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randomized, double-blind, trial

Erandis D Torres-Sánchez, Fermín P Pacheco-Moisés, Miguel A Macias-Islas, Eddic W Morales-Sánchez, Viridiana Ramírez-Ramírez, Alfredo J Celis de la Rosa, Margarita Cid-Hernández, Tanya E Sorto-Gómez, Genaro G Ortiz
BACKGROUND: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system associated with increased oxidative stress (OS) and mitochondrial alterations. Fish oil consumption has neuroprotective, antioxidant and anti-inflammatory effects in patients with relapsing-recurrent MS (RR-MS). OBJECTIVE: To evaluate changes in the hydrolytic activity of ATP synthase and mitochondrial membrane fluidity in patients with RR-MS who receive fish oil or olive oil as a dietary supplement...
January 12, 2018: Nutrición Hospitalaria: Organo Oficial de la Sociedad Española de Nutrición Parenteral y Enteral
Luís A B Tonaco, Flavia L Gomes, Gustavo Velasquez-Melendez, Miriam T P Lopes, Carlos E Salas
INTRODUCTION: The aim of the study was to investigate the role of the proteolytic fraction from Vasconcellea cundinamarcensis, designated as P1G10, on the healing of chronic foot ulcers in neuropathic patients with diabetes 2. METHODS: Fifty patients were enrolled in a prospective, randomized, double-blind trial, to verify the efficacy and safety of a topical dressing formulated with 0.1% P1G10, intended for wound healing, versus a hydrogel (control) protocol. Upon completion of the intervention, the outcome evaluated the number of patients attaining full epithelization (100%), or at least 80% healing...
March 21, 2018: Advances in Therapy
Adrienne L K Li, Kristin Wadsworth, Naveed T Siddiqui, May Alarab, Colleen D McDermott, Nucelio Lemos, Ashraf Dawood, Danny Lovatsis
INTRODUCTION AND HYPOTHESIS: Pre-emptive gabapentin has been shown to decrease postoperative pain in abdominal and vaginal hysterectomy. However, the effect of pre-emptive low-dose gabapentin has not been studied in vaginal hysterectomy combined with concomitant pelvic reconstruction. METHODS: A randomized double-blind placebo-controlled trial assessed all women seen for symptomatic prolapse requiring vaginal hysterectomy with concomitant pelvic reconstruction with or without midurethral sling...
March 21, 2018: International Urogynecology Journal
Yoshihiko Sugihara, Shigehito Ikushima, Mika Miyake, Takayoshi Kirisako, Yukihiro Yada, Daisuke Fujiwara
Purpose: The present study examined the effect of ingestion of Koji extract containing 14-dehydroergosterol (14-DHE), prepared from Aspergillus kawachii NBRC4308, on improvement of skin conditions among healthy volunteers. Subjects and methods: In a randomized, double-blind, placebo-controlled, parallel-group study, 70 healthy adult women who felt that their skin was dry ingested either a placebo dietary supplement or Koji extract (200 mg/day) supplement containing 0...
2018: Clinical, Cosmetic and Investigational Dermatology
Henrik Watz, Nitin Bagul, Klaus F Rabe, Stephen Rennard, Vijay Kt Alagappan, Jonas Román, Axel Facius, Peter Ma Calverley
Background: The oral selective phosphodiesterase-4 inhibitor roflumilast (ROF) reduces exacerbations in patients with severe COPD. Adverse events (AEs) can cause early ROF discontinuation. Alternative dosing strategies may help patients continue their therapy. Methods: In this multicenter, double-blind trial, 1,321 patients with severe COPD were randomized 1:1:1 to 4 weeks' treatment with ROF 250 µg once daily (OD), 500 µg every other day (EOD), or 500 µg OD, each followed by ROF 500 µg OD for 8 weeks, plus standard therapy...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Il Ju Choi, Myeong-Cherl Kook, Young-Il Kim, Soo-Jeong Cho, Jong Yeul Lee, Chan Gyoo Kim, Boram Park, Byung-Ho Nam
BACKGROUND: Patients with early gastric cancers that are limited to gastric mucosa or submucosa usually have an advanced loss of mucosal glandular tissue (glandular atrophy) and are at high risk for subsequent (metachronous) development of new gastric cancer. The long-term effects of treatment to eradicate Helicobacter pylori on histologic improvement and the prevention of metachronous gastric cancer remain unclear. METHODS: In this prospective, double-blind, placebo-controlled, randomized trial, we assigned 470 patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma to receive either H...
March 22, 2018: New England Journal of Medicine
Frederique E C M Peeters, Manouk J W van Mourik, Steven J R Meex, Jan Bucerius, Simon M Schalla, Suzanne C Gerretsen, Casper Mihl, Marc R Dweck, Leon J Schurgers, Joachim E Wildberger, Harry J G M Crijns, Bas L J H Kietselaer
BASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS. Pathophysiologic mechanisms are incompletely defined, and the only treatment available is valve replacement upon progression to severe symptomatic stenosis. Matrix Gla protein (MGP) inactivity is suggested to be involved in progression...
March 21, 2018: Nutrients
Sangkwan Lee, Seon-Jong Kim
BACKGROUND: Arthritis is the most common disease in elderly individuals. Many medications for osteoarthritis treatment have the potential for side effects. Using a bioinformatics tool and preclinical studies, ChondroT, 5 herbal complexes, was identified from Ganghwaljetongyeum, which is a18 herbal complex, which has often used to treat osteoarthritis. The goal of this study is to evaluate short-term safety of ChondroT. METHODS: This will be a multicenter, randomized, double-blind, and placebo-controlled trial...
March 2018: Medicine (Baltimore)
Emmanuel Marret, Raphael Cinotti, Laurence Berard, Vincent Piriou, Jacques Jobard, Benoit Barrucand, Dragos Radu, Samir Jaber, Francis Bonnet
BACKGROUND: Thoracic surgery for lung resection is associated with a high incidence of postoperative pulmonary complications. Controlled ventilation with a large tidal volume has been documented to be a risk factor for postoperative respiratory complications after major abdominal surgery, whereas the use of low tidal volumes and positive end-expiratory pressure (PEEP) has a protective effect. OBJECTIVE: To evaluate the effects of ventilation with low tidal volume and PEEP on major complications after thoracic surgery...
March 19, 2018: European Journal of Anaesthesiology
Heather M O'Leary, Walter E Kaufmann, Katherine V Barnes, Kshitiz Rakesh, Kush Kapur, Daniel C Tarquinio, Nicole G Cantwell, Katherine J Roche, Suzanne A Rose, Alexandra C Walco, Natalie M Bruck, Grace A Bazin, Ingrid A Holm, Mark E Alexander, Lindsay C Swanson, Lauren M Baczewski, Juan M Mayor Torres, Charles A Nelson, Mustafa Sahin
Objective: To measure the efficacy of mecasermin (recombinant human insulin-like growth factor 1, rhIGF-1), for treating symptoms of Rett syndrome (RTT) in a pediatric population using a double-blind crossover study design. Methods: Thirty girls with classic RTT in postregression stage were randomly assigned to placebo or rhIGF-1 in treatment period 1 and crossed over to the opposite assignment for period 2 (both 20 weeks), separated by a 28-week washout period...
March 2018: Annals of Clinical and Translational Neurology
Friedrich Leblhuber, Michael Egger, Burkhard Schuetz, Dietmar Fuchs
No abstract text is available yet for this article.
2018: Frontiers in Aging Neuroscience
Jolien Fleur Leijenaar, Geert Jan Groeneveld, Wiesje Maria van der Flier, Philip Scheltens, Erica Surya Klaassen, Henry Chanoch Weinstein, Geert Jan Biessels, Frederik Barkhof, Niels Daniël Prins
BACKGROUND: People with vascular cognitive impairment (VCI) constitute a clinically heterogeneous group, but previous symptomatic drug trials in VCI did not take this clinical heterogeneity into account. Executive dysfunction and memory impairment are the cognitive domains that are most frequently impaired in VCI, and these impairments are likely to reflect vascular damage to specific neurotransmitter systems, which opens the possibility for targeted symptomatic treatment directed at specific neurotransmitters...
March 20, 2018: JMIR Research Protocols
Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang
BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling and painful joints, eventually leading to joint destruction. There is still a lack of effective therapy to treat RA. The Juanbi pill is a Chinese medicine that has been widely used to treat active RA in China for hundreds of years, relieving pain and protecting the affected joints from malformation. However, there is no solid evidence to show the effect of the Juanbi pill on the management of active RA...
March 20, 2018: Trials
Rasha Babiker, Khalifa Elmusharaf, Michael B Keogh, Amal M Saeed
BACKGROUND: There is a strong association between cardiometabolic risk and adipose tissue dysfunction with great consequences on type 2 diabetic patients. Visceral Adiposity Index (VAI) is an indirect clinical marker of adipose tissue dysfunction. Gum Arabic (GA) is a safe dietary fiber, an exudate of Acacia Senegal. Gum Arabic had shown lipid lowering effect in both humans and animals. The aim of this trial was to determine the effect of GA supplementation on anthropometric obesity marker, Visceral Adiposity Index (VAI) and blood pressure in patients with type 2 diabetes mellitus...
March 20, 2018: Lipids in Health and Disease
Hossein Babaei, Fahimeh Forouzandeh, Leila Maghsoumi-Norouzabad, Hojat Allah Yousefimanesh, Maryam Ravanbakhsh, Ahmad Zare Javid
AIM: The aim of present study was to evaluate the effects of chicory leaf extract on serum oxidative stress markers, lipid profile, and periodontal status in patients with chronic periodontitis. METHODS: In this double-blind, randomized controlled clinical trial 40 patients with chronic periodontitis were allocated to intervention and control groups. The intervention group received a 1-gram chicory leaf methanolic extract capsule twice daily for 8 weeks. In the control group, participants received a placebo capsule (containing 1 gram wheat flour) twice daily for 8 weeks...
March 20, 2018: Journal of the American College of Nutrition
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
Ahmad Rezaeian
Objective Hyposmia is a sensorial disorder in which patients have a reduced sense of smell. However, there are no effective regimens for the management of this disorder. Therefore, the aim of this study is to evaluate the therapeutic effect of intranasal insulin on olfactory recovery in patients with hyposmia. Study Design This is a double-blinded, randomized controlled trial. Setting Intervention. Subjects and Methods This study was administered on 38 patients with hyposmia according to the inclusion and exclusion criteria...
March 1, 2018: Otolaryngology—Head and Neck Surgery
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
Katrin H Preller, Leonhard Schilbach, Thomas Pokorny, Jan Flemming, Erich Seifritz, Franz X Vollenweider
Distortions of self-experience are critical symptoms of psychiatric disorders and have detrimental effects on social interactions. In light of the immense need for improved and targeted interventions for social impairments, it is important to better understand the neurochemical substrates of social interaction abilities. We therefore investigated the pharmacological and neural correlates of self- and other-initiated social interaction. In a double-blind, randomized, counterbalanced, cross-over study 24 healthy human participants (18 males and 6 females) received either 1) placebo+placebo 2) placebo+lysergic acid diethylamide (LSD) (100 μg p...
March 19, 2018: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
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
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