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Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial.
Rochcongar, G, Remazeilles, M, Bourroux, E, Dunet, J, Chapus, V, Feron, M, Praz, C, Buia, G, Hulet, C
Acta orthopaedica. 2021;(2):151-155
Abstract
Background and purpose - Vitamin E-infused polyethylene is a relatively new material in joint arthroplasty; there are no long-term reports, and only few mid-term results. Using radiostereometric analysis (RSA), we primarily determined whether vitamin E-infused highly cross-linked polyethylene (HXLPE/VitE) acetabular cups show less wear than ultra-high molecular weight polyethylene (UHMWPE) acetabular cups at 5 years after total hip arthroplasty (THA). We also assessed whether wear rates correlate with increasing cup inclination angles or cup sizes.Patients and methods - This is a 5-year follow-up of our previously reported randomized controlled trial of 62 patients with 3 years' follow-up, who received THA with either an HXLPE/VitE or a UHMWPE acetabular cup. At 5 years, 40 patients were analyzed (22 in the HXLPE/VitE and 18 in the UHMWPE group).Results - HXLPE/VitE cups continued to show less cumulative femoral head penetration than UHMWPE cups (HXLPE/VitE: 0.24 mm, UHMWPE 0.45 mm; p < 0.001). Distribution of wear was also more even with HXLPE/VitE cups than with UHMWPE cups (p = 0.002). Moreover, the difference in PE wear between 1 and 5 years in both groups showed no statistically significant correlation with increasing cup inclination angles or cup sizes. Finally, no osteolysis and implant loosening occurred, and no revision surgeries were required.Interpretation - Wear rates continue to be lower in HXLPE/VitE cups than in UHMWPE cups at 5 years of follow-up without correlation with increasing cup inclination angles or cup sizes. Finally, HXLPE/VitE cups may have the potential to prevent osteolysis and implant loosening.
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2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene.
van Erp, JHJ, Massier, JRA, Halma, JJ, Snijders, TE, de Gast, A
Acta orthopaedica. 2020;(3):254-259
Abstract
Background and purpose - The long-term survival of arthroplasty components may be limited by polyethylene wear-related problems such as periprosthetic osteolysis and aseptic loosening. Highly cross-linked polyethylene (HXLPE) blended with vitamin E was introduced to improve oxidative stability and to avoid long-term embrittlement. This study clinically compares the tribological behavior and clinical outcome of vitamin E blended HXLPE with ultra-high molecular weight polyethylene (UHMWPE) in an isoelastic monoblock cup for uncemented total hip arthroplasty.Patients and methods - In this randomized controlled trial (RCT), 199 patients were included: 102 patients received the vitamin E blended HXLPE cup, 97 patients the UHMWPE cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperative and at 3, 12, and 24 months. Wear rates were compared using the mean linear femoral head penetration (FHP) rate.Results - 188 patients (94%) completed the 2-year follow-up. Mean patient satisfaction was higher in the vitamin E blended HXLPE group (8.9 [1]) than in in the control group (8.5 [2], p = 0.03). The Harris Hip Score (HHS) was higher in the vitamin E blended HXLPE group (95 [8]) than in the control group (92 [11], p = 0.3). The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed during follow-up, with an excellent 2-year survival to revision rate of 98% for both cups.Interpretation - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with lower linear femoral head penetration rates and better clinical results compared with the UHMWPE acetabular cup after 2 years.
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The Effects of Omega-3 Fatty Acids and Vitamin E Co-Supplementation on Indices of Insulin Resistance and Hormonal Parameters in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.
Ebrahimi, FA, Samimi, M, Foroozanfard, F, Jamilian, M, Akbari, H, Rahmani, E, Ahmadi, S, Taghizadeh, M, Memarzadeh, MR, Asemi, Z
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association. 2017;(6):353-359
Abstract
This study was conducted to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on indices of insulin resistance and hormonal parameters in women with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was done on 68 women diagnosed with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly assigned into 2 groups to receive either 1 000 mg omega-3 fatty acids from flaxseed oil containing 400 mg α-Linolenic acid plus 400 IU vitamin E supplements (n=34) or placebo (n=34) for 12 weeks. Hormonal parameters were quantified at the beginning of the study and after 12-week intervention. After 12 weeks of intervention, compared to the placebo, omega-3 fatty acids and vitamin E co-supplementation resulted in a significant decrease in insulin (-1.0±3.5 vs. +2.7±6.6 µIU/mL, P=0.004), homeostasis model of assessment-estimated insulin resistance (-0.2±0.8 vs. +0.6±1.5, P=0.005), homeostasis model of assessment-estimated B cell function (-4.3±14.3 vs. +10.5±24.5, P=0.004) and a significant increase in quantitative insulin sensitivity check index (+0.006±0.02 vs. -0.01±0.04, P=0.008). Supplementation with omega-3 fatty acids plus vitamin E led to significant reductions in serum total testosterone (-0.5±0.7 vs. -0.1±0.5 ng/mL, P=0.008) and free testosterone (-1.2±2.1 vs. -0.2±1.7, P=0.04) compared to the placebo group. We did not observe any significant effect of omega-3 fatty acids and vitamin E co-supplementation on fasting plasma glucose and other hormonal profiles. Omega-3 fatty acids and vitamin E co-supplementation for 12 weeks in PCOS women significantly improved indices of insulin resistance, total and free testosterone.
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Vitamins (A, C and E) and oxidative status of hemodialysis patients treated with HFR and HFR-Supra.
Palleschi, S, Ghezzi, PM, Palladino, G, Rossi, B, Ganadu, M, Casu, D, Cossu, M, Mattana, G, Pinna, AM, Contu, B, et al
BMC nephrology. 2016;(1):120
Abstract
BACKGROUND Hemodiafiltration with on-line endogenous reinfusion (HFR) is an extracorporeal dialytic method that combines diffusion, convection and adsorption. HFR-Supra (HFR-S) is a second-generation system with increased convective permeability and adsorption capability. Previous studies suggested that HFR reduces oxidative stress compared to standard haemodialysis. The principal aim of the present study was to compare antioxidant vitamins behavior and oxidative status of hemodialysis patients treated with HFR and HFR-S. METHODS The study was designed as a multicenter, randomized, crossover trial. Forty-one patients were recruited from 19 dialysis centers and after a 4-month washout stabilization period in on-line hemodiafiltration (ol-HDF), each patient was randomized to a sequence of treatments (HFR-S followed by HFR or viceversa) with each treatment applied over 6 months. Plasma levels of Advanced Oxidation Protein Products, Total Antioxidant Status, vitamins C, A and E and their ligands (Retinol Binding Protein and total lipids) were measured at baseline and at the end of each treatment period. RESULTS Results show that the higher convective permeability of HFR-S with respect to HFR did not produce additional beneficial effects on the patients' oxidative status, a slight decrease of both Vitamin A and Retinol Binding Protein being the only difference registered in the long-term. However, as compared to ol-HDF, both the re-infusive techniques allowed to reduce the intradialytic loss of Vitamin C and, in the long-term, improve the patients' oxidative status and increase Retinol Binding Protein plasma values. No significant differences were found between the Vitamin C concentration of pre- and post cartridge UF neither in HFR-S nor in HFR showing that the sorbent resin does not adsorb Vitamin C. CONCLUSION HFR-S and HFR are almost equivalent in term of impact on antioxidant vitamins and oxidative status of hemodialysis patients. Nonetheless, as compared to ol-HDF, both treatments produced a sensible sparing of Vitamin C and may represent a new approach for reducing oxidative stress and related complications in dialysis patients. Long-term effects of re-infusive treatments on patients' cardiovascular morbidity and mortality need to be evaluated. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT01492491 , retrospectively registered in 10 December 2011.
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Vitamin E-Coated and Heparin-Coated Dialyzer Membranes for Heparin-Free Hemodialysis: A Multicenter, Randomized, Crossover Trial.
Islam, MS, Hassan, ZA, Chalmin, F, Vido, S, Berrada, M, Verhelst, D, Donnadieu, P, Moranne, O, Esnault, VL
American journal of kidney diseases : the official journal of the National Kidney Foundation. 2016;(5):752-762
Abstract
BACKGROUND Hemodialysis requires effective anticoagulation to avoid blood circuit clotting. In patients at high risk for bleeding, several alternative methods have been developed. STUDY DESIGN Multicenter, prospective, randomized, crossover study evaluating the noninferiority of vitamin E-coated compared with heparin-coated dialyzers in a 4-hour heparin-free hemodialysis strategy. SETTINGS & PARTICIPANTS 32 adult long-term hemodialysis patients from 2 French hemodialysis units with well-functioning fistulas or double-lumen catheters. INTERVENTION Patients were randomly allocated to a first period using either vitamin E- or heparin-coated dialyzers. After a washout period of 2 hemodialysis sessions, each patient was switched to the alternative dialyzer for a second period. Each study period started with 2 hemodialysis sessions with reduced heparin dose (50% and 25% of usual heparin dose, respectively, for sessions 1 and 2) followed by 2 heparin-free sessions. OUTCOMES The primary end point was the percentage of successful study periods, defined as no circuit-clotting event leading to premature interruption of any of the 4 dialysis sessions. Secondary end points included total number and cumulative duration of hemodialysis sessions without clotting, number of saline solution flushes, dialysis circuit bubble trap status and dialyzer membrane status by visual inspection, and dialysis adequacy. RESULTS The percentage of success with vitamin E-coated dialyzers (25/32 study periods [78%]) was not inferior to that with heparin-coated dialyzers (26/32 study periods [81%]). Visual inspection showed equal numbers of clean dialysis circuit bubble traps (vitamin E-coated, 34/121; heparin-coated, 32/120), whereas clean fiber bundles were more frequently noted with the vitamin E-coated compared with heparin-coated dialyzers (25/121 vs 2/120; P=0.002). LIMITATIONS Results may not extrapolate to critically ill patients. Differences in dialyzer transparency may account for visual inspection scores. CONCLUSIONS The success rate of 4-hour heparin-free hemodialysis sessions is lower than that previously claimed in uncontrolled studies. Vitamin E-coated and heparin-coated dialyzers exposed patients to similar and unacceptable high failure rates. Further studies are required to improve heparin-free hemodialysis.
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Vitamin E and essential polyunsaturated fatty acids supplementation in schizophrenia patients treated with haloperidol.
Bošković, M, Vovk, T, Koprivšek, J, Plesničar, BK, Grabnar, I
Nutritional neuroscience. 2016;(4):156-61
Abstract
OBJECTIVES Previously, oxidative damage has been associated with severity of clinical symptoms and supplementation with antioxidants and essential polyunsaturated fatty acids (EPUFAs) was proposed to have beneficial effects in schizophrenia. We evaluated the effects of supplementation with EPUFAs and vitamin E in patients treated with haloperidol depot injection. DESIGN This was a double-blind randomized placebo-controlled study with four arms (Placebo, vitamin E, EPUFAs, and vitamin E + EPUFAs). Biomarkers of oxidative stress, neurochemistry, psychopathology, and extrapyramidal symptoms were assessed at baseline and after 4 months. RESULTS In EPUFAs group of patients, reduced glutathione concentration was increased compared to placebo. Concentration of oxidized glutathione was decreased in patients receiving vitamin E. In addition, compared to placebo a non-significant trend of increased activity of catalase and superoxide dismutase was observed in all three treatment groups. Patients receiving vitamin E experienced less motor retardation. No difference in extrapyramidal symptoms was found. DISCUSSION Our study indicates that supplementation with vitamin E and EPUFAs may improve the antioxidative defense, especially glutathione system, while there is no major effect on symptoms severity. Supplemental treatment with EPUFAs and vitamin E in schizophrenia patients treated with haloperidol is potentially beneficial and a larger independent study appears warranted.
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Femoral Head Penetration of Vitamin E-Infused Highly Cross-Linked Polyethylene Liners: A Randomized Radiostereometric Study of Seventy Hips Followed for Two Years.
Shareghi, B, Johanson, PE, Kärrholm, J
The Journal of bone and joint surgery. American volume. 2015;(16):1366-71
Abstract
BACKGROUND Highly cross-linked polyethylene infused with vitamin E (E-poly) was developed to increase oxidative resistance without affecting mechanical properties. We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis. Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner, ArComXL. We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene. METHODS In this prospective study, sixty-one patients (seventy hips) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner. The patients were followed for two years and evaluated at three time points (three months, one year, and two years). RESULTS The median proximal penetration in the E-poly group increased from 0.04 mm at three months to 0.06 mm at two years of follow-up. Corresponding values for the ArComXL group were 0.03 mm and 0.10 mm. In both groups, significantly increased penetration was observed between three months and two years (E-poly, p = 0.02; ArComXL, p < 0.001), but between one and two years, the increase was significant only in the control group (E-poly, p = 0.23; ArComXL, p = 0.002). CONCLUSIONS The femoral head penetration of E-poly was very low at two years. Whether the increase observed between three months and two years was caused by creep, deformation, wear, or a combination of these cannot be determined by our study. There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL. Currently, the theoretical advantages of E-poly remain to be confirmed.
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Difference in Association of Obesity With Prostate Cancer Risk Between US African American and Non-Hispanic White Men in the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
Barrington, WE, Schenk, JM, Etzioni, R, Arnold, KB, Neuhouser, ML, Thompson, IM, Lucia, MS, Kristal, AR
JAMA oncology. 2015;(3):342-9
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Abstract
IMPORTANCE African American men have the highest rates of prostate cancer incidence and mortality in the United States. Understanding underlying reasons for this disparity could identify preventive interventions important to African American men. OBJECTIVE To determine whether the association of obesity with prostate cancer risk differs between African American and non-Hispanic white men and whether obesity modifies the excess risk associated with African American race. DESIGN, SETTING, AND PARTICIPANTS Prospective study of 3398 African American and 22,673 non-Hispanic white men who participated in the Selenium and Vitamin E Cancer Prevention Trial (2001-2011) with present analyses completed in 2014. MAIN OUTCOMES AND MEASURES Total, low-grade (Gleason score <7), and high-grade (Gleason score ≥7) prostate cancer incidence. RESULTS With a median (interquartile range) follow-up of 5.6 (1.8) years, there were 270, 148, and 88 cases of total, low-, and high-grade prostate cancers among African American men and a corresponding 1453, 898, and 441 cases in non-Hispanic white men, respectively. Although not associated with risk among non-Hispanic white men, BMI was positively associated with an increase in risk among African American men (BMI, <25 vs ≥35: hazard ratio [HR], 1.49 [95% CI, 0.95, 2.34]; P for trend = .03). Consequently, the risk associated with African American race increased from 28% (HR, 1.28 [95% CI, 0.91-1.80]) among men with BMI less than 25 to 103% (HR, 2.03 [95% CI, 1.38-2.98]) among African American men with BMI at least 35 (P for trend = .03). Body mass index was inversely associated with low-grade prostate cancer risk within non-Hispanic white men (BMI, <25 vs ≥35: HR, 0.80 [95% CI, 0.58-1.09]; P for trend = .02) but positively associated with risk within African American men (BMI, <25 vs ≥35: HR, 2.22 [95% CI, 1.17-4.21]; P for trend = .05). Body mass index was positively associated with risk of high-grade prostate cancer in both non-Hispanic white men (BMI, <25 vs ≥35: HR, 1.33 [95% CI, 0.90-1.97]; P for trend = .01) and African American men, although the increase may be larger within African American men, albeit the racial interaction was not statistically significant (BMI, <25 vs ≥35: HR, 1.81 [95% CI, 0.79-4.11]; P for trend = .02). CONCLUSIONS AND RELEVANCE Obesity is more strongly associated with increased prostate cancer risk among African American than non-Hispanic white men and reducing obesity among African American men could reduce the racial disparity in cancer incidence. Additional research is needed to elucidate the mechanisms underlying the differential effects of obesity in African American and non-Hispanic white men.
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Effects of Mediterranean diet supplemented with silybin-vitamin E-phospholipid complex in overweight patients with non-alcoholic fatty liver disease.
Abenavoli, L, Greco, M, Nazionale, I, Peta, V, Milic, N, Accattato, F, Foti, D, Gulletta, E, Luzza, F
Expert review of gastroenterology & hepatology. 2015;(4):519-27
Abstract
BACKGROUND Non-alcoholic fatty liver disease is the most common liver disease worldwide. AIM: The aim of this study is to compare the metabolic effects of the Mediterranean diet versus the diet associated with silybin, phosphatidylcholine and vitamin E complex in overweight patients with non-alcoholic fatty liver disease. METHODS Thirty Caucasian overweight patients were randomized into three groups of 10 (Groups A, B and C). A personalized Mediterranean diet was started in Group A and B patients. In association with the diet, Group B patients were given Realsil complex, daily, for 6 months. Group C patients refused any treatment. RESULTS We showed that the Mediterranean diet alone, or in association with the Realsil complex, led to the significant variation in BMI, waist circumference, total cholesterol and triglycerides. We also observed a statistically significant decrease in homeostasis model assessment technique in Group B patients.
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Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial.
Christen, WG, Glynn, RJ, Gaziano, JM, Darke, AK, Crowley, JJ, Goodman, PJ, Lippman, SM, Lad, TE, Bearden, JD, Goodman, GE, et al
JAMA ophthalmology. 2015;(1):17-24
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Abstract
IMPORTANCE Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention. However, the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium. OBJECTIVE To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men. DESIGN, SETTING, AND PARTICIPANTS The Selenium and Vitamin E Cancer Prevention Trial (SELECT) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT, a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men, 50 years and older for African American participants and 55 years and older for all other men, at 427 participating sites in the United States, Canada, and Puerto Rico. A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study. INTERVENTIONS Individual supplements of selenium (200 μg per day from L-selenomethionine) and vitamin E (400 IU per day of all rac-α-tocopheryl acetate). MAIN OUTCOMES AND MEASURES Incident cataract was defined as a lens opacity, age related in origin, and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review. Cataract extraction was defined as the surgical removal of an incident cataract. RESULTS During a mean (SD) of 5.6 (1.2) years of treatment and follow-up, 389 cases of cataract were documented. There were 185 cataracts in the selenium group and 204 in the no selenium group (hazard ratio, 0.91; 95 % CI, 0.75-1.11; P = .37). For vitamin E, there were 197 cases in the treated group and 192 in the placebo group (hazard ratio, 1.02; 95 % CI, 0.84-1.25; P = .81). Similar results were observed for cataract extraction. CONCLUSIONS AND RELEVANCE These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00784225.