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Plasma Concentration of Essential and Toxic Trace Elements After Brazil Nut Intake: Results from a Randomized Controlled Trial.
Duarte, GBS, Reis, BZ, Rogero, MM, Barbosa, F, Cercato, C, Cozzolino, SMF
Biological trace element research. 2023;(3):1112-1117
Abstract
Brazil nut (BN) is a good source of essential nutrients, but little is known about the content of other components, such as toxic elements. Moreover, the high consumption of BN could probably contribute to increased levels of toxic and essential elements in the blood. Thus, this study aimed to evaluate the concentration of essential and toxic trace elements in BN and their concentration in plasma of obese women after regular intake of BN. A randomized controlled clinical trial was carried out with 55 subjects that were randomly assigned to either the Brazil nut group (BN) (n = 29) or the control group (CO) (n = 26) and followed up for 2 months. The BN group consumed one unit of Brazil nut per day, and the CO group did not receive any intervention. The concentration of essential elements (zinc, copper, manganese, and cobalt) and toxic (barium, lead, and cadmium) in BN samples and plasma of obese women (before and after the intervention) were determined by inductively coupled plasma mass spectrometry. Barium followed by copper, and manganese were the trace elements present in higher amounts in Brazil nuts. After the BN intervention period was observed an increase in plasma cadmium (p = 0.002) and a reduction of plasma manganese (p < 0.001) levels. In conclusion, our findings suggest that the regular consumption of BN from the Brazilian Amazon rainforest contributes to the intake of essential trace elements and can be considered safe regarding the content of heavy metals.
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Randomized Controlled Trial Investigating Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
Tan, GHC, Chia, CS, Wong, JSM, Ong, WS, Zhu, HY, Ong, CJ, Teo, MCC
Annals of surgical oncology. 2023;(2):777-789
Abstract
BACKGROUND Immunonutrition has been shown to reduce hospital stay and postoperative morbidity in patients undergoing gastrointestinal, and head and neck surgery. However, its use has not been demonstrated in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This study aims to determine the effectiveness of perioperative immunonutrition on patients undergoing CRS-HIPEC in reducing length of hospitalization and postoperative complications. PATIENTS AND METHODS From April 2017 to December 2018, patients undergoing CRS-HIPEC for peritoneal metastases in a single center were enrolled in a randomized controlled trial. Patients with evidence of intestinal obstruction or with diabetes mellitus were excluded. Patients were randomly assigned in a 1:1 fashion to receive perioperative oral immunonutrition or standard nutritional feeds. Length of hospital stay and rates of wound infection and complications were recorded and compared between the two groups in an intention-to-treat manner. RESULTS A total of 62 patients were recruited and randomized into two groups. Compliance to nutritional feeds in the preoperative period was significantly higher in the standard nutrition group (95.2% versus 75.4%, p = 0.004). There was no difference in postoperative compliance rates. Length of hospital stay and rates of wound infection and postoperative complications were higher in the standard nutrition group when compared with patients on immunonutrition (15.5 versus 11.1 days, p = 0.186; 19% versus 9.7%, p = 0.473; 16% versus 9.7%, p = 0.653; respectively). CONCLUSIONS Patients undergoing CRS-HIPEC who received perioperative immunonutrition had shorter hospitalization and less wound infections and postoperative complications, although the differences with the standard nutrition group were not statistically significant. Potential benefits of perioperative immunonutrition need to be further evaluated in larger studies.
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Effect of Daily Vitamin D Supplementation on Serum Vitamin D Levels in Children with Epilepsy Receiving Sodium Valproate Monotherapy: A Randomized, Controlled Trial.
Mishra, S, Mishra, D, Mahajan, B, Mantan, M, Khan, AM
Indian journal of pediatrics. 2023;(5):450-456
Abstract
OBJECTIVES To compare the change in serum vitamin D levels and to compare the changes in serum levels of calcium, phosphate, alkaline phosphatase and parathyroid hormone in vitamin D supplemented and unsupplemented groups after 3 mo. METHODS In this randomized, parallel group, nonblinded, controlled trial, 40 children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy, were randomized into the intervention group (n = 20), which was given daily oral 600 IU vitamin D supplementation, and the control group (n = 20), which was not given any supplementation. Changes in the biochemical parameters was measured in the two groups after 3 mo. RESULTS There was a significant reduction in the median (IQR) vitamin D levels in the control group as compared to an increase seen in the intervention group [-6.64 (-8.4, -2.65) vs. 5.66 (1.81, 7.12); p < 0.001]. In the control group, 37.5% children developed vitamin D insufficiency and 12.5% developed deficiency whereas only 5% of the intervention group developed vitamin D insufficiency (p = 0.005). There was a significant decrease in ionized calcium (p = 0.02), increase in serum phosphate (p = 0.02), and alkaline phosphatase level (p = 0.003) in the unsupplemented group as compared to the supplemented group. CONCLUSION Vitamin D supplementation can reduce the valproate-associated decline in vitamin D levels and the negative impact on other markers of bone mineral metabolism. TRIAL REGISTRATION TCTR20200621002, 19.06.2020, retrospectively registered.
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Effects of four-year cyclic versus two-year daily teriparatide treatment on volumetric bone density and bone strength in postmenopausal women with osteoporosis.
Ganapathy, A, Nieves, JW, Keaveny, TM, Cosman, F
Bone. 2023;:116618
Abstract
PURPOSE To evaluate the effects of cyclic vs daily teriparatide treatment (TPTD) on volumetric bone mineral density (vBMD) and bone strength at the hip and spine in women who were previously untreated. METHODS A total of 86 women were randomized to a 24-month open label treatment of either daily TPTD (20 μg daily) or cyclic TPTD (20 μg daily for 3 months followed by 3 months off). During a 2-year extension, women in the daily TPTD group were switched to alendronate (ALN) and those in the cyclic TPTD group continued on cyclic TPTD (without any ALN). QCT images were acquired at baseline, 2-years (n = 54) and 4-years (n = 35) and analyzed for volumetric integral, cortical and trabecular bone mineral density (vBMD) and bone strength (by finite element analysis) at the hip and spine. The primary analysis presented here compared the responses across equal total TPTD doses (2 years daily vs 4 years cyclic). RESULTS In the spine, integral vBMD and strength increased substantially after 2 years daily and 4 years cyclic TPTD, with no significant differences (vBMD +12 % vs +11 %, respectively, p = 0.70; spine strength +21 % vs +16 %, respectively, p = 0.35). At the hip, the gains were smaller, but again no significant differences were detected between the groups for the increases in either vBMD (+2 % in both groups, p = 0.97) or hip strength (3 % vs 3 %, p = 0.91). In the spine, the vBMD increment was about twice as large in the trabecular vs peripheral compartment; in the hip, significant vBMD gain was seen only in the trabecular compartment. CONCLUSIONS The gains in volumetric BMD and bone strength for an equivalent dose of TPTD did not depend on whether it was administered every day over two years or cyclically over four years.
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Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease : A Post Hoc Analysis of DAPA-CKD.
Schechter, M, Jongs, N, Chertow, GM, Mosenzon, O, McMurray, JJV, Correa-Rotter, R, Rossing, P, Langkilde, AM, Sjöström, CD, Toto, RD, et al
Annals of internal medicine. 2023;(1):59-66
Abstract
BACKGROUND Acute hospitalizations are common in patients with chronic kidney disease (CKD) and often lead to decreases in health-related quality of life and increased care costs. OBJECTIVE To determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations. DESIGN Post hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150). SETTING 386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020. PARTICIPANTS Adults with an estimated glomerular filtration rate of 25 to 75 mL/min/1.73 m2 and a urinary albumin-creatinine ratio of 200 to 5000 mg/g, with and without type 2 diabetes. INTERVENTION Dapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio). MEASUREMENTS The effects of dapagliflozin on first hospitalizations for any cause, all hospitalizations, and cause-specific (first and recurrent) hospitalizations were determined. The reported system organ class was used to evaluate reasons for admission. Hospitalizations were analyzed using Cox proportional hazards regression models (first hospitalization), the Lin-Wei-Yang-Ying method (all hospitalizations or death), and negative binomial models (cause-specific hospitalizations). RESULTS The study included 4304 patients (mean age, 61.8 years; 33.1% women). During a median follow-up of 2.4 years, 2072 hospitalizations were reported among 1224 (28.4%) participants. Compared with placebo, dapagliflozin reduced risk for a first hospitalization (hazard ratio, 0.84 [95% CI, 0.75 to 0.94]) and all hospitalizations or death (rate ratio, 0.79 [CI, 0.70 to 0.89]). There was no evidence that the effects of dapagliflozin on first and all hospitalizations varied by baseline presence of type 2 diabetes (P for interaction = 0.60 for each). Compared with placebo, dapagliflozin reduced the rate of admissions due to cardiac disorders, renal and urinary disorders, metabolism and nutrition disorders, and neoplasms. LIMITATIONS This was a post hoc analysis and should be viewed as hypothesis-generating. Hospitalizations and causes were reported by site investigators and were not centrally adjudicated. CONCLUSION Dapagliflozin reduced the risk for hospitalization for any cause in patients with CKD with and without type 2 diabetes. PRIMARY FUNDING SOURCE AstraZeneca.
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Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study.
Verceles, AC, Serra, M, Davis, D, Alon, G, Wells, CL, Parker, E, Sorkin, J, Bhatti, W, Terrin, ML
Heart & lung : the journal of critical care. 2023;:229-235
Abstract
BACKGROUND Neuromuscular electrical stimulation (NMES) with high protein supplementation (HPRO) to preserve muscle mass and function has not been assessed in ICU patients. We compared the effects of combining NMES and HPRO with mobility and strength rehabilitation (NMES+HPRO+PT) to standardized ICU care. OBJECTIVES To assess the effectiveness of combined NMES+HPRO+PT in mitigating sarcopenia as evidenced by CT volume and cross-sectional area when compared to usual ICU care. Additionally, we assessed the effects of the combined therapy on select clinical outcomes, including nutritional status, nitrogen balance, delirium and days on mechanical ventilation. METHODS Participants were randomized by computer generated assignments to receive either NMES+HPRO+PT or standard care. Over 14 days the standardized ICU care group (N = 23) received usual critical care and rehabilitation while the NMES+HPRO+PT group (N = 16) received 30 min neuromuscular electrical stimulation of quadriceps and dorsiflexors twice-daily for 10 days and mean 1.3 ± 0.4 g/kg body weight of high protein supplementation in addition to standard care. Nonresponsive participants received passive exercises and, once responsive, were encouraged to exercise actively. Primary outcome measures were muscle volume and cross-sectional area measured using CT-imaging. Secondary outcomes included nutritional status, nitrogen balance, delirium and days on mechanical ventilation. RESULTS The NMES+HPRO+PT group (N = 16) lost less lower extremity muscle volume compared to the standard care group (N = 23) and had larger mean combined thigh cross-sectional area. The nitrogen balance remained negative in the standard care group, while positive on days 5, 9, and 14 in the NMES+HPRO+PT group. Standard care group participants experienced more delirium than the NMES+HPRO+PT group. No differences between groups when comparing length of stay or mechanical ventilation days. CONCLUSIONS The combination of neuromuscular electrical stimulation, high protein supplementation and mobility and strength rehabilitation resulted in mitigation of lower extremity muscle loss and less delirium in mechanically ventilated ICU patients. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT02509520. Registered July 28, 2015.
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Intravascular volume status and stress markers in patients observing long and short duration of fasting: A prospective single blinded observational study.
Shivhare, A, Jain, A, Sharma, JP, Kaushal, A, Kumar, H, Kumar, A
Journal of clinical anesthesia. 2023;:110992
Abstract
BACKGROUND Preoperative fasting may lead to intravascular volume depletion and this volume depletion may be a cause of perioperative stress. This study intends to compare the levels of stress markers in patients undergoing long and short duration fasting before an elective laparoscopic surgery. METHOD This was a single blind, observational study. Based on the duration of fasting, 70 ASA I and II category patients undergoing elective laparoscopic cholecystectomy(LC) were divided into two groups of 35 patients each. If the surgeon had prescribed a fasting since midnight then patient was considered for inclusion in Long fasting (LF) group; if surgeon had allowed clear fluids till 2 h before surgery then the patient was considered for inclusion in the short fasting(SF) group. The extent of intravascular volume depletion was measured using inferior vena cava collapsibility index (IVCCI). Levels of relevant stress markers i.e. cortisol, Tetraiodothyronine (FT4), C-peptide, C-reactive protein(CRP) and blood glucose (BGL) were measured at 8 PM in the night before surgery, at 7 AM on the day of surgery, 2 h after the surgery and 24 h after the surgery. RESULT IVCCI was significantly more in the LF group; 27.66 ± 3.34% vs17.83 ± 2.22%, 95% CI 8.47-11.18, P-value <0.001). IVCCI had a significant correlation with the duration of fasting, Pearson's correlation r = 0.69,P-value <0.001. Repeated measures ANCOVA revealed that CRP, Free T4 and C-peptide levels got significantly elevated over the study duration, P-values <0.001,<0.001 and 0.03 respectively but with IVCCI, Age and Gender as the covariates, the increase in the levels of CRP, Free T4 and C-peptide were similar in both the groups. CONCLUSION Stress markers levels show significant elevation in the perioperative period, maximum over the study duration, but this change is similar in both the groups. CLINICAL TRIAL NO CTRI/2021/02/031456.
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Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure.
Tardif, JC, Rouleau, J, Chertow, GM, Al-Shurbaji, A, Lisovskaja, V, Gustavson, S, Zhao, Y, Bouabdallaoui, N, Desai, AS, Chernyavskiy, A, et al
ESC heart failure. 2023;(2):1066-1076
Abstract
AIMS: Several patients with heart failure and reduced ejection fraction (HFrEF) do not receive renin-angiotensin-aldosterone system (RAAS) inhibitors at the recommended dose or at all, frequently due to actual or feared hyperkalaemia. Sodium zirconium cyclosilicate (SZC) is an orally administered non-absorbed intestinal potassium binder proven to lower serum potassium concentrations. METHODS AND RESULTS PRIORITIZE-HF was an international, multicentre, parallel-group, randomized, double-blind, placebo-controlled study to evaluate the benefits and risks of using SZC to intensify RAAS inhibitor therapy. Patients with symptomatic HFrEF were eligible and randomly assigned to receive SZC 5 g or placebo once daily for 12 weeks. Doses of study medication and RAAS inhibitors were titrated during the treatment period. The primary endpoint was the proportion of patients at 12 weeks in the following categories: (i) any RAAS inhibitor at less than target dose, and no MRA; (ii) any RAAS inhibitor at target dose and no MRA; (ii) MRA at less than target dose; and (iv) MRA at target dose. Due to challenges in participant management related to the COVID-19 pandemic, the study was prematurely terminated with 182 randomized patients. There was no statistically significant difference in the distribution of patients by RAAS inhibitor treatment categories at 3 months (P = 0.43). The proportion of patients at target MRA dose was numerically higher in the SZC group (56.4%) compared with the placebo group (47.0%). Overall, SZC was well tolerated. CONCLUSIONS PRIORITIZE-HF was terminated prematurely due to COVID-19 and did not demonstrate a statistically significant increase in the intensity of RAAS inhibitor therapies with the potassium-reducing agent SZC compared with placebo.
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Maralixibat Treatment Response in Alagille Syndrome is Associated with Improved Health-Related Quality of Life.
Kamath, BM, Goldstein, A, Howard, R, Garner, W, Vig, P, Marden, JR, Billmyer, E, Anderson, A, Kirson, N, Jacquemin, E, et al
The Journal of pediatrics. 2023;:68-75.e5
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Abstract
OBJECTIVE The objective of this study was to assess the impact of treatment response to the ileal bile acid transporter inhibitor maralixibat on health-related quality of life (HRQoL) in children with Alagille syndrome. STUDY DESIGN This analysis used data from the ICONIC trial, a phase 2 study with a 4-week double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille syndrome with moderate-to-severe pruritus. Clinically meaningful treatment response to maralixibat was defined a priori as a ≥1-point reduction in the Itch-Reported Outcome (Observer) score, from baseline to week 48. HRQoL was assessed using the Pediatric Quality of Life Inventory Generic Core, Family Impact, and Multidimensional Fatigue scale scores, which were collected via the caregiver. The minimal clinically important difference for HRQoL ranged from 4 to 5 points, depending on the scale. RESULTS Twenty of the 27 patients (74%) included in this analysis achieved an Itch-Reported Outcome (Observer) treatment response at week 48. The mean (SD) change in Multidimensional Fatigue score was +25.8 (23.0) for responders vs -3.1 (19.8) for nonresponders (P = .03). Smaller and non-statistically significant mean changes were observed for the Pediatric Quality of Life Inventory Generic Core and Family Impact scores. Controlling for baseline Family Impact score, responders' Family Impact scores increased an average of 16.9 points over 48 weeks compared with non-responders (P = .05). Smaller and non-statistically significant point estimates were observed for the Pediatric Quality of Life Inventory Generic Core and Multidimensional Fatigue scores. CONCLUSION The significant improvements in pruritus seen with maralixibat at week 48 of the ICONIC study are clinically meaningful and are associated with improved HRQoL. TRIAL REGISTRATION ClinicalTrials.gov: NCT02160782.
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Evaluation of the Application Effect of a New Anti-reflux Water Injection Tube Device in the Prevention of the Contamination of Endoscopy Water Injection Bottles.
Liu, Y, Xu, S, Muhetaer, G, Tang, H, Guo, H, Li, H
Digestive diseases and sciences. 2023;(5):1728-1734
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Abstract
BACKGROUND Water delivery tube reflux during gastrointestinal endoscopy examination is widespread and it is the leading cause of water injection bottle pollution. AIM: To evaluate the application effect of a new anti-reflux water injection tube device in preventing the contamination of endoscopy water injection bottles. METHODS A total of 520 cases received gastrointestinal endoscopy examination were included. Patients were randomly divided into the experimental and control group. The experimental group used the anti-reflux injection tube device to assist with water injection, and the control group used the ordinary delivery tube. After every five cases of gastrointestinal endoscopy, water from the injection bottles was collected. Visual inspection, crystalline violet staining, microbial culture, and microbial species analysis were performed to analyze the contamination state of the water samples. RESULTS The contamination rate in the experimental group was 5.66%, significantly lower than 76.47% in the control group. Crystalline violet staining confirmed that microorganisms existed in contaminated water samples. Microbiological culture results showed that the experimental group's undetectable rate of bacteria and fungi was 100%, significantly higher than that of the control group (19.61% for bacteria and 25.49% for fungi). The mean values of the total bacterial and fungal colonies of the control samples were 9.80 × 106 cfu/ml and 9.18 × 106 cfu/ml, respectively. The microbial species in the contaminated samples of the control group were Pseudomonas aeruginosa, Escherichia coli, and Proteus mirabilis. CONCLUSION The anti-reflux water injection tube device can effectively prevent the contamination of the endoscopy water injection bottles caused by the reflux of the ordinary water supply tube.
