摘要 :
We discuss the role of comparators in Helicobacter pylori treatment trials and why anti-H. pylori therapeutic trials (an infectious disease) are fundamentally different from common gastrointestinal diseases (e.g., the absence of a...
展开
We discuss the role of comparators in Helicobacter pylori treatment trials and why anti-H. pylori therapeutic trials (an infectious disease) are fundamentally different from common gastrointestinal diseases (e.g., the absence of a placebo response, the expectation that cure rates in excess of 95%, and the ability to understand why treatment fails). No comparator is absolutely required other than to 100% success and comparison trials should be limited to comparisons between therapies that reliably achieve 90% or greater success (i.e., good therapies). Comparisons with known low success regimens (i.e., bad therapies) are unethical as is withholding information from the subject regarding current effectiveness of a regimen even if that information would reduce the likelihood that the subject would volunteer. We also discuss how it is possible to predict the outcome of a published but locally untried new regimen. The reason for different outcomes of typical gastrointestinal therapies is shrouded in mystery. In contrast, treatment success for H. pylori should be predictable and treatment failures explainable. For too long expectations and analyses of H. pylori therapy has been confused with what is appropriate for gastrointestinal disease such as constipation or irritable bowel syndrome rather than for infectious diseases such as pneumonia.
收起
摘要 :
Introduction: It is estimated that 5%-10% of patients with newly diagnosed glioblastoma (GBM) fail to complete standard chemoradiation (CRT). We sought to determine the impact of failure to complete CRT on survival and to identify risk factors.
摘要 :
While the management of patients with cardiac insufficiency with systolic dysfunction is well established [1], that of cardiac insufficiency with preserved ejection fraction is not based on any evidence. This is why -even though t...
展开
While the management of patients with cardiac insufficiency with systolic dysfunction is well established [1], that of cardiac insufficiency with preserved ejection fraction is not based on any evidence. This is why -even though this pathology is present in more than 50% of patients with heart failure in clinical practice- only a minimal proportion of the latest European guidelines was devoted to this topic (one-quarter of a page within the 61 pages of recommendations and five of 270 references [1]). It also notably demonstrates the limits of the recommendations as well as the difficulty in writing the present paper, with its own limitations (it is a personal opinion and is therefore debatable).
收起
摘要 :
Abstract Two multicenter, randomized, placebo‐controlled, adaptive‐design trials of desvenlafaxine for fibromyalgia syndrome (FMS) were conducted. In study 1, male and female patients were randomized to a 27‐week treatment with...
展开
Abstract Two multicenter, randomized, placebo‐controlled, adaptive‐design trials of desvenlafaxine for fibromyalgia syndrome (FMS) were conducted. In study 1, male and female patients were randomized to a 27‐week treatment with placebo or desvenlafaxine 50, 100, 200, or 400 mg/d. In study 2, female patients were randomized to an 8‐week treatment with placebo, desvenlafaxine 200 mg/d, or pregabalin 450 mg/d after a placebo run‐in. The primary efficacy end point was change from baseline in numeric rating scale (NRS) pain score. Protocol‐specified interim analyses were planned after 12 (study 1) and 8 (study 2) weeks of treatment. Safety data were collected. In all, 697 patients were randomly assigned to treatment in study 1. At the interim analysis (n = 346), none of the desvenlafaxine doses met the efficacy criteria (mean [SE] advantage over placebo, –0.21 [0.36] to 0.04 [0.35]), and the study was terminated. Study 2 was stopped for business reasons before the planned interim analysis. NRS scores in week 8 were –1.98 (0.37), –1.60 (0.37), and –1.70 (0.38) for placebo (n = 26), desvenlafaxine 250 mg/d (n = 24), and pregabalin 450 mg/d (n = 21), respectively; neither active treatment differed significantly from placebo. Desvenlafaxine was generally safe and well tolerated. Efficacy of desvenlafaxine for pain associated with FMS was not demonstrated.
收起
摘要 :
Abstract Two multicenter, randomized, placebo‐controlled, adaptive‐design trials of desvenlafaxine for fibromyalgia syndrome (FMS) were conducted. In study 1, male and female patients were randomized to a 27‐week treatment with...
展开
Abstract Two multicenter, randomized, placebo‐controlled, adaptive‐design trials of desvenlafaxine for fibromyalgia syndrome (FMS) were conducted. In study 1, male and female patients were randomized to a 27‐week treatment with placebo or desvenlafaxine 50, 100, 200, or 400 mg/d. In study 2, female patients were randomized to an 8‐week treatment with placebo, desvenlafaxine 200 mg/d, or pregabalin 450 mg/d after a placebo run‐in. The primary efficacy end point was change from baseline in numeric rating scale (NRS) pain score. Protocol‐specified interim analyses were planned after 12 (study 1) and 8 (study 2) weeks of treatment. Safety data were collected. In all, 697 patients were randomly assigned to treatment in study 1. At the interim analysis (n = 346), none of the desvenlafaxine doses met the efficacy criteria (mean [SE] advantage over placebo, –0.21 [0.36] to 0.04 [0.35]), and the study was terminated. Study 2 was stopped for business reasons before the planned interim analysis. NRS scores in week 8 were –1.98 (0.37), –1.60 (0.37), and –1.70 (0.38) for placebo (n = 26), desvenlafaxine 250 mg/d (n = 24), and pregabalin 450 mg/d (n = 21), respectively; neither active treatment differed significantly from placebo. Desvenlafaxine was generally safe and well tolerated. Efficacy of desvenlafaxine for pain associated with FMS was not demonstrated.
收起
摘要 :
Purpose Antibiotic treatment is the treatment of choice for uncomplicated diverticulitis (uD) and can be performed for mild complicated diverticulitis (mcD). In several cases, outpatient treatment (OT) can be undertaken. This stud...
展开
Purpose Antibiotic treatment is the treatment of choice for uncomplicated diverticulitis (uD) and can be performed for mild complicated diverticulitis (mcD). In several cases, outpatient treatment (OT) can be undertaken. This study assessed the 1-month failure rate of OT for uD/mcD compared to inpatient treatment (IT), and identified predictive factors for treatment failure.
收起
摘要 :
Botulinum toxin (BoNT) is highly effective in the treatment of cervical dystonia (CD), yet a significant proportion of patients report low levels of satisfaction following treatment and fail to follow up for repeated treatments. T...
展开
Botulinum toxin (BoNT) is highly effective in the treatment of cervical dystonia (CD), yet a significant proportion of patients report low levels of satisfaction following treatment and fail to follow up for repeated treatments. The goal of this study was to determine the reasons that some patients have unsatisfactory responses. A total of 35 subjects who came to our center requesting alternative treatments due to unsatisfactory responses following BoNT treatment for CD were evaluated. Included were 26 women and 9 men with an average age of 57.1 years (range 25-82 years), and an average duration of illness of 12.5 years (range 1-55 years). Details of unsatisfactory BoNT treatments were methodically collected by a movement specialist using a standardized intake form, including provider subspecialty, product used, the number of satisfactory or unsatisfactory trials, doses given, specific muscles treated, the use of electromyographic guidance, side effects, and tests of resistance. The specialist then provided repeat treatments if indicated, and followed each case until the reasons for unsatisfactory outcomes could be determined. Multiple reasons for unsatisfactory outcomes were found. They included suboptimal BoNT doses, suboptimal muscle targeting, intolerable side effects, complex movement patterns, discordant perceptions, and incorrect diagnoses. Only one patient was functionally resistant to BoNT. Of 32 subjects who received repeat BoNT treatments, 25 (78 %) achieved satisfactory responses after revision of the original treatment plan. These results indicate that the majority of unsatisfactory responses to BoNT treatment of CD were caused by correctible factors and imply a need for improved education regarding optimal treatment methods.
收起
摘要 :
Despite considerable progress in treating cardiac disorders, the prevalence of heart failure (HF) keeps growing, making it a global medical and economic burden. HF is characterized by profound metabolic remodeling, which mostly oc...
展开
Despite considerable progress in treating cardiac disorders, the prevalence of heart failure (HF) keeps growing, making it a global medical and economic burden. HF is characterized by profound metabolic remodeling, which mostly occurs in the mitochondria. Although it is well established that the failing heart is energy-deficient, the role of mitochondria in the pathophysiology of HF extends beyond the energetic aspects. Changes in substrate oxidation, tricarboxylic acid cycle and the respiratory chain have emerged as key players in regulating myocardial energy homeostasis, Ca2+ handling, oxidative stress and inflammation. This work aims to highlight metabolic alterations in the mitochondria and their far-reaching effects on the pathophysiology of HF. Based on this knowledge, we will also discuss potential metabolic approaches to improve cardiac function.
收起
摘要 :
The newly available clinical guidelines in heart failure (HF) from Europe (2012), the United States (2010 and 2013), and Canada (2015) were compared, focusing on the systems for grading the evidence and classifying the recommendat...
展开
The newly available clinical guidelines in heart failure (HF) from Europe (2012), the United States (2010 and 2013), and Canada (2015) were compared, focusing on the systems for grading the evidence and classifying the recommendations, HF definitions, pharmacologic treatment, and devices used in HF. Some gaps were evident in the methodology for assessing evidence or in HF definitions. Pharmacologic treatments and recommendations for cardiac resynchronization therapy and implantable cardioverter-defibrillators are similar but some differences need to be considered by the practicing clinician. Guideline recommendations regarding new emergent treatments are becoming available.
收起
摘要 :
Background and objective Clinical evaluation of pacing therapy in mitigating the aortic insufficiency after transchateter aortic valve implantation often gives contradictory outcomes. This study presents an in vitro investigation ...
展开
Background and objective Clinical evaluation of pacing therapy in mitigating the aortic insufficiency after transchateter aortic valve implantation often gives contradictory outcomes. This study presents an in vitro investigation aimed at clarifying the effect of pacing on paravalvular leakage.Methods A series of in vitro tests reproducing the heart operating changes clinically obtained by pacing was carried out in a 26?mm Edwards Sapien XT prosthesis with mild paravalvular leakage. The effect of pacing on the regurgitant volumes per cycle and per minute was quantified, and the energy and power consumed by the left ventricle were calculated.Results Results indicate that though pacing results in some reduction in the total regurgitation per cycle, the volume of fluid regurgitating per minute increases substantially, causing overload of left ventricle.Conclusions Our tests indicate no effective haemodynamic benefit from pacing, suggesting a prudential clinical use of this therapy for the treatment of postoperative aortic regurgitation.
收起
原文获取