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randomized, double-blind, trial

Antoun Nader, Mark C Kendall, David W Manning, Matthew Beal, Rohit Rahangdale, Robert Dekker, Gildasio S De Oliveira, Eric Kamenetsky, Robert J McCarthy
BACKGROUND AND OBJECTIVES: A single-dose adductor canal block can provide postoperative analgesia for patients undergoing total knee arthroplasty (TKA). The purpose of this study was to assess postoperative opioid consumption after ultrasound-guided single-injection bupivacaine compared with saline adductor canal block for patients undergoing TKA. METHODS: After institutional review board approval, written informed consent was obtained from patients (>18 years old) undergoing elective TKA...
November 2016: Regional Anesthesia and Pain Medicine
Colin F Royse, Leif Saager, Richard Whitlock, Jared Ou-Young, Alistair Royse, Jessica Vincent, P J Devereaux, Andrea Kurz, Ahmed Awais, Krit Panjasawatwong, Daniel I Sessler
BACKGROUND: Inflammation after cardiopulmonary bypass may contribute to postoperative delirium and cognitive dysfunction. The authors evaluated the effect of high-dose methylprednisolone to suppress inflammation on the incidence of delirium and postoperative quality of recovery after cardiac surgery. METHODS: Five hundred fifty-five adults from three hospitals enrolled in the randomized, double-blind Steroids in Cardiac Surgery trial were randomly allocated to placebo or 250 mg methylprednisolone at induction and 250 mg methylprednisolone before cardiopulmonary bypass...
October 24, 2016: Anesthesiology
Patrick J McCormick, Matthew A Levin, Hung-Mo Lin, Daniel I Sessler, David L Reich
BACKGROUND: We tested the hypothesis that an electronic alert for a "double low" of mean arterial pressure less than 75 mmHg and a bispectral index less than 45 reduces the primary outcome of 90-day mortality. METHODS: Adults having noncardiac surgery were randomized to receive either intraoperative alerts for double-low events or no alerts. Anesthesiologists were not blinded and not required to alter care based upon the alerts. The primary outcome was all-cause 90-day mortality...
October 24, 2016: Anesthesiology
Jedrzej Kosiuk, Romina Milani, Laura Ueberham, Tobias Uhe, Clara Stegmann, Gerhard Hindricks, Andreas Bollmann
Remote ischemic preconditioning (RIPC) has been studied in models of different cardiovascular entities. Recently, a beneficial effect of RIPC on incidence of atrial fibrillation (AF) in postsurgical patients has been suggested. However, the potential impact of RIPC on electrophysiological- and thrombogenesis-related parameters in the setting of paroxysmal nonvalvular AF has not been investigated. The aim of the study is to answer the following questions: (1) Does RIPC have impact on inducibility of AF in patients with known paroxysmal AF? If yes, what are the direct electrophysiological mechanisms of this phenomenon, and could RIPC be implemented to reduce AF burden? (2) Does RIPC have the potential to minimize thrombogenic effects of simulated episodes of AF? If so, what are inhibited components of thrombogenesis and can this be used to reduce thromboembolic risk related to paroxysmal AF? The presented study is a 2-arm, randomized, placebo-controlled, double-blinded, single-center trial in a cohort of 146 patients with paroxysmal AF referred for AF ablation in sinus rhythm...
October 24, 2016: Clinical Cardiology
Nina Kimer, Julie Steen Pedersen, Troels Malte Busk, Lise Lotte Gluud, Lise Hobolth, Aleksander Krag, Søren Møller, Flemming Bendtsen
BACKGROUND AND RATIONALE: Decompensated cirrhosis is characterized by disturbed systemic and splanchnic hemodynamics. Bacterial translocation from the gut is considered the key driver in this process. Intestinal decontamination with rifaximin may improve hemodynamics. This double-blind, randomized, controlled trial investigates the effects of rifaximin on hemodynamics, renal function and vasoactive hormones. METHODS: We randomized 54 stable out-patients with cirrhosis and ascites to rifaximin 550 mg BD (n=36) or placebo BD (n=18)...
October 24, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
S Møller-Bisgaard, B J Ejbjerg, I Eshed, K Hørslev-Petersen, M L Hetland, A G Jurik, H Thomsen, T Torfing, K Stengaard-Pedersen, P Junker, N S Krogh, T Lottenburger, T Ellingsen, L S Andersen, H Skjødt, A J Svendsen, U Tarp, I T Hansen, J Pødenphant, J K Pedersen, H Lindegaard, L G Hanson, A Vestergaard, D Glinatsi, M Østergaard
OBJECTIVES: To investigate whether a treat-to-target strategy based on methotrexate (MTX) and intra-articular (IA) betamethasone suppresses magnetic resonance imaging (MRI)-determined measures of disease activity and reduces joint destruction in early rheumatoid arthritis (eRA) patients, and to investigate whether concomitant cyclosporin A (CyA) provides an additional effect. METHOD: In the 2-year randomized, double-blind, treat-to-target trial CIMESTRA, 160 patients with eRA (< 6 months) were randomized to MTX, intra-articular betamethasone and CyA, or placebo CyA...
October 24, 2016: Scandinavian Journal of Rheumatology
Joel E Gallant, Graeme Moyle, Juan Berenguer, Peter Shalit, Huyen Cao, Ya-Pei Liu, Joel Myers, Lisa Rosenblatt, Lingfeng Yang, Javier Szwarcberg
OBJECTIVES: Cobicistat (COBI) enhances atazanavir (ATV) pharmacokinetic parameters similarly to ritonavir (RTV) in both healthy volunteers and HIV-infected adults. Primary efficacy and safety outcomes of this Phase 3, international, randomized, double-blind, double-dummy, active-controlled trial in HIV-1-infected treatment-naïve adults (GS-US-216-0114/NCT01108510) demonstrated that ATV+COBI was non-inferior to ATV+RTV, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), at Weeks 48 and 144, with high rates of virologic success for both regimens (85...
October 21, 2016: Current HIV Research
Richard A Anderson, Zhiwei Zhan, Rencai Luo, Xiuhua Guo, Qingqing Guo, Jin Zhou, Jiang Kong, Paul A Davis, Barbara J Stoecker
Cinnamon ( ròu guì) has in vitro insulin potentiating activity, and proanthocyanidins from cinnamon prevent in vitro formation of advanced glycation end products. Some human studies were equivocal, but several have shown beneficial effects of cinnamon supplementation on circulating glucose, lipids, and/or insulin. This placebo-controlled double-blind trial tested the effects of a dried water extract of cinnamon (Cinnamomum cassia) on circulating glucose, lipids, insulin, and insulin resistance. Men and women from Beijing and Dalian, China, were invited to participate if they had fasting serum glucose >6...
October 2016: Journal of Traditional and Complementary Medicine
Chung-Hsiang Liu, Chang-Hai Tsai, Tsai-Chung Li, Yu-Wan Yang, Wei-Shih Huang, Ming-Kui Lu, Chun-Hung Tseng, Hui-Chun Huang, Kuan-Fei Chen, Thih-Shan Hsu, Yi-Ting Hsu, Chon-Haw Tsai, Ching-Liang Hsieh
BACKGROUND AND PURPOSE: Astragalus membranaceus (AM) is the first-choice herb for fatigue treatment in traditional Chinese medicine and the main herb used for stroke treatment in China and Taiwan. The purpose of this study was to evaluate the effect of AM on poststroke fatigue (PSF). MATERIALS AND METHODS: This study was designed as a double-blind, randomized, controlled preliminary study. Sixty-four patients with PSF were assigned to treatment group (TG; 31 patients), which received oral administration of AM (2...
October 20, 2016: Journal of Ethnopharmacology
Guido Grassi, Gino Seravalle, Gianmaria Brambilla, Raffaella Dell'Oro, Fosca Quarti Trevano, Francesco Fici, Luc van Bortel, Giuseppe Mancia
INTRODUCTION: The present study was aimed at comparing the antihypertensive efficacy, tolerability, and side effects profile of nebivolol/hydrochlorothiazide (NH) vs irbesartan/hydrochlorothiazide (IH) combination in elderly patients with isolated systolic hypertension (ISH). METHODS: 124 ISH patients aged 69.1 ± 5.1 years (mean ± SD) were enrolled by 13 general practitioners in Netherlands and Belgium and randomized in a double-blind fashion to receive either NH (5/12...
October 22, 2016: Advances in Therapy
Ronald M Rapee, Michael P Jones, Jennifer L Hudson, Gin S Malhi, Heidi J Lyneham, Sophie C Schneider
Use of the partial NMDA receptor agonist d-Cycloserine (DCS) to increase extinction to feared cues among anxious adults has shown mixed, although overall positive effects. Few studies have extended this effect to youth and none have addressed young people with broad-based anxiety such as separation anxiety, social anxiety, or generalised anxiety. In the current trial 51 children and adolescents with diagnosed anxiety disorders, aged 7-14 years received four sessions of graduated, experimenter-led, in vivo exposure to a hierarchy of feared cues relevant to their primary fear...
October 18, 2016: Behaviour Research and Therapy
Guoxun Shi, Minhui Hua, Qiangwei Xu, Tianli Ren
Tumor necrosis factor (TNF) inhibitors have exhibited certain clinical efficacy in treating refractory Takayasu arteritis (TA), albeit with severe adverse effects. We aimed to explore the anti-TNF function of resveratrol, a natural compound, in the treatment of TA. A total of 271 patients diagnosed of acute TA were enrolled in this clinical trial, who were then randomized to be administered 250mg resveratrol or placebo on a daily basis for a period of 3 months, and revisited biweekly to assess treatment outcomes...
October 14, 2016: Immunobiology
Donna M Urquhart, Anita E Wluka, Malcolm R Sim, Maurits van Tulder, Andrew Forbes, Stephen J Gibson, Carolyn Arnold, Chris Fong, Shane N Anthony, Flavia M Cicuttini
BACKGROUND: Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. METHODS/DESIGN: One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations...
October 22, 2016: Trials
Sara Biel, Maria-Dolores Mesa, Rafael de la Torre, Juan-Antonio Espejo, Jose-Ramón Fernández-Navarro, Montserrat Fitó, Estefanía Sánchez-Rodriguez, Carmen Rosa, Rosa Marchal, Juan de Dios Alche, Manuela Expósito, Manuel Brenes, Beatriz Gandul, Miguel Angel Calleja, María-Isabel Covas
BACKGROUND: Virgin olive oil, a recognized healthy food, cannot be consumed in great quantities. We aim to assess in humans whether an optimized virgin olive oil with high phenolic content (OVOO, 429 mg/Kg) and a functional one (FOO), both rich in phenolic compounds (429 mg/Kg) and triterpenic acids (389 mg/kg), could provide health benefits additional to those supplied a by a standard virgin olive oil (VOO). METHODS/DESIGN: A randomized, double-blind, crossover, controlled study will be conducted...
October 22, 2016: BMC Complementary and Alternative Medicine
Kristy Bultema, Sara Fowler, Melissa Drum, Al Reader, John Nusstein, Mike Beck
INTRODUCTION: In the treatment of patients with symptomatic irreversible pulpitis, endodontic debridement is a predictable method to relieve pain. However, there are clinical situations in which emergency care cannot be provided immediately. An unexplored treatment option in these cases may be the use of a long-acting anesthetic to reduce pain in untreated irreversible pulpitis. Some medical studies have shown potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA) to prolong pain relief and reduce opioid use postoperatively...
October 18, 2016: Journal of Endodontics
Sonja Rutten, Chris Vriend, Jan H Smit, Henk W Berendse, Adriaan W Hoogendoorn, Odile A van den Heuvel, Ysbrand D van der Werf
BACKGROUND: A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson's disease (PD). The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT) might be a new treatment option for depression in PD patients. METHODS/DESIGN: In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light with an intensity of 10,000 Lux, while the control device emits dim white light of 200 Lux, which is presumed to be too low to influence the circadian rhythm...
October 21, 2016: BMC Psychiatry
Pang Yao, Liang Sun, Ling Lu, Hong Ding, Xiafei Chen, Lixin Tang, Xinming Xu, Gang Liu, Yao Hu, Yiwei Ma, Feijie Wang, Qianlu Jin, He Zheng, Huiyong Yin, Rong Zeng, Yan Chen, Frank B Hu, Huaixing Li, Xu Lin
CONTEXT: Little is known how genetic and non-genetic factors modify responses of vitamin D supplementation in nonwhite populations. OBJECTIVE: To investigate factors modifying 25-hydroxyvitamin D (25[OH]D) and bioavailable 25(OH)D (25[OH]DBio) responses after vitamin D3 supplementation. Design, Setting, Participants, and Intervention: In this randomized, double-blinded, placebo-controlled trial, 448 Chinese with vitamin D deficiency (25[OH]D<50 nmol/L) received 2000 IU/d vitamin D3 or placebo for 20 weeks...
October 21, 2016: Journal of Clinical Endocrinology and Metabolism
K Reich, M Gooderham, L Green, A Bewley, Z Zhang, I Khanskaya, R M Day, J Goncalves, K Shah, V Piguet, J Soung
BACKGROUND: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis. OBJECTIVE: Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate to severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). METHODS: 250 patients were randomized to placebo (n=84), apremilast 30 mg BID (n=83) or etanercept 50 mg QW (n=83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104...
October 21, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
David E Rosow, Jamal Ahmed
Importance: Adult laryngotracheal stenosis (LTS) is typically managed surgically, but some patients fail treatment because of rapid restenosis or granulation tissue formation. The need for frequent surgery or tracheostomy reduces the quality of life in these patients and poses a significant challenge for the treating physician. New adjuvant treatments are required to reduce the surgical burden of this condition. Objective: To examine whether patients with rapidly recurrent nonvasculitic LTS who fail surgical management of their stenosis (ie, requiring dilation more frequently than every 6 months) experience longer intervals between surgical procedures when receiving adjuvant treatment with low-dose methotrexate...
October 20, 2016: JAMA Otolaryngology—Head & Neck Surgery
Fernando J Martinez, Jørgen Vestbo, Julie A Anderson, Robert D Brook, Bartolome R Celli, Nicholas J Cowans, Courtney Crim, Mark Dransfield, Sally Kilbride, Julie Yates, David E Newby, Dennis Niewoehner, Peter Ma Calverley
BACKGROUND: Inhaled corticosteroids have been shown to decrease exacerbations in COPD patients with moderate to severe COPD. Their effect in patients with milder airflow obstruction remains unclear. OBJECTIVE: This was an analysis of exacerbations in the Study to Understand Mortality and MorbidITy (SUMMIT) study. DESIGN: In a double-blind randomized controlled trial, once daily inhaled placebo, fluticasone furoate (FF, 100 μg), vilanterol (VI, 25 μg) or the combination (FF/VI) was administered...
October 21, 2016: American Journal of Respiratory and Critical Care Medicine
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