Global availability of parenteral nutrition: Pre- and post-COVID-19 pandemic surveys.

OBJECTIVE: Parenteral nutrition represents a therapeutic option for patients with type 3 intestinal failure. If used exclusively, parenteral nutrition has to be complete to provide all essential nutrients. The aim was to assess the availability of parenteral nutrition in all parts of the world, to better comprehend the global situation, and to prepare an action plan to increase access to parenteral nutrition. METHODS: An international survey using an electronic questionnaire was conducted in August 2019 and repeated in May 2022. An electronic questionnaire was sent to 52 members or affiliates of the International Clinical Nutrition Section of the American Society for Parenteral and Enteral Nutrition. Questions addressed the availability of parenteral nutrition admixtures and their components, reimbursement, and prescribing pre- and post-COVID-19 pandemic. All participating countries were categorized by their economic status. RESULTS: Thirty-six country representatives responded, answering all questions. Parenteral nutrition was available in all countries (100%), but in four countries (11.1%) three-chamber bags were the only option, and in six countries a multibottle system was still used. Liver-sparing amino acids were available in 18 (50%), kidney-sparing in eight (22.2%), and electrolyte-free in 11 (30.5%) countries (30.5%). In most countries (n = 28; 79.4%), fat-soluble and water-soluble vitamins were available. Trace elements solutions were unavailable in four (11.1%) countries. Parenteral nutrition was reimbursed in most countries (n = 33; 91.6%). No significant problems due to the coronavirus pandemic were reported. CONCLUSIONS: Despite the apparent high availability of parenteral nutrition worldwide, there are some factors that may have a substantial effect on the quality of parenteral nutrition admixtures. These shortages create an environment of inequality.

ESPEN practical guideline on clinical nutrition in acute and chronic pancreatitis.

Both acute and chronic pancreatitis are frequent diseases of the pancreas, which, despite being of benign nature, are related to a significant risk of malnutrition and may require nutritional support. Acute necrotizing pancreatitis is encountered in 20 % of patients with acute pancreatitis, is associated with increased morbidity and mortality, and may require artificial nutrition by enteral or parenteral route, as well as additional endoscopic, radiological or surgical interventions. Chronic pancreatitis represents a chronic inflammation of the pancreatic gland with development of fibrosis. Abdominal pain leading to decreased oral intake, as well as exocrine and endocrine failure are frequent complications of the disease. All of the above represent risk factors related to malnutrition. Therefore, patients with chronic pancreatitis should be considered at risk, screened and supplemented accordingly. Moreover, osteoporosis and increased facture risk should be acknowledged in patients with chronic pancreatitis, and preventive measures should be considered.

ESPEN guideline on clinical nutrition in acute and chronic pancreatitis.

Both acute and chronic pancreatitis are frequent diseases of the pancreas, which, despite being of benign nature, are related to a significant risk of malnutrition and may require nutritional support. Acute necrotizing pancreatitis is encountered in 20% of patients with acute pancreatitis, is associated with increased morbidity and mortality, and may require artificial nutrition by enteral or parenteral route, as well as additional endoscopic, radiological or surgical interventions. Chronic pancreatitis represents a chronic inflammation of the pancreatic gland with development of fibrosis. Abdominal pain leading to decreased oral intake, as well as exocrine and endocrine failure are frequent complications of the disease. All of the above represent risk factors related to malnutrition. Therefore, patients with chronic pancreatitis should be considered at risk, screened and supplemented accordingly. Moreover, osteoporosis and increased facture risk should be acknowledged in patients with chronic pancreatitis, and preventive measures should be considered.

Detection and treatment of medical inpatients with or at-risk of malnutrition: Suggested procedures based on validated guidelines.

OBJECTIVE: Despite the high prevalence of malnutrition in the general inpatient population, there is a lack of knowledge in regard to detecting disease-related malnutrition and implementing nutritional support. Our aim was to suggest practical procedures for screening and treating malnourished or at-risk patients hospitalized in medical wards, thereby fostering a straightforward implementation of nutritional therapy independent of the underlying disease and comorbidities. METHODS: A working group of experts in clinical nutrition selected and analyzed published disease-specific European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines relevant for our aim. Eight questions in population, intervention, control, outcome format were defined to cover topics such as screening, nutritional targets, and routes of feeding. Individual studies were extracted from the guidelines by applying inclusion and exclusion criteria targeting the heterogeneous population of medical inpatients with or at-risk of disease-related malnutrition. We used those studies as evidence, as well as recommendations from the selected ESPEN guidelines, to formulate answers to the questions. Final agreement with the statement was obtained by consensus of the whole working group. RESULTS: Procedures on how to provide integrated nutritional therapy (oral, enteral, and parenteral) to a heterogeneous patient population were suggested, including how to identify malnourished or at-risk patients, nutrient targets, choice of feeding route, monitoring, and assessment of patients. We also developed a simple algorithm to facilitate the implementation of a nutritional care plan for the general medical inpatient population. CONCLUSION: By compiling evidence and recommendations from disease-specific guidelines, we were able to suggest a nutritional strategy applicable to large and heterogeneous group of malnourished or at-risk patients admitted to hospitals. A large randomized controlled trial is currently investigating whether this strategy improves clinical outcomes of patients.

Development and Clinical Validation of a Blood Test Based on 29-Gene Expression for Early Detection of Colorectal Cancer.

PURPOSE: A blood test for early detection of colorectal cancer is a valuable tool for testing asymptomatic individuals and reducing colorectal cancer-related mortality. The objective of this study was to develop and validate a novel blood test able to differentiate patients with colorectal cancer and adenomatous polyps (AP) from individuals with a negative colonoscopy. EXPERIMENTAL DESIGN: A case-control, multicenter clinical study was designed to collect blood samples from patients referred for colonoscopy or surgery. Predictive algorithms were developed on 75 controls, 61 large AP (LAP) ≥1 cm, and 45 colorectal cancer cases and independently validated on 74 controls, 42 LAP, and 52 colorectal cancer cases (23 stages I-II) as well as on 245 cases including other colorectal findings and diseases other than colorectal cancer. The test is based on a 29-gene panel expressed in peripheral blood mononuclear cells alone or in combination with established plasma tumor markers. RESULTS: The 29-gene algorithm detected colorectal cancer and LAP with a sensitivity of 79.5% and 55.4%, respectively, with 90.0% specificity. Combination with the protein tumor markers carcinoembryonic antigen (CEA) and CYFRA21-2 resulted in a specificity increase (92.2%) with a sensitivity for colorectal cancer and LAP detection of 78.1% and 52.3%, respectively. CONCLUSIONS: We report the validation of a novel blood test, Colox®, for the detection of colorectal cancer and LAP based on a 29-gene panel and the CEA and CYFRA21-1 plasma biomarkers. The performance and convenience of this routine blood test provide physicians a useful tool to test average-risk individuals unwilling to undergo upfront colonoscopy. Clin Cancer Res; 22(18); 4604-11. ©2016 AACR.

Basics in Clinical Medical Nutrition.

Nutrition is a basic requirement for life and plays an important role in health and in disease prevention, but malnutrition is a common event and a cause of increased morbidity and mortality, particularly in patients with disease-related malnutrition showing inflammation and a catabolic state. Malnutrition is often overlooked, and deterioration in the nutritional status following admission to hospital is common. It should be actively pursued by a ubiquitous system of nutrition screening, and full nutritional assessment is required for those found to be at risk. There are simple screening tools which can be used by all health care professionals. Assessment considers body composition, inflammatory status and other aspects of underlying diseases and their functional consequences; it is a more specialist process. It is important to determine the energy and protein needs of each individual patient. Appropriate nutritional intervention can often be offered by the oral route, using food with or without special supplements. When this is insufficient, enteral tube feeding will normally be sufficient, but there is an important subgroup of patients in whom enteral feeding is contraindicated or unsuccessful, and in these patients parenteral nutrition (either total or supplemental) is required. A number of immunonutrients and other special substrates have been shown to be helpful in specific circumstances, but their use is not without potential hazards, and therefore adherence to international guidelines is recommended.

Efficacy of partially hydrolyzed guar gum (PHGG) supplemented modified oral rehydration solution in the treatment of severely malnourished children with watery diarrhoea: a randomised double-blind controlled trial.

OBJECTIVES: To examine whether PHGG added ORS reduce duration of diarrhoea, stool output and enhance weight gain. METHODS: In a double-blind controlled clinical trial, 126 malnourished children (weight for length/weight for age < -3 Z-score with or without pedal edema), aged 6 - 36 months with acute diarrhoea <7 days were studied in two treatment groups; 63 received modified WHO ORS (Na 75, K 40, Cl 87, citrate 7, glucose 90 mmol/L) with PHGG 15 g/L (study group); 63 received modified WHO ORS without PHGG (control). Other treatments were similar in both groups. The study protocol was approved by Ethics Committee of icddr,b; the study was carried out at the Dhaka Hospital. RESULTS: The mean duration of diarrhoea (h) was significantly shorter in children of the study group (Study vs. control, mean ± SD, 57 ± 31 vs. 75 ± 39, p = 0.01). Although there was a trend in stool weight reduction in children receiving ORS with PHGG (study vs. control, stool weight (g), mean ± SD; 1(st) 24 hour, 854.03 ± 532.15 vs. 949.11 ± 544.33, p = 0.32; 2(nd) 24 hour, 579.84 ± 466.01 vs. 761.26 ± 631.64, p = 0.069; 3(rd) 24 hour, 385.87 ± 454.09 vs. 495.73 ± 487.61, p = 0.196), especially in 2(nd) 24 h period, the difference was not statistically significant. The mean time (day) to attain weight for length 80% of NCHS median without edema was significantly shorter in the study group (study vs. control, mean ± SD, 4.5 ± 2.6 vs. 5.7 ± 2.8, p = 0.027). CONCLUSION: PHGG added to ORS substantially reduced duration of diarrhoea. It also enhanced weight gain. Further studies might substantiate to establish its beneficial effect. CLINICAL TRIAL REGISTRATION NUMBER: NCT01821586.

Protein is an important component of nutritional support predicting complications in malnourished hospitalised patients - Details of our previous randomised controlled trial (RCT).

BACKGROUND AND AIMS: Nutritional support can be an effective tool to avoid and reduce malnutrition. However, it is unclear which component, i.e. nutrient, is most efficient. With the present analysis we define the most important predictors of the body weight change and the complication incidence during hospitalisation. METHODS: Data of our previous randomised controlled nutritional trail was analysed according to per-protocol. A factor analysis was performed using binary logistic and multiple linear regression analyses with the outcome variables "complication yes/no" and "body weight change", respectively. RESULTS: Repeated measure ANOVA revealed a highly significant intervention effect for both protein and caloric intake (p < 0.001) after 5 and 10 days of intervention. Patients of the intervention group (IG; n = 59) were able to keep their body weight in contrast to control group (CG; n = 59) patients (68.3 (15.5) kg vs. 64.4 (15.8) kg, p = 0.003). The mean plasma ascorbic acid level was higher in IG than in CG at discharge (47.2 (26.8) µmol/l vs. 34.1 (24.2) µmol/l, p = 0.005). The number of patients suffering from in-hospital complications was lower in IG than in CG (4/59 vs. 13/59, p = 0.034). Positive effects on the antibiotic therapies for infectious complications (1/58 vs. 8/59, p = 0.032), the SF-36 physical summary scale (37 (11) % vs. 33 (9), p = 0.039) and the readmission rates (26/54 vs. 43/58, p = 0.019) were recorded. The mean protein intake predicted the chance of having a complication whereas the body weight change was best predicted by the mean caloric intake. CONCLUSIONS: Caloric and protein intake are important predictors of complications and the change in body weight, respectively. In contrast, age and disease severity did not influence the outcome in our nutritional trial.

The Tibetan herbal formula Padma Digestin in functional dyspepsia: an open-label study.

BACKGROUND: The etiology of functional dyspepsia (FD) is multi-factorial. Its prevalence is high and it considerably impairs the patients' quality of life. The treatment options are limited. Padma Digestin, a multi-herbal formula from Tibetan Medicine, is traditionally used in malabsorption and dyspeptic symptoms as they do occur in FD, but as yet no clinical data exist on the formula. The aim of this study was to evaluate the safety, tolerability, and efficacy of Padma Digestin in patients with FD in a prospective, open, clinical phase III trial. PATIENTS AND METHODS: Patients were recruited by general practitioners, internists, and gastroenterologists and treated with 2 × 3 capsules of Padma Digestin daily for 6 weeks. Dyspeptic symptoms were analyzed using the Domestic/International Gastroenterology Surveillance Study (DIGEST) questionnaire extended by the 2 symptoms stomach cramps and lack of appetite. The quality of life was assessed using the Psychological General Well-Being Index (PGWBI-S) questionnaire (short version). RESULTS: 37 patients were admitted and efficacy could be assessed in 31. In the overall efficacy assessment, the Padma Digestin treatment led to a statistically highly significant reduction of the respective most bothersome symptom scores regarding frequency, severity, and impairment of daily activities (p < 0.01). The treatment also led to significant improvements of the individual symptoms of postprandial fullness, nausea, localized and diffuse epigastric pain, stomach cramps, and lack of appetite. The onset of improvement was after a median of 7 days; time until disappearance of the symptoms was after a median of 22 days. The global efficacy and tolerability were rated as good or very good by the doctors and the patients in 84% and 78%, respectively. The PGWBI-S increased from 55 ± 19.5% to 70.5 ± 15.5%, which is nearly the normal value (73.5 ± 15.4%). As for safety, 11 patients reported a total of 17 adverse events (AE), 1 of which was serious but unrelated to the study medication. The AE were mild or moderate. The safety laboratory data showed no statistically significant or otherwise relevant changes. CONCLUSIONS: The results show that the formula Padma Digestin has a high tolerability and efficacy in FD symptoms and positively influences psychological well-being and thus quality of life. It therefore represents a much needed extension of the therapeutic repertoire in FD.

Measurement of calprotectin in ascitic fluid to identify elevated polymorphonuclear cell count.

AIM: To evaluate the diagnostic capability of calprotectin in ascitic fluid for detecting a polymorphonuclear (PMN) cell count > 250/µL ascites. METHODS: In this prospective observational study, a total of 130 ascites samples were analysed from 71 consecutive patients referred for paracentesis. Total and differential leukocyte cell counts were determined manually with a Neubauer chamber and gentian-violet stain. Calprotectin was measured in 1 mL ascetic fluid by enzyme-linked immunosorbent assay (ELISA) and a point-of-care (POC) lateral flow assay with the Quantum Blue(®) Reader (Bühlmann Laboratories). All measurements were carried out in a central laboratory by senior personnel blinded to patient history. A PMN count > 250/µL was the primary endpoint of the study. The diagnostic value of ascitic calprotectin measurement was assessed by comparing to the final diagnosis of each patient that had been adjudicated by investigators blinded to calprotectin values. RESULTS: The PMN count was > 250/µL in 19 samples (14.6%) from 15 patients (21.1%) and varied widely among the study population (range 10-19 800/mL and 1-17 820/mL, respectively). Spontaneous bacterial peritonitis (SBP) was the final diagnosis in four patients (5.6%). All patients with PMN ≤ 250/µL had negative bacterial culture. PMN count was elevated in five patients with peritoneal carcinomatosis, three with lymphoma, one with neuroendocrine carcinoma, and two with secondary peritonitis due to abdominal perforation. PMN cell counts correlated with ascitic calprotectin values (Spearman's rho; r = 0.457 for ELISA, r = 0.473 for POC). A considerable range of ascitic calprotectin concentrations was detected by ELISA [median 0.43 µg/mL, interquartile range (IQR) 0.23-1.23 (range 0.10-14.93)] and POC [median 0.38 µg/mL, IQR 0.38-0.56 (range 0.38-13.31)]. Ascitic calprotectin levels were higher in samples with PMN > 250/µL, by both ELISA [median (IQR) 2.48 µg/mL (1.61-3.65) vs 0.10 µg/mL (0.10-0.36), P < 0.001] and POC [2.78 µg/mL (2.05-5.37) vs 0.38 µg/mL (0.38-0.41), P < 0.001]. The area under the receiver operating characteristics curve for identifying an elevated PMN count was 0.977 (95%CI: 0.933 to 0.995) for ELISA and 0.982 (95%CI: 0.942 to 0.997) for POC (P = 0.246 vs ELISA). Using the optimal cut-off value for ELISA (0.63 µg/mL), ascitic calprotectin had 94.8% sensitivity, 89.2% specificity, positive and negative likelihood ratios of 8.76 and 0.06 respectively, positive and negative predictive values of 60.0% and 99.0% respectively, and 90.0% overall accuracy. Using the optimal cut-off value for POC (0.51 µg/mL), the respective values were 100.0%, 84.7%, 6.53, 0.00, 52.8%, 100% and 87.7%. Correlation between ELISA and POC was excellent (r = 0.873, P < 0.001). The mean ± SD of the difference was -0.11 ± 0.48 µg/mL with limits of agreement of + 0.8 µg/mL (95%CI: 0.69 to 0.98) and -1.1 µg/mL (95%CI: -1.19 to -0.91). CONCLUSION: Ascitic calprotectin reliably predicts PMN count > 250/µL, which may prove useful in the diagnosis of SBP, especially with a readily available bedside testing device.

Home artificial nutrition in Switzerland: an epidemiological survey from 2005 to 2009.

BACKGROUND AND AIMS: Home artificial nutrition (HAN), including oral nutritional supplements (ONS) and enteral (HEN) and parenteral (HPN) nutrition, is an established, important treatment for malnourished patients. The aim of this study was to analyze the epidemiological data of patients on HAN in Switzerland. METHODS: This retrospective study recorded all new cases of HAN in Switzerland from January 2005 to December 2009. RESULTS: A total of 12,917 cases were recorded: 6,731 (52%) males and 6,186 (48%) females, with a mean age of 65.0 ± 17.6 years. The number of patients on ONS was 7,827 (57.4%), on HEN 3,966 (39.4%) and on HPN 433 (3.2%). The most common underlying disease category was neoplasms (6,519, 50.7%). The number of patients on ONS increased from 57.0% (n = 1,252) to 60.8% (n = 2,039), and on HPN from 2.1% (n = 45) to 4.0% (n = 134) between 2005 and 2009. CONCLUSIONS: This first analysis of the large-scale Swiss registry of HAN shows that approximately half of the patients received ONS, whereas HPN was rarely delivered. The frequency of ONS and HPN increased from the year 2005 to 2009. In accordance with previous European studies, malignant tumors were by far the most frequent indication for HAN.

Salovum egg yolk containing antisecretory factor as an adjunct therapy in severe cholera in adult males: a pilot study.

Cholera involves stimulation of intestinal secretory process in response to cholera toxin leading to profuse watery diarrhoea that might cause death due to dehydration unless timely rehydration therapy is initiated. Efforts to identify and test potential antisecretory agents are ongoing. Antisecretory factor (AF) is a naturally-occurring protein produced in the human secretory organs, including the intestine, with antisectory properties demonstrated in animal and human models of secretory diarrhoea. Salovum egg yolk powder contains antisecretory proteins in a much higher (500 times) concentration than that of normal hen eggs. This is achieved by feeding hens with specially-processed cereals, capable of inducing antisecretory proteins in the yolk. The aim of the study was to examine the effect of Salovum egg yolk powder containing AF in the treatment of adult cholera patients. In an open, randomized controlled trial (pilot study), 40 adult male patients with severe cholera were studied: 20 received standard treatment (oral rehydration solution, antibiotic, and usual hospital diet) plus Salovum egg yolk powder (study group) and 20 received standard treatment alone (control group). All the patients received tablet doxycycline (300 mg) once immediately after randomization. Written informed consent was obtained from each subject before enrollment. The main outcome measures were stool weight and duration of diarrhoea. The demographic and baseline clinical characteristics of the study patients were comparable between the groups. No significant differences were found in the mean stool weight, g/kg of body-weight during the first 24 hours [study vs control group, mean +/- standard deviation (SD), 218 +/- 119 vs 195 +/- 136], second 24 hours (mean +/- SD, 23 +/- 39 vs 22 +/- 34), and cumulative up to 72 hours (mean +/- SD, 245 +/- 152 vs 218 +/- 169). The duration (hours) of diarrhoea after admission in the hospital was also similar in both the groups (mean +/- SD, 33 +/- 14 vs 32 +/- 10). No adverse effect was observed. Salovum egg powder containing AF as an adjunct therapy in the treatment of severe cholera could not demonstrate any beneficial effect. Further studies with higher doses of Salovum egg yolk powder might be considered in future to establish its antisecretory effect.

Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients.

BACKGROUND & AIMS: Strategies to treat malnutrition lack practicability in the hospital setting. The present study aimed at developing and evaluating a routinely manageable concept for an improved nutritional care of malnourished in-hospital patients. METHODS: A randomized controlled intervention study was conducted. 132 risk patients defined by Nutritional Risk Screening 2002, were randomized to individualised nutrition support (intervention group [n = 66]) or standard hospital care (control group [n = 66]). Body weight, plasma vitamin levels, quality of life, complications, antibiotic therapies, readmissions and mortality were assessed. RESULTS: Nutrition interventions led to higher intakes (mean [standard deviation]) in energy (1553 [341] kcal vs. 1115 [381] kcal, p < 0.001) and protein (65.4 [16.4] g vs. 43.9 [17.2] g, p < 0.001). Intervention patients (n = 66) kept their body weight in comparison to control patients (n = 66; 0.0 [2.9] kg vs. -1.4 [3.2] kg, p = 0.008). Positive effects on plasma ascorbic acid level (46.7 [26.7] µmol/l vs. 34.1 [24.2] µmol/l, p = 0.010), SF-36 function summary scale (37 [11] % vs. 32 [9] %, p = 0.030), number of complications (4/66 vs. 13/66, p = 0.035), antibiotic therapies (1/66 vs. 8/66, p = 0.033) and readmissions (17/64 vs. 28/61, p = 0.027) were recorded. CONCLUSIONS: Malnourished patients profit from nutrition support regarding nutrition status and quality of life. They have fewer complications, need fewer antibiotics and are less often re-hospitalised.

Prevalence of undernutrition on admission to Swiss hospitals.

BACKGROUND & AIMS: According to the literature, undernutrition is prevalent in 20-60% of patients on hospital admission. The differences in the rate of undernutrition arise from different diagnostic tools used in the studies. We aimed to investigate the prevalence of undernutrition in Swiss hospitals using a standardized screening tool. METHODS: All patients admitted to the departments of internal medicine of 7 Swiss hospitals were screened at entry for nutritional status using the Nutrition Risk Screening 2002 score. Patients with a score of 3 or more, which denotes severe undernutrition or patient "at risk" for undernutrition were analyzed. RESULTS: Between May 2003 and April 2006 32,837 patients were included in the study. 5978 (18.2%) had a score of 3 or more and were classified as severely undernourished or at high risk for undernutrition (age<45 y: 8%; 45-64 y: 11%; 65-84 y: 22%; >85 y: 28%). A nutritional intervention was made in 4175 patients (12.7%). CONCLUSIONS: Nearly one in five patients was severely undernourished or "at risk" for undernutrition. Undernutrition was directly related to age. Patients with a clear indication for nutrition therapy, as suggested by the formal screening procedure, obtained nutritional intervention in 70%.