Current Issue : July - September Volume : 2020 Issue Number : 3 Articles : 5 Articles
Abstract: Objectives: Fibromyalgia syndrome (FMS) is a chronic clinical condition characterized by\npain, fatigue, altered sleep, and cognitive disturbances. The purpose of this study was to compare\ntwo alternative treatments (nutraceutical and acupuncture) in FMS patients through a randomized\nclinical trial. Research Methods: A total of 60 FMS female patients were randomized for treatment\nwith a nutritional combination containing coenzyme Q10, vitamin D, alpha-lipoic acid, magnesium,\nand tryptophan................
Abstract: Treating sarcopenia in older individuals remains a challenge, and nutritional interventions\npresent promising approaches in individuals that perform limited physical exercise. We assessed\nthe efficacy of leucine administration to evaluate whether the regular intake of this essential amino\nacid can improve muscle mass, muscle strength and functional performance and respiratory muscle\nfunction in institutionalized older individuals. The study was a placebo-controlled, randomized,\ndouble-blind design in fifty participants aged 65 and over (ClinicalTrials.gov identifier NCT03831399).\nThe participants were randomized to a parallel group intervention of 13 weeksâ?? duration with a daily\nintake of leucine (6 g/day) or placebo (lactose, 6 g/day). The primary outcome was to study the\neffect on sarcopenia and respiratory muscle function. The secondary outcomes were changes in\nthe geriatric evaluation scales, such as cognitive function, functional impairment and nutritional\nassessments. We also evaluated whether leucine administration alters blood analytical parameters and\ninflammatory markers. Administration of leucine was well-tolerated and significantly improves some\ncriteria of sarcopenia in elderly individuals such as functional performance measured by walking\ntime (p=0.011), and improved lean mass index. For respiratory muscle function, the leucine-treated\ngroup improved significantly (p=0.026) in maximum static expiratory force compared to the\nplacebo. No significant effects on functional impairment, cognitive function or nutritional assessment,\ninflammatory cytokines IL-6, TNF-alpha were observed after leucine administration compared to the\nplacebo. The use of l-leucine supplementation can have some beneficial effects on sarcopenia and\ncould be considered for the treatment of sarcopenia in older individuals....
Abstract: In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to\ntreat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the\ndouble-blind phase of this randomized, controlled trial, we compared the efficacy and safety of\n400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups\nreceived 240UonabotulinumtoxinA injected in the forearm. An additional 160UonabotulinumtoxinA\n(400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar\nmuscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors\nwas greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U\ngroup). Functional disabilities improved in both groups. No substantial difference was found in\nsafety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U\nonabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar\nefficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed.\nThis final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a\nwide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new\nsafety concerns were identified. The dosing data in the open-label phase will inform optimal use of\nonabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167)....
Clinical research on neglected tropical diseases is a challenge in low-resource countries,\nand the contribution of clinical and operational research to health system strengthening is poorly\ndocumented. Developing new, simple, safe, and effective treatments may improve the effectiveness of\nhealth systems, and conducting research directly in health structures may have an additional impact.\nThis study describes the process of conducting clinical trials in the Democratic Republic of Congo\n(DRC) in compliance with international standards, and the role of the trials in strengthening health\nsystem functions, including governance, human resources, health information, provision of care,\nand the equipping of health services with the necessary supplies and infrastructure. We conclude\nthat conducting clinical trials in endemic areas has not only reinforced and supported the aim of\nconducting high-level clinical research in endemic countries, but has also brought lasting benefits to\nresearchers, staff, and hospitals, as well as to broader health systems, which have positive knock-on\neffect on patients outside of the clinical trials and their communities. Sustainability, however, remains\na challenge in an underfunded health system, especially with respect to specialized equipment.\nClinical research in most of sub-Saharan Africa is highly dependent on international input and\nexternal technical support; there are areas of weaknesses in trial design and documentation, as well\nas in data management and analysis. Financing remains a critical issue, as African investigators have\ndifficulties in directly accessing sources of international research funding....
Mindfulness-based interventions have emerged as unique approaches for addressing a\nrange of clinical and subclinical diffculties such as stress, chronic pain, anxiety, or recurrent depression.\nMoreover, there is strong evidence about the positive effects of yoga practice on stress management\nand prevention of burnout among healthcare workers. The aim of this study was to conduct a\nsingle-arm clinical trial to assess the effectiveness of an intervention based on mindfulness-based\nstress reduction and yoga in improving healthcare workersâ?? quality of life. Healthcare workers of two\nhospitals in Rome were enrolled in a 4-week yoga and mindfulness course. Four questionnaires were\nadministered at dfferent times (Short Form-12 (SF-12), State-Trait Anxiety Inventory (STAI) Y1 and\nY2, and Positive and Negative Affect Schedule (PANAS)) to evaluate the efficacy of the intervention.\nForty participants took part to the study (83.3 %). The Mental Composite Score-12, that is part of\nthe quality of life assessment, passed from a median of 43.5 preintervention to 48.1 postintervention\n(p=0.041), and the negative affect passed from a score of 16 in the preintervention to 10 in the\npostintervention (p < 0.001). Both the forms of the STAI questionnaires showed a decrease after the\nintervention. Yoga and mindfulness administered together seem to be eective to reduce stress and\nanxiety in healthcare workers, providing them with more consciousness and ability to manage work\nstressful demands....
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