Melatonin for rapid eye movement sleep behavior disorder in Parkinson's disease : a randomised controlled trial

Background Melatonin may reduce REM-sleep behavior disorder (RBD) symptoms in Parkinson's disease (PD), though robust clinical trials are lacking. Objective To assess the efficacy of prolonged-release (PR) melatonin for RBD in PD. Methods Randomized, double-blind, placebo-controlled, parallel-group trial with an 8-week intervention and 4-week observation pre- and postintervention (ACTRN12613000648729). Thirty PD patients with rapid eye movement sleep behavior disorder were randomized to 4 mg of prolonged-release melatonin (Circadin) or matched placebo, ingested orally once-daily before bedtime. Primary outcome was the aggregate of rapid eye movement sleep behavior disorder incidents averaged over weeks 5 to 8 of treatment captured by a weekly diary. Data were included in a mixed-model analysis of variance (n = 15 per group). Results No differences between groups at the primary endpoint (3.4 events/week melatonin vs. 3.6 placebo; difference, 0.2; 95% confidence interval = -3.2 to 3.6; P = 0.92). Adverse events included mild headaches, fatigue, and morning sleepiness (n = 4 melatonin; n = 5 placebo). Conclusion Prolonged-release melatonin 4 mg did not reduce rapid eye movement sleep behavior disorder in PD. (c) 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Data from: Agreement between electronic and paper Epworth Sleepiness Scale responses in obstructive sleep apnoea: secondary analysis of a randomised controlled trial undertaken in a specialised tertiary care clinic

Objectives: Originally developed as a paper questionnaire, the electronic Epworth Sleepiness Scale (ESS) is widely used in sleep clinics and sleep population research. Despite potential differences between computer-based and conventional questionnaire delivery, studies have not evaluated the agreement between electronic and paper versions of the ESS. Given the widespread use of the ESS, a bias between results would present considerable data concerns. Thus, the aim of this study was to examine agreement between electronic and paper ESS responses in obstructive sleep apnoea (OSA). Design: We undertook a secondary analysis of baseline data from a randomised controlled trial (ANZCTR: ACTRN12611000847910). Setting: Data were collected in a tertiary sleep research laboratory located in Sydney, Australia. Participants: Data were analysed from 112 adult OSA patients. Measurements: Patients were given the English version of the ESS as part of a battery of sleep laboratory questionnaires. They completed electronic and subsequently paper ESS questionnaires on the same day. Results: We found no significant difference between electronic and paper ESS questionnaires (mean = 0.1, SD = 2.1, 95% CI [-0.3, 0.5], p = .57) or heteroscedasticity. There was no evidence of bias along the range of the measure. 95% limits of agreement at 4.3 and -4.1 were comparable with previous data. Conclusions: We found no evidence of bias between electronic and paper ESS questionnaires in this sample of OSA patients, as the two formats displayed sufficient agreement to be clinically comparable. Regardless of severity, patients reported the same level of daytime sleepiness with the same level of accuracy across both measures

Evaluation of a quantitative food frequency questionnaire for 5-year-old children in an Asian population.

BackgroundFood frequency questionnaires (FFQs) are often used to assess dietary intakes due to their ability to assess intake over extended periods, their low respondent burden, and their cost-effectiveness. A quantitative FFQ that includes locally appropriate food items for 5-year-old children in a multiethnic Asian population was developed, but its validity has not previously been evaluated.ObjectiveTo evaluate the relative validity of a newly developed FFQ as a dietary assessment tool for 5-year-old children in a multiethnic Asian population.DesignThe 112 –food item FFQ was administered by trained interviewers to caregivers of children. Frequency of food items consumed in the previous month and portion size information were collected. The FFQs were evaluated against 3-day nonweighed diet records (DRs) completed by caregivers.Participants/settingThe dietary data of 361 children aged 5 years from the Growing Up in Singapore Towards Healthy Outcomes mother-offspring cohort were collected in 2015-2016.Main outcome measuresNutrients of interest included energy, macronutrients, fiber, cholesterol, vitamin A, beta carotene, calcium, and iron, calculated from the FFQs and DRs.Statistical analyses performedNutrient intakes according to FFQs in relation to DRs were assessed using Pearson’s correlation, Lin’s concordance, Bland-Altman plots, quintile joint classification, and Cohen’s κ statistics.ResultsThe highest energy-adjusted correlation (Pearson’s r=0.71) and concordance (Lin’s concordance=0.69) were observed for calcium. Fiber, saturated fat, polyunsaturated fatty acids (PUFA), cholesterol, and iron also showed correlation coefficients and concordance of at least 0.40. Bland-Altman plots suggested no substantial bias across ranges of intakes for the nutrients with correlations and concordance of 0.40 or above. Quintiles joint classification showed substantial agreement for calcium (κ=0.66), and moderate agreement for iron, fiber, saturated fat, polyunsaturated fat, and beta carotene (κ=0.59, 0.54, 0.49, 0.44, 0.43, respectively).ConclusionsThe newly developed FFQ is in reasonable agreement with DR for estimating intakes of calcium, fiber, saturated fat, PUFA, cholesterol, and iron. In addition, the FFQ is able to classify children according to quintiles of nutrient intakes, with moderate to substantial quintile agreements between FFQ and DR for calcium, iron, fiber, saturated fat, PUFA, and beta carotene. To assess the remaining nutrients, DR method is recommended instead of the FFQ