Postoperative periodontal pain prevention using two dexamethasone medication protocols: A double-blind, parallel-group, placebo-controlled randomized clinical trial

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Effects of isoflavone on the learning and memory of women in menopause: a double-blind placebo-controlled study

Hormone decline is common to all women during aging and, associated with other factors, leads to cognitive impairment. Its replacement enhances cognitive performance, but not all women present a clinical and family or personal history that justifies its use, mainly women with a history of cancer. The aim of this study was to determine whether a daily oral dose of 80 mg of isoflavone extract for 4 months can produce benefits in women with low hormone levels, contributing to improvement in cognitive aspects. The sample comprised 50- to 65-year-old women whose menstruation had ceased at least 1 year before and who had not undergone hormone replacement. The volunteers were allocated to two groups of 19 individuals each, i.e., isoflavone and placebo. There was a weak correlation between menopause duration and low performance in the capacity to manipulate information (central executive). We observed an increase in the capacity to integrate information in the group treated with isoflavone, but no improvement in the capacity to form new memories. We did not observe differences between groups in terms of signs and symptoms suggestive of depression according to the Geriatric Depression Scale. Our results point to a possible beneficial effect of isoflavone on some abilities of the central executive. These effects could also contribute to minimizing the impact of memory impairment. Further research based on controlled clinical trials is necessary to reach consistent conclusions.

Perseveration in congenitally blind children: Effects of luminous and acoustic targets on a modified A-not-B task

The purpose of this study was to determine whether or not blind children perseverate during a modified Piagetian A-not-B reaching task, with conditions that employ luminous AB targets and acoustic AB targets. Ten congenitally blind children, ages 1-4 years, with residual vision for light, took part in this study. Behavioral and kinematic data were computed for participants' reaches, performed in six A trials and in two B trials, in both stimulus conditions. All of the children perseverated in the luminous condition, and none of them perseverated in the condition using acoustic targets. The children tilted their heads in the direction of the target as they reached towards it. However, this coupling action (head-reaching) occurred predominantly in the A trials in the acoustic condition. In the luminous condition, in contrast to the acoustic condition, the children took longer times to initiate the reaching movement. Also, in the luminous condition, the children explored the target surroundings, unlike the acoustic condition, in which they reached straight ahead. For these blind children, sound was more relevant to reaching than was the luminous stimulus. The luminous input caused perseveration in congenitally blind children in a similar way that has been reported in the literature for typically-developing, sighted infants, ages 8-12 months, performing A-not-B tasks with visual inputs. (C) 2012 Elsevier B.V. All rights reserved.

Efficacy and safety of a soy isoflavone extract in postmenopausal women: A randomized, double-blind, and placebo-controlled study

Objective: To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women.Design: In this double-blind, randomized, placebo-controlled study, a total of 80 women (mean age =55.1 years), who reported 5 or more hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max AT) a total of 100 mg/day of isoflavone (n=40) or placebo (n=40). Exclusion criteria included: contra-indication for hormone therapy (HT), chronic gastrointestinal diseases, and users of HT within the preceding 6-months. For 10-months, climacteric symptoms were evaluated using a score card and the menopausal Kupperman index. Compliance and safety were also assessed. At baseline and the end of the study, lipid and hormonal profiles, as well as vaginal, mammographic and ultrasonographic parameters were measured. The t-test, Wilcoxon test and ANOVA were used in the statistical analysis.Results: At baseline, the mean number of hot flushes was 9.6 +/- 3.9 per day in the isoflavone group and 10.1 +/- 4.9 in the placebo group (p>0.05). After 10 months, there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo (3.1 +/- 2.3 and 5.9 +/- 4.3, respectively) (p<0.001). Kupperman index mean values showed a significant reduction in both groups. However, soy isoflavone was significantly superior to placebo, in reducing hot flush severity (69.9% and 33.7%, respectively) (p<0.001). Endometrial thickness, mammography, vaginal cytology, lipids and hormonal profile did not change in both groups. No serious adverse event related to isoflavone treatment was reported.Conclusions: the soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and effective alternative therapeutic for postmenopausal women. (C) 2007 Elsevier B.V.. All rights reserved.

CYTOGENETIC ANALYSIS OF THE BRAZILIAN BLIND CATFISH PIMELODELLA-KRONEI AND ITS PRESUMED ANCESTOR, P-TRANSITORIA

Karyotypes of the blind catfish Pimelodella kronei from three different caves in the southwestern part of the State of São Paulo, Brazil, and of its presumed ancestor Pimelodella transitoria were examined. Chromosome number and formula, as well as C-banding pattern and NOR location were found to be the same in both species, supporting the hypothesis of a close relationship and even conspecificity of P. kronei and P. transitoria.

A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation

Introduction Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.Materials and methods Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm(2). Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.Results the 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.Discussion While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.

Low-level laser therapy for pain relief after episiotomy: a double-blind randomised clinical trial

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

Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial

Background Some children with juvenile idiopathic arthritis either do not respond, or are intolerant to, treatment with disease-modifying antirheumatic drugs, including anti-tumour necrosis factor (TNF) drugs. We aimed to assess the safety and efficacy of abatacept, a selective T-cell costimulation modulator, in children with juvenile idiopathic arthritis who had failed previous treatments.Methods We did a double-blind, randomised controlled withdrawal trial between February, 2004, and June, 2006. We enrolled 190 patients aged 6-17 years, from 45 centres, who had a history of active juvenile idiopathic arthritis; at least five active joints; and an inadequate response to, or intolerance to, at least one disease-modifying antirheumatic drug. All 190 patients were given 10 mg/kg of abatacept intravenously in the open-label period of 4 months. of the 170 patients who completed this lead-in course, 47 did not respond to the treatment according to predefined American College of Rheumatology (ACR) paediatric criteria and were excluded. of the patients who did respond to abatacept, arthritis, and 62 were randomly assigned to receive placebo at the same dose and timing. The primary endpoint was time to flare of arthritis. Flare was defined as worsening of 30% or more in at least three of six core variables, with at least 30% improvement in no more than one variable. We analysed all patients who were treated as per protocol. This trial is registered, number NCT00095173.Findings Flares of arthritis occurred in 33 of 62 (53%) patients who were given placebo and 12 of 60 (20%) abatacept patients during the double-blind treatment (p=0.0003). Median time to flare of arthritis was 6 months for patients given placebo (insufficient events to calculate IQR); insufficient events had occurred in the abatacept group for median time to flare to be assessed (p=0.0002). The risk of flare in patients who contined abatacept was less than a third of that for controls during that double-blind period (hazard ratio 0.31, 95% CI 0.16-0.95). During the double-blind period, the frequency of adverse events did not differ in the two treatment groups, Adverse events were recorded in 37 abatacept recipients (62%) and 34 (55%) placebo recipients (p=0.47); only two serious adverse events were reported, bouth in controls (p=0.50).Interpretation Selective modulation of T-cell costimulation with abatacept is a rational alternative treatment for children with juvenile idiopathic arthritis.Funding Bristol-Myers Squibb.

Double-blind comparison of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia

The purpose of this study was to compare the efficacy and tolerability of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia. This was an 8-week, multicentre, randomized, double-blind, parallel-group comparison of venlafaxine and amitriptyline. Outpatients with DSM-IV major depression, a minimum score of 20 on the 21-item Hamilton Depression Rating Scale (HAM-D), and depressive symptoms for at least 1 month were eligible. Patients were randomly assigned to venlafaxine or amitriptyline, both drugs titrated to a maximum of 150 mg/day until study day 15. The primary efficacy variables were the final on-therapy scores on the HAM-D, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression severity scales. Data were evaluated on an intent-to-treat basis using the LOCF method. One hundred and 16 patients were randomized, and 115 were evaluated for efficacy. Both drugs showed efficacy in the treatment of depression with or without melancholia. No significant differences were noted between treatments for any efficacy parameter. However, significantly (p < 0.05) more patients in the amitriptyline group had at least one adverse event. These results should support the efficacy and tolerability of venlafaxine in comparison with amitriptyline for treating major depression with or without melancholia.

Low intensity laser therapy in the treatment of temporomandibular disorders: A double-blind study

This study aimed to evaluate the effectiveness of low intensity laser therapy (LILT) in 30 patients presenting temporomandibular joint (TMJ) pain and mandibular dysfunction in a random and double-blind research design. The sample, divided into experimental group (1) and placebo group (2), was submitted to the treatment with infrared laser (780 nm, 30 mW, 10 s, 6.3 J/cm2) at three TMJ points. The treatment was evaluated throughout six sessions and 15, 30 and 60 days after the end of the therapy, through visual analogue scale (VAS), range of mandibular movements and TMJ pressure pain threshold. The results showed a reduction in VAS (p < 0.001) and through the ANOVA with repeated measures it was observed that the groups did not present statistically significant differences (P = 0.2060), as the averages of the evaluation times (P = 0.3955) and the interaction groups evaluation times (P = 0.3024), considering the MVO. The same occurred for RLE (P = 0.2988, P = 0.1762 and P = 0.7970), LLE (P = 0.3265, P = 0.4143 and P = 0.0696), PPTD (P = 0.1558, P = 0.4695 and P = 0.0737) and PPTE (P = 0.2376, P = 0.3203 and P = 0.0624). For PE, there were not statistically significant differences for groups (P = 0.7017) and the interaction groups evaluation times (P = 0.6678), even so in both groups the PE varied with time (P = 0.0069). © 2005 Blackwell Publishing Ltd.

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: A double-blind controlled pilot study

Objective: This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). Design: Seventy-two menopausal women (mean age: 53.6 ± 4.27 years) diagnosed with depression (Montgomery-Åsberg Depression Rating Scale [MADRS] scores ≥ 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). Results: Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. Conclusions: Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study. © 2006 by The North American Menopause Society.

Articaine and mepivacaine efficacy in postoperative analgesia for lower third molar removal: a double-blind, randomized, crossover study

Objective: Comparison of the clinical efficacy of 4% articaine in relation to 2% mepivacaine, both with 1:100,000 epinephrine, in the prevention of postoperative pain after lower third molar removal. Study design: Twenty patients underwent removal of bilateral lower third molars under local anesthesia (articaine or mepivacaine) in 2 separate appointments, in a double-blind, randomized, and crossed manner. Objective and subjective parameters were recorded for paired comparison of postoperative courses. Results: Duration of analgesia provided by articaine and mepivacaine was 198.00 ± 25.86, and 125.40 ± 13.96 min, respectively (P = .02), whereas the duration of anesthesia was 273.80 ± 15.94 and 216.85 ± 20.15 min, respectively (P = .06). Both solutions exerted no important effects upon arterial pressure, heart rate, or oxygen saturation (P > .05). Conclusions: Articaine provides a longer period of analgesic effect and a tendency for a longer period of anesthesia as compared to mepivacaine. The presence of a vasoconstrictor agent in local anesthetic solutions does not seem to influence hemodynamic parameters during lower third molar removal in healthy subjects. © 2006 Mosby, Inc. All rights reserved.