Current medical research and opinion
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Randomized Controlled Trial
Long-term safety and efficacy, including anhedonia, of vortioxetine for major depressive disorder: findings from two open-label studies.
Evaluate the long-term safety and efficacy of vortioxetine in the management of major depressive disorder (MDD) in two open-label one-year studies, including a post-hoc analysis of its effects on symptoms related to anhedonia. ⋯ Data from both studies confirm the safety and efficacy of flexibly dosed vortioxetine over 52 weeks of treatment and demonstrate that MADRS anhedonia factor scores continue to improve with long-term maintenance treatment.
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Randomized Controlled Trial Multicenter Study
Early outcomes, associated factors and predictive values of clinical outcomes of tandospirone in generalized anxiety disorder: a post-hoc analysis of a randomized, controlled, multicenter clinical trial.
To examine the early outcomes, associated factors and predictive values of clinical outcomes of different tandospirone doses in patients with a generalized anxiety disorder (GAD). ⋯ The early outcomes of high-dose tandospirone in the treatment of GAD are better than those of the low-dose group. Patients with younger age at onset, milder anxiety symptoms and better physiological functions administered high-dose tandospirone showed rapid onset, great early outcomes, high recovery rate and good prognosis. Drug onset time had a good predictive effect on treatment outcome.
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Randomized Controlled Trial
Nutritional rehabilitation of malnourished children: are nutritional supplements a must?
Malnutrition threatens children worldwide. The objective of the current study was to highlight the role of nutritional screening, evaluate the effectiveness of nutritional intervention program, and whether nutritional supplements have surplus benefit. ⋯ Nutritional screening in pediatric outpatient facilities can lead to implementing prompt nutritional rehabilitation, which can reflect on the patients' overall health. Tailored nutritional plan can accomplish good response in terms of improvement of caloric intake, anthropometric measurements and laboratory parameters. Adding a nutritional supplement to the dietary plan during nutritional rehabilitation isn't a must but it ensures superior goal achievement.
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Randomized Controlled Trial Multicenter Study
Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial.
This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin. ⋯ Rapilin demonstrated non-inferior glycemic control, and matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks.
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Randomized Controlled Trial
Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.
The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6-12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT. ⋯ The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors.