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1.
Exp Oncol ; 41(4): 346-352, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31868332

RESUMO

AIM: Several studies evaluated the association between rs11077 polymorphism located in the 3'UTR of the XPO5 gene and cancer susceptibility. We conducted a meta-analysis to assess the impact of XPO5 rs11077 polymorphism on cancer risk. MATERIALS AND METHODS: The online databases were searched for relevant case-control studies published up to July 2018. 15 articles of 16 studies, with totally 7284 cancer cases and 8511 healthy controls, were eligible for inclusion in the meta-analysis. The data were extracted from the eligible studies and were processed using Stata 14.1 and Revman 5.3 software. Pooled estimates of odds ratio with 95% confidence intervals were used to evaluate the strength of association between XPO5 rs11077 and cancer risk. RESULTS: Overall, our finding showed no significant association between XPO5 rs11077 variant and overall cancer risk, either performed subgroup analysis by cancer types and ethnic groups in all genetic model. CONCLUSION: The findings did not support an association between rs11077 variant and cancer risk. Due to small sample sizes particularly in stratified analysis, further large-scale well designed studies between this polymorphism and cancer risk are warranted.


Assuntos
Carioferinas/genética , Neoplasias/genética , Polimorfismo de Nucleotídeo Único , Estudos de Casos e Controles , Frequência do Gene , Predisposição Genética para Doença , Humanos , Razão de Chances
2.
PLoS One ; 14(12): e0226756, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31869377

RESUMO

BACKGROUND: In recent decades, hypertension has become a popular public health problem in China. In 2017, a cross-sectional survey about hypertension and sodium intake measured by 24-hour (24-h) urine was launched in Zhejiang Province, to provide the basis of the Chinese population to develop a salt reduction intervention and prevention of hypertension strategy. METHODS: Cross-sectional data were obtained from 7512 participants aged 18 to 69 years in Zhejiang Province of China by complex, multistage sampling methods. The survey included face-to-face questionnaires and physical examination among all participants. Blood pressures and the use of anti-hypertension medications were used to determine hypertension. One thousand five hundred participants of them were asked to collect 24-h urine to measure sodium and potassium levels to assess intake. All rates and means were weighted by sampling weight and population structure of the province. RESULTS: The weighted means of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 127.78 mm Hg (95% confidence interval [CI], 127.21-128.36) and 79.40 mm Hg (95%CI, 79.04-79.76). The weighted hypertension prevalence was 30.41% (95%CI, 28.91-31.91). Among those classified as having hypertension, 43.55% (95%CI, 40.77-46.34) were aware of the fact that they were suffering from hypertension, 32.05% (95%CI, 29.49-34.61) of them reported taking anti-hypertension medications, only 14.48% (95%CI, 12.54-16.42) had their blood pressure controlled. The weighted means of 24-h urinary sodium was 165.52 mmol (standard deviation [SD], 2.92), representing that the mean intake of sodium chloride was 9.68g (SD, 0.17) through conversion. CONCLUSION: These cross-sectional survey results show that hypertension and excessive sodium intake in adults are prevalent in Zhejiang Province, China. Salt reduction and prevention of hypertension is still an urgent public health work.


Assuntos
Hipertensão/epidemiologia , Cloreto de Sódio na Dieta/efeitos adversos , Adolescente , Adulto , Idoso , Pressão Sanguínea , China/epidemiologia , Estudos Transversais , Feminino , Humanos , Hipertensão/fisiopatologia , Hipertensão/terapia , Hipertensão/urina , Masculino , Pessoa de Meia-Idade , Prevalência , Cloreto de Sódio na Dieta/urina , Adulto Jovem
3.
BMC Public Health ; 19(1): 1732, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870345

RESUMO

BACKGROUND: Finding effective intervention strategies to combat rising obesity levels could significantly reduce the burden that obesity and associated non-communicable diseases places on both individuals and the National Health Service. METHODS: In this parallel randomised-controlled trial, 76 participants who are overweight or obese (50 female) were given free access to a fitness centre for the duration of the 12-week intervention and randomised to one of three interventions. The commercial intervention, the Healthy Weight Programme, (HWP, n = 25, 10/15 men/women) consisted of twelve 1-h nutrition coaching sessions with a nutritionist delivered as a mixture of group and 1 to 1 sessions. In addition, twice-weekly exercise sessions (24 in total) were delivered by personal trainers for 12 weeks. The NHS intervention (n = 25, 8/17 men/women) consisted of following an entirely self-managed 12-week online NHS resource. The GYM intervention (n = 26, 8/18 men/women) received no guidance or formal intervention. All participants were provided with a gym induction for safety and both the NHS and GYM participants were familiarised with ACSM physical activity guidelines by way of a hand-out. RESULTS: The overall follow-up rate was 83%. Body mass was significantly reduced at post-intervention in all groups (HWP: N = 18, - 5.17 ± 4.22 kg, NHS: N = 21-4.19 ± 5.49 kg; GYM: N = 24-1.17 ± 3.00 kg; p < 0.001) with greater reductions observed in HWP and NHS groups compared to GYM (p < 0.05). Out with body mass and BMI, there were no additional statistically significant time x intervention interaction effects. CONCLUSIONS: This is the first study to evaluate the efficacy of both a free online NHS self-help weight-loss tool and a commercial weight loss programme that provides face-to-face nutritional support and supervised exercise. The findings suggest that both interventions are superior to an active control condition with regard to eliciting short-term weight-loss. TRIAL REGISTRATION: ISRCTN Registry - ISRCTN31489026. Prospectively registered: 27/07/16.


Assuntos
Obesidade/terapia , Sobrepeso/terapia , Programas de Redução de Peso/métodos , Adulto , Feminino , Humanos , Intervenção Baseada em Internet/economia , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Medicina Estatal , Reino Unido , Programas de Redução de Peso/economia , Adulto Jovem
4.
Lipids Health Dis ; 18(1): 228, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870381

RESUMO

BACKGROUND: Influences of atorvastatin on atherosclerosis and glycemic metabolism may be related to its potential impact on circulating adiponectin, an adipocyte that exerts anti-inflammatory, ant-atherosclerotic, and anti-oxidative effects. However, results of previous randomized controlled trials (RCTs) were not consistent. We performed a meta-analysis of RCTs to systematic evaluate the influence of atorvastatin on circulating adiponectin. METHODS: Relevant studies were identified via search of electronic databases of PubMed, Embase, and Cochrane's Library. A random-effect model was applied to pool the results via incorporating the potential heterogeneity. Predefined meta-regression and subgroup analyses were used to evaluate the influences of study characteristics on the outcome. RESULTS: Fourteen datasets from ten RCTs including 931 patients were included. Pooled results showed that atorvastatin did not significantly affect circulating adiponectin as compared with controls (weighed mean difference = - 0.27 µg/mL, 95% confidence interval: - 0.89 to 0.35 µg/mL, p = 0.39). Results of univariate meta-regression analyses showed that study characteristics including number of patients, mean age, proportion of male patients, body mass index, dose of atorvastatin, or treatment duration did not significantly affect the outcome (p all > 0.05). Moreover, subgroup analyses showed that atorvastatin did not significantly affect circulating adiponectin in studies stratified according to these study characteristics (p all > 0.05). CONCLUSIONS: Atorvastatin treatment does not significantly affect circulating adiponectin. Influences of atorvastatin on atherosclerosis and glycemic metabolism are not likely to be mediated by modulation of circulating adiponectin.


Assuntos
Adiponectina/sangue , Aterosclerose/tratamento farmacológico , Atorvastatina/uso terapêutico , Aterosclerose/sangue , Aterosclerose/patologia , Índice de Massa Corporal , Relação Dose-Resposta a Droga , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
BMC Psychol ; 7(1): 89, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870421

RESUMO

BACKGROUND: Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. METHOD: This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. DISCUSSION: This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. TRIAL REGISTRATION: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.


Assuntos
Transtornos de Adaptação/epidemiologia , Neoplasias/psicologia , Psicoterapia , Transtornos de Adaptação/etiologia , Transtornos de Adaptação/terapia , Adulto , Protocolos Clínicos , Análise Custo-Benefício , Feminino , Humanos , Masculino , Atenção Plena , Países Baixos , Prevalência , Psicoterapia/economia , Psicoterapia de Grupo , Qualidade de Vida , Projetos de Pesquisa , Telemedicina , Resultado do Tratamento
6.
Trials ; 20(1): 761, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870424

RESUMO

BACKGROUND: Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visit. AIM: The aim of this trial is to test a new intervention to assess whether guidance on dietary salt restriction provided by physicians during outpatient visits is effective in reducing salt intake in patients with type 2 diabetes mellitus who have an excessive salt intake. METHODS: In this unblinded randomized controlled trial (RCT), a total of 200 patients, male or female, aged between 20 and 90 years, who have type 2 diabetes mellitus and consume excessive salt will be randomly assigned to two groups: an intervention group and a control group. In addition to being given routine treatment, participants in the intervention group will be given individual guidance on restricting their dietary salt intake by a physician upon enrollment. The control group will only be given routine treatment. Participants will be followed up for 24 weeks. The primary outcome will be dietary salt intake, which will be assessed at baseline and at 8, 16, and 24 weeks. The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks. DISCUSSION: The results of this RCT have the potential to provide a simple and novel clinical approach to reduce salt intake among patients with type 2 diabetes, making regular visits to their physician, in outpatient facilities. This protocol will contribute to the literature because it describes a practical intervention that has not been tested previously, and it may serve as guidance to other researchers interested in testing similar interventions. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN), UMIN000028809. Registered retrospectively on 24 August 2017. http://www.umin.ac.jp.


Assuntos
Aconselhamento , Diabetes Mellitus Tipo 2/terapia , Dieta Hipossódica/métodos , Hipertensão/dietoterapia , Médicos , Cloreto de Sódio na Dieta , Assistência Ambulatorial , Pressão Sanguínea , Creatinina/urina , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/metabolismo , Angiopatias Diabéticas/etiologia , Humanos , Hipertensão/complicações , Sódio/urina
7.
Trials ; 20(1): 758, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870427

RESUMO

BACKGROUND: Esophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. Currently, transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy) is a frequently used technique in Japan. However, cervical anastomosis is still an invasive procedure with a high incidence of anastomotic leakage. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube. METHODS: This is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1-3 N0-3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55). The primary outcome is the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage. DISCUSSION: This is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic leakage rate but less pain than placement of a cervical drainage tube. TRIAL REGISTRATION: UMIN-CTR, 000031244. Registered on 1 May 2018.


Assuntos
Anastomose Cirúrgica/métodos , Fístula Anastomótica/epidemiologia , Carcinoma Adenoescamoso/cirurgia , Drenagem/estatística & dados numéricos , Neoplasias Esofágicas/cirurgia , Carcinoma de Células Escamosas do Esôfago/cirurgia , Esofagectomia/métodos , Dor Pós-Operatória/tratamento farmacológico , Analgésicos/uso terapêutico , Carcinoma Adenoescamoso/patologia , Neoplasias Esofágicas/patologia , Carcinoma de Células Escamosas do Esôfago/patologia , Humanos , Japão/epidemiologia , Tempo de Internação/estatística & dados numéricos , Pescoço , Complicações Pós-Operatórias/epidemiologia
8.
Trials ; 20(1): 762, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870456

RESUMO

BACKGROUND: Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults. OBJECTIVE: The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP. METHODS: A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects. DISCUSSION: Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population. CONCLUSION: This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.


Assuntos
Dor Crônica/terapia , Eletroacupuntura/métodos , Dor Lombar/terapia , Terapia por Acupuntura/métodos , Idoso , Brasil , Método Duplo-Cego , Humanos , Pessoa de Meia-Idade , Medição da Dor , Resultado do Tratamento
10.
Nutrients ; 12(1)2019 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-31877685

RESUMO

Childhood obesity is a global public health issue and is linked to metabolic syndrome, which increases the risk of comorbidities such as type 2 diabetes, cardiovascular diseases and cancer. Social, economic and cultural factors influence changes in nutrition and lifestyle characterized by poorer diets and reduced physical activity. This systematic review summarizes the evidence for nutritional education interventions to improve metabolic risks in children and adolescents. Systematic searches of the databases Medline (via PubMed) and Scopus were conducted following PRISMA guidelines. The risk of bias for each study was assessed following the methodology of the Cochrane Collaboration. Ten case-controlled and randomized controlled studies testing nutritional educational interventions targeting children and adolescents from the general population were eligible for inclusion. The sample size was 3915 and the age range was 7-20 years. The duration of intervention ranged from 12 weeks to 20 years. All the studies that provided data on abdominal obesity reported differences in favour of the intervention. However, data on the effects on the remaining components of metabolic syndrome remain inconclusive. These results support the role of nutritional education interventions as a strategy to reduce central adiposity and its possible unhealthy consequences in children and adolescents.


Assuntos
Ciências da Nutrição Infantil/educação , Obesidade Pediátrica/prevenção & controle , Adolescente , Criança , Dieta , Humanos , Fatores de Risco
11.
Artigo em Inglês | MEDLINE | ID: mdl-31877808

RESUMO

BACKGROUND: Psychiatric symptoms have been reported in adult patients with dengue fever (DF); however, information on pediatric patients remains inadequate. We sought to identify the prevalence and predictors of depressive and anxiety symptoms and identify other psychiatric symptoms among pediatric patients with DF. This case-control study involved pediatric in-patients (n = 225) who had clinical or serologic-confirmed DF and healthy school-based controls (n = 260). Participants completed the Revised Child Anxiety and Depression Scale (RCADS). RESULTS: The prevalence of depressive (13.3%) and anxiety (34.2%) symptoms among pediatric patients with DF was significantly (p < 0.001) higher than that among controls (3.5% and 16.2%, respectively). Multiple linear regression analysis found that age, family history of DF, ≤2 days of hospitalization, myalgia, and arthralgia were predictors of increased depressive and anxiety symptoms among the patients. Further, 26.7% of pediatric patients reported irritability, agitation, visual hallucinations, and aggressiveness. CONCLUSION: Pediatric patients present depressive and anxiety symptoms whose levels were associated with social and clinical factors. However, whether these symptoms are present only during the infection or may still persist after recovery or are brought by children's adverse reactions to hospitalization are unknown, and thus, further studies are needed.


Assuntos
Ansiedade/etiologia , Dengue/psicologia , Depressão/etiologia , Adulto , Estudos de Casos e Controles , Criança , Dengue/epidemiologia , Família , Feminino , Hospitalização , Humanos , Masculino , Filipinas/epidemiologia , Prevalência , Análise de Regressão
13.
J Oncol ; 2019: 7634746, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31885584

RESUMO

Objective: The benefits of accelerated hyperfractionated radiotherapy (HART) and conventional fractionation radiotherapy (CFRT) in the treatment of head and neck cancer (HNC) remain controversial. In this study, we analyzed the therapeutic effects of these two treatment regimens to explore whether HART can improve the overall survival (OS) rate and locoregional control (LRC) rate in patients with HNC. Methods: The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for eligible studies. The OS rate and LRC rate were considered as the efficacy outcomes. I 2 was used to test the heterogeneity among studies with a cutoff value of 50%. Potential publication bias was assessed by funnel plots and Egger's test. We also performed a sensitivity analysis to assess the stability of the results. In this meta-analysis, all analyses were performed using R 3.5.3 software. Results: Twelve qualified articles including a total of 2,935 patients were identified. HART had a significant beneficial effect on OS rate (HR = 0.80, 95% CI: 0.65-0.98). Compared with CFRT, HART demonstrated a significantly higher LRC rate (HR = 0.82, 95% CI: 0.71-0.96). Conclusion: Our meta-analysis showed that HART can significantly improve OS and LRC compared with CFRT in patients with HNC.

14.
Cochrane Database Syst Rev ; 12: CD009197, 2019 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-31887786

RESUMO

BACKGROUND: There may be an association between periodontitis and cardiovascular disease (CVD); however, the evidence so far has been uncertain about whether periodontal therapy can help prevent CVD in people diagnosed with chronic periodontitis. This is the second update of a review originally published in 2014, and first updated in 2017. Although there is a new multidimensional staging and grading system for periodontitis, we have retained the label 'chronic periodontitis' in this version of the review since available studies are based on the previous classification system. OBJECTIVES: To investigate the effects of periodontal therapy for primary or secondary prevention of CVD in people with chronic periodontitis. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the Cochrane Oral Health's Trials Register, CENTRAL, MEDLINE, Embase, and CINAHL, two trials registries, and the grey literature to September 2019. We placed no restrictions on the language or date of publication. We also searched the Chinese BioMedical Literature Database, the China National Knowledge Infrastructure, the VIP database, and Sciencepaper Online to August 2019. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared active periodontal therapy to no periodontal treatment or a different periodontal treatment. We included studies of participants with a diagnosis of chronic periodontitis, either with CVD (secondary prevention studies) or without CVD (primary prevention studies). DATA COLLECTION AND ANALYSIS: Two review authors carried out the study identification, data extraction, and 'Risk of bias' assessment independently and in duplicate. They resolved any discrepancies by discussion, or with a third review author. We adopted a formal pilot-tested data extraction form, and used the Cochrane tool to assess the risk of bias in the studies. We used GRADE criteria to assess the certainty of the evidence. MAIN RESULTS: We included two RCTs in the review. One study focused on the primary prevention of CVD, and the other addressed secondary prevention. We evaluated both as being at high risk of bias. Our primary outcomes of interest were death (all-cause and CVD-related) and all cardiovascular events, measured at one-year follow-up or longer. For primary prevention of CVD in participants with periodontitis and metabolic syndrome, one study (165 participants) provided very low-certainty evidence. There was only one death in the study; we were unable to determine whether scaling and root planning plus amoxicillin and metronidazole could reduce incidence of all-cause death (Peto odds ratio (OR) 7.48, 95% confidence interval (CI) 0.15 to 376.98), or all CVD-related death (Peto OR 7.48, 95% CI 0.15 to 376.98). We could not exclude the possibility that scaling and root planning plus amoxicillin and metronidazole could increase cardiovascular events (Peto OR 7.77, 95% CI 1.07 to 56.1) compared with supragingival scaling measured at 12-month follow-up. For secondary prevention of CVD, one pilot study randomised 303 participants to receive scaling and root planning plus oral hygiene instruction (periodontal treatment) or oral hygiene instruction plus a copy of radiographs and recommendation to follow-up with a dentist (community care). As cardiovascular events had been measured for different time periods of between 6 and 25 months, and only 37 participants were available with at least one-year follow-up, we did not consider the data to be sufficiently robust for inclusion in this review. The study did not evaluate all-cause death and all CVD-related death. We are unable to draw any conclusions about the effects of periodontal therapy on secondary prevention of CVD. AUTHORS' CONCLUSIONS: For primary prevention of cardiovascular disease (CVD) in people diagnosed with periodontitis and metabolic syndrome, very low-certainty evidence was inconclusive about the effects of scaling and root planning plus antibiotics compared to supragingival scaling. There is no reliable evidence available regarding secondary prevention of CVD in people diagnosed with chronic periodontitis and CVD. Further trials are needed to reach conclusions about whether treatment for periodontal disease can help prevent occurrence or recurrence of CVD.


Assuntos
Antibacterianos/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Periodontite Crônica/complicações , Prevenção Secundária/métodos , Doenças Cardiovasculares/etiologia , Periodontite Crônica/classificação , Periodontite Crônica/terapia , Raspagem Dentária , Humanos , Saúde Bucal , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Trials ; 20(1): 773, 2019 Dec 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881916

RESUMO

BACKGROUND: Following an acquired brain injury, individuals frequently experience anxiety and/or depressive symptoms. However, current treatments for these symptoms are not very effective. A promising treatment is acceptance and commitment therapy (ACT), which is a third-wave behavioural therapy. The primary goal of this therapy is not to reduce symptoms, but to improve psychological flexibility and general well-being, which may be accompanied by a reduction in symptom severity. The aim of this study is to investigate the effectiveness of an adapted ACT intervention (BrainACT) in people with acquired brain injury who experience anxiety and/or depressive symptoms. METHODS: The study is a multicenter, randomized, controlled, two-arm parallel trial. In total, 94 patients who survive a stroke or traumatic brain injury will be randomized into an ACT or control (i.e. psycho-education and relaxation) intervention. The primary outcome measures are the Hospital Anxiety and Depression Scale and the Depression Anxiety Stress Scale. Outcomes will be assessed by trained assessors, blinded to treatment condition, pre-treatment, during treatment, post-treatment, and at 7 and 12 months. DISCUSSION: This study will contribute to the existing knowledge on how to treat psychological distress following acquired brain injury. If effective, BrainACT could be implemented in clinical practice and potentially help a large number of patients with acquired brain injury. TRIAL REGISTRATION: Dutch Trial Register, NL691, NTR 7111. Registered on 26 March 2018. https://www.trialregister.nl/trial/6916.


Assuntos
Terapia de Aceitação e Compromisso/métodos , Ansiedade , Lesões Encefálicas , Depressão , Adulto , Ansiedade/etiologia , Ansiedade/terapia , Lesões Encefálicas/complicações , Lesões Encefálicas/psicologia , Depressão/etiologia , Depressão/terapia , Humanos , Estudos Multicêntricos como Assunto , Escalas de Graduação Psiquiátrica , Angústia Psicológica , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Resultado do Tratamento
16.
Trials ; 20(1): 770, 2019 Dec 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881929

RESUMO

After publication of our article [1] we were notified that the word "References" was wrongly included in the title.

17.
BMC Cardiovasc Disord ; 19(1): 303, 2019 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-31881946

RESUMO

BACKGROUND: Due to epidemiological transitions, Sub-Saharan Africa is facing a growing burden of non-communicable diseases, including cardiovascular diseases (CVDs). Among their risk factors, hypertension is a major determinant of CVDs, but the prevalence and level of awareness and management of this condition are poorly studied in African populations. The aim of this study was to determine the prevalence of hypertension and identify its associated risk factors as well as the awareness and management of this condition in a community-dwelling cohort in Benin. METHODS: A cross-sectional door-to-door study was conducted in the population over the age of 25 years in Tanve, a rural setting in Benin. The questionnaire and anthropometric measurements of the World Health Organization STEPWISE survey were used. Blood pressure was measured using standard procedures. RESULTS: The sample included 1777 subjects (60.9% females, mean age was 42.5 ± 16.5 years). The prevalence of hypertension was 32.9%, similar in men (32.8%) and women (33.0%, p = 0.9342). Age and obesity were significantly associated with hypertension. Less than half (42%) of hypertensive people were aware about their condition and only 46.3% of them were treated. Awareness ratios differed between men and women (respectively 32.9% vs. 47.5%; p = 0.0039) and was not influenced by age, education, occupation, marital status or income. Female sex was the only factor associated with better controlled HTN, independent of socio-economic parameters. CONCLUSION: This large population-based study confirms the high prevalence, low awareness, and low control of hypertension in men and women in sub-Saharan Africa. Only half of the populations with hypertension are aware of their hypertension, indicating a high burden of undiagnosed and un-controlled high blood pressure in these populations.


Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Conhecimentos, Atitudes e Prática em Saúde , Hipertensão/tratamento farmacológico , Adulto , Benin/epidemiologia , Estudos Transversais , Feminino , Humanos , Hipertensão/epidemiologia , Hipertensão/fisiopatologia , Hipertensão/psicologia , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Fatores de Risco , Fatores Sexuais , Resultado do Tratamento
18.
BMC Psychiatry ; 19(1): 420, 2019 12 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881956

RESUMO

BACKGROUND: Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown. METHODS: This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent of symptom improvement, response rate and remission rate from baseline to week 8 were evaluated using both scales. Analyses were performed for the full cohort and for the subset of patients who at baseline were taking medications predicted by the test to have moderate or significant gene-drug interactions. A Mokken scale analysis was conducted to compare the homogeneity of HAM-D17 with that of HAM-D6. RESULTS: At week 8, the guided-care arm demonstrated statistically significant benefit over TAU when the HAM-D6 (∆ = 4.4%, p = 0.023) was used as the continuous measure of symptom improvement, but not when using the HAM-D17 (∆ = 3.2%, p = 0.069). Response rates increased significantly for guided-care compared with TAU when evaluated using both HAM-D6 (∆ = 7.0%, p = 0.004) and HAM-D17 (∆ = 6.3%, p = 0.007). Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 ∆ = 4.6%, p = 0.031; HAM-D17 ∆ = 5.5%, p = 0.005). Patients in the guided-care arm who at baseline were taking medications predicted to have gene-drug interactions showed further increased benefit over TAU at week 8 for symptom improvement (∆ = 7.3%, p = 0.004) response (∆ = 10.0%, p = 0.001) and remission (∆ = 7.9%, p = 0.005) using HAM-D6. All outcomes showed continued improvement through week 24. Mokken scale analysis demonstrated the homogeneity and unidimensionality of HAM-D6, but not of HAM-D17, across treatment arms. CONCLUSIONS: The HAM-D6 scale identified a statistically significant difference in symptom improvement between combinatorial pharmacogenomics-guided care and TAU, whereas the HAM-D17 did not. The demonstrated utility of pharmacogenomics-guided treatment over TAU as detected by the HAM-D6 highlights its value for future biomarker-guided trials comparing active treatment arms. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02109939. Registered 10 April 2014.


Assuntos
Transtorno Depressivo Maior/diagnóstico , Farmacogenética , Escalas de Graduação Psiquiátrica , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Duplo-Cego , Humanos , Resultado do Tratamento
19.
Trials ; 20(1): 777, 2019 Dec 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881984

RESUMO

BACKGROUND: Nutrition plays a major role in intensive care unit (ICU) treatment, influencing ICU length of stay and patient's survival. If preferable enteral nutrition administration is not feasible, ESPEN and ASPEN guidelines recommend initiation of a supplemental parenteral route between the first and seventh day, but exact timing remains elusive. While rapid development in critical care enabled significant reduction in the mortality rate of ICU patients, this improvement also tripled the number of patients going to rehabilitation. Thus, it is quality of life after ICU that has become the subject of interest of clinicians and healthcare policy-makers. A growing body of evidence indicates that protein turnover in the early phase of critical illness may play a crucial role in the preservation of lean body mass. A negative protein balance may lead to muscle wasting that persists weeks and months after ICU stay, resulting in deterioration of physical functioning. Folliwing oncological gastrointestinal tract surgery, patients are threatened with negative protein turnover due to cancer and extensive surgical insult. METHODS: This is a multi-centre, single-blinded, randomised controlled trial. The study population includes patients admitted to ICU units after major oncological gastrointestinal surgery that require supplemental parenteral nutrition. After initiation of enteral nutrition, the intervention group receives remaining daily requirement via supplemental parenteral nutrition on the first day of ICU stay while the control group is not supplemented parenterally until the seventh day of ICU stay while enteral nutrition is gradually increased. Primary endpoint: long-term quality of life measured in the physical component score (PCS) of SF-36 questionnaire at 3 and 6 months after ICU admission. DISCUSSION: To our knowledge, this is the first trial to investigate the influence of early supplemental parenteral nutrition on long-term quality of life after major oncological gastrointestinal surgery. We assume that, particularly in this population of patients, early supplemental parenteral nutrition may increase the long-term quality of life. The study construction also allows establishment of patients' PCS SF-36 score prior to surgery and mean change in PCS SF-36 score during the recovery period, which is rarely seen in studies on critically ill patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03699371 registered on 12 October 2018.


Assuntos
Suplementos Nutricionais , Neoplasias Gastrointestinais , Nutrição Parenteral/métodos , Cuidados Pós-Operatórios , Qualidade de Vida , Adulto , Estado Terminal/terapia , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Procedimentos Cirúrgicos do Sistema Digestório/métodos , Procedimentos Cirúrgicos do Sistema Digestório/reabilitação , Intervenção Médica Precoce , Neoplasias Gastrointestinais/metabolismo , Neoplasias Gastrointestinais/psicologia , Neoplasias Gastrointestinais/cirurgia , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Cuidados Pós-Operatórios/métodos , Cuidados Pós-Operatórios/reabilitação , Ensaios Clínicos Controlados Aleatórios como Assunto , Tempo
20.
BMC Psychiatry ; 19(1): 423, 2019 12 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881995

RESUMO

BACKGROUND: Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial. METHODS: Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples. DISCUSSION: This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).


Assuntos
Terapia Cognitivo-Comportamental , Depressão/terapia , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Idoso , Idoso de 80 Anos ou mais , Ansiedade/terapia , Biomarcadores/sangue , Depressão/sangue , Depressão/patologia , Depressão/psicologia , Feminino , Alemanha , Humanos , Transtornos de Início Tardio/terapia , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Neuroimagem , Testes Neuropsicológicos , Qualidade de Vida , Projetos de Pesquisa , Método Simples-Cego , Resultado do Tratamento
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