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1.
Säo Paulo med. j ; 140(3): 430-438, May-June 2022. tab, graf
Article in English | LILACS | ID: biblio-1377394

ABSTRACT

ABSTRACT BACKGROUND: Use of inhaled corticosteroids for managing acute asthma exacerbations has been tested since the 1990s. OBJECTIVE: To compare high doses of inhaled ciclesonide with systemic hydrocortisone for managing acute asthma exacerbations in the emergency department. DESIGN AND SETTING: Double-blind, randomized clinical trial in the public healthcare system of the city of São Paulo. METHODS: Fifty-eight patients with moderate or severe asthma with peak flow < 50% of predicted were randomized into two groups. Over the course of four hours, one group received 1440 mcg of inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo), while the other received 500 mg of intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide). The research protocol included spirometry, clinical evaluation, vital signs and electrocardiogram monitoring. Data were obtained at 30 (baseline), 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4, between and within groups. RESULTS: Overall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone for improving clinical parameters (Borg-scored dyspnea, P = 0.95; sternocleidomastoid muscle use, P = 0.55; wheezing, P = 0.55; respiratory effort, P = 0.95); and spirometric parameters (forced vital capacity, P = 0.50; forced expiratory volume in the first second, P = 0.83; peak expiratory flow, P = 0.51). CONCLUSIONS: Inhaled ciclesonide was not inferior to systemic hydrocortisone for managing acute asthma exacerbations, and it improved both clinical and spirometric parameters. TRIAL REGISTRATION: RBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/).


Subject(s)
Asthma/drug therapy , Hydrocortisone/therapeutic use , Hydrocortisone/pharmacology , Pregnenediones , Brazil , Forced Expiratory Volume , Double-Blind Method , Emergency Service, Hospital
2.
Prensa méd. argent ; 108(3): 120-125, 20220000. graf, tab
Article in Spanish | LILACS, BINACIS | ID: biblio-1373050

ABSTRACT

Introducción: El manejo inmediato del dolor postoperatorio es esencial para una comodidad y rehabilitación temprana del paciente Este estudio busca evaluar el efecto analgésico postoperatorio inmediato en cirugías de columna lumbosacra por vía posterior, como los efectos adversos con la administración de analgesia intratecal, usando Clonidina contra Morfina. Material y métodos: Es un estudio analítico de intervención, cuasi experimental, prospectivo, longitudinal, comparativo, doble ciego. Para comparar la eficacia de la analgesia intratecal post operatoria inmediata en cirugías de columna lumbosacra primarias por vía posterior y los efectos adversos. Los pacientes se distribuyeron en dos grupos previamente designados, a un grupo se le administro Clonidina 0.5 microgramos/kg/peso y a otro grupo Morfina 5 microgramos/Kg/Peso. intratecal, intraoperatorio. Resultados: Existió diferencia estadísticamente significativa con mejor manejo del dolor postoperatorio en las primeras horas y menor presencia de vómitos en el grupo de pacientes que se utilizó Clonidina intratecal. No existió diferencia estadísticamente significativa de ambas medicaciones intratecales en la valoración de otros efectos adversos. Discusión: El uso de la analgesia intratecal ha ido ganando relevancia en el tiempo y se fueron sumando estudios para ver la eficacia de diferentes medicamentos, diferentes dosis, menor presencia de efectos adversos. El estudio analiza estas variables buscando una mejor opción terapéutica. Tenemos a favor una muestra representativa a pesar de no ser aleatoria, estricto seguimiento, y análisis estadístico adecuado. Conclusión: La Clonidina intratecal es más efectiva para manejo del dolor post operatorio inmediato de cirugías de columna lumbosacra por vía posterior y con menor presencia de efectos adversos


Introduction: Immediate postoperative pain management is essential for the patient's greater comfort and early rehabilitation. Te goal of this study is to evaluate the immediate analgesic postoperative effect in posterior lumbosacral spine surgery, as well as the adverse effects of the administration of intrathecal analgesia, using Clonidine versus Morphine. Material and methods: An analytical, quasi-experimental, prospective, longitudinal, comparative, double-blinded intervention study was conducted to compare the efficacy of immediate postoperative intrathecal analgesia in primary posterior lumbosacral spine surgery, and the adverse effects. Te patients were divided into two previously designated groups. One group received Clonidine 0.5 microgramos/kg and the other group received Morphine 5 microgramos/kg. Intrathecal, intraoperative. Results: Tere was a statistically significant difference with better postoperative pain management in the first hours and less vomiting in the group of patients who received intrathecal Clonidine. Tere was no statistically significant difference between both intrathecal medications in the evaluation of other adverse effects. Discussion: Te use of intrathecal analgesia, has been on the rise over time and more studies have been conducted to see the efficacy of different drugs, different doses, with fewer adverse effects. Tis study to analyze these variables with a view to finding a better therapeutic option. Te advantage is having a representative if not random sample, strict follow-up, and appropriate statistical analysis Conclusion: Intrathecal Clonidine proved to be more effective in immediate postoperative pain management after posterior lumbosacral spine surgery and with fewer adverse effects


Subject(s)
Humans , Adult , Middle Aged , Aged , Pain, Postoperative/therapy , Pain Measurement , Analgesia, Epidural/methods , Double-Blind Method , Prospective Studies , Longitudinal Studies , Clonidine/administration & dosage , Aftercare , Non-Randomized Controlled Trials as Topic , Lumbosacral Region/surgery , Morphine/administration & dosage
3.
J. oral res. (Impresa) ; 11(1): 1-12, may. 11, 2022. ilus, tab
Article in English | LILACS | ID: biblio-1398536

ABSTRACT

Objective: This study aimed to compare the effect of ibuprofen and low intensity pulsed ultrasound (LIPUS) on the reduction of pain after the placement of initial archwire in orthodontic patients. Material and Methods: This double-blind clinical trial study was carried out on 60 female candidates for fixed orthodontic treatment referring to the Orthodontic Department of School of Dentistry in Mashhad University of Medical Sciences, Mashhad, Iran, during 2015-2016. The subjects were divided into four groups of ibuprofen, LIPUS, placebo, and mock LIPUS. A questionnaire and a rectangular and flexible cubic silicone were given to each patient to record the severity of pain based on the visual analog scale at specified time points (i.e., 2 h, 6 h, at bedtime, 2nd, 3rd, and 7th days after archwire placement) when biting the silicone block with the anterior and posterior teeth and without biting at all. Repeated measures analysis of variance was used in order to compare the pain severity at different time points. Results: The comparison of pain severity at various time points showed that the highest and lowest mean scores of pain were reported at bedtime and seven days after the intervention (p<0.001). In each of the three conditions (i.e., biting the silicone block with the anterior and posterior teeth and without biting the teeth) at six time points (i.e., 2 h, 6 h, at bedtime, 2nd, 3rd, and 7th days following archwire placement), no significant difference was observed in the severity of pain (p>0.05). Conclusion: In conclusion, LIPUS (with a frequency of 1 MHz and an intensity of 100 mW) and ibuprofen have no significant effects on reduction of the pain severity at different time points and various conditions in orthodontic patients.


Objetivo: Este estudio tuvo como objetivo comparar el efecto del ibuprofeno y el ultrasonido pulsado de baja intensidad (LIPUS) en la reducción del dolor después de la colocación del arco inicial en pacientes de ortodoncia. Material y Métodos: Este estudio de ensayo clínico doble ciego se llevó a cabo en 60 candidatas a tratamiento de ortodoncia fija referidas al Departamento de Ortodoncia de la Facultad de Odontología de la Universidad de Ciencias Médicas de Mashhad, Mashhad, Irán, durante 2015-2016. Los sujetos se dividieron en cuatro grupos: ibuprofeno, LIPUS, placebo y LIPUS simulado. Se entregó un cuestionario y un bloque de silicona cúbica rectangular y flexible a cada paciente para registrar la intensidad del dolor según la escala analógica visual en puntos de tiempo específicos (es decir, 2 h, 6 h, hora de acostarse, 2do, 3er y 7mo día después de la colocación del arco) al morder el bloque de silicona con los dientes anteriores y posteriores, y sin morder en absoluto. Se utilizó el análisis de varianza de medidas repetidas para comparar la intensidad del dolor en diferentes momentos.Resultados: La comparación de la intensidad del dolor en varios puntos de tiempo mostró que las puntuaciones medias de dolor más altas y más bajas se informaron a la hora de acostarse y siete días después de la intervención (p<0,001). En cada una de las tres condiciones (es decir, al morder el bloque de silicona con los dientes anteriores y posteriores, y sin morder) en seis momentos (2 h, 6 h, antes de acostarse 2do, 3er y 7mo día después de la colocación del arco), no se observó diferencia significativa en la severidad del dolor (p>0.05).Conclusión: En conclusión, LIPUS (con una frecuencia de 1 MHz y una intensidad de 100 mW) y el ibuprofeno no tienen efectos significativos en la reducción de la severidad del dolor en diferentes puntos de tiempo y diversas condiciones en pacientes de ortodoncia.


Subject(s)
Humans , Female , Child , Adolescent , Adult , Young Adult , Orthodontics , Ultrasonic Therapy , Facial Pain , Ibuprofen/administration & dosage , Orthodontic Wires/adverse effects , Pain Measurement , Double-Blind Method , Surveys and Questionnaires
4.
Int. j. cardiovasc. sci. (Impr.) ; 35(2): 202-213, Mar.-Apr. 2022. tab, graf
Article in English | LILACS | ID: biblio-1364977

ABSTRACT

Abstract Background Short message service (SMS) to promote healthcare improves the control of cardiovascular risk factors, but there is a lack of evidence in low and middle-income countries, particularly after acute coronary syndromes (ACS). Objective This study aims to evaluate whether the use of SMS increases risk factor control after hospital discharge for ACS. Methods IMPACS is a 2-arm randomized trial with 180 patients hospitalized due to ACS at a tertiary hospital in Brazil. Eligible patients were randomized (1:1) to an SMS intervention (G1) or standard care (G2) upon hospital discharge. The primary endpoint was set to achieve 4 or 5 points in a risk factor control score, consisting of a cluster of 5 modifiable risk factors: LDL-C <70mg/dL, blood pressure (BP) <140/90mmHg, regular exercise (≥5 days/week, 30 minutes/session), nonsmoker status, and body mass index (BMI) <25 kg/m2] at 6 months. Secondary outcomes were components of the primary outcome plus rehospitalization, cardiovascular death, and death from any cause. Results are designated as significant if p<0.05. Results From randomized patients, 147 were included in the final analysis. Mean age was 58 (51-64) years, 74% males. The primary outcome was achieved by 12 (16.2%) patients in G1 and 15 (20.8%) in G2 (OR=0.73, 95%CI 0.32-1.70, p=0.47). Secondary outcomes were also similar: LDL-C<70 mg/dl (p=0.33), BP<140/90 mmHg (p=0.32), non-smoker (p=0.74), regular exercise (p=0.97), BMI (p=0.71), and rehospitalization (p=0.06). Death from any cause occurred in three participants (2%), including one cardiovascular death in each group. Conclusion SMS intervention did not significantly improve cardiovascular risk factor control when compared to standard care in patients discharged after ACS in Brazil.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Young Adult , Acute Coronary Syndrome/prevention & control , Secondary Prevention/methods , Text Messaging , Patient Discharge , Double-Blind Method , Follow-Up Studies , Longitudinal Studies , Telemedicine/methods , Heart Disease Risk Factors , Health Promotion/methods
5.
Psico USF ; 27(1): 157-167, jan.-mar. 2022. tab, graf
Article in Portuguese | LILACS, INDEXPSI | ID: biblio-1376039

ABSTRACT

Estudos mostram que o tabagismo é responsável por afetar algumas funções cognitivas. No entanto, a nicotina é apenas um dos componentes existentes no cigarro e existem evidências de que pode servir como agente neuroprotetivo e causar melhoras em algumas funções cognitivas. O objetivo desta pesquisa foi investigar como a nicotina interage com algumas funções cognitivas. Um ensaio clínico piloto com administração de gomas de nicotina contendo 2-mg ou 4-mg, ou gomas placebo contendo a mesma textura, sabor e aparência, foi realizado. Quarenta e dois participantes participaram da pesquisa e os resultados indicaram que a relação entre nicotina e o desempenho na tarefa Go/No-Go podem ser bidirecionais. Os resultados indicaram que participantes do grupo que utilizaram 4-mg de nicotina apresentaram menor desempenho, enquanto os participantes que fizeram uso de 2-mg de nicotina tiveram melhor desempenho do que os demais. Esta pesquisa tem aplicações biopsicossociais e podem ajudar na compreensão da relação entre tabagismo e nicotina, além de contribuir para estratégias que possam ajudar no abandono do cigarro ou na melhora de condições que afetem a cognição (AU).


Past findings in the literature indicated that smoking could affect given cognitive functions. However, nicotine is only one of the components in cigarettes and there is evidence that it may act as a neuroprotective agent and improve some cognitive functions. The purpose of this research was to investigate how nicotine interacts with certain cognitive functions. We conducted a pilot clinical trial using nicotine gum containing 2-mg or 4-mg, or placebo gum with the same texture, flavor, and appearance. Forty-two healthy nonsmokers were enrolled in this research. Our findings indicated that the relationship between nicotine and performance on the Go/No-Go task might be opposite. The results showed that participants in the 4-mg group performed worse, while participants who used 2-mg of nicotine performed better than the others. This research supports biopsychosocial applications and can help interpret the relationship between smoking and nicotine, and contribute to strategies that may support smoking cessation, or improve conditions that affect cognition (AU).


Estudios demuestran que el tabaquismo es responsable de afectar a algunas funciones cognitivas. Sin embargo, la nicotina es solo uno de los componentes de los cigarrillos, y existen evidencias de que la nicotina puede actuar como un agente neuroprotector y mejorar algunas funciones cognitivas. El objetivo de este estudio fue investigar cómo la nicotina interactúa con algunas funciones cognitivas. Se realizó un ensayo clínico piloto con la administración de chicles de nicotina de 2 mg o 4 mg, o chicles de placebo con la misma textura, sabor y apariencia. Cuarenta y dos participantes participaron en la investigación y los resultados indicaron que la relación entre la nicotina y el rendimiento en la tarea Go/No-go puede ser bidireccional. Los resultados indicaron que los participantes del grupo de 4 mg obtuvieron un menor rendimiento en las variables del Go/No-Go, mientras que los participantes que utilizaron 2 mg de nicotina obtuvieron un mejor rendimiento que los demás. Esta investigación respalda las aplicaciones biopsicosociales y puede ayudar a interpretar la relación entre el tabaquismo y la nicotina, además de contribuir a las estrategias que pueden ayudar a dejar de fumar o mejorar las condiciones que afectan la cognición (AU).


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Executive Function , Nicotine Chewing Gum , Nicotine/administration & dosage , Placebos/administration & dosage , Tobacco Use Disorder/psychology , Chi-Square Distribution , Pilot Projects , Double-Blind Method , Analysis of Variance
6.
Article in English | WPRIM | ID: wpr-928957

ABSTRACT

OBJECTIVE@#To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.@*METHODS@#A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.@*RESULTS@#Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000).@*CONCLUSION@#SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).


Subject(s)
Alkaloids , Blood Glucose , Diabetes Mellitus, Type 2/drug therapy , Double-Blind Method , Glycated Hemoglobin A , Humans , Hypoglycemic Agents/therapeutic use , Morus , Tablets/therapeutic use , Treatment Outcome
7.
Article in English | WPRIM | ID: wpr-928937

ABSTRACT

OBJECTIVE@#To confirm the improvement of cardiac function and quality of life (QOL) in patients with chronic heart failure (CHF) via Chinese medicine (CM) Qishen Taohong Granule (, QTG).@*METHODS@#This study was a single-center, prospective, randomized, controlled clinical trial. Seventy-six patients from 27 to 84 years old diagnosed with CHF New York Heart Association (NYHA) class II or III in stage C were enrolled and randomly assigned at a 1:1 ratio to receive QTG or trimetazidine (TMZ), in addition to their standard medications for the treatment of CHF. The study period was 4 weeks. The primary outcomes included cardiac function evaluated by NYHA classification and left ventricular ejection fraction (LVEF), as well as QOL evaluated by CHF Integrated Chinese and Western Medicine Survival Scale (CHFQLS). The secondary outcomes included 6-min walking test (6MWT), CM syndrome score, symptom and sign scores and N-terminal pro-B-type natriuretic peptide (NT-proBNP). All indices were measured at baseline and the end of the trial.@*RESULTS@#At the 4-week follow-up period, the effective rate according to NYHA classification in the QTG group was better than that in the TMZ group (74.29% vs. 54.29%, P<0.05). But there was no significant difference in post-treatment level of LVEF between the two groups (P>0.05). The CHFQLS scores improved by 13.82±6.04 vs. 7.49±2.28 in the QTG and TMZ groups, respectively (P<0.05). Subgroup analysis of the CHFQLS results showed that physiological function, role limitation and vitality were significantly higher in the QTG group than in the TMZ group (15.76±7.85 vs. 7.40±3.36, P<0.05; 16.00±8.35 vs. 10.53±4.64, P<0.05; 15.31±8.09 vs. 7.89±4.60, P<0.05). Compared with TMZ group, treatment with QTG also demonstrated superior performance with respect to 6MWT, CM syndrome, shortness of breath, fatigue, gasping, general edema and NT-proBNP level. No significant adverse reactions or adverse cardiac events occurred during treatment in either group.@*CONCLUSION@#In addition to conventional treatments, the use of QTG as an adjuvant therapy significantly improved cardiac function and QOL in patients with CHF class II or III in stage C. [Registration No. ChiCTR1900022036 (retrospectively registered)].


Subject(s)
Adult , Aged , Aged, 80 and over , Chronic Disease , Double-Blind Method , Heart Failure/drug therapy , Humans , Middle Aged , Natriuretic Peptide, Brain , Peptide Fragments , Prospective Studies , Quality of Life , Stroke Volume , Ventricular Function, Left
8.
Article in English | WPRIM | ID: wpr-928931

ABSTRACT

OBJECTIVE@#To test the hypothesis that β -glucan enhances protective qi (PQi), an important Chinese medicine (CM) concept which stipulates that a protective force circulates throughout the body surface and works as the first line of defense against "external pernicious influences".@*METHODS@#A total of 138 participants with PQi deficiency (PQD) were randomized to receive β -glucan (200 mg daily) or placebo for 12 weeks. Participants' PQi status was assessed every 2 weeks via conventional diagnosis and a standardized protocol from which a PQD severity and risk score was derived. Indices of participants' immune and general health status were also monitored, including upper respiratory tract infection (URTI), saliva secretory IgA (sIgA), and self-reported measures of physical and mental health (PROMIS).@*RESULTS@#PQi status was not significantly different between the β -glucan and placebo treatment groups at baseline but improved significantly in the β -glucan (vs. placebo) group in a time-dependent manner. The intergroup differences [95% confidence interval (CI)] in severity score (scale: 1-5), risk score (scale: 0-1), and proportion of PQD participants (%) at finish line was 0.49 (0.35-0.62), 0.48 (0.35-0.61), and 0.36 (0.25-0.47), respectively. Additionally, β -glucan improved URTI symptom (scale: 1-9) and PROMIS physical (scale: 16.2-67.7) and mental (scale: 21.2-67.6) scores by a magnitude (95% CI) of 1.0 (0.21-1.86), 5.7 (2.33-9.07), and 3.0 (20.37-6.37), respectively, over placebo.@*CONCLUSIONS@#β -glucan ameliorates PQi in PQD individuals. By using stringent evidence-based methodologies, our study demonstrated that Western medicine-derived remedies, such as β -glucan, can be employed to advance CM therapeutics. (ClinicalTrial.Gov registry: NCT03782974).


Subject(s)
Adult , Double-Blind Method , Humans , Qi , Risk Factors , Self Report , beta-Glucans/therapeutic use
9.
Journal of Integrative Medicine ; (12): 321-328, 2022.
Article in English | WPRIM | ID: wpr-939890

ABSTRACT

BACKGROUND@#Patients commonly develop postoperative pain after total knee arthroplasty (TKA). Acupuncture-related techniques and low-level laser therapy could be beneficial for pain management for older individuals.@*OBJECTIVE@#To examine the effect of low-level laser acupuncture (LA) in reducing postoperative pain, pain-related interference in daily life, morphine consumption, and morphine-related side effects in older patients with knee osteoarthritis who underwent TKA.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#A single-blind randomized placebo-controlled trial was conducted. Patients (N = 82) were recruited and randomly assigned via a computer-generated list to the LA group or a placebo group. The LA group received low-level laser therapy at Sanyinjiao (SP6), Taixi (KI3), Kunlun (BL60), Fengshi (GB31), Futu (ST32) and Neiguan (PC6) after TKA, while the placebo acupuncture group received the same treatment procedure without laser energy output.@*MAIN OUTCOME MEASURES@#The primary outcome was postoperative pain intensity, and it was measured at baseline and hours 2, 6, 10, 24, 48 and 72 after TKA. The secondary outcomes, including relative pain, postoperative pain-related interference in daily life and morphine consumption, were measured at hours 24, 48 and 72 after TKA.@*RESULTS@#Generalized estimating equations revealed significant between-group differences in pain intensity (P = 0.01), and trend differences in pain intensity for the LA group starting at hours 10 to 72 (P < 0.05) and morphine consumption at hours 48 and 72 (P < 0.05). The changes in pain-related interference in daily life were significant (P < 0.05) at 72 h, with the exception of the parameters for worst pain, mood, and sleep. Nausea and vomiting side effects from morphine had significant between-group differences at hours 10 and 24 (P < 0.05).@*CONCLUSION@#Low-level LA gradually reduced older patients' postoperative pain intensity and morphine consumption within the first 72 h after their TKA for osteoarthritis. Low-level LA may have benefits as an adjuvant pain management technique for clinical care.@*TRIAL REGISTRATION@#ClinicalTrials.gov registration number NCT03995446.


Subject(s)
Acupuncture Therapy , Aged , Analgesics, Opioid/therapeutic use , Arthroplasty, Replacement, Knee/adverse effects , Double-Blind Method , Humans , Morphine/therapeutic use , Pain, Postoperative/drug therapy , Single-Blind Method
10.
Journal of Integrative Medicine ; (12): 221-229, 2022.
Article in English | WPRIM | ID: wpr-929231

ABSTRACT

BACKGROUND@#Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial.@*OBJECTIVES@#To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.@*DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS@#A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.@*OUTCOME MEASURES@#The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.@*RESULTS@#Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.@*CONCLUSION@#Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.@*TRIAL REGISTRATION@#UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.


Subject(s)
COVID-19/therapy , Double-Blind Method , Homeopathy , Humans , Influenza, Human/drug therapy , Materia Medica/therapeutic use , Primary Health Care , Treatment Outcome
11.
Journal of Integrative Medicine ; (12): 230-236, 2022.
Article in English | WPRIM | ID: wpr-929230

ABSTRACT

BACKGROUND@#Constipation is a common chronic bowel disorder with an incidence of more than 50% in the elderly population. Complementary and alternative medicine is a cost-effective and satisfactory treatment for constipation used widely by the elderly.@*OBJECTIVE@#This study evaluates the efficacy of an herbal formula made from Foeniculum vulgare Mill. and Rosa damascena for the treatment of constipation in an elderly population and consequent changes to their quality of life.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#This double-blind randomized active controlled clinical trial, with parallel group allocation ratio of 1:1, was conducted in a referral clinic in Afzalipour Hospital, affiliated to Kerman University of Medical Sciences in Kerman, Southeastern Iran. Individuals over 60 years of age, diagnosed with functional constipation (based on the Rome IV criteria), were included in this study. Participants received a sachet of 10 g F. vulgare and R. damascena (herbal formula group) or polyethylene glycol 4000 (PEG 4000 group) with a glass of warm water two times a day for 4 weeks and were followed up for 4 additional weeks.@*MAIN OUTCOME MEASURES@#Constipation severity, stool consistency, and the quality of life were used as the primary outcomes. Drug side effects were used as a secondary outcome. The outcomes were assessed using the Constipation Assessment Scale, the Bristol Stool Form Scale, and the Patient Assessment of Constipation Quality of Life questionnaire.@*RESULTS@#A total of 25 participants in each group completed the four-week treatment cycle and the eight-week follow-up. At the end of the four-week treatment cycle, all clinical outcomes had significant improvements in both groups (P < 0.05). The analysis of constipation severity (P < 0.001), stool consistency (P < 0.001), and the quality of life (P < 0.001) showed significant improvements with fewer side effects (mild diarrhea) and a longer duration of symptom relief in the herbal formula group compared to the PEG 4000 group.@*CONCLUSION@#Although both interventions significantly improved the treatment outcomes, constipation severity, stool consistency and the quality of life were improved more effectively by the herbal formula than by PEG 4000; however, the mechanism of action is not yet understood.@*TRIAL REGISTRATION@#This trial was registered in the Iranian Registry of Clinical Trials (IRCTID: IRCT20200108046056N1).


Subject(s)
Aged , Constipation/drug therapy , Double-Blind Method , Foeniculum , Humans , Iran , Middle Aged , Quality of Life , Rosa , Treatment Outcome
12.
Journal of Integrative Medicine ; (12): 135-144, 2022.
Article in English | WPRIM | ID: wpr-929211

ABSTRACT

BACKGROUND@#Beginning with the concepts of stress developed by Selye, an approach to stress and pain management, known as neuro-emotional technique (NET), has been developed. It is a treatment approach based on the principle that the stressor effects of dormant and/or current unresolved issues or trauma are what determine one's bodily responses. These responses are relatively personalized to the conditioned, experiential and emotional reality of the individual.@*OBJECTIVE@#To determine the effect of NET on patients with chronic low back pain (CLBP) over time.@*DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS@#In a randomized, double-blinded, placebo-controlled study conducted in a single clinic, NET or control treatments were given twice weekly for 4 weeks in a population of 112 patients.@*MAIN OUTCOME MEASURES@#Outcome measures, including Oswestry Disability Index, Quadruple Visual Analogue Scale, the psychoneuroimmunology markers of blood serum levels of C-reactive protein, tumour necrosis factor-α, interleukin-1 (IL-1), IL-6, and IL-10, and 10 dimensions of the Short Form Health Survey scale, were assessed at baseline and at 1, 3 and 6 months following the intervention period.@*RESULTS@#Compared to placebo, NET produced clinical and statistical significance (P < 0.001) via declines of virtually all physiological, pain and disability markers, accompanied by gains in quality-of-life indicators at 0 (baseline), 1, 3 and 6 months. Reductions of the percentages of patients whose 5 biomarkers lay outside the normative range were achieved at 1, 3 and 6 months by NET but not control interventions.@*CONCLUSION@#A randomized, controlled trial of CLBP patients indicated that 8 NET interventions, compared to placebo, produced clinically and statistically significant reductions in pain, disability and inflammatory biomarkers, and improvements in quality-of-life measures.@*TRIAL REGISTRATION@#The trial was registered with the Australian and New Zealand Clinical Trials Registry (No. ACTRN12608000002381).


Subject(s)
Australia , Chronic Pain/therapy , Double-Blind Method , Humans , Low Back Pain/therapy , Pain Measurement , Treatment Outcome
13.
Article in English | WPRIM | ID: wpr-928244

ABSTRACT

Background Ultrasound-guided continuous thoracic paravertebral block can provide pain-relieving and opioid-sparing effects in patients receiving open hepatectomy. We hypothesize that these effects may improve the quality of recovery (QoR) after open hepatectomy. Methods Seventy-six patients undergoing open hepatectomy were randomized to receive a continuous thoracic paravertebral block with ropivacaine (CTPVB group) or normal saline (control group). All patients received patient-controlled intravenous analgesia with morphine postoperatively for 48 hours. The primary outcome was the global Chinese 15-item Quality of Recovery score on postoperative day 7, which was statistically analyzed using Student's t-test. Results Thirty-six patients in the CTPVB group and 37 in the control group completed the study. Compared to the control group, the CTPVB group had significantly increased global Chinese 15-item Quality of Recovery scores (133.14 ± 12.97 vs. 122.62 ± 14.89, P = 0.002) on postoperative day 7. Postoperative pain scores and cumulative morphine consumption were significantly lower for up to 8 and 48 hours (P < 0.05; P = 0.002), respectively, in the CTPVB group. Conclusion Perioperative CTPVB markably promotes patient's QoR after open hepatectomy with a profound analgesic effect in the early postoperative period.


Subject(s)
Anesthetics, Local/therapeutic use , Double-Blind Method , Hepatectomy/adverse effects , Humans , Morphine/therapeutic use , Pain Measurement , Pain, Postoperative/etiology , Ultrasonography, Interventional
14.
Article in Chinese | WPRIM | ID: wpr-927387

ABSTRACT

This device is an auxiliary device with reasonable design for placebo acupuncture research, so as to make double-blind placebo acupuncture control possible. This new auxiliary acupuncture device includes an acupuncture device and a placebo acupuncture device with exactly the same appearance. Both of them are composed of a hemispherical base and a telescopic tube. Through the rotation of the telescopic tube in the notch of the base, the insertion angle of needles can be adjusted from 15 degrees to 165 degrees. The operation of twisting and lifting and inserting can be carried out through the horizontal rotation and vertical sliding of the telescopic tube. A silicone needle pad is arranged in the base, which can simulate the blocking feeling of skin and muscle during needle insertion. The bottom of the base is attached with hydrogel, which has good fixity. The auxiliary device is applicable to multiple parts of the human body and can effectively reduce the risk of unblinding.


Subject(s)
Acupuncture Therapy/instrumentation , Biomedical Research/methods , Double-Blind Method , Humans , Needles , Skin
15.
Rev. bras. oftalmol ; 81: e0035, 2022. tab
Article in English | LILACS | ID: biblio-1376791

ABSTRACT

ABSTRACT Objective: To evaluate the efficacy of mitomycin C in anatomical and functional success after modified transcanalicular diode laser dacryocystorhinostomy. Methods: A prospective, double-blinded, randomized placebo-controlled study compared the effect of topical mitomycin C on modified transcanalicular diode laser dacryocystorhinostomy. Group 1 had modified transcanalicular diode laser dacryocystorhinostomy with topical saline, while Group 2 had modified transcanalicular diode laser dacryocystorhinostomy with topical mitomycin C. Success was defined as anatomical patency and relief of symptoms at the end of 6 months. Results: Six months after surgery, Group 1 (30 patients) showed anatomical and functional success rates of 86.7% and 83.3%, respectively. Group 2 (32 patients) showed anatomical and functional success rates of 87.5% and 84.3%, respectively. There was no statistically significant difference between the groups 1 and 2 (p = 1.000). Conclusion: The use of mitomycin C did not improve the anatomical and functional success rates of modified transcanalicular diode laser dacryocystorhinostomy compared to placebo.


RESUMO Objetivo: Avaliar a eficácia da mitomicina C no sucesso anatômico e funcional após dacriocistorrinostomia transcanalicular com laser de diodo. Métodos: Estudo prospectivo, duplo-cego, randomizado e controlado por placebo. Comparou o efeito da mitomicina C tópica na dacriocistorrinostomia transcanalicular com laser de diodo. No Grupo 1, foi utilizada apenas solução salina tópica, enquanto no Grupo 2 foi utilizada mitomicina C tópica. O sucesso foi definido como permeabilidade da via lacrimal e alívio dos sintomas ao final de 6 meses. Resultados: Seis meses após a cirurgia, o Grupo 1 (30 pacientes) apresentou taxas de sucesso anatômico e funcional de 86,7% e 83,3%, respectivamente. O Grupo 2 (32 pacientes) apresentou taxas de sucesso anatômico e funcional de 87,5% e 84,3%, respectivamente. Não houve diferença estatística significante entre os Grupos 1 e 2 (p=1,000). Conclusão: O uso de mitomicina C não melhora as taxas de sucesso anatômico e funcional do dacriocistorrinostomia transcanalicular com laser de diodo em comparação ao placebo.


Subject(s)
Humans , Male , Female , Middle Aged , Dacryocystorhinostomy/methods , Mitomycin/administration & dosage , Mitomycin/therapeutic use , Mitomycin/pharmacology , Lasers, Semiconductor/therapeutic use , Nasolacrimal Duct/drug effects , Placebos , Random Allocation , Double-Blind Method , Prospective Studies , Follow-Up Studies , Treatment Outcome , Chemotherapy, Adjuvant , Dacryocystitis/surgery , Laser Therapy/methods , Lacrimal Duct Obstruction/therapy , Nasolacrimal Duct/surgery
16.
Rev. Bras. Cancerol. (Online) ; 68(2)Abr.-Jun. 2022.
Article in Portuguese | LILACS | ID: biblio-1371205

ABSTRACT

Introdução: A radiodermatite é caracterizada por lesões cutâneas decorrentes da exposição à radiação ionizante, acometendo entre 80%- 90% dos pacientes submetidos à radioterapia na região da cabeça e pescoço. Objetivo: Avaliar a efetividade do uso do creme de camomila em relação ao creme de calêndula na prevenção da radiodermatite aguda em participantes submetidos à radioterapia para câncer de cabeça e pescoço. Método: Ensaio clínico randomizado, duplo-cego, prospectivo, com análise quantitativa. Foram avaliados 23 participantes, aleatoriamente designados para o grupo que fez uso do creme de camomila (n=12) ou para o grupo do creme de calêndula (n=11). A pele no campo de irradiação foi avaliada na primeira sessão de radioterapia, a cada cinco sessões, e após 30 dias do término do tratamento, de acordo com os critérios da Radiation Therapy Oncology Group (RTOG). Resultados: Os participantes apresentaram radiodermatite em todas as avaliações, do grau 1 ao 3, exceto na primeira avaliação. O nível médio mais elevado foi observado, em ambos os grupos, na sexta avaliação (2,10±0,73 no grupo do creme de camomila e 2,37±0,51 no de calêndula). No grupo camomila, o maior grau de radiodermatite foi o 3, na quinta e sexta avaliações; enquanto, no calêndula, o grau 3 foi observado pela primeira vez na sexta avaliação, permanecendo até a oitava. Não houve diferença estatisticamente significativa nos grupos avaliados. Conclusão: Houve equivalência na efetividade do uso do creme de camomila em relação ao creme calêndula na prevenção de radiodermatites agudas em pacientes com câncer de cabeça e pescoço em radioterapia


Introduction: Radiodermatitis is characterized by skin lesions resulting from exposure to ionizing radiation, affecting between 80-90% of patients undergoing radiotherapy in the head and neck region. Objective: To evaluate the effectiveness of using chamomile cream compared with calendula cream in preventing acute radiodermatitis in participants undergoing radiotherapy for head and neck cancer. Method: Randomized, double-blind, prospective clinical trial with quantitative analysis. 23 participants randomly assigned to the group that used chamomile cream (n=12) or to the calendula cream group (n=11) were evaluated. The skin in the irradiation field was evaluated in the first radiotherapy session, every five sessions and after 30 days after the end of the treatment, according to the criteria of the Radiation Therapy Oncology Group (RTOG). Results: Participants had radiodermatitis in all the assessments, from grades 1 to 3, except in the first assessment. The highest mean level was observed in both groups in the sixth assessment (2.10±0.73 in the chamomile and 2.37±0.51 in the calendula group, respectively). In the chamomile group, the highest degree of radiodermatitis was 3, in the fifth and sixth evaluations, while in the calendula, grade 3 was observed for the first time in the sixth evaluation, remaining until the eighth. There was no statistically significant difference in the groups evaluated. Conclusion: There was equivalence in the effectiveness of the use of chamomile cream compared with calendula cream in the prevention of acute radiodermatitis in patients with head and neck cancer undergoing radiotherapy


Introducción: La radiodermatitis se caracteriza por lesiones cutáneas derivadas de la exposición a radiaciones ionizantes, que afectan entre el 80 y el 90% de los pacientes sometidos a radioterapia en la región de cabeza y cuello. Objetivo: Evaluar la efectividad del uso de la crema de manzanilla en relación con la crema de caléndula para prevenir la radiodermatitis aguda en participantes sometidos a radioterapia para el cáncer de cabeza y cuello. Método: Ensayo clínico prospectivo, aleatorizado, doble ciego con análisis cuantitativo. Se evaluaron 23 participantes, asignados aleatoriamente al grupo que usó la crema de manzanilla (n=12) o al grupo crema de caléndula (n=11). La piel en el campo de irradiación se evaluó en la primera sesión de radioterapia, cada cinco sesiones y a los 30 días de finalizado el tratamiento, según los criterios del Grupo de Oncología Radioterápica (RTOG). Resultados: Los participantes presentaron radiodermatitis en todas las evaluaciones, desde el 1º al 3º grado, excepto en la primera evaluación. El nivel medio más alto se observó, en ambos grupos, en la sexta evaluación (2,10±0,73 en el grupo manzanilla y 2,37±0,51 en el de caléndula). En el grupo manzanilla, el mayor grado de radiodermatitis fue 3, en la quinta y sexta evaluaciones, mientras que en la caléndula se observó por primera vez grado 3 en la sexta evaluación, permaneciendo hasta la octava. No hubo diferencia estadísticamente significativa en los grupos evaluados. Conclusión: Hubo equivalencia en la efectividad del uso de crema de manzanilla en relación con la crema de caléndula en la prevención de la radiodermatitis aguda en pacientes con cáncer de cabeza y cuello sometidos a radioterapia


Subject(s)
Humans , Male , Female , Radiodermatitis/prevention & control , Calendula/drug effects , Chamomile/drug effects , Head and Neck Neoplasms/radiotherapy , Double-Blind Method
17.
Motriz (Online) ; 28: e1022008921, 2022. tab, graf
Article in English | LILACS | ID: biblio-1351125

ABSTRACT

Abstract Aim: To contrast the acute effects of whole-body electromyostimulation (WB-EMS) with sham associated with dynamic exercises on cardiovascular, ventilatory, metabolic, and autonomic responses in men with obesity and controls. Methods: A randomized cross-over and double-blind trial with nine eutrophic (23.6 years; 23 ± 1.4 kg/m2) and ten men with obesity (26 ± 4 years; 38 ± 7 kg/m2), who were randomized to receive WB-EMS-Sham or Sham-WB-EMS with 30 min of rest between protocols. WB-EMS protocol (Miha Bodytec®) was applied at the motor level, frequency = 85 Hz, pulse duration = 350 μs, cycle on = 6′; cycle off = 4′. Sham group performed the same exercises with the electric current turned off. Throughout both protocols, subjects executed two dynamic exercises of 5 minutes each (step-up and step down associated with shoulder flexion, and lunge exercise associated with elbow flexion) in the same order. R-R intervals and breath-by-breath respiratory gases analysis were collected during the protocols. Heart rate variability (HRV) indexes were obtained using linear and nonlinear analysis. The level of statistical significance was set at p < 0.05. Results: Regarding both exercises, participants with obesity presented reduced oxygen uptake, higher ventilation, respiratory rate, blood pressure, and Borg scores (p < 0.05) when contrasted with controls, as expected. However, no significant differences were found for HRV indexes between groups (p > 0.05). In addition, WB-EMS did not increase oxygen uptake or altered autonomic modulation when contrasted with sham in both groups (p < 0.05). Conclusion: Obesity has a negative impact on symptoms and functional capacity. However, WB-EMS did not acutely enhance oxygen uptake or HRV during exercise in a population with obesity.


Subject(s)
Humans , Adult , Oxygen Consumption , Exercise , Functional Residual Capacity , Transcutaneous Electric Nerve Stimulation/methods , Heart Rate , Obesity/physiopathology , Double-Blind Method , Cross-Over Studies
19.
Braz. J. Psychiatry (São Paulo, 1999, Impr.) ; 43(5): 467-476, Sept.-Oct. 2021. tab, graf
Article in English | LILACS | ID: biblio-1345480

ABSTRACT

Objective: To assess the efficacy of cannabidiol (CBD) in the management of crack-cocaine craving and the treatment of frequent withdrawal symptoms. Methods: Thirty-one men with a diagnosis of crack-cocaine dependence were enrolled in a randomized, double-blind, placebo-controlled trial. We applied neuropsychological tests and assessed craving intensity, anxiety and depression symptoms, and substance use patterns at baseline and at the end of the trial. The participants were treated with CBD 300 mg/day or placebo for 10 days. During this period, we used a technique to induce craving and assessed the intensity of symptoms before and after the induction procedure. Results: Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups. Craving induction was successful in both groups, with no significant differences between them. Indicators of anxiety, depression, and sleep alterations before and after treatment also did not differ across groups. Conclusion: Under the conditions of this trial, CBD was unable to interfere with symptoms of crack-cocaine withdrawal. Further studies with larger outpatient samples involving different doses and treatment periods would be desirable and timely to elucidate the potential of CBD to induce reductions in crack-cocaine self-administration.


Subject(s)
Humans , Male , Cannabidiol , Crack Cocaine , Cocaine-Related Disorders/drug therapy , Double-Blind Method , Craving
20.
Braz. J. Psychiatry (São Paulo, 1999, Impr.) ; 43(5): 484-493, Sept.-Oct. 2021. tab, graf
Article in English | LILACS | ID: biblio-1345467

ABSTRACT

Objective: Major depressive disorder (MDD) is related to glutamatergic dysfunction. Antagonists of glutamatergic N-methyl-D-aspartate receptor (NMDAR), such as ketamine, have antidepressant properties. Nitrous oxide (N2O) is also a NMDAR antagonist. Thus, this study aimed to evaluate the effects of augmenting antidepressant treatment with N2O. Methods: This double blind, placebo-controlled randomized parallel pilot trial was conducted from June 2016 to June 2018 at the Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo. Twenty-three subjects with MDD (aged 18 to 65, on antidepressants, with a score > 17 on the 17-item-Hamilton Depression Rating Scale [HAM-D17]) received 50% N2O (n=12; 37.17±13.59 years) or placebo (100% oxygen) (n=11; 37.18±12.77 years) for 60 minutes twice a week for 4 weeks. The primary outcome was changes in HAM-D17 from baseline to week 4. Results: Depressive symptoms improved significantly in the N2O group (N2O: from 22.58±3.83 to 5.92±4.08; placebo: from 22.44±3.54 to 12.89±5.39, p < 0.005). A total of 91.7% and 75% of the N2O group subjects achieved response (≥ 50% reduction in HAM-D17 score) and remission (HAM-D17 < 7), respectively. The predominant adverse effects of N2O treatment were nausea, vomiting, and headache. Conclusion: N2O treatment led to a statistically significant reduction in HAM-D17 scores compared to placebo. Clinical trial registration: Brazilian Register of Clinical Trials, RBR-5rz5ch


Subject(s)
Depressive Disorder, Major/drug therapy , Brazil , Pilot Projects , Double-Blind Method , Treatment Outcome , Antidepressive Agents/therapeutic use , Nitrous Oxide/therapeutic use
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