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1.
Artigo em Inglês | MEDLINE | ID: mdl-31840263

RESUMO

OBJECTIVE: Childhood-onset depression is associated with increased risk of recurrent depression and high morbidity extending into adolescence and adulthood. This multisite randomized controlled trial evaluated two active psychosocial treatments for childhood depression: family-focused treatment for childhood depression (FFT-CD) and individual supportive psychotherapy (IP). Aims were to describe effects through 52 weeks postrandomization on measures of depression, functioning, nondepressive symptoms, and harm events. METHODS: Children meeting criteria for depressive disorders (N = 134) were randomly assigned to 15 sessions of FFT-CD or IP and evaluated at mid-treatment for depressive symptoms and fully at roughly 16 weeks (after acute treatment), 32 weeks, and 52 weeks/one year. See clinicaltrials.gov: NCT01159041. RESULTS: Analyses using generalized linear mixed models confirmed the previously reported FFT-CD advantage on rates of acute depression response (≥50% Children's Depression Rating Scale reduction). Improvements in depression and other outcomes were most rapid during the acute treatment period, and leveled off between weeks 16 and 52, with a corresponding attenuation of observed group differences, although both groups showed improved depression and functioning over 52 weeks. Survival analyses indicated that most children recovered from their index depressive episodes by week 52: estimated 76% FFT-CD, 77% IP. However, by the week 52 assessment, one FFT-CD child and six IP children had suffered recurrent depressive episodes. Four children attempted suicide, all in the IP group. Other indicators of possible harm were relatively evenly distributed across groups. CONCLUSIONS: Results indicate a quicker depression response in FFT-CD and hint at greater protection from recurrence and suicide attempts. However, outcomes were similar for both active treatments by week 52/one year. Although community care received after acute treatment may have influenced results, findings suggest the value of a more extended/chronic disease model that includes monitoring and guidance regarding optimal interventions when signs of depression-risk emerge.

2.
Lasers Med Sci ; 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31823135

RESUMO

Stroke results in impairment of basic motor functions, such as muscle weakness in limbs affected by spasticity, leading to peripheral fatigue and impaired functionality. The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue. The aim of this study was to analyze the effects of two distinct therapies in biceps spasticity of chronic hemiparetic patients. We analyzed range of elbow motion, torque, electromyography, and mean spectral frequency after 10 sessions of PBMT (Laser 100 mW, 808 nm, 159.24 J/cm2/point, 5 J/point); PBMT active or placebo was associated with exoskeleton-assisted functional treatment. A double-blind placebo-controlled sequential clinical trial was conducted with 12 healthy volunteers and 15 poststroke patients who presented upper-limb spasticity. The healthy volunteers performed only the evaluation protocol, and the poststroke volunteers participated in three consecutive phases (PBMT, PBMT + exoskeleton, placebo + PBMT) with a washout period of 4 weeks between each phase. We could observe significant increases in range of elbow motion after PBMT from 57.7 ± 14 to 84.3 ± 27.6 degrees (p < 0.001). The root mean square (RMS) values also increased after PBMT + exoskeleton from 23.2 ± 15 to 34.9 ± 21 µV (p = 0.0178). Our results suggest that the application of PBMT may contribute to an increased range of elbow motion and muscle fiber recruitment, increases in muscle strength, and, hence, to increase signal conduction on spastic muscle fibers in spastic patients.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31823301

RESUMO

BACKGROUND: Evidence shows a positive association between the use of statins and new-onset diabetes. There is, however, contradictory evidence as to whether a similar association exists for the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. OBJECTIVE: The aim of this study was to investigate the safety of PCSK9 monoclonal antibodies (PCSK9-mAbs) in regard to incident diabetes. METHODS AND RESULTS: Randomized controlled trials that reported data on the incidence of new-onset diabetes mellitus or the worsening of pre-existing diabetes were searched, and risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to compare the endpoints. Twenty-three studies including 65,957 participants were identified. Compared with controls, PCSK9-mAb treatment was not associated with the adverse event of diabetes (RR 0.97, 95% CI 0.91-1.02; p = 0.22). When we analysed the trials in terms of PCSK9-mAb type, alirocumab was associated with a significant reduction in the risk of diabetes (RR 0.91, 95% CI 0.85-0.98; p = 0.01), whereas no significant reduction was observed in participants receiving evolocumab or bococizumab. Interestingly, compared with ezetimibe, which was actively used as lipid-modifying therapy in the control group, PCSK9-mAbs seem to have a lower risk of incident diabetes (RR 0.60, 95% CI 0.37-0.99; p = 0.04). This meta-analysis also revealed a noticeable increase in the risk of incident diabetes in the evolocumab and alirocumab pool (RR 2.14, 95% CI 1.12-4.07; p = 0.02) when the use of statins was equivalent between the experimental and active comparator arms. CONCLUSION: Compared with placebo or any other comparator, PCSK9-mAb treatment was not associated with the adverse event of diabetes. However, evolocumab and alirocumab show high risk of incident diabetes when there is no interference from unbalanced use of statins. The imbalance in background lipid modifying therapy or different comparators used in the control arms of the studies might have masked the effect of PCSK9-mAb therapy on diabetes.

4.
Cochrane Database Syst Rev ; 12: CD008558, 2019 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-31794067

RESUMO

BACKGROUND: The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether metformin can prevent or delay T2DM and its complications in people with increased risk of developing T2DM is unknown. OBJECTIVES: To assess the effects of metformin for the prevention or delay of T2DM and its associated complications in persons at increased risk for the T2DM. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was March 2019. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with a duration of one year or more comparing metformin with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or standard care in people with impaired glucose tolerance, impaired fasting glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or combinations of these. DATA COLLECTION AND ANALYSIS: Two review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 20 RCTs randomising 6774 participants. One trial contributed 48% of all participants. The duration of intervention in the trials varied from one to five years. We judged none of the trials to be at low risk of bias in all 'Risk of bias' domains. Our main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, non-fatal myocardial infarction or stroke, health-related quality of life and socioeconomic effects.The following comparisons mostly reported only a fraction of our main outcome set. Fifteen RCTs compared metformin with diet and exercise with or without placebo: all-cause mortality was 7/1353 versus 7/1480 (RR 1.11, 95% CI 0.41 to 3.01; P = 0.83; 2833 participants, 5 trials; very low-quality evidence); incidence of T2DM was 324/1751 versus 529/1881 participants (RR 0.50, 95% CI 0.38 to 0.65; P < 0.001; 3632 participants, 12 trials; moderate-quality evidence); the reporting of SAEs was insufficient and diverse and meta-analysis could not be performed (reported numbers were 4/118 versus 2/191; 309 participants; 4 trials; very low-quality evidence); cardiovascular mortality was 1/1073 versus 4/1082 (2416 participants; 2 trials; very low-quality evidence). One trial reported no clear difference in health-related quality of life after 3.2 years of follow-up (very low-quality evidence). Two trials estimated the direct medical costs (DMC) per participant for metformin varying from $220 to $1177 versus $61 to $184 in the comparator group (2416 participants; 2 trials; low-quality evidence). Eight RCTs compared metformin with intensive diet and exercise: all-cause mortality was 7/1278 versus 4/1272 (RR 1.61, 95% CI 0.50 to 5.23; P = 0.43; 2550 participants, 4 trials; very low-quality evidence); incidence of T2DM was 304/1455 versus 251/1505 (RR 0.80, 95% CI 0.47 to 1.37; P = 0.42; 2960 participants, 7 trials; moderate-quality evidence); the reporting of SAEs was sparse and meta-analysis could not be performed (one trial reported 1/44 in the metformin group versus 0/36 in the intensive exercise and diet group with SAEs). One trial reported that 1/1073 participants in the metformin group compared with 2/1079 participants in the comparator group died from cardiovascular causes. One trial reported that no participant died due to cardiovascular causes (very low-quality evidence). Two trials estimated the DMC per participant for metformin varying from $220 to $1177 versus $225 to $3628 in the comparator group (2400 participants; 2 trials; very low-quality evidence). Three RCTs compared metformin with acarbose: all-cause mortality was 1/44 versus 0/45 (89 participants; 1 trial; very low-quality evidence); incidence of T2DM was 12/147 versus 7/148 (RR 1.72, 95% CI 0.72 to 4.14; P = 0.22; 295 participants; 3 trials; low-quality evidence); SAEs were 1/51 versus 2/50 (101 participants; 1 trial; very low-quality evidence). Three RCTs compared metformin with thiazolidinediones: incidence of T2DM was 9/161 versus 9/159 (RR 0.99, 95% CI 0.41 to 2.40; P = 0.98; 320 participants; 3 trials; low-quality evidence). SAEs were 3/45 versus 0/41 (86 participants; 1 trial; very low-quality evidence). Three RCTs compared metformin plus intensive diet and exercise with identical intensive diet and exercise: all-cause mortality was 1/121 versus 1/120 participants (450 participants; 2 trials; very low-quality evidence); incidence of T2DM was 48/166 versus 53/166 (RR 0.55, 95% CI 0.10 to 2.92; P = 0.49; 332 participants; 2 trials; very low-quality evidence). One trial estimated the DMC of metformin plus intensive diet and exercise to be $270 per participant compared with $225 in the comparator group (94 participants; 1 trial; very-low quality evidence). One trial in 45 participants compared metformin with a sulphonylurea. The trial reported no patient-important outcomes. For all comparisons there were no data on non-fatal myocardial infarction, non-fatal stroke or microvascular complications. We identified 11 ongoing trials which potentially could provide data of interest for this review. These trials will add a total of 17,853 participants in future updates of this review. AUTHORS' CONCLUSIONS: Metformin compared with placebo or diet and exercise reduced or delayed the risk of T2DM in people at increased risk for the development of T2DM (moderate-quality evidence). However, metformin compared to intensive diet and exercise did not reduce or delay the risk of T2DM (moderate-quality evidence). Likewise, the combination of metformin and intensive diet and exercise compared to intensive diet and exercise only neither showed an advantage or disadvantage regarding the development of T2DM (very low-quality evidence). Data on patient-important outcomes such as mortality, macrovascular and microvascular diabetic complications and health-related quality of life were sparse or missing.


Assuntos
Diabetes Mellitus Tipo 2/prevenção & controle , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Intolerância à Glucose , Hemoglobina A Glicada , Humanos , Estado Pré-Diabético , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
BMJ Open ; 9(12): e032889, 2019 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-31806615

RESUMO

INTRODUCTION: In recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on). METHODS AND ANALYSIS: This prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%. ETHICS AND DISSEMINATION: The study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00015516; Pre-results.

6.
Clin Nutr ; 2019 Nov 28.
Artigo em Inglês | MEDLINE | ID: mdl-31818531

RESUMO

BACKGROUND: Only a limited number of studies have examined the vascular and postprandial effects of α-linolenic acid (ALA, C18:3n-3). Therefore, we performed a well-controlled trial focusing specifically on the effects of ALA on vascular function and metabolic risk markers during the fasting and postprandial phase in untreated (pre-)hypertensive individuals. METHODS: In a double-blind randomized, placebo-controlled parallel study, 59 overweight and obese adults (40 men and 19 women, aged 60 ± 8 years) with a high-normal blood pressure or mild (stage I) hypertension consumed daily either 10 g of refined cold-pressed flaxseed oil, providing 4.7 g ALA (n = 29), or 10 g of high-oleic sunflower (control) oil (n = 30) for 12 weeks. RESULTS: As compared with the high-oleic oil control, intake of flaxseed oil did not change brachial artery flow-mediated vasodilation, carotid-to-femoral pulse wave velocity, retinal microvascular calibers and plasma markers of microvascular endothelial function during the fasting and postprandial phase. Fasting plasma concentrations of free fatty acid (FFA) and TNF-α decreased by 58 µmol/L (P = 0.02) and 0.14 pg/mL (P = 0.03), respectively. No differences were found in other fasting markers of lipid and glucose metabolism, and low-grade systemic inflammation. In addition, dietary ALA did not affect postprandial changes in glucose, insulin, triacylglycerol, FFA and plasma inflammatory markers after meal intake. CONCLUSION: A high intake of ALA, about 3-5 times the recommended daily intake, for 12 weeks decreased fasting FFA and TNF-α plasma concentrations. No effects were found on other metabolic risk markers and vascular function during the fasting and postprandial phase in untreated high-normal and stage I hypertensive individuals.

7.
BMJ Open ; 9(12): e028017, 2019 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-31818831

RESUMO

INTRODUCTION: Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients. METHODS AND ANALYSIS: The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease. ETHICS AND DISSEMINATION: The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population. TRIAL REGISTRATION NUMBER: NCT03098186.

8.
BMJ Open ; 9(12): e033452, 2019 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-31818843

RESUMO

INTRODUCTION: Approximately 50% of pancreatic ductal adenocarcinoma (PDAC) patients are diagnosed with distant metastasis, especially liver metastasis. The current standard treatment for these stage IV patients is palliative chemotherapy. There is increasing agreement that synchronous PDAC and liver metastasis resection may benefit highly selected patients. Thus, the Chinese Study Group for Pancreatic Cancer (CSPAC)-1 trial is being launched to establish a strategy for selecting PDAC patients with liver oligometastases who may benefit from synchronous resection after conversion chemotherapy. METHODS AND ANALYSIS: In this study, liver oligometastasis is defined as no more than three metastatic lesions irrespective of their distribution within the liver lobes. The trial contains two steps. In the first step, 1000 to 1200 needle biopsy-confirmed PDAC patients with liver oligometastases are eligible for inclusion. Candidates will receive first-line chemotherapy. The RECIST V.1.1 criteria combined with tumour markers will be applied to evaluate the tumour response to chemotherapy every two cycles. Pancreatic cancer and hepatic metastasis resectability will be identified by multidisciplinary teams. Approximately 300 patients who meet our criteria will enter the second step and be randomly assigned at a 1:1 ratio to simultaneous resection of the primary pancreatic cancer lesion and liver oligometastases if no extensive metastatic sites are found during surgery or standard chemotherapy. Postoperative chemotherapy is recommended, and regimen selection should be based on the preoperative chemotherapy regimen. The primary endpoint is real overall survival (from enrolment to death). This study was activated in July 2018 and is expected to complete accrual within 5 years. ETHICS AND DISSEMINATION: This trial has been approved by the Clinical Research Ethics Committee of Fudan University Shanghai Cancer Centre. Written informed consent will be obtained from all participants. Serious adverse events will be reported. Trial results will be submitted for peer-reviewed publication. TRIAL REGISTRATION NUMBER: NCT03398291; Pre-results.

9.
Front Psychiatry ; 10: 863, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31827448

RESUMO

Background: Depressive disorders in childhood and adolescence are a major health problem and often follow a chronic course with severe consequences in later life. Depressive disorders cause the highest burden of disease in this age group across all medical conditions. Treatment adherence is usually very poor, and the use of antidepressant drugs is heavily debated, as suicidal ideations may increase, in particular in the early phase of treatment. Omega-3 fatty acids rich in eicosapentaenoic acid have shown some promising results in over a dozen small scale randomized controlled trials (RCTs) in adult major depressive disorders, with only very few published RCTs in children and adolescents. High-quality phase III RCTs are missing. Methods and Design: The omega-3-pMDD trial is a carefully designed phase III RCT to assess the efficacy and safety of omega-3 fatty acids in the early course of pediatric major depressive disorder (MDD). The study is designed as a multi-center, double-blinded, placebo-controlled, randomized clinical trial enrolling 220 patients aged 8 to 17 years meeting DSM-IV criteria for major depressive disorder of at least moderate symptom severity. After a single-blinded placebo-lead-in phase (7 to 10 days) patients are randomly assigned to omega-3 fatty acids or placebo over 36 weeks. Primary outcomes are changes in depression severity, as well as remission and recovery rates. Secondary outcome measures include the omega-3 index and inflammatory parameters as predictors of response. Data analysis will be performed in the intention-to-treat sample using a (generalized) linear random intercept regression model. Through sampling of blood, hair, saliva, and urine, further putative biological markers for depression and omega-3 fatty response will be investigated. Discussion: This trial addresses if omega-3 fatty acids play a role in the pathogenesis of pediatric MDDs and have antidepressant properties, in particular in clinically depressed children and adolescents with a pre-existing omega-3 fatty acid deficiency, increased markers of oxidative stress, and/or markers of (low grade) inflammation. Ethics and Dissemination: The study was approved by the local ethics committees. The results will be published in peer-reviewed journals irrespective of specific outcomes. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03167307.

10.
Diabetol Metab Syndr ; 11: 101, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31827626

RESUMO

Background: The present study was designed to determine whether zinc supplementation would increase the effects of restricted calorie diet (RCD) on obesity. Methods and materials: A randomized, double-blind clinical trial was performed on 40 obese subjects who were randomly assigned to receive zinc supplements (30 mg/day) or placebo for a period of 15-weeks. Both groups were under a restricted calorie diet (~ 300 kcal lower than the estimated energy requirement). Anthropometric measurements, biochemical markers, appetite, and dietary intakes were determined during the study period. Results: The reductions of body weight, body mass index, waist circumference, and hip circumference were significantly higher in the zinc group compared to the placebo group (P = 0.032, 0.025, 0.003, and 0.0001, respectively). Lower levels of high sensitivity C-reactive protein, apelin, homeostatic model assessment of insulin resistance (HOMA-IR), and appetite score were observed in the zinc group in comparison with the placebo group (P = 0.0001, 0.001, 0.031 and 0.001 respectively). Conclusion: This study indicates that Zn supplementation with a restricted calorie diet has favorable effects in reducing anthropometric measurements, inflammatory markers, insulin resistance and appetite in individuals with obesity, and may play an effective role in the treatment of obesity.Trial registration This clinical trial was registered at clinicaltrials.gov at the U.S. National Library of Medicine (NCT02516475).

11.
Diabetol Metab Syndr ; 11: 103, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31827628

RESUMO

Background: The aim of this randomized, double-blinded, controlled trial was to investigate the effect of daily consumption of a synbiotic bread containing lactic acid on glycemic status, antioxidant biomarkers and inflammation in patients with type 2 diabetes (T2D). Methods: T2D patients, aged 20 to 60 years, were randomly assigned to consume synbiotic + lactic acid (n = 30), synbiotic (n = 30), lactic acid (n = 30), or control (n = 30) bread for 8 weeks. Patients consumed bread 3 times a day in a 40 g package for a total of 120 g/day. Glycemic status, antioxidant capacity, and serum hs-CRP were assessed before and after the intervention. Results: Of a total of 120 patients that were included in the study, 100 completed the trial. In the adjusted analysis, it was found that consumption of synbiotic + lactic acid bread caused a significant decrease in HbA1c compared to the control bread (- 0.41 ± 0.33 vs 0.004 ± 0.10%, respectively; P < 0.001), while it significantly increased serum superoxide dismutase (SOD) (0.87 ± 1.14 vs. 0.18 ± 0.85 mmol/L, P = 0.02). Also, changes in glutathione peroxidase (GSH-Px) were significantly higher following the consumption of synbiotic + lactic acid bread than lactic acid bread. However, it had no significant effect on fasting plasma glucose, serum insulin, and total antioxidant capacity. Conclusion: Overall, daily consumption of a synbiotic bread containing lactic acid for 8 weeks had beneficial effects on HbA1c, SOD, and GSH-Px among T2D patients.Trial registration This study was registered in Iranian Registry of Clinical Trials with number: IRCT201505242709N33 (Registration date: 2015-11-23, http://www.irct.ir/trial/2544).

12.
Oxid Med Cell Longev ; 2019: 5382843, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31827679

RESUMO

Stroke survivors are at substantial risk of recurrent cerebrovascular event or cardiovascular disease. Exercise training offers nonpharmacological treatment for these subjects; however, the execution of the traditional exercise protocols and adherence is constantly pointed out as obstacles. Based on these premises, the present study investigated the impact of an 8-week dynamic resistance training protocol with elastic bands on functional, hemodynamic, and cardiac autonomic modulation, oxidative stress markers, and plasma nitrite concentration in stroke survivors. Twenty-two patients with stroke were randomized into control group (CG, n = 11) or training group (TG, n = 11). Cardiac autonomic modulation, oxidative stress markers, plasma nitrite concentration, physical function and hemodynamic parameters were evaluated before and after 8 weeks. Results indicated that functional parameters (standing up from the sitting position (P = 0.011) and timed up and go (P = 0.042)) were significantly improved in TG. Although not statistically different, both systolic blood pressure (Δ = -10.41 mmHg) and diastolic blood pressure (Δ = -8.16 mmHg) were reduced in TG when compared to CG. Additionally, cardiac autonomic modulation (sympathovagal balance-LF/HF ratio) and superoxide dismutase were improved, while thiobarbituric acid reactive substances and carbonyl levels were reduced in TG when compared to the CG subjects. In conclusion, our findings support the hypothesis that dynamic resistance training with elastic bands may improve physical function, hemodynamic parameters, autonomic modulation, and oxidative stress markers in stroke survivors. These positive changes would be associated with a reduced risk of a recurrent stroke or cardiac event in these subjects.


Assuntos
Estresse Oxidativo , Treinamento de Resistência , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/patologia , Idoso , Pressão Sanguínea , Doença Crônica , Feminino , Força da Mão , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , NADPH Oxidases/metabolismo , Nitritos/sangue , Carbonilação Proteica , Acidente Vascular Cerebral/metabolismo , Superóxido Dismutase/metabolismo , Sobreviventes
13.
Trials ; 20(1): 720, 2019 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-31831080

RESUMO

BACKGROUND: Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug-taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of cognitive bias modification (CBM). Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple laboratory training sessions. Here, we present a protocol for a randomized controlled design to improve CBM training efficiency and facilitate access to the training by providing mobile-phone-based training sessions at home to current smokers motivated to quit smoking. METHODS: Participants (n = 100) are current smokers who smoke at least six cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training application (app) aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at 6-week follow up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, and follow up). After completion of the study, smokers in the control condition will receive access to the training app. DISCUSSION: This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimization and advancement of CBM treatment for addiction. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN15690771. Registered on 20 November 2018.

14.
Sci Rep ; 9(1): 19017, 2019 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-31831868

RESUMO

Saroglitazar is a dual PPAR-α/γ agonist approved for the treatment of diabetic dyslipidemia. In addition to reduction in atherogenic lipids, it may also contribute to improvement in insulin sensitivity through PPAR-α/γ agonism, which remains unexplored. We conducted a randomized, double-blind, placebo-controlled trial in treatment-naive T2DM individuals with serum triglyceride >150 mg/dL. Participants were randomized to receive either saroglitazar 4 mg or placebo (1:1) daily for 4 months (n = 30). Insulin sensitivity (SIclamp) was studied using hyperinsulinemic-euglycemic clamp at baseline and at 4 months. We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo. Further, patients on saroglitazar had a greater improvement in SIclamp (p = 0.026) with the effect persisting despite adjusting for baseline weight, TG, HDL-C and HbA1c (p = 0.002). This was accompanied with significant increase in HOMA-ß (p = 0.01) in the saroglitazar group and change in HOMA-ß showed a trend towards significance with SIclamp (r = 0.503, p = 0.056). However, change in SIclamp did not significantly correlate with reduction in HbA1c and TG. We conclude that saroglitazar effectively reduces hypertriglyceridemia and improves insulin sensitivity along with ß-cell function by reduction in gluco-lipotoxicity and possibly directly through PPAR-γ agonism in patients ofT2DM with hypertriglyceridemia.

15.
Indian J Pharmacol ; 51(5): 316-322, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31831920

RESUMO

OBJECTIVES: The objective of this study was to carry out a head-to-head comparison of topical sucralfate combined with mupirocin versus mupirocin alone in the treatment of chronic skin ulcers with respect to both effectiveness and safety. MATERIALS AND METHODS: A parallel-group, open-label, randomized, controlled trial (CTRI/2015/12/006443) was carried out with patients suffering from skin ulcers of Wagner grading 1 or 2 persisting for over 4 weeks. Ninety-six patients were recruited in total, and the modified intention-to-treat analysis dataset included 44 participants treated with mupirocin 2% and 46 treated with combined mupirocin 2% and sucralfate 7% ointment. Both medications were applied topically thrice daily for 6 weeks. Ulcer area assessed using millimeter graph paper and wound infection score assessed on a three-point scale were effectiveness measures. Treatment-emergent adverse reactions that were reported by patients or observed by the investigators were recorded. RESULTS: The median ulcer area was significantly reduced in the combined treatment group at the end of treatment. Clinically, 41.3% of the participants in the combined group showed complete ulcer healing at 6 weeks compared to 18.18% in the mupirocin alone group (P = 0.022). The wound infection score declined significantly from baseline by the end of 3 weeks of treatment in both the groups. The frequency of qualitative wound attributes, namely pain, discharge, and erythema, remained comparable between the groups except for discharge which disappeared completely from all remaining ulcers in the combined group but was still present in 11.36% of the participants treated with mupirocin alone (P = 0.025) at 6 weeks. Adverse events were few, all local, mild, and tolerable. CONCLUSIONS: The wound healing effect of topical sucralfate adds to the antimicrobial effect of mupirocin toward the overall improvement of chronic skin ulcers. The effect of combined topical treatment needs comparison with other topical medications and wound healing strategies.


Assuntos
Mupirocina/administração & dosagem , Úlcera Cutânea/tratamento farmacológico , Sucralfato/administração & dosagem , Cicatrização/efeitos dos fármacos , Administração Cutânea , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Antiulcerosos/administração & dosagem , Antiulcerosos/efeitos adversos , Doença Crônica , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mupirocina/efeitos adversos , Pomadas , Sucralfato/efeitos adversos , Resultado do Tratamento , Adulto Jovem
16.
Vasc Health Risk Manag ; 15: 485-502, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31802882

RESUMO

Introduction: Smoking is a major risk factor for cardiovascular diseases (CVDs) and for many types of cancers. Despite recent policies, 1.1 billion people are active smokers and tobacco is the leading cause of mortality and illness throughout the world. The aim of this work was to identify smoking cessation interventions which could be implemented in primary care and/or at a community level. Methods: A systematic review of CVDs prevention guidelines was realized using the ADAPTE Process. These were identified on G-I-N and TRIP databases. Additionally, a purposive search for national guidelines was successfully undertaken. Guidelines focusing on non-pharmacological lifestyle interventions, published or updated after 2011, were included. Exclusion criteria were specific populations, management of acute disease and exclusive focus on pharmacological or surgical interventions. After appraisal with the AGREE II tool, high-quality guidelines were included for analysis. High-grade recommendations and the supporting bibliographic references were extracted. References had to be checked in detail where sufficient information was not available in the guidelines. Results: Nine hundred and ten guidelines were identified, 47 evaluated with AGREE II and 26 included. Guidelines recommended that patients quit smoking and that health care professionals provided advice to smokers but failed to propose precise implementation strategies for such recommendations. Only two guidelines provided specific recommendations. In the guideline bibliographic references, brief advice (BA) and multiple session strategies were identified as effective interventions. These interventions used Prochaska theory, motivational interviewing or cognitive-behavioral therapies. Self-help documentation alone was less effective than face-to-face counseling. Community-based or workplace public interventions alone did not seem effective. Discussion: Behavioral change strategies were effective in helping patients to give up smoking. BA alone was less effective than multiple session strategies although it required fewer resources. Evidence for community-based interventions effectiveness was weak, mainly due to the lack of robust studies.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Serviços de Saúde Comunitária , Aconselhamento , Atenção Primária à Saúde , Comportamento de Redução do Risco , Fumantes/psicologia , Abandono do Hábito de Fumar/psicologia , Adolescente , Adulto , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Feminino , Comportamentos Relacionados com a Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Proteção , Medição de Risco , Fatores de Risco , Adulto Jovem
17.
Diabetes Metab Syndr Obes ; 12: 2137-2143, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31802921

RESUMO

Introduction: Diabetes is among the common diseases in the elderly which results in depression, anxiety, and emotional distress in the elderly and impacts the disease control by the individual. This study was conducted with the aim of exploring the effectiveness of acceptance and commitment therapy (ACT) in the improvement of emotional distress in the elderly with type 2 diabetes. Materials and methods: In this randomized control trial, 80 elderly with type 2 diabetes aged ≥60 years were randomly selected among the individuals visiting Yazd Diabetes Research Center. Then, the patients were randomly divided into two 40 individual groups, ie, the intervention group and the control group. The intervention group underwent group ACT during eight 90-min sessions. The diabetes-related emotional distress questionnaire was completed before the intervention, after the end of the group sessions and 2 months after that. The statistical software SPSS version 21 was used for data analysis. Results: The emotional mean scores in the intervention and control groups were not significantly different before the intervention. However, the mean score of the intervention group was lower than of the control group immediately after the intervention (p=0.02) and 2 months after the intervention (p=0.02). Conclusion: ACT results in the improvement of diabetes-related emotional distress in the intervention group. Considering the effectiveness of ACT, this therapeutic method is recommended to be used for the amelioration of emotional distress in the elderly with type 2 diabetes.

18.
Digit Health ; 5: 2055207619890480, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31803491

RESUMO

Objective: Cardiovascular diseases (CVD) are a leading cause of mortality and disease burden. Preventative interventions to augment the population-level adoption of health lifestyle behaviours that reduce CVD risk are a priority. Face-to-face interventions afford individualisation and are effective for improving health-related behaviours and outcomes, but they are costly and resource intensive. Electronic and mobile health (e- and mHealth) approaches aimed at modifying lifestyle risk factors may be an effective and scalable approach to reach many individuals while preserving individualisation. This systematic review aims to (a) determine the effectiveness of multifactorial e- and mHealth interventions on CVD risk and on lifestyle-related cardiometabolic risk factors and self-management behaviours among adults without CVD; and (b) describe the evidence on adverse events and on the cost-effectiveness of these interventions. Methods: Methods were detailed prior to the start of the review in order to improve conduct and prevent inconsistent decision making throughout the review. This protocol was prepared following the PRISMA-P 2015 statement. MEDLINE, CINAHL, Embase, PsycINFO, Web of Science, Cochrane Public Health Group Specialised Register and CENTRAL electronic databases will be searched between 1991 and September 2019. Eligibility criteria are: (a) population: community-dwelling adults; (b) intervention/comparison: randomised controlled trials comparing e- or mHealth CVD risk preventative interventions with usual care; and (c) outcomes: modifiable CVD risk factors. Selection of study reports will involve two authors independently screening titles and abstracts, followed by a full-text review of potentially eligible reports. Two authors will independently undertake data extraction and assess risk of bias. Where appropriate, meta-analysis of outcome data will be performed. Discussion: This protocol describes the pre-specified methods for a systematic review that will provide quantitative and narrative syntheses of current multifactorial e- and mHealth CVD preventative interventions. A systematic review and meta-analysis will be conducted following the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions and reported according to PRISMA guidelines.

19.
Front Public Health ; 7: 347, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31803710

RESUMO

Background: Within health promotion research, there is a need to assess strategies for integration and scale up in primary care settings. Hybrid interventions that combine clinical effectiveness trials with implementation studies can elicit important contextual information on facilitators and barriers to integration within a health care system. This article describes lessons learned in developing and implementing a qualitative study of a cluster-randomized controlled trial (RCT) to reduce cardiovascular disease (CVD) among people with diabetes in Sonora, Mexico, 2015-2019. Methods:The research team worked cooperatively with health center personnel from 12 Centers that implemented the intervention. The study used observations, stakeholder meetings, case studies, staff interviews and decision maker interviews to explore issues such as staff capacity, authority, workflow, space, and conflicting priorities, as well as patients' response to the program within the clinical context and their immediate social environments. Applying a multi-layered contextual framework, two members of the research team coded an initial sample of the data to establish inclusion criteria for each contextual factor. The full team finalized definitions and identified sub nodes for the final codebook. Results: Characteristics of management, staffing, and the local environment were identified as essential to integration and eventual adoption and scale up across the health system. Issues included absence of standardized training and capacity building in chronic disease and health promotion, inadequate medical supplies, a need for program monitoring and feedback, and lack of interdisciplinary support for center staff. Lack of institutional support stemming from a curative vs. preventive approach to care was a barrier for health promotion efforts. Evolving analysis, interpretation, and discussion resulted in modifications of flexible aspects of the intervention to realities of the health center environment. Conclusion: This study illustrates that a robust and comprehensive qualitative study of contextual factors across a social ecological spectrum is critical to elucidating factors that will promote future adoption and scale up of health promotion programs in primary care. Application of conceptual frameworks and health behavior theory facilitates identification of facilitators and barriers across contexts. Trial registration: www.ClinicalTrials.gov, identifier: NCT02804698 Registered on June 17, 2016.

20.
Front Cardiovasc Med ; 6: 160, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31803757

RESUMO

Introduction: Hypertensive disorders (HDP) affect ~7% of pregnancies. Epidemiological evidence strongly suggests HDP independently increases that individual's risk of later cardiovascular disease (CVD). Focus on reduction or mitigation of this risk has been limited. This review seeks to identify trialed interventions to reduce cardiovascular risk after HDP. Methods: Online medical databases were searched to identify full-text published results of randomized controlled trials (RCT) in women <10 years postpartum after HDP that trialed interventions to reduce cardiovascular risk. Outcomes sought included cardiovascular disease events, chronic hypertension, and other measures of cardiovascular risk such as obesity, smoking status, diet, and physical activity. Publications from January 2008 to July 2019 were included. Results: Two RCTs were identified. One, a trial of calcium vs. placebo in 201 women with calcium commenced from the first follow-up visit outside of pregnancy and continued until 20 weeks' gestation if another pregnancy occurred. A non-significant trend toward decreased blood pressure was noted. The second RCT of 151 women tested an online education programme (vs. general information to control group) to increase awareness of risk factors and personalized phone-based lifestyle coaching in women who had a preeclampsia affected pregnancy in the 5 years preceding enrolment. Significant findings included increase in knowledge of CVD risk factors, reported healthy eating and decreased physical inactivity, however adoption of a promoted heart healthy diet and physical activity levels did not differ significantly between groups. Several observational studies after HDP, and one meta-analysis of studies of lifestyle interventions not performed specifically after HDP but used to extrapolate likely benefits of lifestyle interventions, were identified which supported the use of lifestyle interventions. Several ongoing RCTs were also noted. Discussion: There is a paucity of intervention trials in the early years after HDP to guide evidence-based cardiovascular risk reduction in affected women. Limited evidence suggests lifestyle intervention may be effective, however degree of any risk reduction remains uncertain. Conclusion: Sufficiently powered randomized controlled trials of appropriate interventions (e.g., lifestyle behavior change, pharmacological) are required to assess the best method of reducing the risk of cardiovascular disease in this at-risk population of women.

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