Nam S.Y.,Center for Cancer Prevention and Detection |
Choi I.J.,Center for Gastric Cancer |
Ryu K.H.,Center for Cancer Prevention and Detection |
Park B.J.,Center for Cancer Prevention and Detection |
And 2 more authors.
Gastroenterology | Year: 2010
Background & Aims Data on the association between erosive esophagitis and obesity are inconsistent because of variations in study populations and methods used to determine obesity. Methods Participants in a prospective health-screening cohort underwent esophagogastroduodenoscopy and computed tomography. The association between erosive esophagitis and obesity (measured by body mass index [BMI], waist circumference, and abdominal visceral adipose tissue volume) was estimated with odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for confounding factors. We also analyzed the association between obesity and erosive esophagitis by sex. Results The prevalence of erosive esophagitis was 9.3% (495/5329). The OR for erosive esophagitis correlated with obesity measured by BMI, waist circumference, and abdominal visceral adipose tissue volume (P < .001 for each factor). The multivariate OR for erosive esophagitis was 1.97 (95% CI: 1.342.90) for a visceral adipose tissue volume of 500999 cm3, 2.27 (95% CI: 1.513.39) for 10001499 cm3, and 2.94 (95% CI: 1.874.62) for <1500 cm3, compared with participants who had visceral adipose tissue volumes less than 500 cm3. When measures of obesity were analyzed simultaneously, abdominal visceral adipose tissue volume, but not BMI or waist circumference, was associated with erosive esophagitis. The 3 measures of obesity were significantly associated with erosive esophagitis in males, but only visceral adipose tissue volume was associated with erosive esophagitis in females (P = .002). Conclusions In contrast to BMI or waist circumference, abdominal visceral adipose tissue volume is associated with an increased risk of erosive esophagitis in males and females. © 2010 AGA Institute. Source
Akpek E.K.,Wilmer Eye Institute |
Lindsley K.B.,Center for Clinical Trials |
Adyanthaya R.S.,Wilmer Eye Institute |
Swamy R.,Wilmer Eye Institute |
And 2 more authors.
Ophthalmology | Year: 2011
Background: Outcomes-based review of reported treatment options for patients with dry eye secondary to Sjögren's syndrome (SS). Clinical Relevance: Dry eye affects many individuals worldwide. Significant proportion of patients with dry eye has underlying SS, a progressive autoimmune condition. The few suggested guidelines for the treatment of dry eye are mostly based on severity of symptoms and/or clinical findings rather than on outcomes analysis, and do not differentiate SS from other causes of dry eye. Methods and Literature Review: A search strategy was developed to identify prospective, interventional studies of treatments for SS-associated dry eye from electronic databases. Eligible references were restricted to English-language articles published after 1975. These sources were augmented by hand searches of reference lists from accessed articles. Study selection, data extraction, and grading of evidence were completed independently by <4 review authors. Results: The searches identified 3559 references as of August 10, 2010. After duplicate review of the titles and abstracts, 245 full-text papers were assessed, 62 of which were relevant for inclusion in the review. Conclusions: In the current literature on SS-associated dry eye, there is a paucity of rigorous clinical trials to support therapy recommendations. Nonetheless, the recommended treatments include topical lubricants, topical anti-inflammatory therapy, and tear-conserving strategies. The efficacy of oral secretagogues seems greater in the treatment of oral dryness than ocular dryness. Although oral hydroxychloroquine is commonly prescribed to patients with SS to alleviate fatigue and arthralgias, the literature lacks strong evidence for the efficacy of this treatment for dry eye. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. © 2011 American Academy of Ophthalmology. Source
Standardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: A randomized, double-blind, placebo-controlled trial
Mosbech H.,Copenhagen University |
Deckelmann R.,Center for Clinical Trials |
De Blay F.,University of Strasbourg |
Pastorello E.A.,Ospedale Niguarda Ca Granda |
And 3 more authors.
Journal of Allergy and Clinical Immunology | Year: 2014
Background Investigations meeting current standards are limited for the effect of house dust mite (HDM) allergy immunotherapy in asthmatic patients. Objective This trial investigated the efficacy and safety of a standardized quality (SQ; allergen standardization method proprietary to the trial sponsor) HDM SLIT-tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease. This publication reports the results of the endpoints related to asthma. Methods Six hundred four subjects 14 years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized 1:1:1:1 to double-blind daily treatment with one of 3 active doses (1, 3, or 6 SQ-HDM) or placebo. Their use of inhaled corticosteroid (ICS) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control. The primary end point was a reduction in ICS dose from the individual subject's baseline dose after 1 year of treatment. Results The primary analysis revealed a mean difference between 6 SQ-HDM and placebo in the reduction in daily ICS dose of 81 μg (P =.004). Relative mean and median reductions were 42% and 50% for 6 SQ-HDM and 15% and 25% for placebo, respectively. No statistically significant differences were observed for the other assessed asthma parameters, reflecting the intended controlled status of the trial subjects. The most common adverse events were local reactions in the mouth. The rate and severity of adverse events were higher for 3 and 6 SQ-HDM than for 1 SQ-HDM and placebo. Conclusion Efficacy in mild-to-moderate asthma of 6 SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control. All active doses were well tolerated. © 2014 The Authors. Published by Elsevier Inc. Source
Chalmers I.,James Lind Initiative |
Dickersin K.,Center for Clinical Trials
F1000Research | Year: 2013
Stephen Senn challenges Ben Goldacre's assertion in 'Bad Pharma' that biased editorial acceptance of reports with 'positive' findings is not a cause of biased under-reporting of research. We agree with Senn that biased editorial decisions may contribute to reporting bias, but Senn ignores the evidence that biased decisions by researchers to submit reports for possible publication are the main causes of the problem. © 2013 Chalmers I et al. Source
Chan A.-W.,University of Toronto |
Song F.,University of East Anglia |
Vickers A.,Sloan Kettering Cancer Center |
Jefferson T.,Cochrane Collaboration |
And 7 more authors.
The Lancet | Year: 2014
The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally aff ected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets. Source