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1.
Assessment of adverse reactions to α-lipoic acid containing dietary supplements through spontaneous reporting systems.
Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, IC, Moro, PA, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E
Clinical nutrition (Edinburgh, Scotland). 2021;(3):1176-1185
Abstract
BACKGROUND & AIMS Alpha-lipoic acid (ALA)-containing dietary supplements are widely used in clinical practice, although their safety assessment is under-investigated. We characterize the safety profile of ALA-containing products by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS Suspected ARs to ALA-containing products were extracted from the Italian Phytovigilance System (IPS), and scrutinized in terms of seriousness and causality (through WHO UMC system), with a specific focus on important (IMEs) and designated medical events (DMEs). To characterize the reporting profile from an international perspective, the WHO-VigiBase was also queried. RESULTS From March 2002 to February 2020, out of 2147 total reports, 116 reports concerning 212 ARs to ALA-containing products were collected. Women were involved in 68.1% of cases. Skin (44.9%) and gastrointestinal disorders (10.8%) were the most frequently represented ARs. Causality assessment resulted as definite (15), probable (35), possible (24), unlikely (5), and unclassifiable (37). In 70% of cases, events occurred within 30 days of ALA use. Forty-five reports were serious (38.8%), being insulin autoimmune syndrome the most frequently reported (N = 10). IMEs were recorded in 20 cases, including four DMEs (3 angioedema and one anaphylactic shock). Similar distribution emerged from the 5641 reports in the WHO-VigiBase. CONCLUSIONS The remarkable reporting of unpredictable skin, immune and hepatic ARs, coupled with seriousness, strong causality and early onset, calls for a) careful risk-benefit assessment of ALA-containing products by regulators; b) awareness and monitoring by clinicians and c) continuous vigilance of their safety profile through valuable spontaneous reporting systems such as IPS.
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2.
Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study).
Reintam Blaser, A, Padar, M, Mändul, M, Elke, G, Engel, C, Fischer, K, Giabicani, M, Gold, T, Hess, B, Hiesmayr, M, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(8):4932-4940
Abstract
BACKGROUND & AIMS To develop a five grade score (0-4 points) for the assessment of gastrointestinal (GI) dysfunction in adult critically ill patients. METHODS This prospective multicenter observational study enrolled consecutive adult patients admitted to 11 intensive care units in nine countries. At all sites, daily clinical data with emphasis on GI clinical symptoms were collected and intra-abdominal pressure measured. In five out of 11 sites, the biomarkers citrulline and intestinal fatty acid-binding protein (I-FABP) were measured additionally. Cox models with time-dependent scores were used to analyze associations with 28- and 90-day mortality. The models were estimated with stratification for study center. RESULTS We included 540 patients (224 with biomarker measurements) with median age of 65 years (range 18-94), the Simplified Acute Physiology Score II score of 38 (interquartile range 26-53) points, and Sequential Organ Failure Assessment (SOFA) score of 6 (interquartile range 3-9) points at admission. Median ICU length of stay was 3 (interquartile range 1-6) days and 90-day mortality 18.9%. A new five grade Gastrointestinal Dysfunction Score (GIDS) was developed based on the rationale of the previously developed Acute GI Injury (AGI) grading. Citrulline and I-FABP did not prove their potential for scoring of GI dysfunction in critically ill. GIDS was independently associated with 28- and 90-day mortality when added to SOFA total score (HR 1.40; 95%CI 1.07-1.84 and HR 1.40; 95%CI 1.02-1.79, respectively) or to a model containing all SOFA subscores (HR 1.48; 95%CI 1.13-1.92 and HR 1.47; 95%CI 1.15-1.87, respectively), improving predictive power of SOFA score in all analyses. CONCLUSIONS The newly developed GIDS is additive to SOFA score in prediction of 28- and 90-day mortality. The clinical usefulness of this score should be validated prospectively. TRIAL REGISTRATION NCT02613000, retrospectively registered 24 November 2015.
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Risk Factors of Acute Gastrointestinal Failure in Critically Ill Patients With Traumatic Brain Injury.
Fu, W, Shi, N, Wan, Y, Mei, F, Qiu, B, Bao, Y, Zhang, Y, Hao, J, He, J, Peng, X
The Journal of craniofacial surgery. 2020;(2):e176-e179
Abstract
OBJECTIVE To assess the risk factors associated with acute gastrointestinal failure (AGF) in critically ill patients with traumatic brain injury (TBI). METHODS Prospective, observational study was conducted in NanFang Hospital, Southern Medical University. All patients admitted to the Department of Critical Care Medicine and Department of Neurosurgery from June 1, 2017 to December 1, 2018 with TBI were enrolled. RESULTS Overall, 199 patients were enrolled. About 62 episodes (31%) of AGF were diagnosed. In the multivariate analysis, women, severe Glasgow Coma Scale (GCS) classification, frontal lobe injury, abnormal serum sodium, pulmonary infection, and intracranial infection are significantly associated with developing AGF, independent of other prognostic factors. CONCLUSION The AGF occurs frequently in intensive care unit patients who are suffering from TBI. In critically ill patients with TBI, women, severe GCS classification, frontal lobe injury, abnormal serum sodium, pulmonary infection, and intracranial infection are independent risk factors for AGF.
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Clinical Utility of LCT Genotyping in Children with Suspected Functional Gastrointestinal Disorder.
Couce, ML, Sánchez-Pintos, P, González-Vioque, E, Leis, R
Nutrients. 2020;(10)
Abstract
Genetic testing is a good predictor of lactase persistence (LP) in specific populations but its clinical utility in children is less clear. We assessed the role of lactose malabsorption in functional gastrointestinal disorders (FGID) in children and the correlation between the lactase non-persistence (LNP) genotype and phenotype, based on exhaled hydrogen and gastrointestinal symptoms, during a hydrogen breath test (HBT). We also evaluate dairy consumption in this sample. We conducted a 10-year cross-sectional study in a cohort of 493 children with suspected FGID defined by Roma IV criteria. Distribution of the C/T-13910 genotype was as follows: CC, 46.0%; TT, 14.4% (LP allele frequency, 34.1%). The phenotype frequencies of lactose malabsorption and intolerance were 36.3% and 41.5%, respectively. We observed a strong correlation between genotype and both lactose malabsorption (Cramér's V, 0.28) and intolerance (Cramér's V, 0.54). The frequency of the LNP genotype (p = 0.002) and of malabsorption and intolerance increased with age (p = 0.001 and 0.002, respectively). In 61% of children, evaluated dairy consumption was less than recommended. No association was observed between dairy intake and diagnosis. In conclusion, we found a significant correlation between genotype and phenotype, greater in older children, suggesting that the clinical value of genetic testing increases with age.
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Intra-Abdominal Pressure as a Marker of Enteral Nutrition Intolerance in Critically Ill Patients. The PIANE Study.
Bordejé, ML, Montejo, JC, Mateu, ML, Solera, M, Acosta, JA, Juan, M, García-Córdoba, F, García-Martínez, MA, Gastaldo, R, ,
Nutrients. 2019;(11)
Abstract
To determine whether elevated intra-abdominal pressure (IAP) is associated with a higher rate of enteral nutrition-related gastrointestinal (GI) complications; to assess the value of IAP as a predictor of enteral nutrition (EN) intolerance. Intensive Care Unit (ICU) patients on mechanical ventilation requiring at least 5 days of EN were recruited for a prospective, observational, non-interventional, multicenter study. EN was performed and GI complications were managed with an established protocol. IAP was determined via a urinary catheter. Patients who developed any GI complications were considered as presenting EN intolerance. Variables related to EN, IAP and GI complications were monitored daily. Statistical analysis compared patients without GI complications (group A) vs. GI complications (group B). 247 patients were recruited from 28 participating ICUs (group A: 119, group B: 128). No differences between groups were recorded. Patients in group B (p < 0.001) spent more days on EN (8.1 ± 8.4 vs. 18.1 ± 13.7), on mechanical ventilation (8.0 ± 7.7 vs. 19.3 ± 14.9) and in the ICU (12.3 ± 11.4 vs. 24.8 ± 17.5). IAP prior to the GI complication was (14.3 ± 3.1 vs. 15.8 ± 4.8) (p < 0.003). The best IAP value identified for EN intolerance was 14 mmHg but it had low sensitivity and specificity. Although a higher IAP was associated with EN intolerance, IAP alone did not emerge as a good predictor of EN intolerance in critically ill patients.
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Associations of hyperosmolar medications administered via nasogastric or nasoduodenal tubes and feeding adequacy, food intolerance and gastrointestinal complications amongst critically ill patients: A retrospective study.
Wesselink, E, Koekkoek, KWAC, Looijen, M, van Blokland, DA, Witkamp, RF, van Zanten, ARH
Clinical nutrition ESPEN. 2018;:78-86
Abstract
BACKGROUND Adequate nutrition is essential during critical illness. However, providing adequate nutrition is often hindered by gastro-intestinal complications, including feeding intolerance. It is suggested that hyperosmolar medications could be causally involved in the development of gastro-intestinal complications. The aims of the present study were 1) to determine the osmolality of common enterally administered dissolved medications and 2) to study the associations between nasogastric and nasoduodenal administered hyperosmolar medications and nutritional adequacy as well as food intolerance and gastro-intestinal symptoms. METHODS This retrospective observational cohort study was performed in a medical-surgical ICU in the Netherlands. Adult critically ill patients receiving enteral nutrition and admitted for a minimum ICU duration of 7 days were eligible. The osmolalities of commonly used enterally administrated medications were measured using an osmometer. Patients were divided in two groups: Use of hyperosmolar medications (>500 mOsm/kg) on at least one day during the first week versus none. The associations between the use of hyperosmolar medications and nutritional adequacy were assessed using multiple logistic regression analysis. The associations between hyperosmolar medication and food intolerance as well as gastrointestinal symptoms were assessed using ordinal logistic regression. RESULTS In total 443 patients met the inclusion criteria. Of the assessed medications, only three medications were found hyperosmolar. We observed no associations between the use of hyperosmolar medications and nutritional adequacy in the first week of ICU admission (caloric intake β -0.27 95%CI -1.38; 0.83, protein intake β 0.32 95%CI -0.90; 1.53). In addition, no associations were found for enteral feeding intolerance, diarrhea, obstipation, gastric residual volume, nausea and vomiting in ICU patients receiving hyperosmolar medications via a nasogastric tube. A subgroup analysis of patients on duodenal feeding showed that postpyloric administration of hyperosmolar medications was associated with increased risk of diarrhea (OR 138.7 95%CI 2.33; 8245). CONCLUSIONS Our results suggest that nasogastric administration of hyperosmolar medication via a nasogastric tube does not affect nutritional adequacy, development of enteral feeding intolerance and other gastro-intestinal complications during the first week after ICU admission. During nasoduodenal administration an increased diarrhea incidence may be encountered.
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Effect of Yikou-Sizi powder hot compress on gastrointestinal functional recovery in patients after abdominal surgery: Study protocol for a randomized controlled trial.
Cao, L, Wang, T, Lin, J, Jiang, Z, Chen, Q, Gan, H, Chen, Z
Medicine. 2018;(38):e12438
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Abstract
BACKGROUND Postoperative gastrointestinal dysfunction (PGD) is a common complication of patients who have undergone surgery. The clinical manifestations cause great discomfort to postoperative patients and can severely affect postoperative recovery. However, although various pharmacologic agents have been explored for several years, success has been limited. Because some commonly used drugs have caused adverse reactions and because abdominal surgery patients generally cannot consume food or medication during the perioperative period, we were prompted to try an external Chinese medicine treatment method. Yikou-Sizi powder hot compress is an efficient therapy in our hospital, but there is a lack of rigorous studies to certify the safety and effectiveness of its external use to improve gastrointestinal motility. This study aimed to introduce the clinical trial design and test the ability of Yikou-Sizi powder hot compress treatment to accelerate gastrointestinal functional recovery after abdominal surgery. METHODS This study is a randomized controlled clinical trial. The participants will undergo laparoscopic colorectal cancer surgery and laparoscopic total hysterectomy. The primary outcome measure will be the gastrointestinal functional evaluation index, including the time to first passage of flatus, first defecation, first normal bowel sounds, and first consumption of liquid/semigeneral diet foods. According to good clinical practice (GCP), we will evaluate the clinical efficacy and safety of Yikou-Sizi powder hot compress and objectively study the acting mechanism of ghrelin. This pilot trial will be a standard, scientific, and clinical study designed to evaluate the effect of Yikou-Sizi powder hot compress for the recovery of gastrointestinal function after surgery and determine its overall safety. DISCUSSION This is the first study to describe the use of Yikou-Sizi powder hot compress to accelerate the recovery of gastrointestinal function after abdominal surgery. The study is designed as a randomized, controlled, clinical, large sample size and pilot trial. Evaluation will consist of combining the primary outcome measures with secondary outcome measures to ensure the objectivity and scientific validity of the study. Due to the observational design and the limited follow-up period, it is not possible to evaluate to what extent the connection between the observed improvement and the interventions represents a causal relationship. Efficient comparison between groups will be analyzed by chi-square test.
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Perceived life stress and anxiety correlate with chronic gastrointestinal symptoms in runners.
Wilson, PB
Journal of sports sciences. 2018;(15):1713-1719
Abstract
Numerous causes of exercise-related gastrointestinal (GI) distress exist but scarce research has evaluated potential psychological causes. Runners (74 men, 76 women) prospectively recorded running duration, intensity (Rating of Perceived Exertion [RPE]), and GI symptoms for 30 days. Six GI symptoms were rated on a 0-10 scale. The percentage of runs over 30 days that participants reported at least one upper, lower, or any GI symptom ≥3 was calculated. After 30 days, participants completed a questionnaire on GI distress triggers (demographics, anthropometrics, experience, analgesic use, antibiotic use, probiotic consumption, fluid/food intake, stress, anxiety). Stress and anxiety were measured via the Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI). The median percentage of runs that participants experienced at least one GI symptom ≥3 was 45.6% (interquartile range [IQR], 16.6-67.3%). Age and running experience negatively correlated with GI distress occurrence (rho = -0.17 to -0.34; p < 0.05). Run RPE, probiotic food consumption, PSS scores, and BAI scores positively correlated with GI distress occurrence (rho = 0.18 to 0.36; p < 0.05). Associations between GI distress, stress and anxiety remained significant after adjustment for covariates, except for lower GI symptoms. This study suggests that stress and anxiety contribute to running-related GI distress.
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Frequency of Chronic Gastrointestinal Distress in Runners: Validity and Reliability of a Retrospective Questionnaire.
Wilson, PB
International journal of sport nutrition and exercise metabolism. 2017;(4):370-376
Abstract
Gastrointestinal (GI) symptoms may affect up to 90% of competitors during endurance races. Studies have typically assessed GI symptoms retrospectively or only over an acute timeframe, and information on the validity and reliability of the questionnaires employed is lacking. This investigation aimed to estimate the frequency of GI distress experienced by runners over 30 days and to establish the validity and reliability of a retrospective GI symptom questionnaire. Runners (70 men, 75 women) recorded GI symptoms with a prospective journal for 30 days. Retrospective GI symptom data were then collected after the 30-day period on two occasions within one week. GI symptoms were rated on a 0-10 scale. Descriptive statistics for GI symptoms are reported as medians (interquartile ranges) because of nonnormal distributions. Men and women experienced at least one GI symptom on 84.0% (59.8-95.1%) and 78.3% (50.0-95.2%) of runs, respectively. Moderate-to-severe GI symptoms (score of ≥5) were experienced on 13.8% (6.7-37.3%) and 21.7% (5.3-41.2%) of runs for men and women. Spearman's rho correlations between journal ratings and retrospective questionnaire ratings ranged from 0.47 to 0.82 (all p < .001), although they were highest when journal ratings were quantified as mean 30-day values (all rho ≥ 0.59). Reliability of the retrospective questionnaire ratings was high (rho = 0.78-0.92; p < .001). In comparison with tracking GI symptoms with a daily journal, retrospective questionnaires seem to offer a convenient and reasonably valid and reliable method of quantifying GI symptoms over 30 days.
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Gastrointestinal symptoms, inflammation and hypoalbuminemia in chronic kidney disease patients: a cross-sectional study.
Zhang, X, Bansal, N, Go, AS, Hsu, CY
BMC nephrology. 2015;:211
Abstract
BACKGROUND Few studies have focused on investigating hypoalbuminemia in patients during earlier stages of chronic kidney disease (CKD). In particular, little is known about the role of gastrointestinal (GI) symptoms. Our goal in this paper is to study how GI symptoms relate to serum albumin levels in CKD, especially in the context of and compared with inflammation. METHODS We performed a cross-sectional study of 3599 patients with chronic kidney disease enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. All subjects were asked to complete the Modification of Diet in Renal Disease (MDRD) study patient symptom form. Our main predictor is GI symptom score. Serum level of C-reactive protein (CRP) was measured as well. Main outcome measures are serum albumin levels and prevalence of hypoalbuminemia. RESULTS Of the participants assessed, mean serum albumin was 3.95 ± 0.46 g/dL; 12.7 % had hypoalbuminemia. Patients with lower estimated glomerular filtration rate (eGFR) were likely to have more GI symptoms (apparent at an eGFR <45 ml/min/1.73 m(2)). Patients with worse GI symptoms had lower dietary protein intake. GI symptoms, like inflammation, were risk factors for lower serum albumin levels. However, adding GI symptom score or CRP into the multivariable regression analysis, did not attenuate the association between lower eGFR and lower albumin or hypoalbuminemia. CONCLUSIONS Increased prevalence of GI symptoms become apparent among CKD patients at relatively high eGFR levels (45 ml/min/1.73 m(2)), long before ESRD. Patients with more severe GI symptoms scores are more likely to have hypoalbuminemia. But our data do not support GI symptoms/decreased protein intake or inflammation as being the main determinants of serum albumin level in CKD patients.