Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review

ABSTRACT BACKGROUND: The diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult. OBJECTIVE: To identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS. DESING AND SETTING: Systematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil. METHODS: We searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies. RESULTS: We identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia. CONCLUSION: The diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes. REGISTRATION: PROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

Da imaginação à neuroimagem: uma análise antropológica sobre a racionalidade do efeito placebo em ensaios clínicos / From imagination to neuroimage: An anthropological analysis on the rationality of the placebo effect in clinical trials

Resumo O efeito placebo é um ponto de passagem obrigatório para a compreensão da racionalidade envolvida nos ensaios clínicos randomizados. A partir da antropologia da ciência e da tecnologia, este artigo analisa como a noção de efeito placebo tem sido utilizada pela ciência na produção de fronteiras biossociais. Assim, enfoca fenômenos que inicialmente eram atribuídos à imaginação e analisa as consequências de novas metodologias científicas que têm reconhecido outras potencialidades desse efeito, mas tendem a privilegiar marcadores biológicos. O argumento central é que a disputa epistemológica oculta a existência múltipla do efeito placebo que pode ser reconhecida em função das diferentes práticas às quais ele confere racionalidade.

Abstract The placebo effect is an obligatory passage point to understand rationality in randomized clinical trials. From the perspective of science and technology studies, this paper analyzes how the notion of the placebo effect has been used by science in the production of biosocial borders. Thus, it will pay attention to the phenomena considered caused by imagination, and we will analyze the consequences of new methodologies that have recognized other potentialities of this effect but tend to favor biological markers. The central argument is that the epistemological dispute hides the multiple existences of the placebo effect to be recognized due to the different scientific practices to which it confers rationality.

Psicoterapia para la regulación emocional desde un enfoque transdiagnóstico: revisión de ensayos clínicos aleatorizados / Psychotherapy for emotional regulation from transdiagnostic approach: a review of randomized clinical trials

Resumen Introducción: La regulación emocional (RE) refiere a los procesos por los cuales los individuos influyen en las emociones que tienen, cuando las tienen y cómo las experimentan y expresan (Gross, 1998). El uso de estrategias desadaptativas de RE se asocia con distintos cuadros psicopatológicos. La concepción de RE como proceso transdiagnóstico permite sortear el problema de la comorbilidad, y ha sido abordado desde distintos modelos e investigaciones. Objetivo: El presente estudio se propone realizar una revisión de ensayos clínicos aleatorizados de psico-terapia para la RE desde una perspectiva transdiagnóstica. Método: Para ello se realizó una búsqueda en las bases de datos PubMed, SciELO, Redalyc y ScienceDirect. Resultados: Se hallaron 11 artículos que cumplían los criterios de inclusión. Los resultados mostraron que las intervenciones transdiagnósticas obtuvieron mejores resultados que grupos control, que incluyeron otros tratamientos o listas de espera. Conclusión: Se señala la importancia de realizar más ensayos clínicos aleatorizados que comparen nuevas intervenciones con tratamientos de primera línea.

Abstract Introduction: Emotional regulation (ER) refers to the processes by which individuals influence the emotions they have, when they have them and how they experience and express them (Gross, 1998). The use of maladaptive ER strategies is associated with different psychopathological conditions. The conception of ER as a transdiagnostic process allows to overcome the problem of comorbidity, and has been approached from different models and investigations. Objective: The present study aims to conduct a review of randomized clinical trials of psychotherapy for ER from a transdiagnostic perspective. Method: For this, a search was carried out in the databases PubMed, SciELO, Redalyc and ScienceDirect. Results: Eleven articles were found that met the inclusion criteria. The results showed that the transdiagnostic interventions obtained better results than control groups, which included other treatments or waiting lists. Conclusion: The importance of conducting more randomized clinical trials comparing new interventions with first-line treatments is noted.

Ensaios clínicos randomizados sobre unidade de terapia intensiva realizados por enfermeiros no Brasil / Ensayos clínicos aleatorizados sobre la unidad de cuidados intensivos realizados por enfermeras en Brasil / Randomized clinical trials on the intensive care unit conducted by nurses in Brazil

Objetivo: caracterizar os ensaios clínicos randomizados realizados em unidade de terapia intensiva desenvolvidos por enfermeiros no Brasil. Método : trata-se de um estudo descritivo, de natureza quantitativa, com coleta de dados realizada mediante o acesso ao website de Registro Brasileiro de Ensaios Clínicos, no qual foram incluídos os ensaios cadastrados por enfermeiros. A análise ocorreu de forma descritiva a partir do software R. Resultados: a amostra do estudo foi composta por 33 ensaios clínicos. Predominaram os ensaios referentes à especialidade da enfermagem em neonatologia, que representou 16 (48,5%) dos estudos analisados. A maioria das intervenções testadas foram procedimentos de enfermagem, encontradas em 17 (51,5%) estudos. Observou-se predominância do mascaramento aberto, em 19 (57,6%) estudos e a maioria dos autores encontrava-se na docência, em 26 (48,1%) dos estudos. Conclusão: sugere-se que sejam realizados outros estudos que abordem a caracterização de ensaios clínicos realizados por outras categorias profissionais no setor em questão(AU)

Objective: to characterize the randomized clinical trials carried out in an intensive care unit developed by nurses in Brazil. Method: this is a descriptive, quantitative study, with data collection performed by accessing the website of the Brazilian Registry of Clinical Trials, which included trials registered by nurses. The analysis detected descriptively using the R software. Results: the study sample consisted of 33 clinical trials. The trials referring to the specialty of nursing in neonatology predominated, representing 16 (48.5%) of the studies involved. Most of the interventions tested were nursing procedures, found in 17 (51.5%) studies. There was a predominance of open masking in 19 (57.6%) studies and most authors were in teaching, in 26 (48.1%) of the studies. Conclusion: it is necessary to carry out other studies that address the characterization of tests carried out by other professional categories in the sector in question(AU)

Objetivo: caracterizar los ensayos clínicos aleatorizados realizados en una unidad de cuidados intensivos desarrollados por enfermeras en Brasil. Método: se trata de un estudio descriptivo, cuantitativo, con recolección de datos mediante el acceso a la página web del Registro Brasileño de Ensayos Clínicos, que incluyó ensayos registrados por enfermeras. El análisis se detectó de forma descriptiva mediante el software R. Resultados: la muestra de estudio estuvo formada por 33 ensayos clínicos. Predominaron los ensayos referidos a la especialidad de enfermería en neonatología, representando 16 (48,5%) de los estudios involucrados. La mayoría de las intervenciones probadas fueron procedimientos de enfermería, encontrados en 17 (51,5%) estudios. Hubo predominio del enmascaramiento abierto en 19 (57,6%) estudios y la mayoría de los autores estaban en la docencia, en 26 (48,1%) de los estudios. Conclusión: es necesario realizar otros estudios que aborden la caracterización de pruebas realizadas por otras categorías profesionales del sector en cuestión(AU)

Efficacy and safety of Di-Tan Decoction for treating post-stroke neurological disorders: a systematic review and Meta-analysis of randomized clinical trials / 中国天然药物

The management of post-stroke complications plays an important role in the quality of life. Di-Tan Decoction (DTD; ) is a widely used traditional Chinese medicine. This study incorporated systematic review and meta-analysis to evaluate the efficacy of DTD in post-stroke neurological disorders. Randomized clinical trials (RCTs) were searched from English, Chinese and Korean electronic medical databases, by including the keywords "Di-Tan Tang", "Di-Tan Decoction", "Scour Phlegm Decoction", "stroke", and "RCT. Each RCT included control (placebo, conventional therapy, or Western medicine) and experimental (DTD treatment) groups. For patients inflicted with stroke for 1-6 weeks, the outcomes of post-stroke neurological disorders were measured by scales for post-stroke symptoms and were classified as "completely healed", "markedly effective", "effective" and "ineffective". Totally, 11 RCTs (n = 490 controls and n = 502 DTD subjects) were selected from 210 articles identified in the initial search. A meta-analysis of evaluation criteria in post-stroke symptoms revealed that the overall odds ratio (ORs) for alleviating post-stroke neurological disorders were 0.30-fold lower (95% CI = 0.21-0.43) in the DTD group than the control (Western medicine) group (P < 0.000 01). Moreover, regardless of the type of stroke diagnostic scale applied (including NFA, HDS, and NIHSS), the overall post-stroke symptoms determined were less severe in the DTD group (n = 219) than the control group (n = 217). No adverse effects of DTD were observed in the 11 RCTs reviewed. All 11 studies used an appropriate method for randomization of subjects to evaluate the risk of bias (ROB), and 7 studies included allocation concealment as well as blinding of patients and practitioners. High-risk ROB was included in 6 RCTs. No significant publication bias was derived from the funnel plot. Our results indicate that the administration of DTD alone, and DTD in combination with Western medicine, exert greater efficacy for post-stroke complication therapy, than Western medicine administered alone. More rigorous and regulated studies are required to confirm the therapeutic efficacy of DTD for post-stroke neurological disorders. disorders.

Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR / 医学前沿

New targeted therapies have been developed to overcome resistance to endocrine therapy (ET) and improve the outcome of HR

Assessing quality of reporting of herbal dermatology trials from the Philippines using the hCONSORT Checklist: A systematic review

Background@#Herbal medicine is a growing and innovative field in Philippine dermatology. There is a need to assess the quality of reporting of published herbal randomized controlled trials (RCTs) in dermatology since these will serve to guide rational development and use of medicinal plants in the Philippines.@*Objective@#The study aimed to assess the quality of reporting of published herbal RCTs in dermatology from the Philippines based on the hCONSORT checklist.@*Methods@#We searched MEDLINE, CENTRAL, HERDIN (from inception to 20 September 2018), and other secondary sources for published randomized controlled trials that used any herbal preparation as intervention for the treatment or prevention of a dermatologic disease or for maintenance of healthy skin, hair, or nails. We determined the percentage of reported items based from the hCONSORT checklist. @*Results@#We included 41 trials, majority of which were on infections, infestations, and bites (66%). The three most common families of herbs used were Fabaceae/Leguminosae (22%) (Gliricidia sepium (Jacq.) Walp. [kakawati]; Senna alata (L.) Roxb. / Cassia alata (L.) [akapulko]); Arecaceae (12%) (Cocos nucifera L. [coconut]); and Myrtaceae (12%) (Eucalyptus sp [eucalyptus], Psidium guajava L.[guava], and Melaleuca alternifolia (Maiden & Betche) Cheel [tea tree]). Most of the trials (27/41, 66%) were conducted in accredited dermatology training programs of the Philippine Dermatological Society. Only 11 trials (27%) were published in PubMED-indexed journals. More than half of articles were published after the CONSORT publication in 2006 (59%). The mean percentage of reported hCONSORT checklist items in included studies was 39.6% (SD 9.9), with only seven studies reporting more than 50% of the hCONSORT checklist items.@*Conclusion@#Published herbal RCTs in dermatology from the Philippines are poorly reported based on the hCONSORT checklist. There is a need for dissemination of the hCONSORT to local researchers and journal editors to ensure thorough and quality reporting.

Can musical intervention improve memory in Alzheimer's patients? Evidence from a systematic review / Intervenção musical pode melhorar a memória em pacientes com doença de Alzheimer? Uma revisão sistemática

ABSTRACT Treatment with music has shown effectiveness in the treatment of general behavioural and cognitive symptoms of patients with various types of dementia. Objective: To assess the effectiveness of treatment with music on the memory of patients with Alzheimer's disease (AD). Methods: A systematic search was performed on PubMed (Medline), Cochrane Library, PsycINFO and Lilacs databases up to June 2017 and included all randomized controlled trials that assessed memory using musical interventions in patients with AD. Results: Forty-two studies were identified, and 24 studies were selected. After applying the exclusion criteria, four studies involving 179 patients were included. These studies showed the benefits of using music to treat memory deficit in patients with AD. Conclusion: To the best of our knowledge, this is the first systematic review focusing on randomized trials found in the literature that analysed the role of musical interventions specifically in the memory of patients with AD. Despite the positive outcome of this review, the available evidence remains inconsistent due to the small number of randomized controlled trials.

RESUMO O tratamento com música vem demonstrando eficácia no tratamento de sintomas comportamentais e cognitivos gerais de pacientes com vários tipos de demência. Objetivo: Avaliar a eficácia do tratamento com música para a memória de pacientes com doença de Alzheimer (DA). Métodos: Foi realizada uma revisão sistemática nos bancos de dados PubMed (Medline), Cochrane Library, PsycINFO e Lilacs até junho de 2017 que incluiu todos os ensaios clínicos randomizados controlados usando intervenções musicais em pacientes com DA e que avaliaram a memória. Resultados: Foram encontrados 42 estudos sendo selecionados 24 estudos completos. Após a aplicação dos critérios de exclusão, foram incluídos quatro estudos envolvendo 179 pacientes. Esses estudos mostraram os benefícios do uso da música para tratar o déficit de memória em pacientes com DA. Conclusão: Até o momento, este é o primeiro estudo de revisão sistemática que utilizou ensaios clínicos randomizados da literatura que analisou o papel das intervenções musicais especificamente na memória de pacientes com DA. Apesar do resultado positivo desta revisão, a evidência disponível permanece frágil devido ao pequeno número de ensaios clínicos randomizados.

Can implant surfaces affect implant stability during osseointegration? A randomized clinical trial

Abstract This randomized clinical trial evaluated the insertion torque (IT), primary, and secondary stability of dental implants with different surface treatments during the osseointegration period. Nineteen patients with bilateral partial edentulism in the posterior mandibular region were randomly allocated to two implant brand groups and received implants with different surface treatments in the opposite site of the arch: Osseotite and Nanotite or SLA and SLActive. During implant placement, the maximum IT was recorded using a surgical motor equipped with a graphical user interface. The implant stability quotient (ISQ) was assessed immediately after the IT, and was measured weekly via resonance frequency analysis during 3 months. The data were analyzed by a one-way ANOVA, the Bonferroni test, paired t tests and Pearson's correlation coefficient. The IT values were similar (p > 0.05) for all implant types ranging from 43.82 ± 6.50 to 46.84 ± 5.06. All implant types behaved similarly until the 28th day (p > 0.05). Between 35 and 56 days, Osseotite and SLActive showed lower ISQ values (p < 0.001) compared to Nanotite and SLA implants. After 56 days, only Osseotite maintained significantly lower ISQ values than the other implants (p < 0.05). After 91 days the ISQ values were significantly higher than the baseline for all four implant types (p < 0.001). The ISQ and IT values were significantly correlated at the baseline and at the final evaluation for Osseotite, Nanotite, and SLActive implants (p < 0.001). After 91 days, ISQ and IT values were only significantly correlated for the Osseotite implants (p < 0.05). All implants types exhibited acceptable primary and secondary stability.

Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: a double-blind, randomized, placebo-controlled clinical trial / 中西医结合学报

<p><b>BACKGROUND</b>Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal complaints. GERD, caused by the reflux of stomach contents into the esophagus, leads to troublesome symptoms such as heartburn and regurgitation. It is classified into two types: erosive esophagitis, characterized by visible esophageal mucosa erosion in endoscopy, and non-erosive reflux disease (NERD). GERD is a chronic and recurrent disease that impairs the quality of life and imposes socioeconomic and therapeutic burdens to both patients and society.</p><p><b>OBJECTIVE</b>Due to the failure of the conventional treatments for GERD and to the traditional use of Amla (Phyllanthus emblica L.), in addition to beneficial effects shown in recent studies, we evaluated the safety and efficacy of Amla tablet for improvement of symptoms of patients with NERD.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>We designed a double-arm, randomized, double-blind, placebo-controlled clinical trial. Sixty-eight patients who had classic symptoms of GERD (heartburn, regurgitation and epigastralgia) for at least three months before the start of the trial were randomized in two parallel groups. Patients in the Amla group received two 500 mg Amla tablets twice a day, after meals, for 4 weeks. In the control group, patients received placebo tablets similar to the Amla prescription.</p><p><b>MAIN OUTCOME MEASURES</b>The patients were visited at baseline, and at the end of the 2nd and 4th weeks of intervention; their symptoms were measured on a frequency and severity scale for the symptoms of NERD, according to the quality of life in reflux-associated disease questionnaire.</p><p><b>RESULTS</b>Frequencies of heartburn and regurgitation in both groups of the study were significantly reduced after intervention (P < 0.001). Repeated measures logistic regression analysis showed that, in the Amla group, there was a more significant reduction in regurgitation frequency, heartburn frequency, regurgitation severity and heartburn severity during the study period, compared with the placebo group (P < 0.001).</p><p><b>CONCLUSION</b>This randomized double-blind, placebo-controlled clinical trial demonstrated that Amla could reduce frequencies of heartburn and regurgitation and improve heartburn and regurgitation severity in patients with NERD.</p><p><b>TRIAL REGISTRATION</b>Iranian Registry of Clinical Trials IRCT2016061428469N1.</p>

Applied mediation analyses: a review and tutorial / 한국역학회지

In recent years, mediation analysis has emerged as a powerful tool to disentangle causal pathways from an exposure/treatment to clinically relevant outcomes. Mediation analysis has been applied in scientific fields as diverse as labour market relations and randomized clinical trials of heart disease treatments. In parallel to these applications, the underlying mathematical theory and computer tools have been refined. This combined review and tutorial will introduce the reader to modern mediation analysis including: the mathematical framework; required assumptions; and software implementation in the R package medflex. All results are illustrated using a recent study on the causal pathways stemming from the early invasive treatment of acute coronary syndrome, for which the rich Danish population registers allow us to follow patients' medication use and more after being discharged from hospital.

Meta-analysis of Acupuncture as Adjuvant Therapy in Improving Gastrointestinal Function of Acute Pancreatitis Patients / 广州中医药大学学报

Objective To evaluate the clinical effect of acupuncture as an adjuvant therapy for acute pancreatitis (AP).Methods We retrieved the databases ofCNKI,VIP,Wanfang,PubMed,EMBase,and Cochrane Library,selected the relevant randomized clinical trials (RCTs) of AP treated with routine western medicine as control group and treated with routine western medicine combined with acupuncture therapy as trial group.And then,the quality of the qualified RCTs was evaluated,and the end-point outcomes of the RCTs were analyzed by Meta-analysis.Results A total of 7 RCTs involving 371 AP patients were included into the analysis.The time for abdominal pain relief(WMD =-1.44;95％CI:-2.38,-0.50),time for abdominal distension relief (WMD =-2.50;5％CI:-4.07,-0.73),time for the restart of anal exhaust(WMD =-1.79;95％CI:-3.73,-0.14),time for defecation (WMD =-1.95;95％CI:-3.51,-0.39),time for the restart of bowel sound(WMD =-1.39;95％CI:-2.44,-0.34),time for blood amylase becoming normal(WMD =-2.09;95％CI:-3.22,-0.96),and hospitalization time (WMD =-3.70;95％CI:-6.04,-1.36) in the trial group were less than those in the control group,and the differences of the above indexes except for the time for the restart of anal exhaust were significant (P ＜ 0.05).Conclusion Acupuncture as an adjuvant therapy is effective for improving the gastrointestinal function of AP patients,and shortening time for blood amylase becoming normal and hospitalization time.However,due to the low methodological quality,more well-designed randomized controlled trials are needed to confirm the therapeutic effect of acupuncture therapy for AP.

Applied mediation analyses: a review and tutorial / 한국역학회지

In recent years, mediation analysis has emerged as a powerful tool to disentangle causal pathways from an exposure/treatment to clinically relevant outcomes. Mediation analysis has been applied in scientific fields as diverse as labour market relations and randomized clinical trials of heart disease treatments. In parallel to these applications, the underlying mathematical theory and computer tools have been refined. This combined review and tutorial will introduce the reader to modern mediation analysis including: the mathematical framework; required assumptions; and software implementation in the R package medflex. All results are illustrated using a recent study on the causal pathways stemming from the early invasive treatment of acute coronary syndrome, for which the rich Danish population registers allow us to follow patients' medication use and more after being discharged from hospital.

Safety of Cupping Therapy in Studies Conducted in Twenty One Century: A Review of Literature.

Background: Cupping therapy is a well-known traditional treatment modality, and has been used in various diseases around the world since ancient times. This method is reported to have a better clinical as well as adverse events (AEs) profile as found in various studies conducted around the world. Aim: This study identifies, assesses, and classifies the adverse events profile of various types of cupping therapies in studies conducted in twenty one century. Methods: Using electronic and hand searches, three databases including Pub Med, Google Scholar and Cochrane library were searched from the year 2000 to 2016. Studies were included in this review provided they reported adverse effects related to cupping therapy. Observational studies were assessed using the WHO-UMC causality scale. Randomized controlled trials were assessed in accordance to the quality of reporting for harm data. Results: Nine hundred seventy nine (n=979) articles were identified. Based on exclusion and inclusion criteria and extensive review of all retrieved articles by two independent reviewers, only 25 studies that included six RCTs, sixteen single case reports and three case series were finally selected. The mostly observed adverse events of cupping therapy were scar formation reported in four studies that described fifty nine cases, and burns reported in two studies described sixteen cases, respectively. The adverse events of cupping therapy could be classified into local and systemic adverse events. Conclusion: Cupping therapy adverse events were infrequently reported, but they were not rare. Most of adverse effects were mild to moderate in severity. Some of the cupping therapy adverse events were preventable by following the general infection control guidelines, hygienic techniques, safety protocols and rigorous training of cupping therapists. Cupping adverse events should be reported in all studies on cupping, and this therapy should be practiced only by qualified medical professionals.

Clinical trial : A Review.

Randomized clinical trials are scientific investigations that examine and evaluate the safety and efficacy of new drugs, devices, tests, or lifestyle interventions using human subjects. The results that these clinical trials generate are considered to be the most robust data in the era of evidence-based medicine. The primary aim of most clinical trials is to provide an unbiased evaluation of the merits of using one or more treatment options for a given disease or condition of interest. Ideally, clinical trials should be performed in a way that isolates the effect of treatment on the study outcome and provides results that are free from study bias.

Ethical issues of randomized controlled trials.

ABSTRACT: Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must meet all ethics issues. The institutional review board (IRB) must check whether all ethical demands are met or not before permitting the research.

The Necessity of Randomized Clinical Trials.

Aims: The hierarchy of evidence-based medicine determines the inferential powers of different clinical research designs. We want to address the difficult question if observational evidence under some circumstances can validate intervention effects. Methodology: Assessment of previous argumentation aiming at a clear conclusion for future decision-making. Results: We present five arguments demonstrating the fundamental need of randomized clinical trials to sufficiently validate intervention effects. Furthermore, we argue that hindrances to the conduct of randomized clinical trials can be lessened through education, collaboration, infrastructure, and other measures. Our arguments validate why the randomized clinical trial should and must be the study design evaluating interventions. By choosing the randomized clinical trial as the primary study design, effective preventive, prognostic, diagnostic, and therapeutic interventions will reach more patients earlier. Conclusion: Clinical experience or observational studies should never be used as the sole basis for assessment of intervention effects — randomized clinical trials are always needed. Therefore, always randomize the first patient as Thomas C Chalmers suggested in 1977. Observational studies should primarily be used for quality control after treatments are included in clinical practice.

Consideraciones metodológicas y éticas para la conducción de ensayos clínicos controlados aleatorizados (ECCA) sobre intervenciones para las adicciones / Methodological and ethical aspects in conducting randomized controlled clinical trials (RCT) for addictive disorder's interventions

According to epidemiologic reports, the harmful use of alcohol and illicit drugs has increased among the Mexican population. This use is associated to several risks and issues that affect public health and the public well-being of the country. In this article it is acknowledged the need for development of treatment models and interventions whose therapeutic value is demonstrated by scientific evidence, that respond to the attention needs of the population affected by substance use in our country and that can be generalized in community clinical practice. In clinical research, randomized controlled clinical trials (RCT's) are the "gold standard" to demonstrate the effect of a therapeutic intervention. A randomized controlled clinical trial is a prospective study in which the effect, value and safety of one or various experimental interventions are tested against a "control" intervention in human subjects. Acknowledging that in Mexico there is a lack of research on addiction treatment that is compliant with all the requirements to be considered as an RCT, this article presents some methodological and ethical considerations that are neccesary for their design and conduction. These considerations include from the establishment of a relevant research question and objectives, adequate study design, development of strategies for data management, statistical analysis, monitoring of interventions, safety monitoring and research quality assurance and protection of human subjects.

Según reportes epidemiológicos, el consumo nocivo de alcohol y drogas ilegales dentro de la población mexicana ha ido en aumento, lo que se asocia a varios riesgos o problemáticas que afectan la salud y bienestar públicos del país. Se reconoce la necesidad de desarrollar modelos de tratamiento e intervenciones cuyo valor terapéutico esté respaldado por la evidencia científica, que respondan a las necesidades de atención de la población afectada por el consumo de sustancias en nuestro país y que puedan generalizarse en la práctica clínica comunitaria. Dentro de la investigación clínica, el "estándar de oro" para demostrar el efecto de una intervención terapéutica son los ensayos clínicos controlados aleatorizados (ECCA). Un ECCA es un estudio prospectivo en el cual se prueba el efecto, valor y seguridad de una o varias intervenciones experimentales contra una intervención "control" en sujetos humanos. Reconociendo que en México hay una falta de investigaciones sobre tratamientos para las adicciones que cumplan con todos los requisitos para ser considerados ECCA, en este artículo se presentan distintas consideraciones metodológicas y éticas que deben tomarse en cuenta para su diseño y conducción en la materia; abarcando aspectos que parten desde el establecimiento de una pregunta y objetivos relevantes hasta el diseño adecuado del estudio y el desarrollo de estrategias para la administración de datos, análisis estadístico, monitoreo de las intervenciones, monitoreo de seguridad y aseguramiento de la calidad de la investigación y protección de los sujetos humanos que participan.

Efeito do pH e da concentração de fluoreto presente em dentifrícios líquidos no controle de cárie em área fluoretada: estudo clínico randomizado / Effect of liquid dentifrices pH and fluoride concentration on caries control in a region with fluoridated water: randomized clinical trial

Os dentifrícios de baixa concentração de fluoreto têm sido sugeridos como alternativa para reduzir o risco de fluorose dentária, embora não haja consenso quanto a sua eficácia clínica, a qual pode ser aumentada quando o pH é ácido. Este estudo clínico randomizado teve como objetivo avaliar o efeito anti-cárie do pH e da concentração de fluoreto presente em dentifrícios líquidos, em crianças com diferentes status de atividade cariosa. Crianças de 2-4 anos de idade residentes em uma área fluoretada (0,6-0,8 ppm F), com (A) e sem (I) lesões de cárie ativa foram distribuídas aleatoriamente em três grupos de acordo com o tipo de dentifrício utilizado: Grupo 1 (n=48-A/56-I): 550 ppm F pH 4,5, Grupo 2 (n=56-A/48-I) 1100 ppm F pH 7,0, Grupo 3 (n=52-A/55-I): 550 ppm F pH 7,0. O número de lesões tornando-se ativas/cavidades ou inativas, respectivamente, foi avaliado clinicamente após 12 meses, podendo-se determinar se as lesões progrediram ou regrediram. Além disso, as lesões de mancha branca foram avaliadas através da técnica de quantificação de fluorescência induzida por luz (Quantitative Light-Induced Fluorescence - QLF) em uma subamostra de 75 crianças. A concentração de fluoreto nas unhas dos pés e no biofilme dentário também foi avaliada após 6 meses de uso dos dentifrícios. A progressão de cárie seguiu um padrão decrescente de acordo com o dentifrício utilizado (G3>G2>G1), independentemente da atividade de cárie da criança, mas diferenças significativas foram detectadas apenas para a progressão e o incremento de cárie (G1 < G3) no grupo de crianças cárie-ativas, quando avaliadas por inspeção visual. Para a regressão de cárie, os valores encontrados para os 3 grupos foram mais parecidos entre si, não havendo diferenças significativas entre osgrupos. Por outro lado, a análise com o QLF não detectou diferença significativa entre os Grupos 1 e 2, mas eles tiveram um desempenho significativamente melhor que o Grupo 3. Concentrações de fluoreto...

Low-F dentifrices have been suggested as an alternative to reduce the risk of dental fluorosis, although there is no consensus on their clinical efficacy, which may be increased when the pH is acidic.The present randomized clinical trial evaluated the anticaries effect of low-F acidic liquid dentifrice in children at different caries activity status. Two-to-four-year-old schoolchildren living in a fluoridated area (0.6 0.8 ppm F), with (A) or without (I) active caries lesions were randomly allocated into 3 groups differing according to the type of dentifrice used over 12 months: Group 1 (n=48-A/56-I): 550 ppm F pH 4.5, Group 2 (n=56-A/48-I) 1100 ppm F pH 7.0, Group 3 (n=52-A/55-I): 550 ppm F pH 7.0. The number of lesions becoming active/cavities or inactive was clinically evaluated determining progression or regression. Additionally, the white spot lesions were evaluated by the quantitative light-induced fluorescence (QLF) method in a subsample of 75 children. Toenail and plaque fluoride concentration were also evaluated 6 months after the use of the dentifrices. Plaque samples were collected 5 and 60 minutes after the last use of the dentifrices. Caries net increment followed a decreasing pattern according to the dentifrice used (G3>G2>G1) regardless caries activity, but significant differences were detected only for caries progression and net increment (G1 < G3) for the cariesactive group when evaluated through visual inspection. For the regression, the values found for the three groups were more similar, without significant differences. QLF analysis detected no significant difference between Groups 1 and 2, but they performed significantly better than Group 3. Toenail fluoride concentration significantly lower was observed when children used the low-fluoride dentifrices. Plaque F concentration was significantly higher for Group 2 compared to group 3, egardless the time, while Group 1 did not significantly differ Group 2, but was...

Efeito do pH e da concentração de fluoreto presente em dentifrícios líquidos no controle de cárie em área fluoretada: estudo clínico randomizado / Effect of liquid dentifrices pH and fluoride concentration on caries control in a region with fluoridated water: randomized clinical trial

Os dentifrícios de baixa concentração de fluoreto têm sido sugeridos como alternativa para reduzir o risco de fluorose dentária, embora não haja consenso quanto a sua eficácia clínica, a qual pode ser aumentada quando o pH é ácido. Este estudo clínico randomizado teve como objetivo avaliar o efeito anti-cárie do pH e da concentração de fluoreto presente em dentifrícios líquidos, em crianças com diferentes status de atividade cariosa. Crianças de 2-4 anos de idade residentes em uma área fluoretada (0,6-0,8 ppm F), com (A) e sem (I) lesões de cárie ativa foram distribuídas aleatoriamente em três grupos de acordo com o tipo de dentifrício utilizado: Grupo 1 (n=48-A/56-I): 550 ppm F pH 4,5, Grupo 2 (n=56-A/48-I) 1100 ppm F pH 7,0, Grupo 3 (n=52-A/55-I): 550 ppm F pH 7,0. O número de lesões tornando-se ativas/cavidades ou inativas, respectivamente, foi avaliado clinicamente após 12 meses, podendo-se determinar se as lesões progrediram ou regrediram. Além disso, as lesões de mancha branca foram avaliadas através da técnica de quantificação de fluorescência induzida por luz (Quantitative Light-Induced Fluorescence - QLF) em uma subamostra de 75 crianças. A concentração de fluoreto nas unhas dos pés e no biofilme dentário também foi avaliada após 6 meses de uso dos dentifrícios. A progressão de cárie seguiu um padrão decrescente de acordo com o dentifrício utilizado (G3>G2>G1), independentemente da atividade de cárie da criança, mas diferenças significativas foram detectadas apenas para a progressão e o incremento de cárie (G1 < G3) no grupo de crianças cárie-ativas, quando avaliadas por inspeção visual. Para a regressão de cárie, os valores encontrados para os 3 grupos foram mais parecidos entre si, não havendo diferenças significativas entre osgrupos. Por outro lado, a análise com o QLF não detectou diferença significativa entre os Grupos 1 e 2, mas eles tiveram um desempenho significativamente melhor que o Grupo 3. Concentrações de fluoreto...

Low-F dentifrices have been suggested as an alternative to reduce the risk of dental fluorosis, although there is no consensus on their clinical efficacy, which may be increased when the pH is acidic.The present randomized clinical trial evaluated the anticaries effect of low-F acidic liquid dentifrice in children at different caries activity status. Two-to-four-year-old schoolchildren living in a fluoridated area (0.6 0.8 ppm F), with (A) or without (I) active caries lesions were randomly allocated into 3 groups differing according to the type of dentifrice used over 12 months: Group 1 (n=48-A/56-I): 550 ppm F pH 4.5, Group 2 (n=56-A/48-I) 1100 ppm F pH 7.0, Group 3 (n=52-A/55-I): 550 ppm F pH 7.0. The number of lesions becoming active/cavities or inactive was clinically evaluated determining progression or regression. Additionally, the white spot lesions were evaluated by the quantitative light-induced fluorescence (QLF) method in a subsample of 75 children. Toenail and plaque fluoride concentration were also evaluated 6 months after the use of the dentifrices. Plaque samples were collected 5 and 60 minutes after the last use of the dentifrices. Caries net increment followed a decreasing pattern according to the dentifrice used (G3>G2>G1) regardless caries activity, but significant differences were detected only for caries progression and net increment (G1 < G3) for the cariesactive group when evaluated through visual inspection. For the regression, the values found for the three groups were more similar, without significant differences. QLF analysis detected no significant difference between Groups 1 and 2, but they performed significantly better than Group 3. Toenail fluoride concentration significantly lower was observed when children used the low-fluoride dentifrices. Plaque F concentration was significantly higher for Group 2 compared to group 3, egardless the time, while Group 1 did not significantly differ Group 2, but was...