apps. Sixty-nine apps met inclusion criteria and were systematically assessed. There were 20 depression management apps (29%), 3 (4%) depression management and suicide prevention apps, and 46 (67%) suicide prevention apps. Eight (12%) depression management apps were chatbots. Only 5/69 apps (7%) incorporated all six suicide prevention strategies. Six apps (6/69, 9%), including two apps available in both app stores and downloaded more than one million times each, provided an erroneous crisis helpline number. Most apps included emergency contact information (65/69 apps, 94%) and direct access to a crisis helpline through the app (46/69 apps, 67%). CONCLUSIONS: Non-existent or inaccurate suicide crisis helpline phone numbers were provided by mental health apps downloaded more than 2 million times. Only five out of 69 depression and suicide prevention apps offered all six evidence-based suicide prevention strategies. This demonstrates a failure of Apple and Google app stores, and the health app industry in self-governance, and quality and safety assurance. Governance levels should be stratified by the risks and benefits to users of the app, such as when suicide prevention advice is provided.


Asunto(s)
Trastorno Depresivo/diagnóstico , Adhesión a Directriz/normas , Aplicaciones Móviles/normas , Suicidio/prevención & control , Telemedicina/métodos , Humanos , Medición de Riesgo , Gestión de Riesgos
10.
BMC Pulm Med ; 19(1): 251, 2019 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-31852460

RESUMEN

BACKGROUND: Mycoplasma pneumoniae is one of the most common pathogens causing community acquired pneumonia in children. Although the rate of macrolide-refractory Mycoplasma pneumoniae (MRMP) has increased, systemic glucocorticoids as a treatment option has not been validated yet. The purpose of this study was to assess the efficacy of glucocorticoids add-on in the treatment of MRMP in children through systematic review and meta-analysis. METHODS: Data sources A systematic literature search was conducted using ten electronic bibliographic databases including English, Korean, Chinese and Japanese languages, up to March 8, 2018. Study selection The study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and selected randomized control trials which compared the efficacy of glucocorticoids add-on to macrolide in the treatment of MRMP in children. Data extraction Two independent reviewers extracted: primary outcomes as hospital days, fever duration, and change in C-reactive protein (CRP) and main analysis was performed through meta-analysis with random effects model. RESULTS: Twenty-four unique randomized controlled trials met the inclusion criteria. The mean length of hospital stay in glucocorticoids treatment group was significantly shorter than that in conventional macrolide-treatment group (Weighted mean difference (WMD) = - 4.03 days). The mean length of fever duration was significantly shorter in the glucocorticoid treatment group in comparison with the conventional treatment group (WMD = -3.32 days). Level of CRP after treatment was significantly lower in the glucocorticoid treatment group than that in the conventional treatment group (WMD = -16.03). Sensitivity analysis and subgroup analysis showed no significant improvement in heterogeneity. As limitations of the study, most of the studies included were from a single country and we were unable to control for heterogeneity across interventions, lack of standardized measures, and different time points of assessments across studies. CONCLUSIONS: Glucocorticoid add-on treatment for MRMP can significantly shorten the duration of fever and hospital stay and decrease the level of CRP. These results should be confirmed by adequately powered studies in the future.


Asunto(s)
Antibacterianos/uso terapéutico , Glucocorticoides/uso terapéutico , Macrólidos/uso terapéutico , Neumonía por Mycoplasma/tratamiento farmacológico , Proteína C-Reactiva/metabolismo , Niño , Preescolar , Quimioterapia Combinada , Femenino , Fiebre , Humanos , Tiempo de Internación , Masculino , Mycoplasma pneumoniae , Neumonía por Mycoplasma/metabolismo , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Insuficiencia del Tratamiento , Resultado del Tratamiento
11.
BMC Cancer ; 19(1): 1233, 2019 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-31852462

RESUMEN

BACKGROUND: Mouse and human studies support the promise of dry beans to improve metabolic health and to lower cancer risk. In overweight/obese patients with a history of colorectal polyps or cancer, the Beans to Enrich the Gut microbiome vs. Obesity's Negative Effects (BE GONE) trial will test whether and how an increase in the consumption of pre-cooked, canned dry beans within the context of usual diet and lifestyle can enhance the gut landscape to improve metabolic health and reduce cancer risk. METHODS/DESIGN: This randomized crossover trial is designed to characterize changes in (1) host markers spanning lipid metabolism, inflammation, and obesity-related cancer risk; (2) compositional and functional profiles of the fecal microbiome; and (3) host and microbial metabolites. With each subject serving as their own control, the trial will compare the participant's usual diet with (intervention) and without (control) dry beans. Canned, pre-cooked dry beans are provided to participants and the usual diet continually assessed and monitored. Following a 4-week run-in and equilibration period, each participant provides a total of 5 fasting blood and 6 stool samples over a total period of 16 weeks. The intervention consists of a 2-week ramp-up of dry bean intake to 1 cup/d, which is then continued for an additional 6 weeks. Intra- and inter-individual outcomes are assessed across each crossover period with consideration of the joint or modifying effects of the usual diet and baseline microbiome. DISCUSSION: The BE GONE trial is evaluating a scalable dietary prevention strategy targeting the gut microbiome of high-risk patients to mitigate the metabolic and inflammatory effects of adiposity that influence colorectal cancer risk, recurrence, and survival. The overarching scientific goal is to further elucidate interactions between diet, the gut microbiome, and host metabolism. Improved understanding of the diet-microbiota interplay and effective means to target these relationships will be key to the future of clinical and public health approaches to cancer and other major diet- and obesity-related diseases. TRIAL REGISTRATION: This protocol is registered with the U.S. National Institutes of Health trial registry, ClinicalTrials.gov, under the identifier NCT02843425. First posted July 25, 2016; last verified January 25, 2019.


Asunto(s)
Neoplasias del Colon/dietoterapia , Pólipos del Colon/dietoterapia , Microbioma Gastrointestinal , Obesidad/fisiopatología , Sobrepeso/fisiopatología , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias del Colon/microbiología , Neoplasias del Colon/patología , Neoplasias del Colon/prevención & control , Pólipos del Colon/microbiología , Pólipos del Colon/patología , Pólipos del Colon/prevención & control , Estudios Cruzados , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Obesidad/microbiología , Sobrepeso/microbiología , Supervivencia sin Progresión , Factores de Riesgo
12.
Trials ; 20(1): 744, 2019 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-31852492

RESUMEN

BACKGROUND: Breast cancer is the most common cancer and the leading cause of cancer mortality among Latinas. As more is learned about the association between mammographic breast density (MBD) and breast cancer risk, a number of U.S. states adopted legislation and now a federal law mandates written notification of MBD along with mammogram results. These notifications vary in content and readability, though, which may limit their effectiveness and create confusion or concern, especially among women with low health literacy or barriers to screening. The purpose of this study is to determine whether educational enhancement of MBD notification results in increased knowledge, decreased anxiety, and adherence to continued mammography screening among Latina women in a limited-resources setting. METHODS: Latinas LEarning About Density (LLEAD) is a randomized clinical trial (RCT) comparing the impact of three notification approaches on behavioral and psychological outcomes in Latina women. Approximately 2000 Latinas undergoing screening mammography in a safety-net community clinic will be randomized 1:1:1 to mailed notification (usual care); mailed notification plus written educational materials (enhanced); or mailed notification, written educational materials, plus verbal explanation by a promotora (interpersonal). The educational materials and verbal explanations are available in Spanish or English. Mechanisms through which written or verbal information influences future screening motivation and behavior will be examined, as well as moderating factors such as depression and worry about breast cancer, which have been linked to diagnostic delays among Latinas. The study includes multiple psychological measures (anxiety, depression, knowledge about MBD, perceived risk of breast cancer, worry, self-efficacy) and behavioral outcomes (continued adherence to mammography). Measurement time points include enrollment, 2-4 weeks post-randomization, and 1 and 2 years post-randomization. Qualitative inquiry related to process and outcomes of the interpersonal arm and cost analysis related to its implementation will be undertaken to understand the intervention's delivery and transferability. DISCUSSION: Legislation mandating written MBD notification may have unintended consequences on behavioral and psychological outcomes, particularly among Latinas with limited health literacy and resources. This study has implications for cancer risk communication and will offer evidence on the potential of generalizable educational strategies for delivering information on breast density to Latinas in limited-resource settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02910986. Registered on 21 September 2016. Items from the WHO Trial Registration Data Set can be found in this protocol.


Asunto(s)
Neoplasias de la Mama/diagnóstico , Comunicación en Salud/métodos , Hispanoamericanos/psicología , Mamografía/psicología , Educación del Paciente como Asunto/métodos , Adulto , Anciano , Ansiedad/prevención & control , Ansiedad/psicología , Densidad de la Mama , Neoplasias de la Mama/psicología , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/psicología , Femenino , Conocimientos, Actitudes y Práctica en Salud , Alfabetización en Salud , Humanos , Tamizaje Masivo/métodos , Tamizaje Masivo/psicología , Persona de Mediana Edad , Cooperación del Paciente/psicología , Investigación Cualitativa , Ensayos Clínicos Controlados Aleatorios como Asunto
13.
BMC Public Health ; 19(1): 1700, 2019 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-31852536

RESUMEN

BACKGROUND: The rate of tobacco use among people with mental illness is nearly twice that of the general population. Psychotropic medications for tobacco cessation are relatively expensive for most Kenyans. Behavioral counseling and group therapy are effective lower cost strategies to promote tobacco cessation, yet have not been studied in Kenya among individuals with concomitant mental illness. METHODS/DESIGN: One hundred tobacco users with mental illness who were part of an outpatient mental health program in Nairobi, Kenya were recruited and allocated into intervention and control groups of the study (50 users in intervention group and 50 users in control group). Participants allocated to the intervention group were invited to participate in 1 of 5 tobacco cessation groups. The intervention group received the 5As (Ask, Advise, Assess, Assist and Arrange) and tobacco cessation group behavioral intervention, which included strategies to manage cravings and withdrawal, stress and anxiety, and coping with depression due to withdrawal; assertiveness training and anger management; reasons to quit, benefits of quitting and different ways of quitting. Individuals allocated to the control group received usual care. The primary outcome was tobacco cessation at 24 weeks, measured through cotinine strips. Secondary outcomes included number of quit attempts and health-related quality of life. DISCUSSION: This study will provide evidence to evaluate the efficacy and safety of a tobacco cessation group behavioral intervention among individuals with mental illness in Kenya, and to inform national and regional practice and policy. TRIAL REGISTRATION: Trial registration number: NCT04013724. Name of registry: ClinicalTrials.gov. URL of registry: https://register.clinicaltrials.gov Date of registration: 9 July 2019 (retrospectively registered). Date of enrolment of the first participant to the trial: 5th September 2017. Protocol version: 2.0.


Asunto(s)
Terapia Conductista/métodos , Análisis Costo-Beneficio/estadística & datos numéricos , Consejo/métodos , Calidad de Vida/psicología , Cese del Hábito de Fumar/métodos , Cese del Uso de Tabaco/psicología , Tabaquismo/terapia , Adulto , Anciano , Anciano de 80 o más Años , Terapia Conductista/economía , Consejo/economía , Femenino , Humanos , Kenia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Cese del Hábito de Fumar/economía , Cese del Uso de Tabaco/estadística & datos numéricos
15.
Leuk Lymphoma ; 60(13): 3107-3115, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31842650

RESUMEN

The application of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has revolutionized the treatment of acute promyelocytic leukemia (APL). More than 80-90% of patients are expected to be cured with a combination of ATRA, ATO and/or chemotherapy. In this review, we focus on the remaining obstacles to a cure for all patients with APL. We review the issue of early death and coagulopathy and discuss the particular challenges in the care of patients with high-risk APL and patients with relapsed APL. We also give recommendations and highlight ongoing efforts to improve the persistently high early death rate and the outcomes of high risk and relapsed APL patients.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Hemorragia/mortalidad , Leucemia Promielocítica Aguda/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Inducción de Remisión/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Trióxido de Arsénico/administración & dosificación , Trióxido de Arsénico/efectos adversos , Supervivencia sin Enfermedad , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Humanos , Incidencia , Leucemia Promielocítica Aguda/mortalidad , Leucemia Promielocítica Aguda/patología , Mortalidad , Recurrencia Local de Neoplasia/epidemiología , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Nivel de Atención , Factores de Tiempo , Tretinoina/administración & dosificación , Tretinoina/efectos adversos
16.
BMC Cancer ; 19(1): 1215, 2019 12 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842784

RESUMEN

BACKGROUND: The optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing. METHODS: The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. DISCUSSION: To date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23-30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT3465982.


Asunto(s)
Adenocarcinoma/tratamiento farmacológico , Quimioradioterapia , Laparoscopía , Terapia Neoadyuvante , Neoplasias del Recto/tratamiento farmacológico , Adenocarcinoma/cirugía , Adulto , Anciano , Supervivencia sin Enfermedad , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Pronóstico , Estudios Prospectivos , Neoplasias del Recto/cirugía , Factores de Tiempo , Adulto Joven
17.
Trials ; 20(1): 722, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842937

RESUMEN

BACKGROUND: In the Pakistani textile industry the prevalence of workplace respiratory illnesses, including byssinosis, is high. The MultiTex RCT study aims to determine the effectiveness of a multifaceted intervention package in reducing dust levels in cotton mills, decreasing the frequency of respiratory symptoms among cotton textile workers, and improving their lung function. METHODS/DESIGN: We will conduct a cluster-randomized controlled trial at 28 textile mills in Karachi. The intervention will comprise: training in occupational health for all workers and managers reinforced by regular refresher sessions; the formation of workplace committees to draw up, agree and promote a health and safety plan that includes wet mopping, safe disposal of cotton dust, and the use of simple face-masks, as well as further publicity about the risks from cotton dust; and provision of adequate supplies of face-masks to support the health and safety plan. Participating mills will be randomized to intervention and control arms following a baseline survey. The impact of the intervention will be determined through follow-up surveys conducted at 3, 12 and 18 months. Data collection in the surveys will include spirometry, questionnaire-based interviews and cotton-dust measurements. DISCUSSION: If successful, the study may pave the way for simple, low-cost interventions that can help reduce cotton-dust levels in textile mills, and improve the respiratory health of textile workers in developing countries such as Pakistan. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03738202. Registered on 12 November 2018.


Asunto(s)
Contaminantes Ocupacionales del Aire/efectos adversos , Contaminación del Aire Interior/prevención & control , Bisinosis/prevención & control , Fibra de Algodón/efectos adversos , Exposición por Inhalación/prevención & control , Exposición Profesional/prevención & control , Salud Laboral , Industria Textil , Contaminación del Aire Interior/efectos adversos , Bisinosis/diagnóstico , Bisinosis/etiología , Monitoreo del Ambiente , Educación en Salud , Servicio de Limpieza , Humanos , Exposición por Inhalación/efectos adversos , Máscaras , Estudios Multicéntricos como Asunto , Exposición Profesional/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo
18.
Trials ; 20(1): 725, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842950

RESUMEN

BACKGROUND: Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH. METHODS/DESIGN: A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15-70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded. DISCUSSION: We aimed to determine the efficacy and safety of TMP for the treatment of PH. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.


Asunto(s)
Antihipertensivos/uso terapéutico , Presión Arterial/efectos de los fármacos , Hipertensión Pulmonar/tratamiento farmacológico , Pirazinas/uso terapéutico , Vasodilatadores/uso terapéutico , Adolescente , Adulto , Anciano , Antihipertensivos/efectos adversos , China , Tolerancia al Ejercicio/efectos de los fármacos , Femenino , Humanos , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/fisiopatología , Masculino , Persona de Mediana Edad , Pirazinas/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento , Vasodilatadores/efectos adversos , Adulto Joven
19.
Trials ; 20(1): 735, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842969

RESUMEN

BACKGROUND: The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. METHODS/DESIGN: This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. DISCUSSION: This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Pulmón/efectos de los fármacos , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , China , Progresión de la Enfermedad , Método Doble Ciego , Medicamentos Herbarios Chinos/efectos adversos , Estudios de Equivalencia como Asunto , Femenino , Humanos , Pulmón/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Factores de Tiempo , Resultado del Tratamiento
20.
Trials ; 20(1): 729, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842982

RESUMEN

BACKGROUND: A considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy. METHODS: We conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard. RESULTS: Thirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence. CONCLUSIONS: The overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility.


Asunto(s)
Lista de Verificación/normas , Exactitud de los Datos , Retinopatía Diabética/tratamiento farmacológico , Ácidos Fíbricos/uso terapéutico , Adhesión a Directriz/normas , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Retinopatía Diabética/diagnóstico , Ácidos Fíbricos/efectos adversos , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Resultado del Tratamiento
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