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Randomised trial

Richard Ac Hughes, Ruth Brassington, Angela A Gunn, Pieter A van Doorn
BACKGROUND: Guillain-Barré syndrome (GBS) is an acute paralysing disease caused by inflammation of the peripheral nerves, which corticosteroids would be expected to benefit. OBJECTIVES: To examine the ability of corticosteroids to hasten recovery and reduce the long-term morbidity from GBS. SEARCH METHODS: On 12 January 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase...
October 24, 2016: Cochrane Database of Systematic Reviews
Thaís da Silva Ferreira, Priscila Mansur Leal, Vanessa Parada Antunes, Antonio Felipe Sanjuliani, Márcia Regina Simas Torres Klein
Recent studies suggest that supplemental Ca (SC) increases the risk of cardiovascular events, whereas dietary Ca (DC) decreases the risk of cardiovascular events. Although frequently consumed with meals, it remains unclear whether Ca can mitigate or aggravate the deleterious effects of a high-fat meal on cardiovascular risk factors. This study aimed to evaluate the effects of SC or DC on blood pressure (BP) and microvascular function (MVF) in the postprandial period in obese women challenged with a high-fat meal...
October 24, 2016: British Journal of Nutrition
Ken M Kunisaki, Dennis E Niewoehner, Gary Collins, Bitten Aagaard, Nafisah B Atako, Elzbieta Bakowska, Amanda Clarke, Giulio Maria Corbelli, Ernest Ekong, Sean Emery, Elizabeth B Finley, Eric Florence, Rosa M Infante, Cissy M Kityo, Juan Sierra Madero, Daniel E Nixon, Ellen Tedaldi, Jørgen Vestbo, Robin Wood, John E Connett
BACKGROUND: Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to investigate the effect of immediate versus deferred ART on decline in lung function in HIV-positive individuals. METHODS: We did a nested substudy within the randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial at 80 sites in multiple settings in 20 high-income and low-to-middle-income countries...
October 20, 2016: Lancet Respiratory Medicine
Dimitrios Venetsanos, Sofia Sederholm Lawesson, Eva Swahn, Joakim Alfredsson
AIMS: To provide pharmacodynamic data of crushed and chewed ticagrelor tablets, in comparison with standard integral tablets. METHODS: Ninety nine patients with stable angina were randomly assigned, in a 3:1:1 fashion, to one of the following 180mg ticagrelor loading dose (LD) formulations: A) Integral B) Crushed or C) Chewed tablets. Platelet reactivity (PR) was assessed with VerifyNow before, 20 and 60min after LD. High residual platelet reactivity (HRPR) was defined as >208 P2Y12 reaction units (PRU)...
October 15, 2016: Thrombosis Research
Alexander Konnopka, Hans-Helmut König, Claudia Kaufmann, Nina Egger, Beate Wild, Joachim Szecsenyi, Wolfgang Herzog, Dieter Schellberg, Rainer Schaefert
BACKGROUND: Collaborative group intervention (CGI) in patients with functional somatic syndromes (FSS) has been shown to improve mental quality of life. OBJECTIVE: To analyse incremental cost-utility of CGI compared to enhanced medical care in patients with FSS. METHODS: An economic evaluation alongside a cluster-randomised controlled trial was performed. 35 general practitioners (GPs) recruited 300 FSS patients. Patients in the CGI arm were offered 10 group sessions within 3months and 2 booster sessions 6 and 12months after baseline...
November 2016: Journal of Psychosomatic Research
Muath M Altarawneh, Aaron Petersen, Robert Smith, David M Rouffet, Francois Billaut, Ben D Perry, Victoria L Wyckelsma, Antony Tobin, Michael J McKenna
PURPOSE: Salbutamol inhalation is permissible by WADA in athletic competition for asthma management and affects potassium regulation, which is vital for muscle function. Salbutamol effects on arterial potassium concentration ([K(+)]a) during and after high-intensity continuous exercise (HIcont) and intermittent exercise comprising repeated, brief sprints (HIint), and on performance during HIint are unknown and were investigated. METHODS: Seven recreationally active men participated in a double-blind, randomised, cross-over design, inhaling 1000 µg salbutamol or placebo...
October 22, 2016: European Journal of Applied Physiology
Emmanuel Futier, Catherine Paugam-Burtz, Thomas Godet, Linda Khoy-Ear, Sacha Rozencwajg, Jean-Marc Delay, Daniel Verzilli, Jeremie Dupuis, Gerald Chanques, Jean-Etienne Bazin, Jean-Michel Constantin, Bruno Pereira, Samir Jaber
PURPOSE: High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap. METHODS: A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation...
October 22, 2016: Intensive Care Medicine
Nigel Lee, Sue Kildea, Helen Stapleton
PROBLEM/BACKGROUND: Sterile water injections (SWI) are gaining popularity amongst women and midwives for the relief of back pain in labour. However the brief but intense pain associated with the injection has been cited as a deterrent to use and may negatively affect the birth experience. AIM: To explore women's experiences of using sterile water injections as analgesia for back pain in labour. DESIGN: A qualitative study, which generated data through individual semi-structured interviews with postnatal women...
October 19, 2016: Women and Birth: Journal of the Australian College of Midwives
Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z Omar, Meghan Craig, Mark Hinton
BACKGROUND: Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards...
October 22, 2016: Trials
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
Bernard X W Liew, Susan Morris, Justin W L Keogh, Brendyn Appleby, Kevin Netto
BACKGROUND: In recent years, athletes have ventured into ultra-endurance and adventure racing events, which tests their ability to race, navigate, and survive. These events often require race participants to carry some form of load, to bear equipment for navigation and survival purposes. Previous studies have reported specific alterations in biomechanics when running with load which potentially influence running performance and injury risk. We hypothesize that a biomechanically informed neuromuscular training program would optimize running mechanics during load carriage to a greater extent than a generic strength training program...
October 22, 2016: BMC Musculoskeletal Disorders
S J Lain, C L Roberts, D M Bond, J Smith, J M Morris
OBJECTIVE: This study is an economic evaluation of immediate birth compared with expectant management in women with preterm prelabour rupture of the membranes near term (PPROMT). DESIGN: A cost-effectiveness analysis alongside the PPROMT randomised controlled trial. SETTING: Obstetric departments in 65 hospitals across 11 countries. POPULATION: Women with a singleton pregnancy with ruptured membranes between 34(+0) and 36(+6) weeks gestation...
October 21, 2016: BJOG: An International Journal of Obstetrics and Gynaecology
T Meng, Z Zhong, L Meng
Lumbar spinal surgery is most commonly performed under general anaesthesia. However, spinal anaesthesia has also been used. We aimed to systematically review the comparative evidence. We only included randomised, controlled trials in this meta-analysis and calculated the risk ratio or standardised mean difference for haemodynamics, blood loss, surgical time, analgesic requirement, nausea and/or vomiting, and length of hospital stay. Eight studies with a total of 625 patients were included. These were considered to be at high risk of bias...
October 22, 2016: Anaesthesia
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C Dueck, Nancy Devlin, Hans-Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean-Francois Hamel, Madeleine King, Paul G Kluetz, Michael Koller, Daniel C Malone, Francesca Martinelli, Sandra A Mitchell, Carol M Moinpour, Jammbe Musoro, Daniel O'Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L Pimentel, Chantal Quinten, Jaap C Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M Soltys, Martin J B Taphoorn, Galina Velikova, Corneel Coens
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established...
October 18, 2016: Lancet Oncology
Yitao Zhang, Weijie Zeng, Shiyao Cheng, Zhichong Chen, Jiaojie Xue, Qing Wang, Maode Ou, Kanglin Cheng
BACKGROUND: Pulmonary hypertension (PH) is a serious disease, and treatment is a continuing challenge. Some in vitro and in vivo studies identified that statins were effective for PH. However, results of some randomised controlled trials (RCTs) have been controversial. The objective of our study was to clarify whether statins are effective and safe for pulmonary hypertension. METHODS: We systematically searched for eligible RCTs from PubMed, EMBASE, Web of Science, and the Cochrane Library during January 2016...
September 15, 2016: Heart, Lung & Circulation
Simon Tarp, Daniel E Furst, Anna Dossing, Mikkel Østergaard, Tove Lorenzen, Michael S Hansen, Jasvinder A Singh, Ernest H Choy, Maarten Boers, Maria E Suarez-Almazor, Lars E Kristensen, Henning Bliddal, Robin Christensen
OBJECTIVES: To summarize and compare the benefits and harms of biological agents used as monotherapy for rheumatoid arthritis (RA) in order to inform decisions for patients who are intolerant to conventional DMARD therapy. METHODS: We searched MEDLINE, EMBASE, CENTRAL, and other sources for randomised trials that compared biological monotherapy with methotrexate, placebo, or other biological monotherapies. Primary outcomes were ACR50 and the number of patients who discontinued due to adverse events...
September 14, 2016: Seminars in Arthritis and Rheumatism
Jyh-Ming Liou, Yu-Jen Fang, Chieh-Chang Chen, Ming-Jong Bair, Chi-Yang Chang, Yi-Chia Lee, Mei-Jyh Chen, Chien-Chuan Chen, Cheng-Hao Tseng, Yao-Chun Hsu, Ji-Yuh Lee, Tsung-Hua Yang, Jiing-Chyuan Luo, Chun-Chao Chang, Chi-Yi Chen, Po-Yueh Chen, Chia-Tung Shun, Wen-Feng Hsu, Wen-Hao Hu, Yen-Nien Chen, Bor-Shyang Sheu, Jaw-Town Lin, Jeng-Yih Wu, Emad M El-Omar, Ming-Shiang Wu
BACKGROUND: Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple therapy, and 14-day triple therapy in the first-line treatment of H pylori. METHODS: In this multicentre, open-label, randomised trial, we recruited adult patients (aged >20 years) with H pylori infection from nine medical centres in Taiwan...
October 18, 2016: Lancet
Sarah A Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price
BACKGROUND: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities...
October 21, 2016: Trials
Allan Riis, Cathrine Elgaard Jensen, Flemming Bro, Helle Terkildsen Maindal, Karin Dam Petersen, Mette Dahl Bendtsen, Martin Bach Jensen
BACKGROUND: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). METHODS: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate...
October 21, 2016: Implementation Science: IS
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