Current medical research and opinion
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This post hoc analysis assessed improvements in a broad range of psychopathological dimensions and in interference of pain with functioning as well as the time course of these improvements in patients with major depressive disorder (MDD) and pain treated with duloxetine versus placebo. ⋯ Pain was only assessed as a symptom and no further clinical diagnosis for pain syndromes were performed. CLINICAL TRIAL REGISTRY ID: www.clinicaltrial.gov - NCT00191919.
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The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.
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Randomized Controlled Trial Multicenter Study Comparative Study
Preference for a new prefilled insulin pen compared with the original pen.
The prevalence of diabetes is increasing in the United States and worldwide. Insulin injection pens are preferred over vial/syringe methods, and are designed to facilitate use, improve adherence, and provide accurate insulin delivery. ⋯ FT was found to be comparable to FP with respect to the efficacy and safety profile. Significantly more subjects favored the FT device in terms of ease of use, insulin injection, diabetes management, and overall preference. A limitation of the present study was its open-label design because the pen devices used to administer the insulin were distinctively different and the use of a double-dummy design was precluded by the absence of placebo pen devices. The questionnaires about treatment were related to the use of the device and therefore a blinded study was not possible.
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Randomized Controlled Trial
Safety and pharmacokinetic evaluation of intravenous colistin methanesulfonate sodium in Japanese healthy male subjects.
The study aimed at evaluating the pharmacokinetics of colistin methanesulfonate sodium (CMS-Na) and describing observed safety findings in Japanese healthy male subjects. ⋯ CMS-Na was safely administered to healthy volunteers but resulted in transient increase of urinary N-acetyl-β-D-glucosaminidase (NAG) and protein. Based on this study, the highest recommended dose of CMS-Na had sufficient bacteriostatic effect.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy of topical 10% urea-based lotion in patients with ichthyosis vulgaris: a two-center, randomized, controlled, single-blind, right-vs.-left study in comparison with standard glycerol-based emollient cream.
Ichthyoses are genetic disorders of keratinization which are uncomfortable due to their conspicuous scaling, itching and cosmetic problems. Ichthyoses can lead to social discrimination and psychological problems. Ichthyosis vulgaris (IV) is the most common form of these geno-dermatoses. IV is a chronic disorder that often requires continuous therapy. Emollient and keratolytic products are the mainstay treatments of IV. It is important that efficient, safe and well tolerated therapies should be available. Direct comparative data regarding efficacy of different emollient products in IV patients are very few. ⋯ Ureadin Rx 10 lotion has shown a greater efficacy on ichthyosis vulgaris in term of reduction of scaling, roughness, redness and cracking in comparison with a glycerol-based emollient cream. Tolerability of the two topical treatments was comparable. Further studies with larger sample sizes are needed for the evaluation of safety and tolerability of urea 10% lotion in this clinical setting.