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1.
Medicine (Baltimore) ; 98(31): e16539, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374015

RESUMO

BACKGROUND: Chronic stable angina (CSA) is a cardiovascular disease with high prevalence. At present, drug treatment is still the main measure of stable angina pectoris. Traditional Chinese medicine has a long history in the treatment of CSA. Qi stagnation and Blood stasis syndrome is a common syndrome of CSA. Xinnaoning (XNN) capsule is considered as an effective adjuvant treatment for CSA with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. The purpose of this study is to evaluate the efficacy and safety of XNN capsule compared with placebo by clinical trial. METHODS: This multicenter, randomized, double-blind, placebo-controlled trial will be conducted with a total of 240 participants diagnosed with chronic stable angina (qi stagnation and blood stasis syndrome). The participants will be randomized (1:1) into groups receiving either XNN or placebo for 12 weeks. After a 2-week run-in period, they will receive either XNN or placebo (3 pills, 3 times daily) for 12 weeks on the basis of conventional therapy. The primary outcomes include changes in the integral scores of angina symptoms. The secondary outcome measures include changes in the total score of traditional Chinese medicine syndrome, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of seattle angina scale, serum homocysteine, incidence of cardiovascular events. Safety outcomes will also be assessed. Adverse events will be monitored throughout the trial. RESULTS: This study will investigate whether XNN capsule can alleviate clinical symptoms, and improve quality of life of patients with chronic stable angina (qi stagnation and blood stasis syndrome). The results of this study will provide clinical evidence for the application of XNN capsule in the treatment of chronic stable angina. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03914131.


Assuntos
Angina Estável/terapia , Adulto , Idoso , Análise de Variância , Distribuição de Qui-Quadrado , Angiografia Coronária/métodos , Método Duplo-Cego , Feminino , Homocisteína/análise , Homocisteína/sangue , Humanos , Masculino , Medicina Tradicional Chinesa/métodos , Medicina Tradicional Chinesa/normas , Pessoa de Meia-Idade , Placebos , Inquéritos e Questionários , Resultado do Tratamento
2.
Pharm Res ; 36(9): 135, 2019 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-31317279

RESUMO

PURPOSE: The aim of this work was to allow combination of information from recent and historical trials in Parkinson's Disease (PD) by developing bridging methodology between two versions of the clinical endpoint. METHODS: A previously developed Item Response Model (IRM), that described longitudinal changes in Movement Disorder Society (MDS) sponsored revision of Unified Parkinson's Disease Rating Scale (UPDRS) [MDS-UPDRS] data from the De Novo PD cohort in Parkinson's Progression Markers Initiative, was first adapted to describe baseline UPDRS data from two clinical trials, one in subjects with early PD and another in subjects with advanced PD. Assuming similar IRM structure, items of the UPDRS version were mapped to those in the MDS-UPDRS version. Subsequently, the longitudinal changes in the placebo arm of the advanced PD study were characterized. RESULTS: The parameters reflecting differences in the shared items between endpoints were successfully estimated, and the model diagnostics indicated that mapping was better for early PD subjects (closer to De Novo cohort) than for advanced PD subjects. Disease progression for placebo in advanced PD patients was relatively shallow. CONCLUSION: An IRM able to handle two variants of clinical PD endpoints was developed; it can improve the utilization of data from diverse sources and diverse disease populations.


Assuntos
Doença de Parkinson/classificação , Índice de Gravidade de Doença , Estudos de Coortes , Avaliação da Deficiência , Humanos , Modelos Teóricos , Doença de Parkinson/fisiopatologia , Placebos
3.
N Engl J Med ; 381(2): 132-141, 2019 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-31291515

RESUMO

BACKGROUND: Episodic cluster headache is a disabling neurologic disorder that is characterized by daily headache attacks that occur over periods of weeks or months. Galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, may be a preventive treatment for cluster headache. METHODS: We enrolled patients who had at least one attack every other day, at least four total attacks, and no more than eight attacks per day during a baseline assessment, as well as a history of cluster headache periods lasting at least 6 weeks, and randomly assigned them to receive galcanezumab (at a dose of 300 mg) or placebo, administered subcutaneously at baseline and at 1 month. The primary end point was the mean change from baseline in the weekly frequency of cluster headache attacks across weeks 1 through 3 after receipt of the first dose. The key secondary end point was the percentage of patients who had a reduction from baseline of at least 50% in the weekly frequency of cluster headache attacks at week 3. Safety was also assessed. RESULTS: Recruitment was halted before the trial reached the planned sample size of 162 because too few volunteers met the eligibility criteria. Of 106 enrolled patients, 49 were randomly assigned to receive galcanezumab and 57 to receive placebo. The mean (±SD) number of cluster headache attacks per week in the baseline period was 17.8±10.1 in the galcanezumab group and 17.3±10.1 in the placebo group. The mean reduction in the weekly frequency of cluster headache attacks across weeks 1 through 3 was 8.7 attacks in the galcanezumab group, as compared with 5.2 in the placebo group (difference, 3.5 attacks per week; 95% confidence interval, 0.2 to 6.7; P = 0.04). The percentage of patients who had a reduction of at least 50% in headache frequency at week 3 was 71% in the galcanezumab group and 53% in the placebo group. There were no substantial between-group differences in the incidence of adverse events, except that 8% of the patients in the galcanezumab group had injection-site pain. CONCLUSIONS: Galcanezumab administered subcutaneously at a dose of 300 mg once monthly reduced the weekly frequency of attacks of episodic cluster headache across weeks 1 through 3 after the initial injection, as compared with placebo. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT02397473.).


Assuntos
Analgésicos/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Cefaleia Histamínica/prevenção & controle , Adulto , Analgésicos/administração & dosagem , Analgésicos/efeitos adversos , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Injeções Subcutâneas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Placebos/uso terapêutico
4.
N Engl J Med ; 381(2): 142-149, 2019 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-31291516

RESUMO

BACKGROUND: Calcitonin gene-related peptide receptor has been implicated in the pathogenesis of migraine. Rimegepant is an orally administered, small-molecule, calcitonin gene-related peptide receptor antagonist that may be effective in acute migraine treatment. METHODS: In a multicenter, double-blind, phase 3 trial, we randomly assigned adults with at least a 1-year history of migraine and two to eight migraine attacks of moderate or severe intensity per month to receive rimegepant orally at a dose of 75 mg or matching placebo for the treatment of a single migraine attack. The primary end points were freedom from pain and freedom from the most bothersome symptom (other than pain) identified by the patient, both of which were assessed 2 hours after the dose of rimegepant or placebo was administered. RESULTS: A total of 1186 patients were randomly assigned to receive rimegepant (594 patients) or placebo (592 patients); of these, 537 patients in the rimegepant group and 535 patients in the placebo group could be evaluated for efficacy. The overall mean age of the patients evaluated for efficacy was 40.6 years, and 88.7% were women. In a modified intention-to-treat analysis, the percentage of patients who were pain-free 2 hours after receiving the dose was 19.6% in the rimegepant group and 12.0% in the placebo group (absolute difference, 7.6 percentage points; 95% confidence interval [CI], 3.3 to 11.9; P<0.001). The percentage of patients who were free from their most bothersome symptom 2 hours after the dose was 37.6% in the rimegepant group and 25.2% in the placebo group (absolute difference, 12.4 percentage points; 95% CI, 6.9 to 17.9; P<0.001). The most common adverse events were nausea and urinary tract infection. CONCLUSIONS: Treatment of a migraine attack with the oral calcitonin gene-related peptide receptor antagonist rimegepant resulted in a higher percentage of patients who were free of pain and free from their most bothersome symptom than placebo. (Funded by Biohaven Pharmaceuticals; ClinicalTrials.gov number, NCT03237845.).


Assuntos
Analgésicos/uso terapêutico , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Piperidinas/uso terapêutico , Piridinas/uso terapêutico , Administração Oral , Adulto , Analgésicos/efeitos adversos , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/complicações , Náusea/induzido quimicamente , Piperidinas/efeitos adversos , Placebos/uso terapêutico , Piridinas/efeitos adversos
5.
Rev Infirm ; 68(251): 42-43, 2019 May.
Artigo em Francês | MEDLINE | ID: mdl-31208568

RESUMO

THE PLACEBO, BETWEEN ETHICS AND CARE: A placebo is used to fight pain, insomnia or anxiety. The placebo effect is said to be this one produced by this 'fake' medication. However, could it not chiefly be the effect produced by the trust relationship established between a patient and a caregiver at a given moment? This article reflects on the results of a survey carried out in the hospital sector.


Assuntos
Relações Médico-Paciente , Efeito Placebo , Confiança/psicologia , Ansiedade/prevenção & controle , Pesquisas sobre Serviços de Saúde , Humanos , Dor/prevenção & controle , Relações Médico-Paciente/ética , Placebos , Distúrbios do Início e da Manutenção do Sono/prevenção & controle
6.
Clin Drug Investig ; 39(7): 691-697, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31172447

RESUMO

Rifamycin SV MMX® (Aemcolo™; Relafalk™) is a novel oral formulation of the antibacterial rifamycin SV that uses MultiMatrix (MMX®) technology to enable colonic delivery. Specifically, the active ingredient (rifamycin SV) is released throughout the colon, where it acts locally in the intestinal lumen; systemic absorption is minimal. Rifamycin SV MMX® exhibits antibacterial activity against a broad spectrum of clinically relevant enteropathogens and is available in the EU and the USA for the treatment of adults with traveller's diarrhoea. In two multinational, phase III studies, rifamycin SV MMX® (400 mg twice daily for 3 days) effectively shortened the duration of non-dysenteric traveller's diarrhoea in adults, being significantly more effective than placebo and noninferior to ciprofloxacin in reducing median time to last unformed stool. As expected (given its poor systemic absorption), rifamycin SV MMX® was well tolerated in this patient population, with the overall incidence of treatment-emergent adverse events generally similar to those of placebo and ciprofloxacin. Current evidence indicates that twice-daily rifamycin SV MMX® is an effective and well tolerated treatment option for shortening the duration of non-dysenteric traveller's diarrhoea in adults.


Assuntos
Antibacterianos/uso terapêutico , Diarreia/tratamento farmacológico , Rifamicinas/uso terapêutico , Adulto , Antibacterianos/farmacocinética , Humanos , Placebos , Rifamicinas/farmacocinética
7.
Rev Infirm ; 68(250): 42-43, 2019 Apr.
Artigo em Francês | MEDLINE | ID: mdl-31147077

RESUMO

While the placebo is a pharmacologically inert substance, the effect it can produce is undeniable and unquestioned and all hospitals use it. This article presents the results of a survey carried out with nurses from Dreux general hospital, aiming to assess the place of the placebo in their professional practices.


Assuntos
Hospitais , Cuidados de Enfermagem , Placebos , Prática Profissional , Humanos , Inquéritos e Questionários
8.
Medicine (Baltimore) ; 98(18): e15317, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31045769

RESUMO

INTRODUCTION: Over the last 10 years, it has been demonstrated that photobiomodulation therapy (PBMT), also known as phototherapy, using low-level laser therapy (LLLT) and/or light-emitting diode therapy (LEDT) has ergogenic effects, improving athletic performance and also accelerating post-exercise recovery. However, many aspects related to these effects and its clinical applicability remain unknown. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT in detraining after an aerobic endurance training protocol. METHODS AND ANALYZES: A randomized, triple-blind, placebo-controlled clinical trial will be carried out. Healthy male volunteers will be randomly distributed into 4 experimental groups: PBMT before and after training sessions + PBMT during detraining, PBMT before and after training sessions + placebo during detraining, placebo before and after training sessions + PBMT during detraining, and placebo before and after training sessions + placebo during detraining. The aerobic endurance training sessions will be carried out using motorized treadmills during 12 weeks, and the detraining period will consist in the next 4 weeks after that. It will be analyzed the time until exhaustion, maximal oxygen uptake (VO2max), and fat percentage of volunteers. DISCUSSION: Despite the increasing body of evidence for the use of PBMT as an ergogenic agent, several aspects remain unknown. The findings of this study will contribute to the advance of knowledge in this field regarding clinical applications. ETHICS AND DISSEMINATION: This study was approved by the Research Ethics Committee of Nove de Julho University. The results from this study will be further disseminated through scientific publications in international peer-reviewed journals and presentations at national and international scientific meetings. TRIAL REGISTRATION NUMBER: NCT03879226.


Assuntos
Desempenho Atlético/estatística & dados numéricos , Treino Aeróbico/métodos , Terapia com Luz de Baixa Intensidade/efeitos adversos , Substâncias para Melhoria do Desempenho/efeitos adversos , Adolescente , Adulto , Desempenho Atlético/fisiologia , Distribuição da Gordura Corporal/estatística & dados numéricos , Teste de Esforço/métodos , Humanos , Terapia com Luz de Baixa Intensidade/métodos , Masculino , Consumo de Oxigênio/fisiologia , Placebos , Adulto Jovem
9.
Medicine (Baltimore) ; 98(18): e15343, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31045775

RESUMO

BACKGROUND: The primary objective of the study was to evaluate the efficacy of 300 milligrams (mg) and 600 mg of pregabalin compared to placebo in the reduction of pain in patients with noncritical partial and full thickness burn injuries. METHODS: A prospective, randomized, double-blinded, single center, placebo-controlled trial was conducted. Simple randomization method was used in this trial. After subjects met all the inclusion and none of the exclusion criteria, they were randomized and assigned to 1 of the 3 18-day treatments groups: Pregabalin 300 group, Pregabalin 600 group, or Placebo group. Demographics and clinical characteristics were recorded. The severity of pain was assessed by using the visual analog scale for pain intensity at baseline on day 3, day 9 ±â€Š3, day 25 ±â€Š7, day 90 ±â€Š6, and day 180 ±â€Š12. RESULTS: A total of 54 subjects were randomly assigned, and 51 were included in the data analysis. Demographics and clinical characteristics did not differ significantly between the 3 groups. There was a statistically significant difference in pain between the Pregabalin 300 and Pregabalin 600 groups (P-value = .0260). The Pregabalin 300 group had 17.93 units (95% confidence interval: 1.83-34.04) higher pain scores on average than the Pregabalin 600 group, regardless of time. The adjusted P-value comparing 0 to 300 was .1618, while the adjusted P-value for 0 versus 600 was .5304. There was an overall difference in pain across time regardless of study group (P-value = <.0001). An overall difference in opioid consumption (P-value = .0003) and BSHS (P-value = .0013) across time regardless of study group was noted. CONCLUSIONS: Pregabalin could be part of a promising multimodal analgesic regimen in noncritical burn population. Future placebo-controlled studies assessing the use of pregabalin in burn victim patients may further endorse our findings.


Assuntos
Analgésicos Opioides/uso terapêutico , Queimaduras/complicações , Dor/tratamento farmacológico , Pregabalina/uso terapêutico , Adulto , Analgésicos/uso terapêutico , Queimaduras/classificação , Queimaduras/tratamento farmacológico , Queimaduras/patologia , Terapia Combinada , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Dor/prevenção & controle , Medição da Dor/métodos , Placebos , Estudos Prospectivos , Resultado do Tratamento , Escala Visual Analógica
11.
Eur J Endocrinol ; 181(1): 23-30, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31075759

RESUMO

Objective: Acyl ghrelin, which is the endogenous ligand for the growth hormone secretagogue receptor, potently stimulates pituitary growth hormone release, and to some degree adrenocorticotropic hormone and prolactin. Ghrelin is also orexigenic and has recently been shown to stimulate renal sodium absorption in rodent models. Increased thirst sensation has been observed as a side effect of acyl ghrelin administration in some human studies. The objective of this clinical trial was to investigate the direct effects of acyl ghrelin on thirst sensation and sodium excretion in hypopituitary patients. Design: Hypopituitary patients on stable replacement with hydrocortisone and growth hormone were investigated in two double-blind and placebo-controlled crossover studies. The patients received a 5-h intravenous infusion of acyl ghrelin (5 pmol/kg/min in the first study and 1 pmol/kg/min in the second study). Thirst sensation was measured on a Visual Analog Scale (VAS). In the second study plasma osmolality, vasopressin, copeptin, water intake, diuresis and urinary excretion of sodium and creatinine were measured. Results: In the initial study, acyl ghrelin (5 pmol/kg/min) increased thirst sensation (time × treatment analysis of variance for the effect of acyl ghrelin infusion P = 0.003). In the second study acyl ghrelin (1 pmol/kg/min) also increased thirst (P = 0.04) but did not affect urinary excretion of either sodium or water. Conclusions: We demonstrate that acyl ghrelin infusion increases thirst sensation, without affecting sodium excretion or diuresis in human subjects.


Assuntos
Grelina/administração & dosagem , Grelina/efeitos adversos , Hipopituitarismo/tratamento farmacológico , Natriurese/efeitos dos fármacos , Sede/efeitos dos fármacos , Arginina Vasopressina/sangue , Creatinina/urina , Estudos Cross-Over , Método Duplo-Cego , Ingestão de Líquidos , Grelina/sangue , Glicopeptídeos/sangue , Hormônio do Crescimento/uso terapêutico , Humanos , Hidrocortisona/uso terapêutico , Hipopituitarismo/fisiopatologia , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Concentração Osmolar , Placebos
12.
Clin Biochem ; 69: 15-20, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31129183

RESUMO

OBJECTIVE: Despite the current guidelines for the management of type 2 diabetes mellitus (T2DM), patients still struggle with the hyperglycemia consequences. Imbalance in zinc homeostasis, in particular, renders diabetic patients more susceptible to the damages of oxidative stress. This study aimed to evaluate the effects of zinc supplementation on the superoxide dismutase gene expression and enzyme activity in overweight individuals with T2DM. Additionally, biochemical parameters, such as fasting blood glucose (FBG), insulin, glycated hemoglobin (HbA1c), homeostasis model of assessment-insulin resistance (HOMA-IR), serum levels of zinc and lipid profile, were assessed. METHODS: In this randomized, double-blind, placebo-controlled trial, 70 overweight (BMI > 25) T2DM patients were selected based on the inclusion criteria. They were divided into two groups for supplementation of daily 50 mg zinc gluconate or placebo for 8 weeks. Blood samples were collected from all the individuals in the zinc group and controls for analysis. RESULTS: The results showed that, in comparison with the control group, zinc supplementation increased both gene expression and enzyme activity of SOD (p < 0.01) as well as the levels of insulin (p = 0.02) among the patients in the zinc group. Moreover, there was a meaningful reduction in the levels of FBG, HbA1c and HOMA-IR value (p < 0.001), triglycerides and total cholesterol (p < 0.05) after the zinc treatment. CONCLUSIONS: Taken together, the current study suggests that daily supplementation with 50 mg zinc gluconate could be a useful approach for the management of overweight T2DM. CLINICAL TRIAL REGISTRATION: IRCT2015083102.


Assuntos
Diabetes Mellitus Tipo 2/metabolismo , Sobrepeso/complicações , Superóxido Dismutase/genética , Superóxido Dismutase/metabolismo , Zinco/administração & dosagem , Adulto , Idoso , Biomarcadores/sangue , Glicemia/análise , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/enzimologia , Diabetes Mellitus Tipo 2/genética , Método Duplo-Cego , Feminino , Humanos , Lipídeos/sangue , Masculino , Pessoa de Meia-Idade , Placebos , RNA Mensageiro/metabolismo
13.
N Engl J Med ; 380(25): 2406-2417, 2019 06 20.
Artigo em Inglês | MEDLINE | ID: mdl-31075187

RESUMO

BACKGROUND: Bruton's tyrosine kinase (BTK) regulates the functions of B cells and myeloid cells that are implicated in the pathogenesis of multiple sclerosis. Evobrutinib is a selective oral BTK inhibitor that has been shown to inhibit B-cell activation both in vitro and in vivo. METHODS: In this double-blind, randomized, phase 2 trial, we assigned patients with relapsing multiple sclerosis to one of five groups: placebo, evobrutinib (at a dose of 25 mg once daily, 75 mg once daily, or 75 mg twice daily), or open-label dimethyl fumarate (DMF) as a reference. The primary end point was the total (cumulative) number of gadolinium-enhancing lesions identified on T1-weighted magnetic resonance imaging at weeks 12, 16, 20, and 24. Key secondary end points included the annualized relapse rate and change from baseline in the score on the Expanded Disability Status Scale (EDSS). RESULTS: A total of 267 patients were randomly assigned to a trial group. The mean (±SD) total number of gadolinium-enhancing lesions during weeks 12 through 24 was 3.85±5.44 in the placebo group, 4.06±8.02 in the evobrutinib 25-mg group, 1.69±4.69 in the evobrutinib 75-mg once-daily group, 1.15±3.70 in the evobrutinib 75-mg twice-daily group, and 4.78±22.05 in the DMF group. The baseline adjusted rate ratios for the total number of lesions over time as compared with placebo were 1.45 in the evobrutinib 25-mg group (P = 0.32), 0.30 in the evobrutinib 75-mg once-daily group (P = 0.005), and 0.44 in the evobrutinib 75-mg twice-daily group (P = 0.06). The unadjusted annualized relapse rate at week 24 was 0.37 in the placebo group, 0.57 in the evobrutinib 25-mg group, 0.13 in the evobrutinib 75-mg once-daily group, 0.08 in the evobrutinib 75-mg twice-daily group, and 0.20 in the DMF group. There was no significant effect of trial group on the change from baseline in the EDSS score. Elevations in liver aminotransferase values were observed with evobrutinib. CONCLUSIONS: Patients with relapsing multiple sclerosis who received 75 mg of evobrutinib once daily had significantly fewer enhancing lesions during weeks 12 through 24 than those who received placebo. There was no significant difference with placebo for either the 25-mg once-daily or 75-mg twice-daily dose of evobrutinib, nor in the annualized relapse rate or disability progression at any dose. Longer and larger trials are required to determine the effect and risks of evobrutinib in patients with multiple sclerosis. (Funded by EMD Serono; ClinicalTrials.gov number, NCT02975349.).


Assuntos
Tirosina Quinase da Agamaglobulinemia/antagonistas & inibidores , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Piperidinas/uso terapêutico , Inibidores de Proteínas Quinases/uso terapêutico , Pirimidinas/uso terapêutico , Administração Oral , Adulto , Encéfalo/diagnóstico por imagem , Encéfalo/patologia , Fumarato de Dimetilo/uso terapêutico , Progressão da Doença , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Imunossupressores/uso terapêutico , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem , Esclerose Múltipla Recidivante-Remitente/patologia , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Placebos/uso terapêutico , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/efeitos adversos , Pirimidinas/administração & dosagem , Pirimidinas/efeitos adversos , Transaminases/sangue , Resultado do Tratamento
14.
BMC Infect Dis ; 19(1): 453, 2019 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-31117986

RESUMO

BACKGROUND: High hemagglutination inhibition (HAI) and neuraminidase inhibition (NAI) titers are generally associated with reduced influenza risk. While repeated influenza vaccination reduces seroresponse, vaccine effectiveness is not always reduced. METHODS: During the 2007-2008 influenza season, a randomized, placebo-controlled trial (FLUVACS) evaluated the efficacies of live-attenuated (LAIV) and inactivated influenza vaccines (IIV) among healthy adults aged 18-49 in Michigan; IIV vaccine efficacy (VE) and LAIV VE against influenza disease were estimated at 68% and 36%. Using the principal stratification/VE moderation framework, we analyzed data from this trial to assess how each VE varied by HAI or NAI responses to vaccination observed for vaccinated individuals and predicted counterfactually for placebo recipients. We also assessed how each VE varied with pre-vaccination/baseline variables including HAI titer, NAI titer, and vaccination history. RESULTS: IIV VE appeared to increase with Day 30 post-vaccination HAI titer, albeit not significantly (p=0.20 and estimated VE 14.4%, 70.5%, and 85.5% at titer below the assay lower quantification limit, 512, and 4096 (maximum)). Moreover, IIV VE increased significantly with Day 30 post-vaccination NAI titer (p=0.040), with estimated VE zero at titer 10 and 92.2% at highest titer 640. There was no evidence that fold-change in post-vaccination HAI or NAI titer associated with IIV VE (p=0.76, 0.38). For LAIV, there was no evidence that VE associated with post-vaccination or fold-rise HAI or NAI titers (p-values >0.40). For IIV, VE increased with increasing baseline NAI titer in those previously vaccinated, but VE decreased with increasing baseline NAI titer in those previously unvaccinated. In contrast, for LAIV, VE did not depend on previous vaccination or baseline HAI or NAI titer. CONCLUSIONS: Future efficacy trials should measure baseline and post-vaccination antibody titers in both vaccine and control/placebo recipients, enabling analyses to better elucidate correlates of vaccine- and natural-protection. TRIAL REGISTRATION: ClinicalTrials.gov NCT00538512. October 1, 2007.


Assuntos
Testes de Inibição da Hemaglutinação , Vacinas contra Influenza/uso terapêutico , Vacinas Atenuadas/uso terapêutico , Vacinas de Produtos Inativados/uso terapêutico , Adolescente , Adulto , Humanos , Imunogenicidade da Vacina , Testes Imunológicos , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Pessoa de Meia-Idade , Neuraminidase/antagonistas & inibidores , Placebos , Fatores de Tempo , Vacinas Atenuadas/imunologia , Vacinas de Produtos Inativados/imunologia
15.
Molecules ; 24(7)2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-30959740

RESUMO

The concentration of volatile organic compounds (VOCs) can inform about the metabolic condition of the body. In the small intestine of untreated persons with celiac disease (CD), chronic inflammation can occur, leading to nutritional deficiencies, and consequently to functional impairments of the whole body. Metabolomic studies showed differences in the profile of VOCs in biological fluids of patients with CD in comparison to healthy persons; however, there is scarce quantitative and nutritional intervention information. The aim of this study was to evaluate the effect of the supplementation of a gluten-free diet (GFD) with prebiotic oligofructose-enriched inulin (Synergy 1) on the concentration of VOCs in the urine of children and adolescents with CD. Twenty-three participants were randomized to the group receiving Synergy 1 (10 g per day) or placebo for 12 weeks. Urinary VOCs were analyzed using solid-phase microextraction and gas chromatography⁻mass spectrometry. Sixteen compounds were identified and quantified in urine samples. The supplementation of GFD with Synergy 1 resulted in an average concentration drop (36%) of benzaldehyde in urine samples. In summary, Synergy 1, applied as a supplement of GFD for 12 weeks had a moderate impact on the VOC concentrations in the urine of children with CD.


Assuntos
Doença Celíaca/dietoterapia , Dieta Livre de Glúten , Inulina/administração & dosagem , Oligossacarídeos/administração & dosagem , Adolescente , Doença Celíaca/patologia , Doença Celíaca/urina , Criança , Pré-Escolar , Cromatografia Gasosa , Sinergismo Farmacológico , Feminino , Humanos , Inulina/urina , Masculino , Espectrometria de Massas , Oligossacarídeos/urina , Placebos , Prebióticos/administração & dosagem , Compostos Orgânicos Voláteis/administração & dosagem , Compostos Orgânicos Voláteis/química , Compostos Orgânicos Voláteis/urina
16.
Nutrients ; 11(4)2019 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-30979038

RESUMO

This four-week, randomized, double-blind, placebo-controlled study investigated the effects of Lactobacillus plantarum PS128 (PS128) on boys with autism spectrum disorder (ASD) aged 7-15 in Taiwan. All subjects fulfilled the criteria for ASD diagnosis of DSM-V and the Autism Diagnostic Interview-Revised (ADI-R). Questionnaires used for the primary outcome measure include the Autism Behavior Checklist-Taiwan version (ABC-T), the Social Responsiveness Scale (SRS) and the Child Behavior Checklist (CBCL). The Swanson, Nolan, and Pelham-IV-Taiwan version (SNAP-IV) and the Clinical Global Impression-improvement (CGI-I) were used for the secondary outcome measure. The results showed that PS128 ameliorated opposition/defiance behaviors, and that the total score of SNAP-IV for younger children (aged 712) improved significantly compared with the placebo group. Additionally, several elements were also notably improved in the PS128 group after 28-day consumption of PS128. Further studies are needed to better clarify the effects of PS128 for younger children with ASD on broader symptoms.


Assuntos
Transtorno do Espectro Autista/terapia , Lactobacillus plantarum , Probióticos/administração & dosagem , Adolescente , Fatores Etários , Transtorno do Espectro Autista/psicologia , Criança , Comportamento Infantil/fisiologia , Método Duplo-Cego , Humanos , Masculino , Placebos , Comportamento Social , Inquéritos e Questionários , Taiwan
18.
Medicine (Baltimore) ; 98(8): e14520, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30813155

RESUMO

BACKGROUND: In this randomized, double-blind, parallel-group trial, we aimed to explore the effectiveness of trigger point dry needling in patients with chronic tension-type headache in reducing headache frequency, intensity and duration, and improvement of health-related quality of life. METHODS: The 168 patients in 2 neurology clinics with chronic tension-type headache. The participants were randomly assigned to one of two treatment groups for dry needling or sham dry needling, delivered in 3 sessions a week for 2 weeks. The 160 patients fulfilled the study requirements. The dry needling was applied in active trigger points located in the musculature of the head and the neck. The patients received dry needling using sterile stainless-steel acupuncture needles of 0.25 × 40 mm and 0.25 × 25 mm dimensions. The sham dry needling procedure was applied into the adipose tissue located at any area where an active trigger point was absent. The primary outcome measurement was the headache intensity. Secondary outcomes were frequency and duration of headache, and quality of life, assessed by the Short Form-36. All outcomes were measured at baseline, at the end of 2-week, and 1-month follow-up period. RESULTS: In the dry needling group, intensity, frequency and duration of headache, and the scores of Short Form-36 subscales were significantly improved after treatment (P < .05). In the dry needling group, all the effect sizes for headache variables were large. CONCLUSIONS: The results of this clinical trial suggest that trigger point dry needling in patients with chronic tension-type headache is effective and safe in reducing headache intensity, frequency and duration, and increasing health-related quality of life. TRIAL REGISTRATION: Clinical Trials NCT03500861.


Assuntos
Terapia por Acupuntura/métodos , Cefaleia do Tipo Tensional/terapia , Adulto , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Placebos , Qualidade de Vida , Resultado do Tratamento , Pontos-Gatilho , Turquia
19.
Einstein (Sao Paulo) ; 17(2): eGS4414, 2019 Mar 07.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30843996

RESUMO

OBJECTIVE: To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. METHODS: We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. RESULTS: Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. CONCLUSION: The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.


Assuntos
Antagonistas de Androgênios/economia , Androstenos/economia , Antineoplásicos Hormonais/economia , Análise Custo-Benefício/métodos , Docetaxel/economia , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/economia , Antagonistas de Androgênios/uso terapêutico , Androstenos/uso terapêutico , Antineoplásicos Hormonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Brasil , Docetaxel/uso terapêutico , Humanos , Masculino , Placebos/economia , Placebos/uso terapêutico , Intervalo Livre de Progressão , Neoplasias da Próstata/mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Valores de Referência , Reprodutibilidade dos Testes , Fatores de Tempo , Resultado do Tratamento
20.
Int Arch Allergy Immunol ; 179(1): 1-9, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30893694

RESUMO

BACKGROUND: The double-blind, placebo-controlled food challenge (DBPCFC) is still considered to be the gold standard in food allergy diagnosis. This test is however not common practice in routine due to several practical limitations, especially for non-IgE-mediated food allergy with its typical delayed food allergic reactions. OBJECTIVE: The aim of this study was to develop and evaluate DBPCFC matrices for the diagnosis of milk and egg allergies which can be applied at home for the diagnosis of delayed food allergic reactions. The main focus was the blinding of milk and raw egg and the development of matrices which can be prepared and consumed conveniently at home with a sufficiently long shelf life (+/- 6 months or longer). METHODS: A sensory test evaluated the blinding of the egg and milk in the matrices. The microbiological analysis confirmed the safety and stability of the developed matrices. To assess the applicability of the matrices, a pilot DBPCFC study for milk including 7 patients was conducted. RESULTS: Sensory tests confirmed that the masking of the allergenic ingredients was sufficient. Microbial safety and stability of the matrices were confirmed up to 6 months of storage at ambient temperatures in the dark. The DBPCFC for milk showed different outcomes and proved its applicability for use at home. CONCLUSION: A novel stable DBPCFC matrix for milk and raw egg has been developed that allows convenient use at the patients' home.


Assuntos
Hipersensibilidade a Ovo/diagnóstico , Hipersensibilidade a Leite/diagnóstico , Adulto , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Masculino , Placebos , Sensação , Testes Cutâneos
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