Pregabalin is effective in reducing fibromyalgia pain
Commentary on: Derry S, Cording M, Wiffen PJ, et al.. Pregabalin for pain in fibromyalgia in adults. Cochrane Database Syst Rev 2016;9:CD011790. Context Anticonvulsants have been widely used in pain management for more than 50 years. Published neuropathic pain treatment guidelines have suggested their use, especially for neuropathic pain.1 The review by Derry et al focuses on the use of one such agent, pregabalin, in the treatment of fibromyalgia, an accepted and validated but heterogeneous condition in which diagnosis is made through history, physical examination and the exclusion of other diseases explaining the key...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Argoff, C. Tags: Therapeutics/Prevention Source Type: research

SGLT2 inhibitor empagliflozin reduces renal outcomes and dampens the progressive reduction in glomerular filtration rate in patients with type 2 diabetes and antecedents of cardiovascular disease
Commentary on: Wanner C, Inzucchi SE, Lachin JM, et al.. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med 2016;375:323–34. Context Patients with type 2 diabetes (T2D) are exposed to a high risk of cardiovascular disease (CVD) and premature mortality. A multirisk approach has proven to reduce both major cardiovascular events and mortality.1 However, improved longevity may lead to a higher risk of developing other diabetic complications, among which chronic kidney disease represents a major burden. Inhibitors of renal sodium-glucose cotransporters type 2 (SGLT2) are oral glucose-lowering...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Scheen, A. J. Tags: Therapeutics/Prevention Source Type: research

Placing preterm infants on their side at birth does not increase 5 min SpO2
Commentary on: Stenke E, Kieran EA, McCarthy LK, et al.. A randomised trial of placing infants on their back or left side after birth. Arch Dis Child Fetal Neonatal Ed 2016;101:F397–400. Placing preterm infants on their side appears to improve oxygenation and breathing patterns after1 2 and at birth.3 Current neonatal guidelines do not recommend any particular position,4 but previous guidelines5 6 suggested that infants could either be placed on their back or their sides during resuscitation or stabilisation. Preterm infants have floppy airways that may exacerbate respiratory distress leading to the assumption in th...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Oei, J. L. Tags: Therapeutics/Prevention Source Type: research

CPAP did not reduce cardiovascular events in patients with coronary or cerebrovascular disease and moderate to severe obstructive sleep apnoea
Commentary on: McEvoy RD, Antic NA, Heeley E, et al.. CPAP for prevention of cardiovascular events in obstructive sleep apnea. N Engl J Med 2016;375:919–31 Context Cardiovascular disease (CVD) is a major health problem globally. Many of the traditionally recognised risk factors contributing to adverse outcomes in these patients are managed in secondary prevention models. Obstructive sleep apnoea (OSA), a common condition in such patients,1 has been largely neglected. The first-line treatment of OSA is nasal continuous positive airway pressure (CPAP) treatment, which reduces daytime sleepiness and improves quality of ...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Peker, Y., Strollo, P. J. Tags: Therapeutics/Prevention Source Type: research

General practices that reduce antibiotic prescribing for self-limiting respiratory tract infections by 10% can expect to see one extra patient with pneumonia each year and one peritonsillar abscess each decade
This study explored whether the incidence of specific infective complications was higher in patients registered with general practices that prescribed fewer antibiotics for self-limiting RTIs. Methods This was a retrospective observational cohort study using routinely collected data from 2005 to 2014 in the... (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: van Hecke, O., Butler, C. C. Tags: Therapeutics/Prevention Source Type: research

Stress management training should be an integral component of cardiac rehabilitation
Commentary on: Blumenthal JA, Sherwood A, Smith PJ, et al.. Enhancing cardiac rehabilitation with stress management training: a randomized, clinical efficacy trial. Circulation 2016;133:1341–50. Context There is mounting evidence that psychosocial risk factors, including stress, anxiety, depression and social isolation, impede recovery after acute cardiac events and are associated with increased morbidity and premature death.1 While cardiac rehabilitation (CR) is the standard care for patients after an acute event, and has been shown to improve survival,2 it does not routinely address psychosocial risks or assist pat...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Murphy, B. M. Tags: Therapeutics/Prevention Source Type: research

Thalamotomy using MRI-guided focused ultrasound significantly improves contralateral symptoms and quality of life in essential tremor
Commentary on: Elias WJ, Lipsman N, Ondo WG, et al.. A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med 2016;375:730–9. Context Propranolol and primidone significantly reduce tremor by around 60% in 50% of patients with essential tremor (ET). When medication is ineffective or causes intolerable side effects, neurosurgical intervention may be considered. Until recently, radiofrequency (RF) ablation or deep brain stimulation (DBS) of the ventralis intermedius (VIM) thalamic nucleus were the main surgical options. Gamma knife thalamotomy avoids a burrhole but delayed effects make int...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Zrinzo, L. Tags: Therapeutics/Prevention Source Type: research

Nasal continuous positive airway pressure outperforms heated high-flow nasal cannula therapy as primary respiratory therapy in preterm infants
Commentary on: Roberts CT, Owen LS, Manley BJ, et al.. Nasal high-flow therapy for primary respiratory support in preterm infants. N Engl J Med 2016;375:1142–51. Context High-flow nasal cannula (HFNC) therapy for preterm newborn infants has quickly gained popularity,1 despite few studies evaluating the underlying mechanisms and lack of high-quality studies evaluating its efficacy.2 Our recent systematic review and meta-analysis,3 and the Cochrane review4 suggested that HFNC therapy was comparable in efficacy to continuous positive airway pressure (CPAP) as a primary mode of support in preterm infants at birth, for re...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Kotecha, S. J., Chakraborty, M., Kotecha, S. Tags: Therapeutics/Prevention Source Type: research

Single dose of prophylactic oral dextrose gel reduces neonatal hypoglycaemia
Commentary on: Hegarty JE, Harding JE, Gamble GD, et al.. Prophylactic oral dextrose gel for newborn babies at risk of neonatal hypoglycaemia: a randomised controlled dose-finding trial (the Pre-hPOD Study). PLoS Med 2016;13:e1002155. Context Oral dextrose gel is a novel therapeutic option to manage asymptomatic neonatal hypoglycaemia. Previous studies1–3 have shown that the use of 40% buccal dextrose gel along with feeds reduces the need for intravenous dextrose therapy, promotes maternal infant bonding and reduces cost. The ease of administering the dextrose gel via the buccal mucosa2 and improvement in breastfeedi...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Chandrasekharan, P., Lakshminrusimha, S. Tags: Therapeutics/Prevention Source Type: research

Decompressive craniectomy for severe traumatic brain injury reduces mortality but increases survival with severe disability
Commentary on: Hutchinson PJ, Kolias AG, Timofeev IS, et al.. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med 2016;375:1119–30. Context There is little doubt that decompressive craniectomy can reduce mortality in traumatic brain injury; this was clearly demonstrated by previous trials investigating the efficacy of decompressive hemicraniectomy following ischaemic stroke.1 However, surgical decompression will not reverse the effects of the pathology that precipitated the neurological crisis and the concern has always been that the reduction in mortality comes at the cost of an ...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Honeybul, S. Tags: Therapeutics/Prevention Source Type: research

Having your cake and EATing it too: early timing of multiple allergen introduction does not increase the risk of developing food allergy in standard risk, breastfed infants
In this study, 1303 exclusively breastfed infants with no risk... (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Greenhawt, M., Venter, C. Tags: Therapeutics/Prevention Source Type: research

In simulation modelling, there are multiple ways to effectively screen for colorectal cancer
Commentary on: Knudsen AB, Zauber AG, Rutter CM, et al.. Estimation of Benefits, Burden, and Harms of Colorectal Cancer Screening Strategies: Modeling Study for the US Preventive Services Task Force. JAMA 2016;315(23):2595–609. Context Of the available colorectal cancer (CRC) screening tests, only flexible sigmoidoscopy and faecal occult blood tests have been evaluated with randomized controlled trials (RCTs). Colonoscopy and faecal immunochemical tests (FITs) are commonly used for CRC screening, but RCT evidence will not be available for at least a decade. Methods For its 2016 CRC screening recommendation, the US Pr...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Levin, T. R. Tags: Therapeutics/Prevention Source Type: research

Semaglutide is non-inferior to placebo for cardiovascular outcomes in patients with type 2 diabetes
Commentary on: Marso SP, Bain SC, Consoli A, et al.. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. NEJM 2016;375:1834–44. Context Semaglutide is a glucagon-like peptide 1 (GLP-1) analogue under development for the treatment of type 2 diabetes. It is molecularly related to liraglutide but has a longer half-life, requiring once weekly dosing. US Food and Drug Administration (FDA) regulatory guidance requires evidence that new therapies for type 2 diabetes are not associated with an unacceptable increase in cardiovascular risk.1 2 This is defined as evidence that compared with placebo the ris...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Campbell-Scherer, D. Tags: Editor's choice Therapeutics/Prevention Source Type: research

Reflections on using non-inferiority randomised placebo controlled trials in assessing cardiovascular safety of new agents for treatment of type 2 diabetes
The 2008 Food and Drug Administration (FDA) guidance to industry requires experimental evidence that new agents to treat type 2 diabetes do not have an unacceptable increase in cardiovascular risk. They specify this unacceptable increase to be a risk ratio of 1.3 in non-inferiority trials which may use placebo control. Clinically, this means that if a new agent achieves this threshold of not being 30% worse than placebo it is declared ‘non-inferior’. This guidance was in response to safety concerns raised about medications approved on their basis of reducing glycated haemoglobin alone. There was concern that th...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Campbell-Scherer, D. Tags: Editor's choice Perspective Source Type: research

The Maimed Martian, credible intervals and bias against benefit
The objective prior knowledge that is available is the fact that there were researchers who felt it worthwhile to conduct the trial and journal editors who felt it worthwhile publishing the results. It is shown here that the use of this information contracts the width of the log CI by a factor of about three quarters on average. Unlike standard CIs, these new intervals also have the advantage of being directly interpretable in terms of probabilities. These probabilities also enable calculation of improved point estimates. These calculations are applied to 100 randomly selected Cochrane systematic reviews and show serious p...
Source: Evidence-Based Medicine - March 23, 2017 Category: Internal Medicine Authors: Kault, D. Tags: Methods Source Type: research