Modified dietary fat intake for treatment of gallstone disease in people of any age.

BACKGROUND: The prevalence of gallstones varies between less than 1% and 64% in different populations and is thought to be increasing in response to changes in nutritional intake and increasing obesity. Some people with gallstones have no symptoms but approximately 2% to 4% develop them each year, predominantly including severe abdominal pain. People who experience symptoms have a greater risk of developing complications. The main treatment for symptomatic gallstones is cholecystectomy. Traditionally, a low-fat diet has also been advised to manage gallstone symptoms, but there is uncertainty over the evidence to support this. OBJECTIVES: To evaluate the benefits and harms of modified dietary fat intake in the treatment of gallstone disease in people of any age. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE ALL Ovid, Embase Ovid, and three other databases to 17 February 2023 to identify randomised clinical trials in people with gallstones. We also searched online trial registries and pharmaceutical company sources, for ongoing or unpublished trials to March 2023. SELECTION CRITERIA: We included randomised clinical trials (irrespective of language, blinding, or status) in people with gallstones diagnosed using ultrasonography or conclusive imaging methods. We excluded participants diagnosed with another condition that may compromise dietary fat tolerance. We excluded trials where data from participants with gallstones were not reported separately from data from participants who did not have gallstones. We included trials that investigated other interventions (e.g. trials of drugs or other dietary (non-fat) components) providing that the trial groups had received the same proportion of drug or other dietary (non-fat) components in the intervention. DATA COLLECTION AND ANALYSIS: We intended to undertake meta-analysis and present the findings according to Cochrane recommendations. However, as we identified only five trials, with data unsuitable and insufficient for analyses, we described the data narratively. MAIN RESULTS: We included five trials but only one randomised clinical trial (69 adults), published in 1986, reported outcomes of interest to the review. The trial had four dietary intervention groups, three of which were relevant to this review. We assessed the trial at high risk of bias. The dietary fat modifications included a modified cholesterol intake and medium-chain triglyceride supplementation. The control treatment was a standard diet. The trial did not report on any of the primary outcomes in this review (i.e. all-cause mortality, serious adverse events, and health-related quality of life). The trial reported on gallstone dissolution, one of our secondary outcomes. We were unable to apply the GRADE approach to determine certainty of evidence because the included trial did not provide data that could be used to generate an estimate of the effect on this or any other outcome. The trial expressed its finding as "no significant effect of a low-cholesterol diet in the presence of ursodeoxycholic acid on gallstone dissolution." There were no serious adverse events reported. The included trial reported that they received no funding that could bias the trial results through conflicts of interest. We found no ongoing trials. AUTHORS' CONCLUSIONS: The evidence about the effects of modifying dietary fat on gallstone disease versus standard diet is scant. We lack results from high-quality randomised clinical trials which investigate the effects of modification of dietary fat and other nutrient intakes with adequate follow-up. There is a need for well-designed trials that should include important clinical outcomes such as mortality, quality of life, impact on dissolution of gallstones, hospital admissions, surgical intervention, and adverse events.

WITHDRAWN: Usefulness of nabilone as an antiemetic in persistent vomiting due to refractory gastrointestinal disorders.

Nabilone, a synthetic analogue of delta-9-Tetrahydrocannabinol, is an agonist of cannabinoid receptors (CB-1 and CB-2) approved to treat chemotherapy-induced vomiting refractory to antiemetics. Its use in patients with refractory vomiting due to gastrointestinal dysmotility (GID) has not been reported. Our study aims are to assess nabilone usefulness and side-effects in patients with refractory vomiting due to GID. Patients prescribed nabilone at St. Mark's intestinal rehabilitation unit (January 2017 to September 2022) due to GID vomiting have been retrospectively reviewed. Descriptive analysis has been done. Variables measured: age, sex, comorbidities, antiemetics/prokinetics, enteral or parenteral nutrition, nabilone prescription, subjective symptom improvement and side-effects. Seven patients received nabilone. 5/7 (72%) were females. Median age:25 years (23-37). 3/7 (43%) had gastroparesis (1/3 related to postural orthostatic tachycardia syndrome -POTS- , 1/3 to Ehlers-Danlos' Syndrome, POTS, Crohn's Disease and adrenal insufficiency -AI- and 1/3 to sinus node ablation and AI), 2/7 (29%) had gastroparesis and intestinal dysmotility (1/2 related to POTS and 1/2 related to EDS and other connective tissue diseases) and 2/7 (29%) had intestinal dysmotility (1/2 because of polyglucosan body visceral myopathy and 1/2 to intestinal surgery). All patients had received antiemetics or prokinetics before (median of 5 drugs; 2-11). 1/7 (14%) received enteral supplements, 5/7 (72%) enteral nutrition through enteral tubes and 4/7 (57%) parenteral nutrition. 5/7 (72%) patients received 1mg of nabilone bd orally, 1/7 (14%) 2 mg bd through jejunostomy and 1/7 (14%) started nabilone at 2 mg bd orally, but had to be switched to 1 mg bd because of side-effects. The median treatment's duration was 9 days (7-35). Regarding the efficacy of nabilone, 3/7 (43%) had symptomatic improvement. In terms of side-effects 4/7 (57%) patients reported some incidence under the treatment such as headache, light-headedness, drowsiness, dizziness or hallucinations. Patients with refractory GID vomiting despite multiple anti-sickness are difficult to treat. Nabilone improved symptoms in almost half of the patients although adverse effects appeared in more than 50%. Doses higher than 1 mg bd po did not show benefit. Although our study has important limitations, nabilone might be a temporary measure in these patients. Side-effects should be taken into consideration.

A new palatable oral rehydration solution: A randomised controlled cross-over study in patients with a high output stoma.

BACKGROUND: Patients with a jejunostomy or high output stoma may need a glucose-sodium oral rehydration solution drink to maintain hydration. These solutions are unpalatable and a new flavoured pre-packaged solution was developed. METHODS: After 8 h of fasting, 27 patients took 500 mL of the modified World Health Organization (WHO) cholera solution or Glucodrate® (Vitaflo) on two occasions in a cross-over random order and urine and stomal output was collected for 6 h. RESULTS: There was a small but significant difference in net sodium absorption in favour of the modified WHO cholera solution (10 ± 28 mmol modified WHO cholera solution vs. -1 ± 26 mmol Glucodrate®, p = 0.01). However the Glucodrate® was more palatable, with 24 patients (89%) preferring it to the modified WHO cholera solution (p < 0.005). CONCLUSIONS: Glucodrate® is a more palatable solution than the modified WHO cholera solution and is almost as effective and so can be used when patients find the modified WHO cholera solution unpalatable.

A one size vial does not fit all: An evaluation of the micronutrient status of adult patients receiving home parenteral nutrition (HPN).

BACKGROUND & AIMS: Patients with chronic intestinal failure require HPN. Previous studies have reported a high prevalence of micronutrient deficiencies. We examined the micronutrient status of our patients receiving. METHODS: We measured vitamins A, E, D, B12, Folate, Zinc, Selenium and Copper. Patients were excluded if they had undergone surgery or amendments in IV or oral micronutrient provision in the past six months. Blood samples were excluded if C-reactive protein was >15 mg/L. Univariate and multivariate analyses were performed on concentrations below normal to determine if clinical or demographic categories were significant. RESULTS: 93 samples were included (33 males:60 females). Samples were excluded due to surgery (n = 8) amendment in micronutrient provision (n = 42) or if C-reactive protein >15 mg/L (n = 18). Vitamins A, D and E were below normal in 26%, 33% and 13% of patients respectively. Lower vitamin A was more likely in patients >50 years (P = 0.02) and lower vitamin E was more likely in men (P = 0.02). No patients had low vitamin B12 or folate whereas 29% and 9% had concentrations above the normal range respectively. Zinc and selenium were below normal in 19% and 13% respectively. Patients with surgical complications were more likely to have lower zinc (P = 0.007) and selenium (P = 0.04). Lower zinc was more likely in patients with a BMI of >25 kg/m2 (P = 0.01) and those who received Additrace® ≤3 day/week (P = 0.06). DISCUSSION: Low and high concentrations were observed in our patients but clinical and demographic factors did not impact consistently on micronutrient concentrations highlighting the importance of ongoing monitoring and adequate supplementation as per ESPEN guidelines. Current micronutrient preparations may be inadequate for some patients with dependent on HPN. Our results indicate a need for a preparation with higher amounts of vitamin D.

Investigating the Relationship between Home Parenteral Support and Needs-Based Quality of Life in Patients with Chronic Intestinal Failure: A National Multi-Centre Longitudinal Cohort Study.

Home parenteral support (HPS) is an essential but potentially burdensome treatment that can affect quality of life (QoL). The aims of this longitudinal study were to understand whether any changes in HPS over time were associated with QoL. The Parenteral Nutrition Impact Questionnaire (PNIQ) was used, and data were collected on HPS prescribed at three time points. Data were analysed using multi-level mixed regression models presented as effect size and were adjusted for confounders. Study recruited 572 participants from 15 sites. Of these, 201 and 145 completed surveys at second and third time-points, respectively. PNIQ score was out of 20 with a higher score indicating poorer QoL. Any reduction in HPS infusions per week was associated with an improved PNIQ score of -1.10 (95% CI -2.17, -0.02) unadjusted and -1.34 (95% CI -2.45, -0.24) adjusted. Per day change to the number of infusions per week was associated with a change in the PNIQ score of 0.32 (95% CI -0.15, 0.80) unadjusted and 0.34 (95% CI -0.17, 0.85) adjusted. This is the largest national study to demonstrate improvements in QoL associated with HPS reduction over time using an HPS-specific and patient-centric tool, adding unique data for use of therapies in intestinal failure.

A dangerous combination of binge and purge.

We present a 36-year-old female diagnosed with Crohn's disease at the age of 11 years. In 2001, she underwent a total colectomy and further small bowel resection as a result of active Crohn's. Her residual anatomy consisted of 150 cm of small bowel to an end jejunostomy. Subsequently, she developed short bowel syndrome with recurrent episodes of hypomagnesaemia, hypocalcaemia, and hypokalaemia. Dietetic assessment revealed her to be severely underweight at 37 kg with a bodymass index (BMI) of 14.4 kg/m(2) . During her admission, our patient underwent psychiatric assessment and was established on home parenteral nutrition (HPN). At the time of discharge, 1 month later, her weight had increased to 44 kg (BMI = 17.7 kg/m(2) ). Over the following 12-month period, she lost weight (BMI, 15.4 mg/m(2) ; weight, 39.5 kg) and she described a high stoma output (up to 17 L) and dehydration. Assessment of her oral intake found she was consuming an estimated 14,000 kcal and 600 g protein per day. At this time, the possibility of a new form of eating disorder was discussed with the patient and she agreed that her behavior i.e., using her stoma as a purging device, fulfilled the criteria for a diagnosis of bulimia nervosa and she was referred to a specialist eating disorder unit.

Delay in Transit: selected recommendations from the NCEPOD report on acute bowel obstruction.

Delayed in Transit, the report of the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) on acute bowel obstruction (ABO), highlighted a number of areas for improvement in this group of patients. The overarching finding was that there were delays in the pathway of care for patients with ABO at every stage of the clinical pathway, including diagnosis, decision-making and the availability of operating theatres. Furthermore, basic measures including hydration, nutritional screening and nutritional assessment were noted to be deficient. Patients who were admitted to non-surgical wards had an increased risk of delayed treatment and subsequently a longer starvation period. There was room for improvement of nutritional screening and assessment on admission, throughout the hospital stay and on discharge. A selection of the report recommendations that address these areas requiring improvement is discussed here.

Volume based feeding versus rate based feeding in the critically ill: A UK study.

BACKGROUND: Underfeeding in intensive care patients on enteral nutrition is commonplace and multifactorial. This can be exacerbated by interruptions caused by routine fasting for procedures and investigations. Our study aims to demonstrate that a volume based feeding protocol can overcome the barriers of underfeeding and safely increase energy and protein delivery in UK intensive care patients, potentially improving clinical outcomes. METHODS: In this single centre cohort study, data were collected from adult mechanically ventilated patients. We compared the standard care of rate based feeding, from an International Nutrition Survey (2014/15) to the new intervention of volume based feeding, in a mixed medical and surgical intensive care unit. The primary outcomes were the proportion of energy and protein daily targets delivered. Secondary outcomes compared the effects on gastrointestinal tolerance, glycaemic control, mortality, mechanical ventilation days, length of stay in intensive care unit and hospital. RESULTS: From a total of 82 patients (rate based feeding = 27, volume based feeding = 55), volume based feeding patients received significantly more prescribed energy (52% versus 81%; p < 0.001) and protein (40% versus 74%; p < 0.001). There was no significant difference in gastrointestinal symptoms such as gastric residual volumes (p = 0.62), glycaemic control (p = 0.94) or insulin usage (p = 0.75). Although there was an improvement in energy and protein delivery, there were no differences in mechanical ventilation days (p = 0.12), mortality (p = 0.06), length of stay in intensive care unit (p = 0.93) and hospital (p = 0.72) between the groups. CONCLUSION: Compared to rate based feeding, volume based feeding significantly improved energy and protein provision with no adverse effects on glycaemic control or gastrointestinal tolerance, clinical outcomes were not affected.

Development and validation of the Parenteral Nutrition Impact Questionnaire (PNIQ), a patient-centric outcome measure for Home Parenteral Nutrition.

BACKGROUND & AIMS: Patients with Type 3 Intestinal Failure (IF) who need Home Parenteral Nutrition (HPN) face several clinical, psychological and social problems. The study was designed to produce and test the first patient-centric measure for HPN ('PNIQ: Parenteral Nutrition Impact Questionnaire'). The new measure focused on the extent to which patients were able to fulfil their human needs. METHODS: Questionnaire content was derived from the analysis of transcripts of interviews conducted with UK HPN patients. Cognitive debriefing interviews (CDIs) were performed to ensure patients found the draft scale clear, relevant and accessible. Finally, a test--retest postal validation survey was conducted to reduce the number of items in the scale and to ensure that; it was unidimensional, reproducible and had construct validity. RESULTS: The 30 interview transcripts were analysed to identify issues related to a wide range of needs. Fifteen CDIs showed that patients found the draft scale easy to complete and highly relevant. The postal survey included 233 patients on HPN recruited through two IF units. Items were rejected if they did not fit the Rasch model, had too similar content to other items or displayed differential item functioning related to age, gender or underlying mechanism of IF. A 20-item unidimensional scale was identified with high internal consistency (0.91) and test-retest reliability (0.92). Scores on PNIQ correlated moderately highly with social isolation, emotional reactions and energy level and were related to perceived interference on life of HPN. The underlying cause of IF did not influence the way the scale worked. CONCLUSIONS: The PNIQ is a scientifically rigorous, unidimensional outcome measure that provides a complete assessment of the effect of HPN on everyday life. It will prove useful for measuring patient value in clinical practice and for determining outcome in clinical trials, audit, economic evaluations and outcomes-based reimbursement.

Management and prevention of refeeding syndrome in medical inpatients: An evidence-based and consensus-supported algorithm.

OBJECTIVES: Refeeding syndrome (RFS) can be a life-threatening metabolic condition after nutritional replenishment if not recognized early and treated adequately. There is a lack of evidence-based treatment and monitoring algorithm for daily clinical practice. The aim of the study was to propose an expert consensus guideline for RFS for the medical inpatient (not including anorexic patients) regarding risk factors, diagnostic criteria, and preventive and therapeutic measures based on a previous systematic literature search. METHODS: Based on a recent qualitative systematic review on the topic, we developed clinically relevant recommendations as well as a treatment and monitoring algorithm for the clinical management of inpatients regarding RFS. With international experts, these recommendations were discussed and agreement with the recommendation was rated. RESULTS: Upon hospital admission, we recommend the use of specific screening criteria (i.e., low body mass index, large unintentional weight loss, little or no nutritional intake, history of alcohol or drug abuse) for risk assessment regarding the occurrence of RFS. According to the patient's individual risk for RFS, a careful start of nutritional therapy with a stepwise increase in energy and fluids goals and supplementation of electrolyte and vitamins, as well as close clinical monitoring, is recommended. We also propose criteria for the diagnosis of imminent and manifest RFS with practical treatment recommendations with adoption of the nutritional therapy. CONCLUSION: Based on the available evidence, we developed a practical algorithm for risk assessment, treatment, and monitoring of RFS in medical inpatients. In daily routine clinical care, this may help to optimize and standardize the management of this vulnerable patient population. We encourage future quality studies to further refine these recommendations.

Revisiting the refeeding syndrome: Results of a systematic review.

OBJECTIVE: Although described >70 y ago, the refeeding syndrome (RFS) remains understudied with lack of standardized definition and treatment recommendations. The aim of this systematic review was to gather evidence regarding standardized definition, incidence rate and time course of occurrence, association with adverse clinical outcomes, risk factors, and therapeutic strategies to prevent or treat this condition. METHODS: We searched MEDLINE and EMBASE for interventional and observational clinical trials focusing on RFS, excluding case reports and reviews. We extracted data based on a predefined case report form and assessed bias. RESULTS: Of 2207 potential abstracts, 45 records with a total of 6608 patients were included (3 interventional trials, 16 studies focusing on anorexic patients). Definitions for RFS were highly heterogenous with most studies relying on blood electrolyte disturbances only and others also including clinical symptoms. Incidence rates varied between 0% and 80%, depending on the definition and patient population studied. Occurrence was mostly within the first 72 h of start of nutritional therapy. Most of the risk factors were in accordance with National Institute for Health and Care Excellence guidelines, with older age and enteral feeding being additional factors. There was no strong evidence regarding association of RFS and adverse outcomes, as well as regarding preventive measures and treatment algorithms. CONCLUSION: This systematic review focusing on RFS found consensus regarding risk factors and timing of occurrence, but wide variations regarding definition, reported incidence rates, preventive measures and treatment recommendations. Further research to fill this gap is urgently needed.

Refeeding hypophosphataemia is more common in enteral than parenteral feeding in adult in patients.

BACKGROUND & AIMS: Refeeding hypophosphataemia (RH) can result in sudden death. This study aimed to compare the incidence of RH between patients fed enterally and those fed parenterally. METHODS: The risk of RH in adult patients fed parenterally (PN) or nasogastrically (NG) was assessed by comparison of patient records with the UK NICE guidelines for refeeding syndrome, between December 2007 and December 2008. A fall in serum phosphate to less than 0.6 mmol/L was indicative of RH. RESULTS: Of 321 patients,92 were at risk of RH. Of these, 23 (25%) patients developed RH (p = 0.003). 18 (33%) of NG fed, 'at-risk' patients developed RH vs 5 (13%) fed parenterally (p = 0.03). Death within 7 days and RH were not associated. The sensitivity and specificity of the NICE criteria for defining patient's risk of RH was calculated: 0.76 and 0.50 respectively for NG feeding; 0.73 and 0.38 respectively for parenteral feeding. CONCLUSION: Patients fed by NG tube and deemed at risk of RH are more likely to develop RH than patients fed by PN. The higher risk with NG feeding may be due to the incretin effect from absorption of glucose. The UK guidelines lack specificity.