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1.
Medicina (B Aires) ; 84(5): 929-936, 2024.
Artigo em Espanhol | MEDLINE | ID: mdl-39399933

RESUMO

INTRODUCTION: Clinical trials that involve medicines are performed in order to determine their effectiveness and safety. In Argentina, these studies are presented either to National Administration of Drugs, Food and Medical Technology (ANMAT) to obtain drug registration, or to the National Ministry of Health (MSAL) (to obtain the official recognition). This work was carried out to increase the knowledge about the clinical trials performed in Argentina. MATERIALS AND METHODS: The MSAL/ANMAT databases were explored. The variables were: dates of request, institution, phase of the study, enrollment modality, product investigated, therapeutic group, comparator, pathology involved, and location of laboratory performance. RESULTS: A total of 201 protocols were detected in the period of study, all of them performed with registration purposes. Twenty pharmaceutical companies carried out 60% of the studies (17 with foreign capital). Seventy percent were phase III (90% multicenter protocols). Three out of 4 trials corresponded to the oncology / immunosuppressant therapeutical group. In 65% the comparator used was placebo. A 71% of the studies were carried out in health institutions of Buenos Aires City. Ninety-eight per cent of laboratory controls were carried out abroad. DISCUSSION: Foreign pharmaceutical companies are the only ones that carry out clinical trials on medicines in Argentina, all of them for registration purposes. The use of placebo as a comparator is inappropriate, since each drug is expected to be validated against another of recognized efficacy already available in the market. Oncological/immunological pathologies are the ones that arouse greater interest among local researchers due to their prevalence and their greater profitability in the pharmaceutical market.


Introducción: Los ensayos clínicos que involucran medicamentos, tienen como objetivo determinar su eficacia y seguridad. En Argentina, estos estudios se presentan ante la agencia reguladora Administración Nacional Medicamentos, Alimentos y Tecnología Médica (ANMAT), para registrarlos; o bien ante el Ministerio de Salud de la Nación (MSAL). El objetivo de este trabajo fue conocer cuáles son los medicamentos de interés y quiénes son los que llevan adelante este tipo investigación clínica en Argentina. Materiales y métodos: Se exploraron las bases de datos MSAL/ANMAT. Las variables fueron fechas de solicitud del trámite, institución solicitante, fase del estudio, modalidad de enrolamiento, producto investigado, grupo terapéutico, comparador, enfermedad involucraday lugar de realización de laboratorio. Resultados: Se detectaron en el periodo 201 protocolos, todos ellos con fines registrales. Veinte compañías farmacéuticas realizaron el 60% de los estudios (17 de capitales extranjeros). El 70% fueron fase III (90% multicéntricos). Tres de cada 4 ensayos correspondieron al grupo de oncológicos/ inmunosupresores. En el 65% el comparador fue placebo. El 71% de los estudios se realizaron en instituciones de la Ciudad Autónoma de Buenos Aires. El 98 % de controles de laboratorio se realizaron en el exterior. Discusión: Las compañías farmacéuticas extranjeras son quienes realizan con fines registrales el mayor número de ensayos clínicos sobre medicamentos en Argentina. El predominio del uso de placebo como comparador resulta inapropiado, ya que el verdadero valor del estudio es cuando un fármaco innovador demuestra superioridad contra otro ya existente de reconocida eficacia. Las enfermedades oncológicas/inmunológicas fueron aquellas que despertaron mayor interés entre los investigadores y patrocinantes por prevalencia y rentabilidad.


Assuntos
Ensaios Clínicos como Assunto , Argentina , Humanos , Indústria Farmacêutica , Pesquisa Biomédica/estatística & dados numéricos
2.
Nutrients ; 16(18)2024 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-39339818

RESUMO

The objective of this review article is to systematically identify the caffeine placebo effect in sport and exercise activities. We selected randomized controlled trial studies to better understand the impact of caffeine and its placebo effect on sports performance. We extracted a set of articles that refer strictly to the topics of caffeine and its placebo effect in sport and exercise, considering the databases integrated to the Core Collection Web of Science and Scopus, as well as the registration of the documents in PubMed®, a system with a selection process aligned with the guidelines for the PRISMA methodology, establishing the eligibility criteria of the articles with the PICOS tool, to which a systematic review is applied. Finally, the results show that caffeine improves anaerobic capacity and endurance, while placebo perceived as caffeine can also increase performance by reducing pain and improving concentration. This finding underscores the influence of expectations and placebo on physical performance, suggesting that managing these expectations may be an effective strategy for improving athletic performance.


Assuntos
Desempenho Atlético , Cafeína , Exercício Físico , Efeito Placebo , Humanos , Desempenho Atlético/fisiologia , Cafeína/administração & dosagem , Cafeína/farmacologia , Resistência Física/efeitos dos fármacos , Ensaios Clínicos Controlados Aleatórios como Assunto , Esportes
3.
Rev Alerg Mex ; 71(2): 85-90, 2024 Jun 30.
Artigo em Espanhol | MEDLINE | ID: mdl-39298119

RESUMO

OBJETIVES: To evaluate the impact of cholecalciferol (D3) supplementation using clinical and paraclinical variables in patients with RA and vitamin D insufficiency and deficiency. METHODS: A randomized, double-blind, placebo-controlled study included patients from 5 to 40 years with a diagnosis of RA and vitamin D insufficiency and deficiency. They were supplemented for 8 weeks with 4000 or 5000 IU, depending on age. Total nasal symptoms score (TNSS) was measured monthly and 25(OH)D3 levels at baseline and at the end of the study. RESULTS: A total of 31 patients were included, with a mean age of 18.19 years. In the active group, there was a significant improvement in symptomatology with respect to the TNSS score and an increase in serum vitamin D levels (p < 0.01). There were no adverse reactions with cholecalciferol or placebo. CONCLUSIONS: Supplementing patients with vitamin D3, at the evaluated dose, together with conventional treatent for allergic rhinitis results in symptoms and quality of life improvement in patients with this disease.


OBJETIVOS: Evaluar el impacto de la suplementación con colecalciferol (D3) mediante variables clínicas y paraclínicas en pacientes con RA e insuficiencia y deficiencia de vitamina D. MÉTODOS: Estudio aleatorio, doble ciego, placebo controlado, en el que se incluyeron pacientes de 5 a 40 años, con diagnóstico de RA e insuficiencia y deficiencia de vitamina D. Fueron suplementados con 4000 o 5000 UI, dependiendo de la edad, durante 8 semanas. Mensualmente se midió la puntuación total síntomas nasales (TNSS) y las concentraciones de 25(OH)D3 al inicio y al final del estudio. RESULTADOS: Se incluyeron 31 pacientes, con una edad promedio de 18.19 años. En el grupo activo existió una mejoría significativa en la sintomatología respecto a la puntación de TNSS y un incremento en los niveles séricos de vitamina D (p < 0.01). No se presentaron reacciones adversas con la ingesta de colecalciferol o placebo. CONCLUSIONES: Suplementar a los pacientes con vitamina D3, a la dosis evaluada, junto con el tratamiento convencional para la rinitis alergica resulta en una mejoría sintomática y en la calidad de vida de los pacientes con esta enfermedad.


Assuntos
Colecalciferol , Suplementos Nutricionais , Rinite Alérgica , Deficiência de Vitamina D , Humanos , Método Duplo-Cego , Masculino , Feminino , Adolescente , México , Adulto , Adulto Jovem , Colecalciferol/uso terapêutico , Colecalciferol/administração & dosagem , Deficiência de Vitamina D/tratamento farmacológico , Deficiência de Vitamina D/complicações , Criança , Rinite Alérgica/tratamento farmacológico , Pré-Escolar , Vitaminas/uso terapêutico , Vitaminas/administração & dosagem , Vitamina D/uso terapêutico , Vitamina D/sangue
4.
Musculoskeletal Care ; 22(2): e1894, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38712487

RESUMO

BACKGROUND: Understanding the influence of contextual factors (CFs) on interventions for mechanical neck pain (MNP) is essential for evidence-based practice in physical therapy. However, the specific effects and synergies of combining different CFs remain unclear. OBJECTIVE: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care (SC) approach is an effective treatment for MNP in terms of reducing pain and improving function. METHODS: This will be an assessor-blinded, 2-group (1:1) randomised clinical trial (RCT) aiming to enrol 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of SC twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence. The primary outcomes will encompass changes in pain and disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline. RESULTS: We hypothesise that a 4-week CFs-Enriched SC approach will be superior to SC alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively. CONCLUSION: This RCT rigorously assesses the effect of purposeful manipulation of CFs during MNP treatment. By elucidating the role of these factors, our findings have the potential to significantly refine clinical practice in managing MNP, thereby enhancing patient care, and advancing the fields of physical therapy and rehabilitation.


Assuntos
Cervicalgia , Humanos , Cervicalgia/terapia , Medição da Dor , Modalidades de Fisioterapia , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Front Vet Sci ; 11: 1352314, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38645644

RESUMO

Introduction: Cannabinoids show great therapeutic potential, but their effect on anesthesia still remains unclear. Use of chronic recreational Cannabis in humans undergoing anesthetic procedures tends to require a higher dose when compared to non-users. On the other hand, studies on rodents and dogs have shown that cannabinoid agonists may potentiate certain anesthetics. This contrast of effects possibly occurs due to different time lengths of administration of different phytocannabinoids at different doses, and their distinct effects on the Endocannabinoid System, which is also affected by anesthetics such as propofol and isoflurane. Methods: Twenty-seven healthy male dogs, client-owned, ranging from 1 to 7 years, and from 5 to 35 kg were selected, mean weight 15.03±7.39 kg, with owners volunteering their animals to participate in the research performed in the Federal University of Santa Catarina (UFSC). Dogs were randomized into 3 groups. The Control Group (CON, n = 9), receiving only Extra Virgin Olive Oil, the same oil-base used in the treatment groups. Group 2 (G2, n = 9) received 2 mg/kg of total phytocannabinoids, and Group 3 (G3, n = 9) received 6 mg/kg of total phytocannabinoids. All groups received their treatments transmucosally, 75 min before their induction with propofol. Heart and respiratory rate, blood pressure, temperature and sedation were evaluated prior to, and at 30, 60, and 75 min after administration of the fsCBD-rich extract or Placebo extract. Preanesthetic medication protocol was also included across all treatment groups, 15 min before induction. Parametric data was analyzed with one-way ANOVA, followed by Student-Newman-Keuls (SNK) if significant statistical differences were found. Non-parametric data was analyzed using Friedman's test, followed by Dunn test for comparisons between all timepoints in the same group. Kruskal-Wallis followed by Dunn was utilized for between groups comparisons. Propofol dose necessary for induction was analyzed through One-way ANOVA followed by Tukey's Multiple Comparisons Test, using Instat by Graphpad, and differences were considered statistically significant when p < 0.05. Our analysis assessed if statistical significance was present between time points in the same group, and between groups in the same time points. Results: In our study, 6 mg/kg of total phytocannabinoids were able to reduce the dose of propofol necessary for induction by 23% when compared to the control group. The fsCBD-rich extract did not produce significant sedation within or between groups, although statistically significant differences in heart rate and systolic blood pressure were found. Discussion: Our findings indicate that phytocannabinoids could be an adjunct option in anesthesia, although further research is necessary to better confirm this data. Additionally, further research is needed to determine the best dosage, delivery method, time for administration, ideal molecular profile for desired effects, safety, drug-drug interactions, and transurgical effects.

6.
Clin Pract ; 14(2): 461-472, 2024 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-38525714

RESUMO

This systematic review and meta-analysis aimed to evaluate the analgesic efficacy and adverse effects of celecoxib after total knee arthroplasty. Keywords in the PubMed and Scopus databases were used to find article abstracts. Each included clinical trial was assessed using the Cochrane Collaboration risk of bias tool, and we extracted data on postoperative pain assessment using the Visual Analogue Scale (VAS) at rest, ambulation, and active range of motion, rescue analgesic intake, and adverse effects. Inverse variance tests with mean differences were used to analyze the numerical variables. The Mantel-Haenszel statistical method and the odds ratio were used to evaluate the dichotomous data. According to this qualitative assessment (n = 482), two studies presented conclusions in favor of celecoxib (n = 187), one showed similar results between celecoxib and the placebo (n = 44), and three clinical trials did not draw conclusions as to the effectiveness of celecoxib versus the placebo (n = 251). Moreover, the evaluation of the rescue analgesic intake showed that the patients receiving celecoxib had a lower intake compared to patients receiving a placebo (n = 278, I2 = 82%, p = 0.006, mean difference = -6.89, 95% IC = -11.76 to -2.02). In conclusion, the pooled analysis shows that administration of celecoxib alone results in a decrease in rescue analgesic consumption compared to a placebo after total knee surgery.

7.
Photobiomodul Photomed Laser Surg ; 42(3): 225-229, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38407832

RESUMO

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm2; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm2; irradiation time: 10 sec per point within 1 cm2 surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.


Assuntos
Síndrome da Ardência Bucal , Terapia com Luz de Baixa Intensidade , Humanos , Síndrome da Ardência Bucal/radioterapia , Terapia com Luz de Baixa Intensidade/métodos , Método Simples-Cego , Anti-Inflamatórios , Protocolos Clínicos
8.
Int J Health Sci (Qassim) ; 17(6): 39-42, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37929237

RESUMO

Objective: We tested the impact of subjects' belief in an ingested substance's ergogenic or ergolytic properties on muscular endurance performance and perceived exertion. Methods: Trained men (n = 15, age = 41 ± 4 y; body mass = 82.1 ± 15.8 kg; height = 173 ± 8 cm; experience = 7.4 ± 2.3 y) completed one set to failure at 80% repetition maximum of the bench press under three conditions. In all conditions, subjects ingested capsules of an identical, inert substance (300 mg cellulose), but, in a randomized order, subjects were told that they were either ingesting caffeine (Placebo), lactic acid (Nocebo), or cellulose (Control) and received information on the respective alleged ergogenic/ergolytic/neutral effects of each. Repetitions completed and rating of perceived exertion (RPE) were recorded. The data were analyzed among conditions using a Friedman test with post hoc analyses accomplished through Durbin-Conover tests. Spearman correlations were used to compare repetitions performed and RPE between Nocebo and Placebo conditions. Statistical significance was set at P ≤ 0.05. Results: Subjects lifted more (P < 0.001) repetitions in the Placebo condition (14.1 ± 3.0) versus Control (10.3 ± 2.9) or Nocebo (7.5 ± 2.6), while Control and Nocebo performances were similar (P = 0.192). Lower RPE was noted in Placebo versus Control (P = 0.003) and Nocebo (P < 0.001) and lower in Control versus Nocebo (P = 0.025). Subjects who performed more repetitions with Placebo tended to perform fewer repetitions under the Nocebo condition (Spearman's Rho =-0.578). Conclusion: This study believes that the ergogenic or ergolytic properties of a substance can measurably impact upper-body muscular endurance performance and RPE in trained men.

9.
Nicotine Tob Res ; 2023 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-37934573

RESUMO

INTRODUCTION: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. METHODS: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. RESULTS: Treatment arm belief was significantly associated with actual arm assignment (χ2(2)=13.0, p=0.002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, vs. "not sure" (RR=3.05 [1.41-6.60], p=0.005). Participants in the placebo arm were just as likely to believe they were taking placebo vs. "not sure" (χ2[2]=0.75, p=0.69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR=5.91 [2.06-16.92], p=0.001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline B=0.077 [0.002-0.192], p <0.05). CONCLUSIONS: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.

10.
Eur J Appl Physiol ; 2023 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-38032386

RESUMO

The study aimed to investigate the effects of sodium bicarbonate (NaHCO3) intake with divergent verbal and visual information on constant load cycling time-to-task failure, conducted within the severe intensity domain. Fifteen recreational cyclists participated in a randomized double-blind, crossover study, ingesting NaHCO3 or placebo (i.e., dextrose), but with divergent information about its likely influence (i.e., likely to induce ergogenic, inert, or harmful effects). Performance was evaluated using constant load cycling time to task failure trial at 115% of peak power output estimated during a ramp incremental exercise test. Data on blood lactate, blood acid-base balance, muscle electrical activity (EMG) through electromyography signal, and the twitch interpolation technique to assess neuromuscular indices were collected. Despite reduced peak force in the isometric maximal voluntary contraction and post-effort peripheral fatigue in all conditions (P < 0.001), neither time to task failure, EMG nor, blood acid-base balance differed between conditions (P > 0.05). Evaluation of effect sizes of all conditions suggested that informing participants that the supplement would be likely to have a positive effect (NaHCO3/Ergogenic: 0.46; 0.15-0.74; Dextrose/Ergogenic: 0.45; 0.04-0.88) resulted in improved performance compared to control. Thus, NaHCO3 ingestion consistently induced alkalosis, indicating that the physiological conditions to improve performance were present. Despite this, NaHCO3 ingestion did not influence performance or indicators of neuromuscular fatigue. In contrast, effect size estimates indicate that participants performed better when informed that they were ingesting an ergogenic supplement. These findings suggest that the apparently ergogenic effect of NaHCO3 may be due, at least in part, to a placebo effect.

11.
Nutr Health ; : 2601060231196590, 2023 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-37608532

RESUMO

Background: The pink color enhances the perceived sweetness, increasing the individuals' expectation of the presence of sugar/carbohydrate in a beverage. Hence, it is plausible to speculate that providing a pink solution during exercise could induce an ergogenic benefit through a potential placebo effect. Aim: We examined whether ingesting a pink non-caloric, artificially sweetened solution can improve endurance strength exercise performance and psychological responses. Methods: Eighteen strength-trained individuals (34 ± 7 y; 1.74 ± 0.06 m; 79.86 ± 10.91 kg) completed three experimental trials in a randomized, single-blind, crossover counterbalanced fashion. In each trial, participants performed a 5-set strength endurance test at 70% of the one-repetition maximum in the bench press exercise, interspersed by 2 min. Before each set, participants ingested either a pink (PINK) or a transparent (TRANSP) non-caloric, artificially sweetened solution. A session without ingestion (CON) was also completed. Total number of repetitions and psychological responses such as motivation, emotional arousal, affect, and ratings of perceived exertion were obtained throughout the exercise protocol. Results: Total repetitions improved in PINK (60 ± 12 reps) compared to TRANSP (p = 0.03; 56 ± 10 reps; ES = 0.22; ±3.8%) and CON (p = 0.01; 56 ± 9 reps; ES = 0.33; ±6.6%), but no difference occurred between TRANSP and CON (p = 0.84; ES = 0.12; ±2.4%). Comparable responses were observed in motivation, emotional arousal, affect, and ratings of perceived exertion in PINK, TRANSP, and CON trials (all, p > 0.05), despite the greater total physical work performed in PINK trial. Conclusion: Ingesting a pink non-caloric, artificially sweetened solution improved strength endurance performance with comparable psychological responses. These results have implications for future nutritional studies and performance assessments in real-world sports scenarios.

12.
Nutrients ; 15(16)2023 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-37630714

RESUMO

BACKGROUND: Glycemic variability in patients with type 2 diabetes mellitus (T2DM) may be associated with chronic complications of the disease. Melatonin is a hormone that plays a crucial role in biological rhythms. Previous studies have indicated that individuals with T2DM often exhibit reduced melatonin production. In this study, our objective was to investigate whether nighttime melatonin supplementation could mitigate glycemic variability in these patients. METHODS: Crossover, double-blind, placebo-controlled, randomized study. A total of 30 patients were enrolled in this study. The study included 15 participants who followed the intervention sequence of placebo (7 days)-washout (7 days)-melatonin (3 mg) (7 days), and another 15 participants who followed the sequence of melatonin (3 mg) (7 days)-washout (7 days)-placebo (7 days). During the final three days of the first and third weeks, the participants measured their pre- and postprandial capillary blood glucose levels. This study was reported according to the CONSORT 2010 statement: extension to randomized crossover trials. RESULTS: There was a significant absolute difference in the breakfast blood glucose levels (p = 0.016) on Day 7. The use of melatonin determined a greater positive variation between pre- and postprandial glycemia than the placebo. The difference in glycemic amplitude between post-dinner Day 6 and pre-breakfast Day 7 was also significantly higher in the melatonin group (p = 0.032). CONCLUSIONS: Melatonin increased glycemic variability in individuals with type 2 diabetes mellitus (T2DM). These results can be attributed to the residual daytime effects of melatonin, prospective proximal effects, and damage to the prospective distal effects of exogenous melatonin. Therefore, caution should be exercised when administering melatonin supplementation to patients with T2DM, taking into consideration factors such as dosage, duration of use and genetic considerations.


Assuntos
Diabetes Mellitus Tipo 2 , Melatonina , Humanos , Melatonina/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glicemia , Estudos Prospectivos , Método Duplo-Cego
13.
Lancet Reg Health Am ; 21: 100497, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37192953

RESUMO

Background: The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50 µg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5 mL in the deltoid region, in a three-dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of the vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Findings: Between March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group. Interpretation: The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8 °C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Funding: Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

14.
Homeopatia Méx ; (n.esp): 112-122, feb. 2023. tab
Artigo em Espanhol | LILACS, HomeoIndex - Homeopatia, MOSAICO - Saúde integrativa | ID: biblio-1416736

RESUMO

Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.


To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.


Assuntos
Humanos , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Terapêutica Homeopática , Dor Pélvica/terapia , Endometriose/complicações , Estrogênios/uso terapêutico , Placebos , Método Duplo-Cego
15.
J Biophotonics ; 16(5): e202200299, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36640122

RESUMO

This study evaluated the efficacy and safety of multiwavelength photobiomodulation (MPBM) in healing soft tissue injuries associated with tibial and/or ankle fractures. Participants were randomized into the MPBM or control group. Primary outcome was wound healing, measured by the Bates-Jensen scale. Assessments were performed daily. Twenty-seven hospitalized adults were included. MPBM showed an improvement in the daily mean Bates-Jensen scale (MPBM 32.1 vs. control 34.2; p = 0.029), daily mean pain score change (MPBM 0.5 vs. control 0.2; p = 0.04) and occurrence of infection at the site of the external fixator pins (MPBM 15.3% vs. control 57.1%; p = 0.02). MPBM group also showed faster-wound resolution (MPBM 13.1 vs. control 23.1 days). Subgroup analysis showed improvement in the MPBM group among less severe patients on the Bates-Jensen scale (MPBM 27.4 vs. control 34.7; p = 0.0081) and mean time for wound resolution (MPBM 7.0 vs. control 14.6 days; p = 0.03). MPBM appears safe and effective in reducing wound resolution time, infection in the surgical pin sites, reported pain and time before definitive surgery.


Assuntos
Fraturas Ósseas , Lesões dos Tecidos Moles , Adulto , Humanos , Resultado do Tratamento , Fraturas Ósseas/complicações , Fraturas Ósseas/terapia , Fixadores Externos , Lesões dos Tecidos Moles/radioterapia , Cicatrização
17.
Physis (Rio J.) ; 33: e33043, 2023.
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1440730

RESUMO

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.

18.
Rev. bioét. (Impr.) ; 30(4): 870-882, out.-dez. 2022. tab
Artigo em Português | LILACS | ID: biblio-1423052

RESUMO

Resumo Espiritualidade é a força que une os diferentes aspectos componentes do ser e, quando trabalhada, proporciona uma vivência harmônica e promove equilíbrio entre bem-estar físico, social e mental. Nesse sentido, objetivou-se abordar, secularmente, como a espiritualidade é vista na medicina, sua influência na saúde e a percepção de profissionais e pacientes acerca desse assunto. Para tanto, realizou-se revisão narrativa que priorizou buscas na plataforma PubMed por meio dos seguintes descritores: "medicine and spirituality and secularismo" e "placebo effect and spirituality and medicine". Em seguida foram analisadas fontes referenciadas pela leitura dos artigos primordiais. Percebeu-se que há confusão quanto ao uso do termo espiritualidade e que a capacidade e efetividade do cuidado espiritual prestado por profissionais da saúde são débeis, contrastando com inúmeros benefícios oferecidos por essa atenção, que é uma ferramenta para um trabalho mais ético e humano.


Abstract Spirituality is a uniting force between different constituents of the human being and, when exercised, provides a harmonious experience and promotes balance between physical, social, and mental well-being. As such, this narrative review proposes a secular approach to how spirituality is understood by medicine, its influence on health, and how it is perceived by professionals and patients. Bibliographic search was conducted on the PubMed database, using the following descriptors: "medicine and spirituality and secularism" and "placebo effect and spirituality and medicine." After reading the primary articles, the referenced sources were analyzed. Results show a confusion on how the term spirituality is used and a weak capacity and effectiveness with respect to the spiritual care provided by health personnel, thus ignoring the several benefits offered by such care, which is a tool for a more ethical and humane work.


Resumen La espiritualidad es la fuerza que une los diferentes componentes del ser y al estimularse proporciona una experiencia armoniosa, además de promover el equilibrio de bienestar físico, social y mental. Ante lo anterior, este texto tuvo por objetivo abordar cómo se ve secularmente la espiritualidad en la medicina, su influencia en la salud y la percepción de profesionales y pacientes sobre este tema. Para ello, se realizó una revisión narrativa en la base de datos PubMed utilizando los siguientes descriptores: "medicine and spirituality and secularismo" y "placebo effect and spirituality and medicine". Después, se analizaron las fuentes mediante la lectura de los artículos principales. Se encontró una confusión con relación al uso del término espiritualidad, y es deficiente la habilidad y eficacia del cuidado espiritual que brindan los profesionales de la salud, contrastando con los numerosos beneficios de este cuidado, una herramienta para un trabajo más ético y humanizado.


Assuntos
Sociedades , Efeito Placebo , Espiritualidade , Medicina
19.
Mol Med ; 28(1): 131, 2022 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-36348276

RESUMO

BACKGROUND: Respiratory failure in severe coronavirus disease 2019 (COVID-19) is associated with a severe inflammatory response. Acetylcholine (ACh) reduces systemic inflammation in experimental bacterial and viral infections. Pyridostigmine increases the half-life of endogenous ACh, potentially reducing systemic inflammation. We aimed to determine if pyridostigmine decreases a composite outcome of invasive mechanical ventilation (IMV) and death in adult patients with severe COVID-19. METHODS: We performed a double-blinded, placebo-controlled, phase 2/3 randomized controlled trial of oral pyridostigmine (60 mg/day) or placebo as add-on therapy in adult patients admitted due to confirmed severe COVID-19 not requiring IMV at enrollment. The primary outcome was a composite of IMV or death by day 28. Secondary outcomes included reduction of inflammatory markers and circulating cytokines, and 90-day mortality. Adverse events (AEs) related to study treatment were documented and described. RESULTS: We recruited 188 participants (94 per group); 112 (59.6%) were men; the median (IQR) age was 52 (44-64) years. The study was terminated early due to a significant reduction in the primary outcome in the treatment arm and increased difficulty with recruitment. The primary outcome occurred in 22 (23.4%) participants in the placebo group vs. 11 (11.7%) in the pyridostigmine group (hazard ratio, 0.47, 95% confidence interval 0.24-0.9; P = 0.03). This effect was driven by a reduction in mortality (19 vs. 8 deaths, respectively). CONCLUSION: Our data indicate that adding pyridostigmine to standard care reduces mortality among patients hospitalized for severe COVID-19.


Assuntos
Tratamento Farmacológico da COVID-19 , Adulto , Masculino , Humanos , Pessoa de Meia-Idade , Feminino , Brometo de Piridostigmina/uso terapêutico , SARS-CoV-2 , Respiração Artificial , Inflamação , Resultado do Tratamento
20.
Braz J Phys Ther ; 26(5): 100449, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36283240

RESUMO

BACKGROUND: Multiple sclerosis has a great disability burden. Management of the disease is complex, and patients often seek new conservative approaches. OBJECTIVE: To investigate the effect of low-frequency pulsed electromagnetic field (PEMF) therapy, compared to placebo, on the level of fatigue, walking performance, symptoms of depression, and quality of life (QOL) in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: Forty-four adults with RRMS and minimal to significant disability were randomly assigned to a 4-week protocol using a PEMF or a placebo whole-body mat. The PEMF group were initially treated with 15Hz frequency, gradually increased to 30Hz (intensity between 25-35µT). The primary outcome was fatigue, assessed with the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). Secondary measures included walking function (GAITRite system and Timed 25-Foot Walk test), the Beck Depression Inventory-II, and the Multiple Sclerosis International Quality of Life Questionnaire. Data were collected at baseline, after intervention, and at 3-months post-intervention (follow-up). RESULTS: There were no differences between groups for changes in fatigue symptoms from baseline to end of intervention (mean and 95% confidence interval FSS: -0.6, 95%CI: -1.3, 0.1; MFIS: -5.4, 95% CI: -15.1, 4.4) or at follow-up (FSS: -0.6, 95% CI: -1.4, 0.2; MFIS: -2.1, 95% CI: -10.9, 6.8). Similarly, both groups did not differ for any of the secondary outcomes at post-intervention or follow-up. CONCLUSIONS: Low-frequency PEMF therapy is no more effective than placebo to produce changes in fatigue, gait performance, severity of depression, and QOL in people with RRMS and minimal to significant disability.


Assuntos
Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Adulto , Humanos , Qualidade de Vida , Esclerose Múltipla/complicações , Campos Eletromagnéticos , Depressão/terapia , Fadiga/terapia , Caminhada , Esclerose Múltipla Recidivante-Remitente/complicações , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico
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