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Hans W Voß, Andreas Michalsen, Rainer Brünjes
BACKGROUND: A randomised, placebo-controlled clinical trial in children suffering from acute dry cough was performed to assess the efficacy and tolerability of a complex homeopathic drug (Drosera, Coccus cacti, Cuprum Sulfuricum, Ipecacuanha=Monapax syrup, short: verum). METHODS: 89 children received verum and 91 received placebo daily for 7 days (age groups 0.5-3, 4-7 and 8-12 years). The primary efficacy variable was the improvement of the Cough Assessment Score...
March 20, 2018: Drug Research
Jieun Yoon, Akihiro Kanamori, Keisuke Fujii, Hiroko Isoda, Tomohiro Okura
PURPOSE: Maslinic acid (MA) is a component derived from a natural olive-based extract known to have pharmacological functions that include suppressing inflammation. This study examined how MA, in conjunction with whole-body vibration training (WBVT), can improve knee and muscle function in elderly women with knee osteoarthritis (OA). METHODS: The study was a double-blinded, placebo-controlled, randomized intervention study that enrolled individuals with knee pain...
2018: PloS One
Daniel O Scharfstein, Aidan McDermott
Randomized trials with patient-reported outcomes are commonly plagued by missing data. The analysis of such trials relies on untestable assumptions about the missing data mechanism. To address this issue, it has been recommended that the sensitivity of the trial results to assumptions should be a mandatory reporting requirement. In this paper, we discuss a recently developed methodology (Scharfstein et al., Biometrics, 2018) for conducting sensitivity analysis of randomized trials in which outcomes are scheduled to be measured at fixed points in time after randomization and some subjects prematurely withdraw from study participation...
January 1, 2018: Statistical Methods in Medical Research
Nazarii Kobyliak, Ludovico Abenavoli, Galyna Mykhalchyshyn, Liudmyla Kononenko, Luigi Boccuto, Dmytro Kyriienko, Oleg Dynnyk
BACKGROUND: Probiotics have a beneficial effect on nonalcoholic fatty liver disease (NAFLD) in animal models. Randomized placebo-controlled trials (RCTs) in NAFLD are still lacking in humans despite a large number of data from animal research. AIM: We performed a double-blind single center RCT of live multi-strain probiotic vs. placebo in type 2 diabetes patients with NAFLD. METHODS: A total of 58 patients met the criteria for inclusion. They were randomly assigned to receive the multi-probiotic "Symbiter" (concentrated biomass of 14 probiotic bacteria genera Bifidobacterium, Lactobacillus, Lactococcus, Propionibacterium) or placebo for 8-weeks administered as a sachet formulation in double-blind treatment...
March 2018: Journal of Gastrointestinal and Liver Diseases: JGLD
Frank Häßler, Steffen Weirich
A Multi-arm Placebo-controlled Study with Glutamic Acid Conducted in Rostock in 1953/1954 Glutamic acid was commonly used in the treatment of intellectually disabled children in the 50s. Koch reported first results of an observation of 140 children treated with glutamic acid in 1952. In this line is the multi-arm placebo-controlled study reported here. The original study protocols were available. 58 children with speech problems who attending a school of special needs received glutamic acid, or vitamin B, or St...
September 2017: Praxis der Kinderpsychologie und Kinderpsychiatrie
Kah Kheng Goh, Chun-Hsin Chen, Mong-Liang Lu
OBJECTIVE: Weight gain is one of the most challenging issues in patients with schizophrenia treated with antipsychotics. Several meta-analyses have been conducted to review the efficacy of topiramate in reducing weight, however, several issues regarding the methodology had arisen of which make the results remain ambiguous. METHODS: We conducted a meta-analysis of randomised controlled trials about the use of topiramate in patients with schizophrenia for weight reduction...
March 20, 2018: International Journal of Psychiatry in Clinical Practice
Tim L Wigal, Jeffrey H Newcorn, Nelson Handal, Sharon B Wigal, Ioulietta Mulligan, Virginia Schmith, Eric Konofal
BACKGROUND: Mazindol is under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD) because of its alertness-enhancing properties. A novel controlled-release (CR) formulation of mazindol was developed to allow once-daily dosing. OBJECTIVE: The aim of this study was to evaluate the efficacy of mazindol CR in adults with ADHD. DESIGN: We conducted a randomized, double-blind, placebo-controlled 6-week trial. METHODS: Subjects diagnosed with ADHD using the Mini-International Neuropsychiatric Structured Interview (MINI) and with an ADHD Rating Scale, Diagnostic and Statistical Manual of Mental Disorders 5th Edition (ADHD-RS-DSM5) score ≥ 28 were randomized to receive placebo or 1-3 mg/day of mazindol for 6 weeks...
March 19, 2018: CNS Drugs
Simon Krabbe, Inge J Sørensen, Bente Jensen, Jakob M Møller, Lone Balding, Ole R Madsen, Robert G W Lambert, Walter P Maksymowych, Susanne J Pedersen, Mikkel Østergaard
Background: The Canada-Denmark (CANDEN) definitions of spinal MRI lesions allow a detailed anatomy-based evaluation of inflammatory and structural lesions in vertebral bodies and posterior elements of the spine in patients with axial spondyloarthritis (axSpA). The objective was to examine the reliability, responsiveness and discrimination of scores for spinal inflammation, fat, bone erosion and new bone formation based on the CANDEN system and to describe patterns of inflammatory and structural lesions and their temporal development...
2018: RMD Open
Désirée van der Heijde, Atul Deodhar, Oliver FitzGerald, Roy Fleischmann, Dafna Gladman, Alice B Gottlieb, Bengt Hoepken, Lars Bauer, Oscar Irvin-Sellers, Majed Khraishi, Luke Peterson, Anthony Turkiewicz, Jürgen Wollenhaupt, Philip J Mease
Objective: To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods: RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4)...
2018: RMD Open
Chau Le Bao Ho, Monique Breslin, Jenny Doust, Christopher M Reid, Mark R Nelson
OBJECTIVES: In many current guidelines, blood pressure (BP)-lowering drug treatment for primary prevention of cardiovascular disease (CVD) is based on absolute risk. However, in clinical practice, therapeutic decisions are often based on BP levels alone. We sought to investigate which approach was superior by conducting a post hoc analysis of the Australian National Blood Pressure (ANBP) cohort, a seminal study establishing the efficacy of BP lowering in 'mild hypertensive' persons. DESIGN: A post hoc subgroup analysis of the ANBP trial results by baseline absolute risk tertile...
March 19, 2018: BMJ Open
Adrian L Lopresti, Hemant Gupta, Stephen J Smith
BACKGROUND: To evaluate the efficacy and tolerability of a poly-herbal formulation, Herbagut, for the treatment of gastrointestinal symptoms and its effect on quality of life parameters in patients presenting with self-reported, unsatisfactory bowel habits. METHODS: This was a randomised, double-blind, placebo-controlled trial. Fifty adults with self-reported unsatisfactory bowel habits, primarily characterised by chronic constipation were randomly allocated to take Herbagut or a matching placebo for 28 days...
March 20, 2018: BMC Complementary and Alternative Medicine
Richard A Pollak, Ira J Gottlieb, Fardin Hakakian, John C Zimmerman, Stewart W McCallum, Randall J Mack, Rosemary Keller, Alex Freyer, Wei Du
OBJECTIVE: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30▒mg) in subjects with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation. METHODS: Subjects who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30▒mg (n=100) or placebo (n=101) administered once daily...
March 16, 2018: Clinical Journal of Pain
Nafiseh Saghafi, Maryam Karjalian, Masumeh Ghazanfarpour, Imaneh Khorsand, Hassan Rakhshandeh, Masumeh Mirteimouri, Masoudeh Babakhanian, Talat Khadivzadeh, Mohammad Javad Najafzadeh, Ahmad Ghorbani, Leila Pourali, Sara Bahman
The goal of this study was to compare the effect of Anethum graveolens (dill) vaginal suppositories and 100 mg clotrimazole vaginal tablets on vulvovaginal Candidiasis. This study was a single centre, single-blind, randomised, placebo-controlled trial, in which 60 women with microbiology-confirmed vulvovaginal candidiasis were randomly assigned to dill and clotrimazole groups. At the end of the study, the estimated prevalence of leucorrhoea, burning, and itching was 23%, 23% and 20% in dill users, respectively...
March 19, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Helton O Campos, Lucas R Drummond, Quezia T Rodrigues, Frederico S M Machado, Washington Pires, Samuel P Wanner, Cândido C Coimbra
Nitrate (NO3 -) is an ergogenic nutritional supplement that is widely used to improve physical performance. However, the effectiveness of NO3 - supplementation has not been systematically investigated in individuals with different physical fitness levels. The present study analysed whether different fitness levels (non-athletes v. athletes or classification of performance levels), duration of the test used to measure performance (short v. long duration) and the test protocol (time trials v. open-ended tests v...
March 2018: British Journal of Nutrition
Conor P Kerley, Eamon Dolan, Philip E James, Liam Cormican
Dietary nitrate has been shown to increase nitrate/nitrite levels and decrease blood pressure (BP) in multiple populations. There are few reports among hypertensives and these reports have provided conflicting evidence. We aimed to assess the effect of daily nitrate compared with placebo in subjects with uncontrolled hypertension (HTN). On day 0, hypertensives wore an ambulatory BP monitor (ABPM) for 24 h and blood was taken. Subjects were then randomised to 7-d nitrate-rich beetroot juice (NO3 -) (12·9 mmol nitrate) followed by 7-d nitrate-depleted beetroot juice (0·5 mmol nitrate) or vice versa...
March 2018: British Journal of Nutrition
Karim Yahia Jaffer, Tiffany Chang, Brigitte Vanle, Jonathan Dang, Alexander J Steiner, Natalie Loera, Marina Abdelmesseh, Itai Danovitch, Waguih William Ishak
OBJECTIVE: While trazodone is approved for the treatment of depression, the off-label use of this medication for insomnia has surpassed its usage as an antidepressant. In this systematic review, we examined the evidence for the efficacy and safety of trazodone for insomnia. METHODS: A literature search was conducted using MEDLINE/PubMed databases from the past 33 years (1983-2016) and the keywords insomnia, trazodone, sedative, treatment, and hypnotics. The results were restricted to English language and human subjects...
July 2017: Innovations in Clinical Neuroscience
François Jacques, Adrian Schembri, Avi Nativ, Chantal Paquette, Pawel Kalinowski
Background: Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients. Their combined effect is, however, understudied. Objective: The objective of this paper is to determine if PRF augments the beneficial effect of EAMT in MS patients as opposed to placebo. Method: This is a pilot, randomized, placebo-controlled, double-blind 14-week study. Participants were randomly assigned to receive PRF 10 mg BID ( n  = 21) or placebo ( n  = 20)...
January 2018: Multiple Sclerosis Journal—Experimental, Translational and Clinical
Sheylla M Felau, Lucas P Sales, Marina Y Solis, Ana Paula Hayashi, Hamilton Roschel, Ana Lúcia Sá-Pinto, Danieli Castro Oliveira De Andrade, Keyla Y Katayama, Maria Claudia Irigoyen, Fernanda Consolim-Colombo, Eloisa Bonfa, Bruno Gualano, Fabiana B Benatti
Endothelial cells are thought to play a central role in the pathogenesis of antiphospholipid syndrome (APS). Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation has been shown to improve endothelial function in a number of diseases; thus, it could be of high clinical relevance in APS. The aim of this study was to evaluate the efficacy of n-3 PUFA supplementation on endothelial function (primary outcome) of patients with primary APS (PAPS). A 16-week randomized clinical trial was conducted with 22 adult women with PAPS...
2018: Frontiers in Immunology
Mika J Mäkelä, Pär Gyllfors, Erkka Valovirta, Maria A Steffensen, Pernille M Grønager, Johannes Savolainen, Lone Winther
PURPOSE: The SQ tree sublingual immunotherapy (SLIT)-tablet containing allergen extracts with the major allergen Bet v 1 from birch pollen is currently being developed for the treatment of tree pollen-induced allergic rhinitis/conjunctivitis with or without asthma. The aim of this Phase II trial was to investigate the dose-related efficacy and safety of the SQ tree SLIT-tablet. METHODS: This study was a randomized, parallel-group, double-blind, placebo-controlled, multi-national trial conducted in Europe...
March 15, 2018: Clinical Therapeutics
Zhi-Wei Lai, Ryan Kelly, Thomas Winans, Ivan Marchena, Ashwini Shadakshari, Julie Yu, Maha Dawood, Ricardo Garcia, Hajra Tily, Lisa Francis, Stephen V Faraone, Paul E Phillips, Andras Perl
BACKGROUND: Patients with systemic lupus erythematosus have T-cell dysfunction that has been attributed to the activation of the mammalian target of rapamycin (mTOR). Rapamycin inhibits antigen-induced T-cell proliferation and has been developed as a medication under the generic designation of sirolimus. We assessed safety, tolerance, and efficacy of sirolimus in a prospective, biomarker-driven, open-label clinical trial. METHODS: We did a single-arm, open-label, phase 1/2 trial of sirolimus in patients with active systemic lupus erythematosus disease unresponsive to, or intolerant of, conventional medications at the State University of New York Upstate Medical University (Syracuse, NY, USA)...
March 15, 2018: Lancet
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