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1.
Birth ; 2024 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-38804004

RESUMO

INTRODUCTION: This exploratory review aimed to provide empirical evidence on the definitions of labor, the statistical approaches and measures reported in randomized controlled trials (RCTs) and observational studies measuring the duration of labor. METHODS: A systematic electronic literature search was conducted using different databases. An extraction form was designed and used to extract relevant data. English, French, and German studies published between 1999 and 2019 have been included. Only RCTs and observational studies analyzing labor duration (or a phase of labor duration) as a primary outcome have been included. RESULTS: Ninety-two RCTs and 126 observational studies were eligible. No definition of the onset of labor was provided in 21.7% (n = 20) of the RCTs and 23.8% (n = 30) of the observational studies. Mean was the most frequently applied measure of labor duration in the RCTs (89.1%, n = 82), and median in the observational studies (54.8%, n = 69). Most RCTs (83%, n = 76) and observational studies (70.6%, n = 89) analyzed labor duration using a bivariate method, with the t-test being the most frequently applied (45.7% and 27%, respectively). Only 10.8% (n = 10) of the RCTs and 52.4% (n = 66) of the observational studies conducted a multivariable regression: 3 (30%; out of 10) RCTs and 37 (56%; out of 66) observational studies used a time-to-event adapted model. CONCLUSION: This survey reports a lack of agreement with respect to how the onset of labor and phases of labor duration are presented. Concerning the statistical approaches, few studies used survival analysis, which is the appropriate statistical framework to analyze time-to-event data.

2.
BMC Neurol ; 24(1): 48, 2024 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-38287288

RESUMO

OBJECTIVE: This meta-analysis and systematic review were conducted to comprehensively evaluate the efficacy and safety of mesenchymal stem cells in patients with acute ischemic stroke. METHOD: We conducted a manual search of electronic databases, including PubMed, Embase, the Cochrane Library, and Web of Science, with a search deadline set for February 1, 2023. Data analysis was performed using Stata version 15.0. RESULT: A total of 9 randomized controlled studies were included, involving a total of 316 people, including 159 mesenchymal stem cells and 147 control groups. Results of meta-analysis: Compared to a placebo group, the administration of mesenchymal stem cells resulted in a significant reduction in the National Institutes of Health Stroke Scale (NIHSS) scores among patients diagnosed with acute ischemic stroke [SMD=-0.99,95% CI (-1.93, -0.05)]. Compared to placebo, barthel index [SMD = 0.48,95% CI (-0.55,1.51)], modified rankin score [SMD = 0.45, 95% CI (1.11, 0.21)], adverse events (RR = 0.68, 95% CI (0.40, 1.17)] the difference was not statistically significant. CONCLUSION: Based on current studies, mesenchymal stem cell transplantation can ameliorate neurological deficits in patients with ischemic stroke to a certain extent without increasing adverse reactions. However, there was no significant effect on Barthel index and Modified Rankin score.


Assuntos
AVC Isquêmico , Transplante de Células-Tronco Mesenquimais , Acidente Vascular Cerebral , Estados Unidos , Humanos , Acidente Vascular Cerebral/tratamento farmacológico , Transplante de Células-Tronco Mesenquimais/efeitos adversos
3.
J Obstet Gynaecol Res ; 49(9): 2213-2231, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37365015

RESUMO

OBJECTIVE: To assess whether nonsurgical therapies were related with clearance of cervical infection of high-risk human papilloma virus (hr-HPV) or regression of mild abnormal cytology related with hr-HPV. METHODS: Until March 2023, we identified a total of 10 424 women with cervical infection of hr-HPV and 1966 women with mild abnormal cytology related with hr-HPV from 44 studies that met the inclusion criteria. RESULTS: After systematically retrieving literature, we identified 2317 citations and 44 randomized controlled studies (RCT) were enrolled. Cumulative results suggested women with cervical infection of hr-HPV might benefit from nonsurgical therapies. Both the clearance of hr-HPV (OR: 3.83, I2 = 99%, p < 0.00001) and regression of mild abnormal cytology related with hr-HPV (OR: 3.12, I2 = 63%, p < 0.00001) were significantly higher than control group. Subgroup analysis stratified by systematic therapy, topical therapy, traditional Chinese medicines (TCMs), and presistent hr-HPV got consistent results. There was substantial heterogeneity between trials (I2 = 87% for clearance of hr-HPV and 63% for regression of cytology), sensitivity analysis was performed by excluding single study one by one, and found the cumulative results were stable and dependable. Both the funnel plots for clearance of hr-HPV and regression of abnormal cytology were asymmetrical, significant publication bias might exist. CONCLUSION: Nonsurgical therapies might benefit women who had a cervical infection of hr-HPV with/without mild abnormal cytology related with hr-HPV. Both the clearance of hr-HPV and regression of abnormal cytology were significantly higher than control group. More studies with less heterogeneity were needed urgently to draw concrete conclusion.


Assuntos
Infecções por Papillomavirus , Displasia do Colo do Útero , Neoplasias do Colo do Útero , Feminino , Humanos , Neoplasias do Colo do Útero/terapia , Papillomavirus Humano , Infecções por Papillomavirus/terapia , Colo do Útero , Esfregaço Vaginal , Papillomaviridae
4.
Orthopadie (Heidelb) ; 52(6): 447-454, 2023 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-37222751

RESUMO

Register-based research offers a good opportunity to generate knowledge on questions from the clinical practice. Methodologically high-quality register studies can complement clinical studies, especially for questions that cannot be answered with randomized controlled trials (RCT). The ad hoc committee on healthcare data of the German Network for Health Services Research (DNVF) has set methodological guidelines for register-based studies with a manual for methods and the use of healthcare data. The methodological advantages of both approaches can be integrated through RCTs embedded in registers. In Germany there is a diverse register landscape as shown by the register report commissioned by the Federal Ministry of Health, which, however, show a varying degree of internationally recognized quality criteria. The relevance of register-based studies for the clinical practice (e. g. guideline development) is shown in the examples of applications cited in the article. Although a lot has already been done here in Germany with existing register data, sustainable coordination and promotion of the research infrastructure and research culture, especially in international comparison are necessary.


Assuntos
Atenção à Saúde , Pesquisa sobre Serviços de Saúde , Alemanha
5.
Ther Clin Risk Manag ; 19: 279-290, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36941980

RESUMO

Purpose: No consensus has been established on the safety and effectiveness of out-of-hospital management of Vitamin K antagonists (VKA) therapy combining portable coagulometers and telemedicine. The present meta-analysis investigated the safety and effectiveness of this hybrid anticoagulants management model. Methods: The PubMed, Embase, Cochrane, and Web of Science databases were searched for papers published before May 1, 2022. To reduce bias, only randomized controlled trials were included. RevMan 5.3 (Cochrane) software was used to evaluate and analyze clinical outcomes, including the effectiveness and safety of patient management approaches, determined by the time in the therapeutic range (TTR) and occurrence of thrombotic and bleeding events. Results: Eight studies, comprising 3853 patients, were selected. The meta-analysis showed that anticoagulant management combining portable coagulometers and telemedicine significantly improved frequency of testing (mean difference [MD]= 12.95 days; 95% CI, 8.77-17.12; I2= 92%; P< 0.01) and TTR (MD= 9.50%; 95% CI, 3.16-15.85; I2= 87%; P< 0.01). Thromboembolism events were reduced (RR= 0.72; 95% CI, 0.51-1.01; I2= 0%; P= 0.05), but the results were not statistically significant. And no significant differences in major bleeding events, rehospitalization rate, mortality, or overall treatment cost existed between the two groups. Conclusion: Although the safety of remote cardiovascular disease management is not superior to that of conventional outpatient anticoagulant management, it provides a more stable monitoring of coagulation status.

6.
Expert Rev Clin Pharmacol ; 15(4): 433-442, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35596576

RESUMO

BACKGROUND AND AIMS: Recent studies have found potential benefits of vitamin D in relieving pain, and the results from randomized controlled trials of vitamin D for fibromyalgia have been promising. We conducted a comprehensive systematic review and meta-analysis to evaluate the efficacy of vitamin D for treating fibromyalgia. RESEARCH DESIGN AND METHODS: PubMed, Web of Science, Embase, and Cochrane Library databases were systematically searched for English-language articles. Based on the inclusion and exclusion criteria, we selected only randomized controlled studies that reported vitamin D versus placebo-controlled cure for fibromyalgia. After extracting valid data, a meta-analysis was performed using Stata 12.0. The major outcome in the pooled analysis was the Fibromyalgia Impact Questionnaire and Visual Analogue Scale (VAS) changes. RESULTS: Five studies including 315 participants were identified. These studies found that vitamin D was effective in reducing Fibromyalgia Impact Questionnaire scores compared with those of the control group, with significant differences (weighted mean difference = -7.82, 95% confidence interval: -12.05 to -3.59, P < 0.001). However, there was no statistical difference in VAS between the two groups (weighted mean difference = -0.60, 95% confidence interval: -1.38 to 0.17, P > 0.05). CONCLUSIONS: Vitamin D supplementation may be an effective fibromyalgia therapeutic approach.


Assuntos
Fibromialgia , Fibromialgia/tratamento farmacológico , Humanos , Dor , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Vitamina D , Vitaminas/uso terapêutico
7.
Rheumatology (Oxford) ; 61(4): 1328-1340, 2022 04 11.
Artigo em Inglês | MEDLINE | ID: mdl-34664615

RESUMO

OBJECTIVE: To determine the placebo response rate in PsA randomized clinical trials (RCTs), its contributing factors and impact on the effect size of active treatments. METHODS: We searched multiple databases, from inception to 20 December 2020, for placebo-controlled RCTs in PsA. We used a random-effects meta-analysis to pool the response rates for the ACR20 criteria in the placebo arm, determined the risk difference for treatment vs placebo, and used meta-regression to determine the factors associated with placebo response rates. The risk of bias was assessed in duplicate. The study protocol was registered with PROSPERO: CRD42021226000. RESULTS: We included 42 RCTs (5050 patients receiving placebo) published between 2000 and 2020. The risk of bias was low in 28 trials, high in four, and with some concerns in 10. The pooled placebo response rate was 20.3% (95% CI: 18.6%, 22.1%; predicted intervals, 11.7-29.0%), with significant between-trial heterogeneity (I2 = 56.8%, P < 0.005). The pooled risk difference for treatment vs placebo was 27% (95% CI: 24%, 31%). In the multivariable meta-regression, there was a 15% (95% CI: 2.9%, 29.8%) increase in the odds of achieving the placebo response for each 5-year increment in publication year (P = 0.016). In addition, the active treatment risk difference decreased for every 5-year increment in publication year (ß = -0.053, 95% CI: -0.099, -0.007; P = 0.024) but was not associated with the placebo response. CONCLUSION: Despite increasing over time, the placebo response for ACR20 in PsA RCTs was not associated with the active treatment effect size.


Assuntos
Artrite Psoriásica , Artrite Psoriásica/tratamento farmacológico , Humanos , Efeito Placebo
8.
Heliyon ; 7(8): e07837, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34485731

RESUMO

Chronic pain increases the risk of sleep disturbances, depression and disability. Even though medical treatments have limited value, the use of prescription-based analgesics have increased over the recent years. It is therefore important to evaluate the effect of non-pharmacological treatments. A systematic search for studies evaluating the effect of relaxation techniques on chronic pain was conducted. Randomized controlled trials were included. Significant effects on pain, or on pain and one or more secondary outcome measure, were found in 21 studies. Four studies found significant effects on secondary outcome measures only. Four studies showed no significant effects on any outcome measure. Thus, most of the studies reported that relaxation techniques reduced pain and/or secondary outcome measures. However, the included studies have evaluated effects across a wide variety of chronic pain conditions and relaxation techniques. Hence, there is a large degree of heterogeneity among the included studies. This complicates the effect evaluation and makes it difficult to draw a clear and unambiguous conclusion. Relaxation techniques are probably most effective when used through regular and continued practice. Future studies should therefore investigate long-term effects of relaxation technique interventions, evaluate the dose-response relationship and examine efficacy differences across pain conditions and interventions.

9.
Nervenarzt ; 92(8): 744-751, 2021 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-33942134

RESUMO

BACKGROUND: In 2015, randomized controlled trials (RCT) provided high-level evidence for the efficacy of endovascular thrombectomy in selected patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation. Ever since, thrombectomy is strongly recommended for these patients and has been broadly implemented in clinical practice. OBJECTIVE: To determine whether registry studies depicting real-life data provide additional information beyond RCTs. MATERIAL AND METHODS: Literature review of RCTs and registry studies related to thrombectomy. RESULTS: Data from registry studies on thrombectomy are important to 1. evaluate whether RCT results can be directly transferred into clinical practice, 2. comparatively describe the efficacy of thrombectomy in patient groups underrepresented in RCTs, such as older patients, 3. compare device performances and assess technical developments, and 4. determine how treatment processes and outcomes change over time. CONCLUSION: Beyond RCTs, registry studies are imperative for the continuous analysis and improvement of treatment processes and outcomes as well as technical devices in daily clinical practice.


Assuntos
Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Sistema de Registros , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/cirurgia , Trombectomia , Resultado do Tratamento
10.
Vestn Otorinolaringol ; 85(2): 26-30, 2020.
Artigo em Russo | MEDLINE | ID: mdl-32476385

RESUMO

THE OBJECTIVE: Of the work was to describe the basics of a meta-analysis with features for evaluating models with fixed and random effects, to present principles for interpreting the graphical results of a meta-analysis (forest plot or blobogram) of comparative reviews of randomized clinical trials (RCTs). MATERIAL AND METHODS: To illustrate the possibility of efficient use of the R software environment for meta-analysis, we used the results of RCTs of various tonsillectomy methods already published in the Cochrane Database review. RESULTS: The article provides explanations for the calculation of effect size, heterogeneity statistic, and other meta-analysis statistics and their interpretation for evaluating RCTs and recommendations for choosing a model depending on the on the general research concept. CONCLUSION: The described method allows meta-analysis and gives an idea of the principles for preparing the results of clinical trials with the expectation of their subsequent use in systematic reviews and meta-analysis.


Assuntos
Otolaringologia
11.
Cir Esp (Engl Ed) ; 98(3): 119-126, 2020 Mar.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31932028

RESUMO

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.


Assuntos
Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Pesquisa Biomédica/economia , Pesquisa Biomédica/organização & administração , Lista de Checagem , Humanos , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
12.
Front Pharmacol ; 11: 608247, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33732144

RESUMO

Background: This study aims to explore the role of low-dose rivaroxaban (≤10 mg daily) for the treatment of atherosclerotic cardiovascular disease (ASCVD). Methods: PubMed, Embase and the Cochrane Library were searched for randomized controlled trials (RCTs) of low-dose rivaroxaban in patients with ASCVD including coronary artery disease (CAD) and peripheral artery disease (PAD). Literature screening, data extraction, and risk of bias assessment were carried out independently by two researchers. Hazard ratio (HR) and 95% confidence interval (CI) were calculated using random-effect models to determine risks of outcomes in ASCVD patients treated with rivaroxaban and comparators, and meta-analysis was conducted via Review Manager 5.3.5 software. Results: 3,768 records were obtained through literature search, and 9 articles representing 6 RCTs ultimately qualified for this study. The meta-analysis indicated that for patients with CAD, the addition of rivaroxaban (5 mg daily) to aspirin could significantly reduce the risk of major adverse cardiovascular events (MACEs) compared with aspirin alone (HR 0.81, 95% CI, 0.72 to 0.91, p = 0.0004, I2 = 60%, 4 studies). For PAD patients receiving rivaroxaban (5 mg daily) plus aspirin, there was no significant reduction in the risk of MACEs (HR 0.84, 95% CI, 0.63 to 1.13, p = 0.25, I2 = 74%, 2 studies); however, there was significant reduction in major adverse limb events (MALEs) (HR 0.54, 95% CI, 0.35 to 0.83, p = 0.005, one studies) and in the composite of MACEs or MALEs (HR 0.78, 95% CI, 0.64 to 0.95, p = 0.02, I2 = 66%, 2 studies) when compared with patients receiving aspirin alone. Meanwhile, rivaroxaban combined with aspirin significantly increased the risk of International Society on Thrombosis and Haemostasis (ISTH) major bleeding compared with aspirin alone in patients with CAD (HR 1.74, 95% CI, 1.43 to 2.13, p < 0.00001, I2 = 0%, 2 studies) and PAD (HR 1.47, 95% CI, 1.19 to 1.83, p = 0.0004, I2 = 0%, 2 studies). Conclusions: Compared with standard antiplatelet therapy, the addition of a 5 mg daily dose of rivaroxaban to standard antiplatelet therapy may improve cardiovascular or limb outcomes of patients with ASCVD, with an increase in major bleeding. Patients who would benefit from the addition of low-dose rivaroxaban to antiplatelet agents and appropriate dual-pathway antithrombotic strategies should be identified in clinical practice to individualize antithrombotic therapy.

13.
Eur Arch Psychiatry Clin Neurosci ; 270(6): 655-659, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30600352

RESUMO

The mean age and gender distribution of patients seeking help for mental disorders have not yet been investigated systematically. Epidemiological surveys can provide data on gender distribution of disorders and an age range in which a disorder is most frequent, but do not offer data on the average help-seeking patient, and they are usually conducted by lay interviewers with non-clinical subjects. However, this information on age and gender can be simply extracted from randomized clinical trials (RCTs) in which consecutive clinical patients are included. As it can be assumed that the average patient tends to participate in a clinical trial when her/his illness severity has reached its highpoint, the mean age of patients in RCTs is a good estimator of the peak severity of a disorder. In RCTs, diagnoses are made by psychiatrists and only clinical patients fulfilling a minimum degree of severity are included. From 10.465 records found by electronic and hand search, we extracted 832 eligible RCTs with 151,336 patients with the 19 most relevant mental disorders. We provide a table with the mean age, standard deviation and gender distributions of all major mental disorders. These results can be used in scientific articles and educational materials and can help health care providers or researchers planning treatment programs. Patients can be informed about the natural course of the disorder. By determining the reasons why some disorders occur predominantly in a certain age or have an unbalanced gender distribution information the aetiology of these disorders may further be elucidated.


Assuntos
Transtornos Mentais/epidemiologia , Transtornos Mentais/terapia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Seleção de Pacientes , PubMed/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Distribuições Estatísticas , Adulto Jovem
14.
World Psychiatry ; 17(3): 330-340, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30192088

RESUMO

Tardive dyskinesia (TD) risk with D2/serotonin receptor antagonists or D2 receptor partial agonists (second-generation antipsychotics, SGAs) is considered significantly lower than with D2 antagonists (first-generation antipsychotics, FGAs). As some reports questioned this notion, we meta-analyzed randomized controlled studies (RCTs) to estimate the risk ratio (RR) and annualized rate ratio (RaR) of TD comparing SGAs vs. FGAs and SGAs vs. SGAs. Additionally, we calculated raw and annualized pooled TD rates for each antipsychotic. Data from 57 head-to-head RCTs, including 32 FGA and 86 SGA arms, were meta-analyzed, yielding 32 FGA-SGA pairs and 35 SGA-SGA pairs. The annualized TD incidence across FGA arms was 6.5% (95% CI: 5.3-7.8%) vs. 2.6% (95% CI: 2.0-3.1%) across SGA arms. TD risk and annualized rates were lower with SGAs vs. FGAs (RR=0.47, 95% CI: 0.39-0.57, p<0.0001, k=28; RaR=0.35, 95% CI: 0.28-0.45, p<0.0001, number-needed-to-treat, NNT=20). Meta-regression showed no FGA dose effect on FGA-SGA comparisons (Z=-1.03, p=0.30). FGA-SGA TD RaRs differed by SGA comparator (Q=21.8, df=7, p=0.003), with a significant advantage of olanzapine and aripiprazole over other non-clozapine SGAs in exploratory pairwise comparisons. SGA-SGA comparisons confirmed the olanzapine advantage vs. non-clozapine SGAs (RaR=0.66, 95% CI: 0.49-0.88, p=0.006, k=17, NNT=100). This meta-analysis confirms a clinically meaningfully lower TD risk with SGAs vs. FGAs, which is not driven by high dose FGA comparators, and documents significant differences with respect to this risk between individual SGAs.

15.
Adv Cancer Res ; 136: 1-48, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29054414

RESUMO

The relation between selenium and cancer has been one of the most hotly debated topics in human health over the last decades. Early observational studies reported an inverse relation between selenium exposure and cancer risk. Subsequently, randomized controlled trials showed that selenium supplementation does not reduce the risk of cancer and may even increase it for some types, including advanced prostate cancer and skin cancer. An increased risk of diabetes has also been reported. These findings have been consistent in the most methodologically sound trials, suggesting that the early observational studies were misleading. Other studies have investigated selenium compounds as adjuvant therapy for cancer. Though there is currently insufficient evidence regarding the utility and safety of selenium compounds for such treatments, this issue is worthy of further investigation. The study of selenium and cancer is complicated by the existence of a diverse array of organic and inorganic selenium compounds, each with distinct biological properties, and this must be taken into consideration in the interpretation of both observational and experimental human studies.


Assuntos
Neoplasias/tratamento farmacológico , Selênio/efeitos adversos , Selênio/farmacologia , Animais , Humanos , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Nutrition ; 33: 76-82, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27553772

RESUMO

Multivitamin/mineral supplements (MVM) are widely used in many populations. In particular, in pregnant women, MVM together with iron and folic acid are recommended to improve birth outcome and reduce low birth weight and rates of miscarriage. However, MVM use is common in the general population. This raises questions regarding the safety of long-term use of these supplements. To estimate the safety of MVM use, we performed a literature search for randomized, controlled studies for supplements with a combination of at least nine vitamins and three minerals at a maximum concentration of 100% of the recommended dietary allowance. We found nine studies evaluating the use and efficacy of MVM in pregnant women and healthy adults and six studies in the elderly where adverse effects were explicitly addressed. Only minor adverse effects (e.g., unspecific gastrointestinal symptoms) were reported in all studies. In particular, there were no significant differences between treatment and placebo groups. MVM use within the range of the dietary reference intake will not result in excess intake, even when including the impact of food and fortified food, and does not increase mortality. Taken together, these findings indicate that MVM can be safe for long-term use (more than 10 y).


Assuntos
Suplementos Nutricionais/efeitos adversos , Minerais/efeitos adversos , Recomendações Nutricionais , Oligoelementos/efeitos adversos , Vitaminas/efeitos adversos , Humanos , Minerais/administração & dosagem , Minerais/uso terapêutico , Oligoelementos/administração & dosagem , Oligoelementos/uso terapêutico , Vitaminas/administração & dosagem , Vitaminas/uso terapêutico
17.
Encephale ; 42(6S): S12-S17, 2016 Dec.
Artigo em Francês | MEDLINE | ID: mdl-28236986

RESUMO

An inventory on the two critical dimensions that structure the Randomized Controlled Trial in Psychiatry, namely the definition of inclusion criteria for eligible patients for testing and the choice of psychometric methods of pathology assessment and its evolution during the experiment, considers the importance of increasingly numerous and precise international recommendations. Taking into account the formal constraints of industrial, questioning the cultural differences of the methodological approach of the tests, meeting the requirements of feasibility and ever increasing security, frequent cumbersome procedure often contrasts with the modest nature of the results. A better definition to include patients in randomized trials is desirable and it asks to return to the clinic studying the expectations of patients and their response to the therapeutic situation. Excessive standardization otherwise required for ensuring the objective nature of the assessment hampers the collection of original and varied clinical features of importance in the further definitions of indications. On the way to a resumption of the single case study, we can expect from qualitative methods applied to small groups of subjects, optimization principles of patient selection for the upcoming randomized trial and greater chance to address the relevant details of clinical response to the therapeutic situation. This is what has led to the discovery of psychotropic drugs and which is involved in the various modalities of the qualitative approach. For example, and beyond the exploration of clinical drug effects, the study of the experience of psychiatric inpatient care in the Healing Garden, conducted on a small group and on the basis of the narrative analysis of their experience, notes several operating thematic dimensions: a reduction in the perception of symptoms of the disease, the impression of regaining a foothold into reality, the interest of a differently perceived doctor-patient relationship, the advantage of renewed power to act and the recognition of the importance of support from others, patients recovering somehow « vitality ¼ of touch with reality. This suggests the possibility to establish an appropriate rating scale for such a specific therapeutic situation and to provide a more accurate and efficient recruitment for a comparative objective demonstration. Moreover, this construction of meaning reinforces the therapeutic benefit of treatment in Healing Garden and offers new dimensions for research.


Assuntos
Seleção de Pacientes , Psiquiatria/métodos , Psicometria/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/terapia , Serviços de Saúde Mental/organização & administração , Serviços de Saúde Mental/normas , Guias de Prática Clínica como Assunto , Psiquiatria/normas , Psicometria/normas , Pesquisa Qualitativa , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
19.
Tex Heart Inst J ; 35(2): 152-61, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18612446

RESUMO

We sought to determine U.S. physicians' knowledge and perspectives regarding the 2004 American College of Cardiology/American Heart Association guidelines for management of patients who have ST-segment-elevation myocardial infarction (STEMI). We invited 45,998 physicians from the American Medical Association's roster to take an Internet survey of U.S. cardiologists and emergency physicians who were hospital-based or who had hospital-admitting privileges. To represent individual and combined populations, data were weighted on the basis of years in practice, sex, and geographic region. Of 505 cardiologists and 509 emergency physicians who completed the survey, 90% worked in an urban or suburban setting and 82% at hospitals with a cardiac catheterization laboratory. Sampling error was +/-3.4%. Most respondents (61%) believed that overall myocardial infarction treatment needed a "great deal" or "fair amount" of improvement; 24% were "somewhat" or "not at all" familiar with the guidelines. Although 84% knew the recommended STEMI treatments for a patient who presents within 3 hours of symptom onset without contraindications to reperfusion or delay to invasive treatment, only 11% knew that there is no preferred approach. If percutaneous coronary intervention proved impossible within 90 minutes of presentation, 21% reported that eligible patients--assuming early presentation, confirmed STEMI diagnosis, and no high-risk STEMI or contraindications to fibrinolysis--would "rarely" or "never" receive guideline-recommended fibrinolysis. Many cardiologists and emergency physicians are unfamiliar with the guidelines and with the uncertainty that surrounds therapeutic approaches, which suggests the need for increased education on effective treatments to expedite myocardial reperfusion in STEMI.


Assuntos
Atitude do Pessoal de Saúde , Cardiologia , Competência Clínica , Medicina de Emergência , Infarto do Miocárdio/terapia , Médicos , Adulto , Angioplastia Coronária com Balão , Feminino , Fidelidade a Diretrizes , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/fisiopatologia , Guias de Prática Clínica como Assunto , Terapia Trombolítica , Estados Unidos
20.
Neuropsychiatr Dis Treat ; 4(6): 1181-91, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19337458

RESUMO

Quetiapine has demonstrated efficacy in schizophrenia, bipolar disorder and in the treatment of specific symptom clusters such as agitation and sleep problems in mood disorders. In this review, randomized controlled studies demonstrating efficacy, safety and tolerability of quetiapine in major depressive disorder (MDD) and general anxiety disorder (GAD) are evaluated. The results show that quetiapine monotherapy and quetiapine augmentation of antidepressant treatment in MDD and GAD are efficacious for short-term and maintenance treatment at a dose range between 50 and 300 mg/day. Quetiapine appears to have a specific but overall mild side-effect profile, though, some adverse effects such as sedation and somnolence may lead to withdrawal from treatment in some patients. Overall, the available evidence suggests that there is a significant role for quetiapine in the treatment of MDD and GAD.

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