A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial

Background: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.Methods/design: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.Discussion: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials registration number: ClinicalTrials.gov: NCT00971165. © 2011 Fuchs et al; licensee BioMed Central Ltd.

Erythromycin versus neomycin in the treatment of hepatic encephalopathy in cirrhosis: A randomized double-blind study

Background: Hepatic encephalopathy (HE) is a severe complication in patients with hepatic cirrhosis, which causes numerous hospital admissions and deaths. Antibiotics are the best options in HE treatment, but head-to-head comparisons between these drugs are scarce. Erythromycin combines the antimicrobial effect and prokinetic properties in the same drug, but it has never been used in HE treatment. Our aim was to evaluate the efficacy of erythromycin as an HE treatment.Methods: We achieved a randomized controlled trial of adult patients with HE and hepatic cirrhosis admitted in our hospital. After randomization, the subjects received either erythromycin 250 mg or neomycin 1 g orally QID until hospital discharge or prescription of another antibiotic. All subjects were blindly evaluated every day towards quantifying clinical, neuropsychometric, hepatic and renal exams. Statistical analysis was employed to compare the groups and correlate the variables with hospitalization duration.Results: 30 patients were evaluated (15 treated with each drug). At hospital admission, the groups were homogeneous, but the erythromycin group subjects achieved a shorter hospitalization stay (p = 0.032) and a more expressive reduction in alanine aminotranspherase levels (p = 0.026). Hospitalization duration was positively correlated with C reactive protein levels measured previous to (p = 0.015) and after treatment (p = 0.01).Conclusions: In the sample evaluated erythromycin was associated with significant reductions in hospital stay and in alanine aminotranspherase values. Hospitalization time was positive correlated with C reactive protein levels measured before and after the treatments. © 2013 Romeiro et al.; licensee BioMed Central Ltd.

Effects of soy isoflavones on mammographic density and breast parenchyma in postmenopausal women: A randomized, double-blind, placebo-controlled clinical trial

OBJECTIVE: This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women. METHODS: In this randomized, double-blind, placebo-controlled study, 80 women (aged ≥45 y and with amenorrhea >12 mo) with vasomotor symptoms were randomized to receive either 250 mg of standardized soy extract corresponding to isoflavone 100 mg/day (n = 40) or placebo (n = 40) for 10 months. Breasts were evaluated through mammographic density and breast parenchyma using ultrasound (US) at baseline and 10-month follow-up. Independent t test, analysis of variance, Mann-Whitney U test, and χ2 trend test were used in statistical analysis. RESULTS: Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group, with mean (SD) age of 55.1 (6.0) and 56.2 (7.7) years, mean (SD) menopause duration of 6.6 (4.8) and 7.1 (4.2) years, and mean (SD) body mass index of 29.7 (5.0) and 28.5 (4.9) kg/m2, respectively (P > 0.05). The study was completed by 32 women on isoflavone and 34 women on placebo. The groups did not differ in mammographic density or breast parenchyma by US (P > 0.05). Within each group, the baseline and final moments did not differ in mammography or US parameters significantly (P > 0.05). CONCLUSIONS: The use of soy isoflavone extract for 10 months does not affect breast density, as assessed by mammography and US, in postmenopausal women. © 2013 by The North American Menopause Society.

Treatment of Comorbid Migraine and Temporomandibular Disorders: A Factorial, Double-Blind, Randomized, Placebo-Controlled Study

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial

Background: Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life.Methods/Design: A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height(2); circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life.Discussion: CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients.

Long-wave infrared radiation reflected by compression stockings in the treatment of cellulite: a clinical double-blind, randomized and controlled study

SynopsisBackgroundCellulite refers to changes in skin relief on the thighs and buttocks of women, with a prevalence of 80-90%, causing dissatisfaction and search for treatment. Etiopathogenesis is multifactorial, as follows: herniation of the hypodermis towards the dermis, facilitated by perpendicular fibrous septa, changes in the dermal extracellular matrix, decreased adiponectin, genetic polymorphism, microcirculation alterations and inflammatory process. There are numerous therapeutic approaches, with little evidence of effectiveness. The long-wave infrared (LWIR) radiation interacts with water, improves microcirculation and stimulates metabolic processes. To date, the use of tissues with potential reflection of LWIR radiation has not been systematically investigated as adjuvant treatment for cellulite.ObjectiveTo investigate the efficacy and safety of the treatment of cellulite through the use of compression stockings made with thread reflecting LWIR radiation.Patients and methodsClinical study of therapeutic intervention, controlled and double-blind, including 30 women, aging from 25 to 40years, with cellulite of grades II and III on the thighs and buttocks who used compression stockings, pantyhose model, made with reflector thread of LWIR radiation, on only one randomized side. Women under other treatments for cellulite and with venous and/or blood insufficiencies were excluded. Evaluation of efficacy by clinical parameters, photographs, Dermatology Life Quality Index (DLQI), cutometry and high frequency ultrasonography and security by observation of adverse events and venous EcoDoppler recordings.ResultsDLQI scores showed significant reduction; the two-dimensional high-frequency ultrasonography showed an insignificant increase in dermal echogenicity as well as other efficacy parameters demonstrated no or slight improvement, with no differences between the sides exposed or not to LWIR; and there were no severe adverse events.ConclusionCompression stockings, with or without thread reflector of LWIR, showed slight effects in the appearance of cellulite, but the treatment determined a positive impact on women quality of life.

Metabolic parameters of postmenopausal women after quinoa or corn flakes intake - a prospective and double-blind study

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Double-Blind clinical study of a multivitamin and polymineral complex associated with Panax ginseng (Gerovital)

The present study aimed to evaluate the efficacy of a multivitamin and poly minerals supplemented with Panax ginseng extract (Gerovital®) on patients suffering from common physical or mental stress. The study design was controlled, parallel and double blind. Patients were randomly divided in two groups and underwent a thorough clinical and laboratory examination. Group A received placebo capsules and group B received Gerovital® capsules. In both cases, two capsules were taken daily during meals for eight weeks. Mood as well as physical activity were evaluated through a questionnaire assessing quality of life. From the 126 patients enrolled, 12 patients (8 in group A and 4 in group B) were excluded due to voluntary withdrawal, 55 patients completed the study in group A and 59 in group B. The treatment with Gerovital® significantly increased the quality of life when compared to placebo. After 15 days of study no difference between groups was observed. However, at 30th, 45th and 60th day, group B showed a statistically significant increase in average score from 30.05 to 41.96, 47.01 and finally 50.81 points. No increase in body weight was detected in either group. No difference in blood pressure or heart rate was also observed between treatments. The present study has shown that the daily use of Gerovital® over a 2-month period can be effective in improving quality of life in patients suffering from physical and mental stress among individuals of different ages, ranging from adults to elderly. Moreover, its use has been associated to a lower incidence of flu-like seasonal respiratory illnesses. Finally, the incidence of undesired effects was similar to placebo.

TACTILE CARTOGRAPHY EXPERIENCES IN BRAZIL: METHODOLOGIES AND DIDACTICAL MATERIAL WITH TECHNOLOGICAL RESOURCES FOR INCLUSION OF BLIND AND LOW VISION STUDENTS

The tactile cartography is an area of Cartography that aims the development of methodologies and didactical material to work cartographic concepts with blind and low vision people. The main aim of this article is to present the experience of Tactile Cartography Research Group from Sao Paulo State University (UNESP), including some didactical material and courses for teachers using the System MAPAVOX. The System MAPAVOX is software developed by our research group in a partnership with Federal University of Rio de Janeiro (UFRJ) that integrates maps and models with a voice synthesizer, sound emission, texts, images and video visualizing for computers. Our research methodology is based in authors that have in the students the centre of didactical activity such as Ochaita and Espinosa in [1], which developed studies related to blind children's literacy. According to Almeida the child's drawing is, thus, a system of representation. It isn't a copy of objects, but interpretation of that which is real, done by the child in graphic language[2]. In the proposed activities with blind and low vision students they are prepared to interpret reality and represent it by adopting concepts of graphic language learned. To start the cartographic initialization it is necessary to use personal and quotidian references, for example the classroom tactile model or map, to include concepts in generalization and scale concerning to their space of life. During these years many case studies were developed with blind and low vision students from Special School for Hearing Impaired and Visually Impaired in Araras and Rio Claro, Sao Paulo - Brazil. The most part of these experiences and others from Brazil and Chile are presented in [3]. Tactile material and MAPAVOX facilities are analysed by students and teachers who contribute with suggestions to reformulate and adapt them to their sensibility and necessity. Since 2005 we offer courses in Tactile Cartography to prepare teachers from elementary school in the manipulation of didactical material and attending students with special educational needs in regular classroom. There were 6 classroom and blended courses offered for 184 teachers from public schools in this region of the Sao Paulo state. As conclusion we can observe that methodological procedures centred in the blind and low vision students are successful in their spatial orientation if use didactical material from places or objects with which they have significant experience. During the applying of courses for teachers we could see that interdisciplinary groups can find creative cartographic alternatives more easily. We observed too that the best results in methodological procedures were those who provided concreteness to abstract concepts using daily experiences.

Longitudinal effect of curcumin-photodynamic antimicrobial chemotherapy in adolescents during fixed orthodontic treatment: a single-blind randomized clinical trial study

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Is there difference of Streptococcus mutans count and adherence on amalgam and resin occlusal restorations? A blind clinical study

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Free-running circadian rhythms of muscle strength, reaction time, and body temperature in totally blind people

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Effect of vitamin D supplementation alone on muscle function in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial

The present study investigates the effects of vitamin D on muscle function in postmenopausal women. It has been shown that vitamin D supplementation in postmenopausal women with hypovitaminosis D provides significant protective factor against sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass. We aimed to evaluate the effect of supplementation of vitamin D (VITD) alone on muscle function in younger postmenopausal women. In this double-blind, placebo-controlled clinical trial, 160 Brazilian postmenopausal women were randomized into two groups: VITD group consisting of patients receiving vitamin D3 1000 IU/day orally (n = 80) or placebo group (n = 80). Women with amenorrhea for more than 12 months and age 50-65 years, with a history of falls (previous 12 months), were included. The intervention time was 9 months, with assessments at two points, start and end. Lean mass was estimated by total-body dual-energy X-ray absorptiometry (DXA) and muscle strength by handgrip strength and chair rising test. The plasma concentrations of 25-hydroxyvitamin D [25(OH)D] were measured by high-performance liquid chromatography (HPLC). Statistical analysis was by intention to treat (ITT), using ANOVA, Student's t test, and Tukey's test. After 9 months, average values of 25(OH)D increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/ml (+45.4 %) in the VITD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/ml (-18.5 %) in the placebo group (p < 0.001). In the VITD group, there was significant increase in muscle strength (+25.3 %) of the lower limbs by chair rising test (p = 0.036). In women in the placebo group, there was considerable loss (-6.8 %) in the lean mass (p = 0.030). The supplementation of vitamin D alone in postmenopausal women provided significant protective factor against the occurrence of sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass.

Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial

The aim of this clinical randomized double-blind split-mouth study was to assess the effectiveness of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent. 31 patients were treated with: one upper hemiarcade with a 35% hydrogen peroxide bleaching agent and the other hemiarcade with a 6% hydrogen peroxide. Two applications were completed each treatment session and three sessions were appointed, with one week interval between them. Tooth colour was registered each session and 1 week and 1 months after completing the treatment by spectrophotometer, registering parameters L*, a* and b*, and subjectively using VITA Classic guide. Tooth sensitivity was registered by VAS and patient satisfaction and self-perception result was determined using OHIP-14. Tooth colour variation and sensitivity were compared between both bleaching agents. Both treatment showed a change between baseline colour and all check-points with a ΔE=5.57 for 6% and of ΔE=7.98 for the 35% one month after completing the (p<0.05). No statistical differences were seen when subjective evaluations were compared. Also, no differences were seen in tooth sensitivity between bleaching agents. OHIP-14 questionnaire demonstrated a significant change for all patients after bleaching. A 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated agent is effective for tooth bleaching, reaching a ΔE of 5.57 one month after completing the treatment, with no clinical differences to a 35% agent neither in colour change or in tooth sensitivity. A low concentration hydrogen peroxide bleaching agent may reach good clinical results with less adverse effects.