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Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.
Lara-Guzmán, OJ, Medina, S, Álvarez, R, Oger, C, Durand, T, Galano, JM, Zuluaga, N, Gil-Izquierdo, Á, Muñoz-Durango, K
Free radical biology & medicine. 2020;:604-617
Abstract
Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F2t-isoprostanes (F2t-IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).
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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial.
Ni, J, Chen, H, Chen, G, Ji, Y, Yi, F, Zhang, Z, Yang, Y, Wu, J, Cai, X, Shao, B, et al
BMC neurology. 2020;(1):282
Abstract
BACKGROUND Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke. METHODS Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram. RESULTS In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups. CONCLUSIONS The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported. TRIAL REGISTRATION Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.
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Incorporation of Astragalus polysaccharides injection during concurrent chemoradiotherapy in advanced pharyngeal or laryngeal squamous cell carcinoma: preliminary experience of a phase II double-blind, randomized trial.
Hsieh, CH, Lin, CY, Hsu, CL, Fan, KH, Huang, SF, Liao, CT, Lee, LY, Ng, SK, Yen, TC, Chang, JT, et al
Journal of cancer research and clinical oncology. 2020;(1):33-41
Abstract
PURPOSE Concurrent chemoradiotherapy (CCRT) is one of the standard treatments for patients with advanced head and neck squamous cell carcinoma (HNSCC). However, CCRT may lead to decreased quality of life (QoL) and treatment compliance. This study aimed to determine the effects of PG2 (Astragalus polysaccharides) injection on CCRT-associated adverse events (AEs) and patients' compliance with the CCRT course. METHODS In this phase II double-blind randomized placebo-controlled trial, PG2 injection (sterile powder form) or placebo was administrated three times per week in parallel with CCRT to patients with HNSCC. The chemotherapy regimen included 50 mg/m2 cisplatin every 2 weeks with daily tegafur-uracil (300 mg/m2) and leucovorin (60 mg/day). RESULTS The study was terminated prematurely due to the successful launch of a newly formulated PG2 injection (lyophilized form). A total of 17 patients were enrolled. The baseline demographics and therapeutic compliance were comparable between the CCRT/PG2 and CCRT/placebo groups. During CCRT, severe treatment-associated AEs were less frequent in the CCRT/PG2 group than in the CCRT/placebo group. Furthermore, less QoL fluctuations from the baseline during CCRT were noted in the CCRT/PG2 group than in the CCRT/placebo group, with a significant difference in the pain, appetite loss, and social eating behavior. The tumor response, disease-specific survival and overall survival did not differ between the two groups. CONCLUSION This preliminary study demonstrated PG2 injection exhibited an excellent safety profile, and has potential in ameliorating the deterioration in QoL and the AEs associated with active anticancer treatment among patients with advanced pharyngeal or laryngeal HNSCC under CCRT. Further research in patients with other cancer types or treatment modalities may widen PG2's application in clinical settings.
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Manual Physical Therapy in the Treatment of Functional Constipation in Children: A Pilot Randomized Controlled Trial.
Blanco Díaz, M, Bousoño García, C, Segura Ramírez, DK, Rodríguez Rodriguez, ÁM
Journal of alternative and complementary medicine (New York, N.Y.). 2020;(7):620-627
Abstract
Objectives: Make a preliminary assessment of the efficacy of manual physical therapy (MPT) compared to conventional pharmacologic treatment (CPT) in chronic pediatric functional constipation (CPC). Design: A pilot randomized and controlled trial was conducted. Settings/Location: Subjects were recruited in a tertiary university hospital in the north of Spain. Subjects: Forty-seven children (2-14 years) were included. Participants were assessed by Pediatric Gastroenterologist. They were recruited in a tertiary university hospital. Subjects were randomly allocated. MPT was performed in a private clinic. Interventions: Control group (CG) received CPT and intervention group (IG) received MPT, consisting in nine sessions of MPT with a 45-min initial session and 30 min for the rest of sessions distributed weekly during the first and second months and biweekly in the third month. Outcome Measures: At times 0-1-3 months and 5 years, results obtained were checked and compared, according to the defecatory pattern ("Symptom Severity Score" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF). Results: Results from SSS, BSFS, and DF revealed no statistically significant differences between groups in median values at any follow-up. However, there were significant changes over time. The full sample median for SSS was reduced from baseline 24 (interquartile range 20-27) to 11 (6-13) at month 1, 7 (3-13) at month 3, (8 CG; 5 IG), and 5 (1-12) at year 5. The BSFS scale increased from 2 (1-3) at baseline to 4 (3-4) at month 1 and year 5. DF increases progressively from 1 per week to 5 in the fifth year. Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores. Conclusions: This study gives preliminary evidence of no difference between MPT and CPT for improvement in measures of CPC, although there was some advantage for MPT in quality of life. Study results justify the conduct of a full-scale efficacy trial of MPT, as well as a noninferiority trial comparing MPT and CPT.
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Beta alanine supplementation effects on metabolic contribution and swimming performance.
Norberto, MS, Barbieri, RA, Bertucci, DR, Gobbi, RB, Campos, EZ, Zagatto, AM, De Freitas, EC, Papoti, M
Journal of the International Society of Sports Nutrition. 2020;(1):40
Abstract
BACKGROUND Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. METHODS Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day- 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La-]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). RESULTS No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). CONCLUSIONS Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn't affect metabolic contribution and performance during 400-m freestyle.
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[Clinical observation on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy].
Liu, XX, Wu, JY, Zhao, Y
Zhongguo zhen jiu = Chinese acupuncture & moxibustion. 2020;(8):805-9
Abstract
OBJECTIVE To observe the clinical effect on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy. METHODS A total of 46 patients with post-stroke oculomotor nerve palsy were randomized into an observation group and a control group, 23 cases in each one. In the control group, the intramusclar injection of mecobalamine at the buttock region was given, 1 mL each time, once every two days, 3 times weekly. Besides, citicoline sodium capsules were prescribed for oral administration, 0.2 g each time, 3 times daily. In the observation group, on the base of the treatment as the control group, the interaction of twelve meridian muscle regions and contralateral needling therapy was supplemented. Acupoints on the health sides included Juliao (ST 3) and Hanyan (GB 4), acupoints on the affected side included Jingming (BL 1), Sibai (ST 2), Yangbai (GB 14), Cuanzhu (BL 2), Shangming (Extra), Sizhukong (TE 23), Tongziliao (GB 1) and bilateral Fengchi (GB 20), Quchi (LI 11), Pianli (LI 6), Waiguan (TE 5), Hegu (LI 4) were selected. The needles were retained for 30 min in each acupuncture treatment, once a day, 5 times weekly. The treatment for 4 weeks was required in the two groups. Before and after treatment, the score of cervical range of motion (CROM), pupil size, eye fissure width and eyeball mobility were observed in the patients of the two groups. The clinical effect was evaluated in the two groups. RESULTS After treatment, CROM scores and pupil size were reduced in the patients of the two groups (P<0.05), and the values in the observation group were lower than the control group (P<0.05). The eye fissure width and eyeball mobility were increased in the two groups (P<0.05), the eye fissure width and the mobility of the muscles of rectus internus, inferior rectus and inferior oblique in the observation group were larger than the control group (P<0.05). The effective rate was 82.6% (19/23) in the observation group, higher than 65.2% (15/23) in the control group (P<0.05). CONCLUSION The interaction of twelve meridian muscle regions and contrallateral needling therapy effectively relieves diplopia, pupil dilation, narrow eye fissure and limited eyeball mobility in the patients with post-stroke oculomotor nerve palsy.
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Unwrapping nutrition: Exploring the impact of hospital food and beverage packaging on plate waste/intake in older people.
Bell, AF, Tapsell, LC, Walton, K, Batterham, M
Appetite. 2020;:104463
Abstract
Food and beverage packaging is increasingly used in hospital food service provision. Previous research has identified that the packaging used in New South Wales hospitals can be difficult to open by older adults. As older adults experience high rates of malnutrition, it is important to understand the effects of packaging on actual consumption of food and fluids. The aim of this study was to explore the impact of hospital food and beverage packaging on dietary intakes of 62 independently living older people (65 years and over) in a university simulated hospital ward in NSW, Australia. Participants were allocated to either a breakfast and snack meal or a lunch and snack meal on two occasions one week apart. Meals were served in a shared ward environment and each participant experienced a 'sealed' and 'pre-opened' meal and snack condition. The nutritional status of participants was measured using the Mini Nutritional Assessment - Short Form (MNA®-SF) and intake was estimated through an aggregated plate waste method. Overall findings were not significant for dietary intakes and the 'sealed' versus 'pre-opened' conditions. However, for the seven participants classified by the MNA®-SF as 'at risk' of malnutrition, packaging impeded intake for breakfast (η2 = -0.34) and the high protein snack (cheese and biscuits) (η2 = -0.24) meals. This finding has implications for the provision of packaged high protein snacks (cheese portions) and breakfast meals for the older inpatient. Further research is required for nutritionally compromised and frail older people in the hospital environment to investigate the impact of packaging on food and beverage consumption in detail.
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Acute exposure to traffic-related air pollution alters antioxidant status in healthy adults.
Cosselman, KE, Allen, J, Jansen, KL, Stapleton, P, Trenga, CA, Larson, TV, Kaufman, JD
Environmental research. 2020;:110027
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Abstract
BACKGROUND Exposure to traffic-related air pollution is associated with an increased risk of cardiovascular and respiratory disease. Evidence suggests that inhaled pollutants precipitate these effects via multiple pathways involving oxidative stress. OBJECTIVE Postulating that a decrease in circulating antioxidant levels reflect an oxidative response, we investigated the effect of inhaled diesel exhaust (DE) on the ratio of reduced to oxidized glutathione (GSH/GSSG) in healthy adults, and whether pre-exposure antioxidant supplementation blunted this response. We also examined exposure-related changes in antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels. METHODS Nineteen nonsmoking adults participated in a double-blind, randomized, four-way crossover study. Each subject completed 120-min exposures to filtered air and DE (200 μg/m3), with and without antioxidant pretreatment. Antioxidant comprised 1000 mg ascorbate for 7 days and 1200 mg N-acetylcysteine 1 day prior to exposure, with 1000 mg and 600 mg, respectively, administered 2 h prior to exposure. Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression were quantified pre, during and post exposure. RESULTS Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p = 0.001) and a 4-fold increase in IL-6 mRNA (p = 0.01) post exposure. Antioxidant pretreatment did not significantly mediate the effect of DE exposure on GSH/GSSG, though appeared to decrease the effect of exposure on IL-6 mRNA expression. CONCLUSIONS Acute DE inhalation induced detectable oxidative effects in healthy adults, which were not significantly attenuated by the selected antioxidant pre-treatment. This finding supports the premise that oxidative stress is one mechanism underlying the adverse effects of traffic-related air pollution.
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Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial.
Muresanu, DF, Florian, S, Hömberg, V, Matula, C, von Steinbüchel, N, Vos, PE, von Wild, K, Birle, C, Muresanu, I, Slavoaca, D, et al
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2020;(5):1171-1181
Abstract
INTRODUCTION The objective of this trial was to evaluate the efficacy and safety of Cerebrolysin in treating patients after moderate to severe traumatic brain injury (TBI) as an adjunct to standard care protocols. The trial was designed to investigate the clinical effects of Cerebrolysin in the acute (neuroprotective) stage and during early and long-term recovery as part of a neurorestorative strategy. MATERIALS AND METHODS The study was a phase IIIb/IV single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients with a Glasgow Coma Score (GCS) between 7 and 12 received study medication (50 ml of Cerebrolysin or physiological saline solution per day for 10 days, followed by two additional treatment cycles with 10 ml per day for 10 days) in addition to standard care. We tested ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses using a multivariate, directional test, to reflect the global status of patients after TBI. RESULTS The study enrolled 142 patients, of which 139 underwent formal analysis (mean age = 47.4, mean admission GCS = 10.4, and mean Baseline Prognostic Risk Score = 2.6). The primary endpoint, a multidimensional ensemble of 13 outcome scales, indicated a "small-to-medium"-sized effect in favor of Cerebrolysin, statistically significant at day 90 (MWcombined = 0.59, 95% CI 0.52 to 0.66, P = 0.0119). Safety and tolerability observations were comparable between treatment groups. CONCLUSION Our trial confirms previous beneficial effects of the multimodal, biological agent Cerebrolysin for overall outcome after moderate to severe TBI, as measured by a multidimensional approach. Study findings must be appraised and aggregated in conjunction with existing literature, as to improve the overall level of insight regarding therapeutic options for TBI patients. The widely used pharmacologic intervention may benefit from a large-scale observational study to map its use and to establish comparative effectiveness in real-world clinical settings.
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Protective effect of the oral administration of cystine and theanine on oxaliplatin-induced peripheral neuropathy: a pilot randomized trial.
Kobayashi, M, Sato, R, Komura, T, Ichikawa, H, Hirashima, T, Otake, S, Akazawa, N, Yazawa, T, Abe, T, Okada, T, et al
International journal of clinical oncology. 2020;(10):1814-1821
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Abstract
BACKGROUND Oxaliplatin, one of the key cytotoxic drugs for colorectal cancer, frequently causes peripheral neuropathy which leads to dose modification and decreased patients' quality of life. However, prophylactic or therapeutic measures have not yet been established. Orally administered amino acids, cystine and theanine, promoted the synthesis of glutathione which was one of the potential candidates for preventing the neuropathy. The aim of this study was to determine whether daily oral administration of cystine and theanine attenuated oxaliplatin-induced peripheral neuropathy (OXLIPN). METHODS Twenty-eight colorectal cancer patients who received infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy were randomly and evenly assigned to the cystine and theanine group and the control group. OXLIPN was assessed up to the sixth course using original 7-item questionnaire as well as Common Terminology Criteria for Adverse Events (CTCAE) grading scale. RESULTS Neuropathy scores according to our original questionnaire were significantly smaller in the cystine and theanine group at the fourth (p = 0.026), fifth (p = 0.029), and sixth course (p = 0.038). Furthermore, significant differences were also observed in CTCAE neuropathy grades at the fourth (p = 0.037) and the sixth course (p = 0.017). There was one patient in each group who required dose reduction due to OXLIPN. Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin. CONCLUSION The results demonstrated the daily oral administration of cystine and theanine attenuated OXLIPN.