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Negative trials

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93 papers 1000+ followers Studies that did not show the result that they were looking for: in various areas
By Faye Kehler Family Physician and GP Anesthetist since 1987 interested in all aspects of Medicine
S Claiborne Johnston, Pierre Amarenco, Gregory W Albers, Hans Denison, J Donald Easton, Scott R Evans, Peter Held, Jenny Jonasson, Kazuo Minematsu, Carlos A Molina, Yongjun Wang, K S Lawrence Wong
BACKGROUND: Ticagrelor may be a more effective antiplatelet therapy than aspirin for the prevention of recurrent stroke and cardiovascular events in patients with acute cerebral ischemia. METHODS: We conducted an international double-blind, controlled trial in 674 centers in 33 countries, in which 13,199 patients with a nonsevere ischemic stroke or high-risk transient ischemic attack who had not received intravenous or intraarterial thrombolysis and were not considered to have had a cardioembolic stroke were randomly assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive either ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2 through 90) or aspirin (300 mg on day 1 followed by 100 mg daily for days 2 through 90)...
July 7, 2016: New England Journal of Medicine
Joanna M Young, Christopher M Florkowski, Sarah L Molyneux, Roberta G McEwan, Christopher M Frampton, Peter M George, Russell S Scott
Myalgia is the most frequently reported adverse side effect associated with statin therapy and often necessitates reduction in dose, or the cessation of therapy, compromising cardiovascular risk management. One postulated mechanism for statin-related myalgia is mitochondrial dysfunction through the depletion of coenzyme Q(10), a key component of the mitochondrial electron transport chain. This pilot study evaluated the effect of coenzyme Q(10) supplementation on statin tolerance and myalgia in patients with previous statin-related myalgia...
November 1, 2007: American Journal of Cardiology
Mario Castro, Tonya S King, Susan J Kunselman, Michael D Cabana, Loren Denlinger, Fernando Holguin, Shamsah D Kazani, Wendy C Moore, James Moy, Christine A Sorkness, Pedro Avila, Leonard B Bacharier, Eugene Bleecker, Homer A Boushey, James Chmiel, Anne M Fitzpatrick, Deborah Gentile, Mandeep Hundal, Elliot Israel, Monica Kraft, Jerry A Krishnan, Craig LaForce, Stephen C Lazarus, Robert Lemanske, Njira Lugogo, Richard J Martin, David T Mauger, Edward Naureckas, Stephen P Peters, Wanda Phipatanakul, Loretta G Que, Ajay Sheshadri, Lewis Smith, Julian Solway, Lisa Sullivan-Vedder, Kaharu Sumino, Michael E Wechsler, Sally Wenzel, Steven R White, E Rand Sutherland
IMPORTANCE: In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency. OBJECTIVE: To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels. DESIGN, SETTING, AND PARTICIPANTS: The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014...
May 2014: JAMA: the Journal of the American Medical Association
Jacques-Eric Gottenberg, Philippe Ravaud, Xavier Puéchal, Véronique Le Guern, Jean Sibilia, Vincent Goeb, Claire Larroche, Jean-Jacques Dubost, Stéphanie Rist, Alain Saraux, Valérie Devauchelle-Pensec, Jacques Morel, Gilles Hayem, Pierre Hatron, Aleth Perdriger, Damien Sene, Charles Zarnitsky, Djilali Batouche, Valérie Furlan, Joelle Benessiano, Elodie Perrodeau, Raphaele Seror, Xavier Mariette
IMPORTANCE: Primary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited. OBJECTIVE: To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjögren syndrome: dryness, pain, and fatigue. DESIGN, SETTING, AND PARTICIPANTS: From April 2008 to May 2011, 120 patients with primary Sjögren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind, parallel-group, placebo-controlled trial...
July 16, 2014: JAMA: the Journal of the American Medical Association
Jennifer S Gewandter, Andrew McKeown, Michael P McDermott, Jordan D Dworkin, Shannon M Smith, Robert A Gross, Matthew Hunsinger, Allison H Lin, Bob A Rappaport, Andrew S C Rice, Michael C Rowbotham, Mark R Williams, Dennis C Turk, Robert H Dworkin
UNLABELLED: Peer-reviewed publications of randomized clinical trials (RCTs) are the primary means of disseminating research findings. "Spin" in RCT publications is misrepresentation of statistically nonsignificant research findings to suggest treatment benefit. Spin can influence the way readers interpret clinical trials and use the information to make decisions about treatments and medical policies. The objective of this study was to determine the frequency with which 4 types of spin were used in publications of analgesic RCTs with nonsignificant primary analyses in 6 major pain journals...
January 2015: Journal of Pain: Official Journal of the American Pain Society
Rong Wang, Yan Zheng, Jing-Yang Huang, Ai-Qin Zhang, Yu-Hao Zhou, Jie-Ning Wang
BACKGROUND: Studies have reported inconsistent results concerning the existence of associations of folate intake and serum folate levels with prostate cancer risk. This study sought to summarise the evidence regarding these relationships using a dose-response meta-analysis approach. METHODS: In January 2014, we performed electronic searches of PubMed, Embase, and the Cochrane Library to identify studies examining the effect of folate on the incidence of prostate cancer...
December 29, 2014: BMC Public Health
Bongani M Mayosi, Mpiko Ntsekhe, Jackie Bosch, Shaheen Pandie, Hyejung Jung, Freedom Gumedze, Janice Pogue, Lehana Thabane, Marek Smieja, Veronica Francis, Laura Joldersma, Kandithalal M Thomas, Baby Thomas, Abolade A Awotedu, Nombulelo P Magula, Datshana P Naidoo, Albertino Damasceno, Alfred Chitsa Banda, Basil Brown, Pravin Manga, Bruce Kirenga, Charles Mondo, Phindile Mntla, Jacob M Tsitsi, Ferande Peters, Mohammed R Essop, James B W Russell, James Hakim, Jonathan Matenga, Ayub F Barasa, Mahmoud U Sani, Taiwo Olunuga, Okechukwu Ogah, Victor Ansa, Akinyemi Aje, Solomon Danbauchi, Dike Ojji, Salim Yusuf
BACKGROUND: Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis. METHODS: Using a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M...
September 18, 2014: New England Journal of Medicine
Marc A Rodger, William M Hague, John Kingdom, Susan R Kahn, Alan Karovitch, Mathew Sermer, Anne Marie Clement, Suzette Coat, Wee Shian Chan, Joanne Said, Evelyne Rey, Sue Robinson, Rshmi Khurana, Christine Demers, Michael J Kovacs, Susan Solymoss, Kim Hinshaw, James Dwyer, Graeme Smith, Sarah McDonald, Jill Newstead-Angel, Anne McLeod, Meena Khandelwal, Robert M Silver, Gregoire Le Gal, Ian A Greer, Erin Keely, Karen Rosene-Montella, Mark Walker, Philip S Wells
BACKGROUND: Thrombophilias are common disorders that increase the risk of pregnancy-associated venous thromboembolism and pregnancy loss and can also increase the risk of placenta-mediated pregnancy complications (severe pre-eclampsia, small-for-gestational-age infants, and placental abruption). We postulated that antepartum dalteparin would reduce these complications in pregnant women with thrombophilia. METHODS: In this open-label randomised trial undertaken in 36 tertiary care centres in five countries, we enrolled consenting pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta-mediated pregnancy complications...
November 8, 2014: Lancet
Ana R Vieira, Snieguole Vingeliene, Doris S M Chan, Dagfinn Aune, Leila Abar, Deborah Navarro Rosenblatt, Darren C Greenwood, Teresa Norat
Smoking is estimated to cause about half of all bladder cancer cases. Case-control studies have provided evidence of an inverse association between fruit and vegetable intake and bladder cancer risk. As part of the World Cancer Research/American Institute for Cancer Research Continuous Update Project, we conducted a systematic review and meta-analysis of prospective studies to assess the dose-response relationship between fruit and vegetables and incidence and mortality of bladder cancer. We searched PubMed up to December 2013 for relevant prospective studies...
January 2015: Cancer Medicine
Ludwig Kappos, Hans-Peter Hartung, Mark S Freedman, Alexey Boyko, Ernst Wilhelm Radü, Daniel D Mikol, Marc Lamarine, Yann Hyvert, Ulrich Freudensprung, Thomas Plitz, Johan van Beek
BACKGROUND: Depletion of B lymphocytes is associated with suppression of inflammatory activity in multiple sclerosis. We aimed to assess the safety and efficacy of atacicept, a recombinant fusion protein that suppresses B-cell function and antibody production. METHODS: In this placebo-controlled, double-blind, 36-week, phase 2 trial (ATAMS) in Australia, Canada, Europe, and the USA, patients aged 18-60 years with relapsing multiple sclerosis were randomly assigned via an interactive voice response system in a 1:1:1:1 ratio, stratified by geographical region, to receive weekly subcutaneous injections with atacicept (25, 75, or 150 mg) or placebo...
April 2014: Lancet Neurology
Stephen J Allen, Kathie Wareham, Duolao Wang, Caroline Bradley, Hayley Hutchings, Wyn Harris, Anjan Dhar, Helga Brown, Alwyn Foden, Michael B Gravenor, Dietrich Mack
BACKGROUND: Antibiotic-associated diarrhoea (AAD) occurs most frequently in older (≥65 years) inpatients exposed to broad-spectrum antibiotics. When caused by Clostridium difficile, AAD can result in life-threatening illness. Although underlying disease mechanisms are not well understood, microbial preparations have been assessed in the prevention of AAD. However, studies have been mostly small single-centre trials with varying quality, providing insufficient data to reliably assess effectiveness...
October 12, 2013: Lancet
Joseph B Muhlestein, Donald L Lappé, Joao A C Lima, Boaz D Rosen, Heidi T May, Stacey Knight, David A Bluemke, Steven R Towner, Viet Le, Tami L Bair, Andrea L Vavere, Jeffrey L Anderson
IMPORTANCE: Coronary artery disease (CAD) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus, yet CAD often is asymptomatic prior to myocardial infarction (MI) and coronary death. OBJECTIVE: To assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes...
December 3, 2014: JAMA: the Journal of the American Medical Association
R Scott Miller, Lindell K Weaver, Nazanin Bahraini, Susan Churchill, Robert C Price, Virginia Skiba, James Caviness, Scott Mooney, Brian Hetzell, Jun Liu, Kayla Deru, Richard Ricciardi, Susan Fracisco, Nicole C Close, Gerald W Surrett, Corinna Bartos, Margaret Ryan, Lisa A Brenner
IMPORTANCE: Improvement has been anecdotally observed in patients with persistent postconcussion symptoms (PCS) after mild traumatic brain injury following treatment with hyperbaric oxygen (HBO). The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date. OBJECTIVES: To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone, care supplemented with HBO, or a sham procedure. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado, North Carolina, California, and Georgia between April 26, 2011, and August 24, 2012...
January 2015: JAMA Internal Medicine
Patrick H Pun, Anne S Hellkamp, Gillian D Sanders, John P Middleton, Stephen C Hammill, Hussein R Al-Khalidi, Lesley H Curtis, Gregg C Fonarow, Sana M Al-Khatib
BACKGROUND: Sudden cardiac death is the leading cause of death among end-stage kidney disease patients (ESKD) on dialysis, but the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in this population is uncertain. We conducted this investigation to compare the mortality of dialysis patients receiving a primary prevention ICD with matched controls. METHODS: We used data from the National Cardiovascular Data Registry's ICD Registry to select dialysis patients who received a primary prevention ICD, and the Get with the Guidelines-Heart Failure Registry to select a comparator cohort...
May 2015: Nephrology, Dialysis, Transplantation
W E Mehling, A L Avins, M C Acree, T S Carey, F M Hecht
BACKGROUND: The 9-item STarT-Back screening tool was developed in primary care patients with low back pain (LBP) to identify those at greatest risk for chronic pain and requiring targeted treatment. We conducted a secondary data analysis study to examine the performance of comparable questionnaire items in a sample of primary care patients with well-defined acute LBP. METHODS: In a prospective cohort study, 605 primary care patients with LBP of less than 30 days answered a questionnaire with 6 items identical and 3 items analogous to the 9-item STarT-Back...
March 2015: European Journal of Pain: EJP
(no author information available yet)
The Folfiri protocol is often proposed to patients with metastatic colorectal cancer in relapse or treatment failure after the Folfox protocol. The benefit of adding a monoclonal antibody is far from certain. In two trials, addition of bevacizumab, a VEGF inhibitor, to a second-line regimen prolonged survival by about two months, at a cost of many additional serious or even life-threatening adverse effects. Aflibercept (Zaltrap, Sanofi Aventis), another VEGF inhibitor, has been authorised in the European Union as an adjunct to the Folfiri protocol in patients with metastatic colorectal cancer in treatment failure or relapse after a first-line regimen including oxaliplatin (Folfox protocol, for example)...
September 2014: Prescrire International
Anthony H V Schapira, Michael P McDermott, Paolo Barone, Cynthia L Comella, Stefan Albrecht, Helen H Hsu, Daniel H Massey, Yoshikuni Mizuno, Werner Poewe, Olivier Rascol, Kenneth Marek
BACKGROUND: In models of dopaminergic neuronal loss, the dopamine agonist pramipexole has exhibited neuroprotective properties. The Pramipexole On Underlying Disease (PROUD) study was designed to identify whether early versus delayed pramipexole initiation has clinical and neuroimaging benefits in patients with Parkinson's disease (PD). METHODS: Between May 24, 2006, and April 22, 2009, at 98 centres, we recruited patients with PD diagnosed within 2 years and aged 30-79 years...
August 2013: Lancet Neurology
Gilles Montalescot, Leonardo Bolognese, Dariusz Dudek, Patrick Goldstein, Christian Hamm, Jean-Francois Tanguay, Jurrien M ten Berg, Debra L Miller, Timothy M Costigan, Jochen Goedicke, Johanne Silvain, Paolo Angioli, Jacek Legutko, Margit Niethammer, Zuzana Motovska, Joseph A Jakubowski, Guillaume Cayla, Luigi Oltrona Visconti, Eric Vicaut, Petr Widimsky
BACKGROUND: Although P2Y12 antagonists are effective in patients with non-ST-segment elevation (NSTE) acute coronary syndromes, the effect of the timing of administration--before or after coronary angiography--is not known. We evaluated the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography if percutaneous coronary intervention (PCI) was indicated. METHODS: We enrolled 4033 patients with NSTE acute coronary syndromes and a positive troponin level who were scheduled to undergo coronary angiography within 2 to 48 hours after randomization...
September 12, 2013: New England Journal of Medicine
Marius N Stan, James A Garrity, Barbara G Carranza Leon, Thapa Prabin, Elizabeth A Bradley, Rebecca S Bahn
CONTEXT: Graves' orbitopathy (GO) is a potentially sight-threatening disease for which available medical therapy is not uniformly successful. Multiple case series suggest that rituximab (RTX) may be effective therapy for GO patients. OBJECTIVE: To determine the efficacy of RTX in GO. DESIGN: It is a prospective, randomized, double-masked, placebo-controlled trial. SETTING: The study was conducted at a large academic private practice...
February 2015: Journal of Clinical Endocrinology and Metabolism
Sabine L Vriezinga, Renata Auricchio, Enzo Bravi, Gemma Castillejo, Anna Chmielewska, Paula Crespo Escobar, Sanja Kolaček, Sibylle Koletzko, Ilma R Korponay-Szabo, Eckart Mummert, Isabel Polanco, Hein Putter, Carmen Ribes-Koninckx, Raanan Shamir, Hania Szajewska, Katharina Werkstetter, Luigi Greco, Judit Gyimesi, Corina Hartman, Caroline Hogen Esch, Erica Hopman, Anneli Ivarsson, Tunde Koltai, Frits Koning, Eva Martinez-Ojinaga, Chantal te Marvelde, Ana Pavic, Jihane Romanos, Els Stoopman, Vincenzo Villanacci, Cisca Wijmenga, Ricardo Troncone, M Luisa Mearin
BACKGROUND: A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled dietary-intervention study involving 944 children who were positive for HLA-DQ2 or HLA-DQ8 and had at least one first-degree relative with celiac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo...
October 2, 2014: New England Journal of Medicine
2014-10-24 13:24:51
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