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Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial.
Torrecilla, C, Fernández-Concha, J, Cansino, JR, Mainez, JA, Amón, JH, Costas, S, Angerri, O, Emiliani, E, Arrabal Martín, MA, Arrabal Polo, MA, et al
BMC urology. 2020;(1):65
Abstract
BACKGROUND Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. METHODS A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. RESULTS The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. CONCLUSIONS Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. TRIAL REGISTRATION This trial was registered at www.clinicaltrials.gov under the name "Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent" with date 2nd November 2017, code NCT03343275, and URL.
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Comparative effects of acute-methionine loading on the plasma sulfur-amino acids in NAC-supplemented HIV+ patients and healthy controls.
Burini, RC, Borges-Santos, MD, Moreto, F, Yu, YM
Amino acids. 2018;(5):569-576
Abstract
In this study, an acute overloading of methionine (MetLo) was used to investigate the trassulfuration pathway response comparing healthy controls and HIV+ patients under their usual diet and dietary N-acetyl-L-cysteine (NAC) supplementation. MetLo (0.1 g Met/kg mass weight) was given after overnight fasting to 20 non-HIV+ control subjects (Co) and 12 HIV+ HAART-treated patients. Blood samples were taken before and after the MetLo in two different 7-day dietary situations, with NAC (1 g/day) or with their usual diet (UD). The amino acids (Met, Hcy, Cys, Tau, Ser, Glu and Gln) and GSH were determined by HPLC and their inflow rate into circulation (plasma) was estimated by the area under the curve (AUC). Under UD, the HIV+ had lower plasma GSH and amino acids (excepting Hcy) and higher oxidative stress (GSSG/GSH ratio), similar remethylation (RM: Me/Hcy + Ser ratio), transmethylation (TM; Hcy/Met ratio) and glutaminogenesis (Glu/Gln ratio), lower transsulfuration (TS: Cys/Hcy + Ser ratio) and Cys/Met ratio and, higher synthetic rates of glutathione (GG: GSH/Cys ratio) and Tau (TG: Tau/Cys ratio). NAC supplementation changed the HIV pattern by increasing RM above control, normalizing plasma Met and TS and, increasing plasma GSH and GG above controls. However, plasma Cys was kept always below controls probably, associatively to its higher consumption in GG (more GSSG than GSH) and TG. The failure of restoring normal Cys by MetLo, in addition to NAC, in HIV+ patients seems to be related to increased flux of Cys into GSH and Tau pathways, probably strengthening the cell-antioxidant capacity against the HIV progression (registered at http://www.clinicaltrials.gov , NCT00910442).
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Double-blind placebo-controlled multicenter phase II trial to evaluate D-methionine in preventing/reducing oral mucositis induced by radiation and chemotherapy for head and neck cancer.
Hamstra, DA, Lee, KC, Eisbruch, A, Sunkara, P, Borgonha, S, Phillip, B, Campbell, KCM, Ross, BD, Rehemtulla, A
Head & neck. 2018;(7):1375-1388
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Abstract
BACKGROUND The purpose of this study was to test if oral D-methionine (D-met) reduced mucositis during chemoradiotherapy. METHODS We conducted a placebo-controlled double-blind randomized phase II trial of D-met (100 mg/kg p.o. b.i.d.) testing the rate of severe (grades 3-4) mucositis. RESULTS Sixty patients were randomized. Grade 2 + oral pain was higher with placebo (79% vs 45%; P = .0165), whereas grade 2 + body odor was greater with D-met (3% vs 41%; P = .0015). Mucositis was decreased with D-met by the physician (World Health Organization [WHO], P = .007; Radiation Therapy Oncology Group [RTOG], P = .009) and patient functional scales (RTOG, P = .0023). The primary end point of grades 3 to 4 mucositis on the composite scale demonstrated a decrease with D-met (48% vs 24%; P = .058), which was borderline in significance. A planned secondary analysis of a semiquantitative scoring system noted decreased oral ulceration (2.2 vs 1.5; P = .023) and erythema (1.6 vs 1.1; P = .048) with D-met. CONCLUSION Although not meeting the primary end point, results of multiple assessments suggest that D-met decreased mucositis.
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Effect of a Food Supplement Containing L-Methionine on Urinary Tract Infections in Pregnancy: A Prospective, Multicenter Observational Study.
Passaro, M, Mainini, G, Ambrosio, F, Sgambato, R, Balbi, G
Journal of alternative and complementary medicine (New York, N.Y.). 2017;(6):471-478
Abstract
OBJECTIVE Adjuvants or alternatives to antibiotics in urinary tract infections (UTIs) during pregnancy seem advisable because of possible fetal stress. The present study assessed the effectiveness of a food supplement containing L-methionine and Hibiscus sabdariffa L. and Boswellia serrata Roxb. extracts as a treatment for symptomatic UTIs in pregnancy. DESIGN Pregnant patients with symptomatic cystitis were screened for UTIs in three different clinical centers. Those unwilling to take antibiotics were offered two alternative treatments: (A) a 1-week treatment with the food supplement or (B) a week in which they were advised to increase their fluid consumption to more than 1.5 L daily. After 1 week, group B patients who still had positive urine cultures (UCs) or had no UC performed took the food supplement for an additional week. UCs were performed on all patients at the first visit (w0) and on most of them at 7 days (w1). Patients who were still positive at w1 or had no UC performed at w1 had UC performed 14 days (w2) thereafter. RESULTS Of 264 pregnant women enrolled, 216 joined group A, while 48 joined group B. At w1, 70.0% of group A patients and 43.2% of those in group B had negative UCs (p = 0.003). The reduction of bacterial load was 42.2% ± 8.0% and 4.5% ± 9.2%, respectively (p < 0.0001). At w1, symptoms disappeared in 135 patients (62.5%) in group A and 22 patients (45.8%) in group B (p = 0.03). At w2, 30 of 32 group B patients who switched to taking the supplement for the second week had negative UCs, including 20 who had been positive at w1. At w2, all group A patients had negative UCs. No side effects were reported. CONCLUSIONS The food supplement provided effective treatment and might be an adjuvant or alternative to antibiotic therapy of symptomatic UTI in pregnancy.
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Assessment of pre- and post-methionine load homocysteine for prediction of recurrent stroke and coronary artery disease in the Vitamin Intervention for Stroke Prevention Trial.
Pettigrew, LC, Bang, H, Chambless, LE, Howard, VJ, Toole, JF, ,
Atherosclerosis. 2008;(2):345-9
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Methionine (Met) loading increases total plasma homocysteine (tHcy) and assesses homocysteine metabolism. We tested the hypothesis that pre- or post-Met tHcy will predict recurrent stroke or coronary artery disease (CAD) in a subgroup analysis of the Vitamin Intervention for Stroke Prevention (VISP) trial. VISP subjects with non-disabling stroke underwent measurement of tHcy at baseline (fasting pre- and post-Met load) and were randomized to high/low-dose B-vitamin therapy for prevention of recurrent stroke or CAD. In the sample cohort of 2124 subjects, mean+/-S.D. tHcy levels in micromol/l were pre-Met 13.2+/-4.3, post-Met 30.4+/-9.76, and pre/post-Met Delta 17.1+/-8.3. The hazard ratio (HR) for recurrent stroke was 1.16 (p=0.026) for 1 S.D. higher pre-Met tHcy and 1.15 (p=0.054) for 1 S.D. higher post-Met tHcy. For CAD, the HR for 1 S.D. higher pre-Met tHcy was 1.27 (p=0.001) and was 1.00 (p=0.99) for post-Met tHcy. In survival analyses using pre- or post-Met as covariates, the coefficient of pre/post-Met Delta was not significant for stroke and was only marginally significant for CAD (p<0.08), but was negative. We conclude that fasting, pre-Met tHcy is as effective as post-Met tHcy or pre/post-Met Delta in predicting the risk for stroke and CAD.
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L-methionine as immune supportive supplement: a clinical evaluation.
Van Brummelen, R, du Toit, D
Amino acids. 2007;(1):157-63
Abstract
The objective of the study was to test L-methioinine as a possible immune supportive supplement in HIV infected patients by means of a clinical study. A double-blind, placebo-controlled study was designed. The patients (n = 253) from four different trial centres were randomly divided into two groups, active and placebo, and regularly assessed by clinical and safety parameters. After six months from commencement, clinically and statistically significant differences were observed. The females of the active treatment group presented with a decreased level of decline in their CD4 counts (p = 0.0027), so also the patients of Centre 1 (p = 0.0377). All patients were placed onto active treatment after 12 months and were followed up for 48 months after the trial started. The same tendencies could be observed in the group as a whole, with no serious side effects directly associated to treatment. The study confirmed the supportive role of L-methionine in immune-compromised or deficient patients.