GastroHep最新文献

Background. Complementary and alternative medicines (CAMs) are used by patients with chronic disorders, such as inflammatory bowel disease (IBD), with a desire to manage their disease. Methods. Patients visiting an IBD outpatient clinic and infusion unit in a tertiary referral center were surveyed through an anonymized Dutch version of the international questionnaire to measure the use of CAMs. Results. Of the 467 IBD patients who responded to the survey, 41.8% (n = 195) reported the use of CAMs. Gender (p = 0.03, higher in females), educational qualification (p = 0.02, higher in more educated patients), and number of prior IBD medical treatments (p = 0.05, higher in patients having received more than one therapy) were significantly associated with CAM usage. Overall, there was no significant difference in CAM-usage between UC (45.3%) and CD (38.2%) patients. Over two-thirds of patients reported using CAMs to alleviate IBD-related symptoms. The most prevalent reason for CAM-usage was to minimize stress and symptoms. The top five nonsupplemental CAMs used by IBD patients included probiotics, curcumin, yoghurt, homeopathy, and yoga. Among CAMs with a minimum of 25 users, yoga (93.5%), cannabis (87.5%), and mindfulness (84.6%) had high self-reported efficacy indices. Fifty-six percent of the patients who affirmed the economic worthiness of CAMs expressed their interest to consult with their gastroenterologist about CAM-conventional therapy interactions. Conclusion. CAM usage in IBD patients is highly prevalent, and consultation of the patients with the gastroenterologist about the use of CAMs is warranted. Since CAMs can interact with conventional therapies, a debate could help optimizing CAM use, eventually resulting in better disease management.

Background. In most clinical trials focusing on precirrhotic nonalcoholic steatohepatitis (NASH), a liver biopsy is required for confirmation of diagnosis, staging fibrosis, and grading steatohepatitis activity. Reliance on the biopsy, both as a requisite for study entry, as well as for a primary endpoint in clinical trials, poses several challenges that need to be overcome: patient reluctance to undergo the procedure; potential sampling error; concern regarding the handling, processing and shipping of the biopsy of the biopsy material to the central reader(s); and the degree of pathologists’ intra- and interobserver variability in biopsy interpretation. Aims. To provide recommendations for improving the liver biopsy process in order to maximize the accuracy of its histological interpretation in NASH clinical trials. Methods and Results. These recommendations were created by an expert panel of participants from the United States and European Union who met multiple times and reached alignment through review of available data and their individual clinical experiences. The recommendations include the methodology for biopsy procedure, central lab and pathology processing of the specimen, and recommendations to minimize the intra- and intersubject variability. Finally, we are discussing digital pathology technology and machine learning applications as important additions to enhance liver biopsy interpretation.Conclusions. Liver biopsy poses multiple challenges in clinical trials in NASH, and there is a need to standardize the processes to maximize accuracy and minimize variability. Many questions remained unanswered due to limited available data. New evolving modalities may help in the future, but generation of robust data is warranted.

Aims. Chronic liver disease and cirrhosis are associated with immune dysregulation and might increase the risk of acquiring COVID-19 and developing more severe outcomes of it. In a population-based cohort study of patients with chronic liver disease and cirrhosis, we investigated the association between liver disease and COVID-19. We assessed the impact of COVID-19 infection on disease severity and the course of liver disease. Methods. We included all patients living in the Capital Region of Denmark and Region Zealand with chronic liver disease and a positive RT-PCR test for SARS-CoV-2. The background population was 2.7 million people; of these, 19,743 people had a diagnosis of liver disease. Between Feb 1, 2020, and Feb 27, 2021, 7,240 people with chronic liver disease were tested for SARS-CoV-2. Results. There were 261 patients with chronic liver disease and COVID-19 in the study. Sixty-four (24.2%) patients had cirrhosis. People with cirrhosis were more likely to require hospitalization than patients with chronic liver disease (71.8% versus 16.2%, p < 0.001) and more likely to be admitted to an intensive care unit (7.8% versus 3.6%, p = 0.005) and had higher rates of mortality (18.7% versus 1.5%, p = 0.001). In univariate analyses controlled for age, gender, and comorbidities, cirrhosis remained an independent predictor of severe COVID-19. Of hospitalized patients with cirrhosis, 41% experienced a worsening of their liver disease during their COVID-19 infection. Conclusion. Patients with chronic liver disease, especially those with cirrhosis, are at major risk of a severe COVID-19 disease course and higher mortality.

Background. Despite high efficacy rates for direct acting antiviral regimens to cure hepatitis C virus infection, many patients experience treatment-related symptoms. Accurate reporting of adverse events is mandatory to determine drug safety. Previous research in other medical conditions has documented discordance between clinician-reported and patient-reported symptomatic adverse events. Aims. To explore concordance and associated factors, between clinician-recorded and patient-reported fatigue, headache, and nausea/vomiting during a clinical trial of three treatment regimens. Methods. Data were collected between treatment start and 31 days posttreatment. Patients completed Patient-Reported Outcomes Measurement Information System measures of fatigue and nausea/vomiting and the Headache Impact Test. Clinician-recorded data were abstracted from medical records. Concordance was evaluated by weighted kappa. Demographic and clinical factors associated with concordance were identified using logistic regression models. Results. Participants included 1,058 patients treated for chronic hepatitis C (average 54.9 years; 43% Black; 59% male). Weighted kappa estimates and 95% confidence intervals between patients (no/mild vs. moderate/severe symptoms) and clinicians (not present vs. present) were fatigue (k = 0.09, 0.02-0.16), headache (k = 0.08, 0.02-0.14), and nausea/vomiting (k = 0.20, 0.11-0.28). Older age and having private insurance (compared to Medicaid) were associated with better headache concordance. Older age, male, absence of psychiatric condition, and ≤2 comorbidities were associated with better nausea/vomiting concordance. Conclusions. Poor concordance was observed between patient-reported and clinician-recorded symptomatic adverse events. Despite study limitations, previous literature in other conditions support these findings. Integrating patient-reported data to inform adverse event reporting would improve evaluations of treatment safety (http://CT.gov/ Registration: NCT02786537).

Background. Untreated Helicobacter pylori is associated with gastrointestinal conditions including peptic ulcer disease, chronic gastritis, and gastric cancer. The ACG guidelines presently call for triple therapy consisting of a PPI, clarithromycin, and amoxicillin or metronidazole for 14 days. The ACG recommends this treatment as a first-line therapy despite the recognition of growing resistance to clarithromycin, presently upwards of 15-20%. Aims. Studied was the effectiveness of a 5-day concomitant eradication protocol. Methods. This was a retrospective study of 77 H. pylori infected, treatment naïve patients, prescribed a 5-day concomitant therapy containing levofloxacin 500 mg b.i.d., amoxicillin 1 gm b.i.d., tinidazole 500 mg b.i.d., and esomeprazole 40 mg b.i.d. in our New Jersey community setting. Eradication was confirmed with C13 urea breath test. Results. In our intention-to-treat analysis of 65 patients, 54 patients (83.03%) achieved eradication confirmed by C13 urea breath testing. Conclusions. Highly efficacious eradication rates of 80-90% can be achieved with 5-day concomitant treatment (levofloxacin, esomeprazole, tinidazole, and amoxicillin) in a community practice. Our treatment protocol achieves comparable, if not better, clearance rates as compared to agents specified in the ACG consensus guidelines recommending a longer 10–14-day treatment. Additionally, our protocol resulted in better patient compliance, was more cost-effective, shorter, and was well-tolerated compared even to newer treatments, like rifabutin. Thus, these results successfully demonstrate that this 5-day b.i.d. therapy, originally identified over 20 years ago, continues to be an effective choice option and is likely superior as it has comparable clearance rates to traditional 10–14-day therapy.

Background. Terlipressin is a long acting synthetic analogue of vasopressin, which is used to manage variceal bleeding and hepatorenal syndrome. Terlipressin is being developed to treat refractory ascites in cirrhotic patients who are no longer responsive to diuretic drugs and require repeated paracentesis. This study evaluated the safety, tolerability, pharmacokinetics (PK), and efficacy of a continuous intravenous (IV) infusion of terlipressin as an outpatient treatment for refractory ascites in patients with advanced liver cirrhosis. Methods. This was an open-label Phase 2a trial. Patients received a continuous IV infusion of terlipressin 2 mg/day escalating to 4 mg/d during an initial 7-day inpatient period, followed by 21 days as outpatients. The PK, safety/tolerability, and effects on the need for and volume of paracentesis were evaluated. Results. Four of 6 patients experienced ≥50% increase in the interval between large volume paracenteses (LVP) with terlipressin. The volume of ascites removed by LVP in the 28-day treatment period was reduced in all patients by ≥30% compared with pretreatment. Terlipressin was rapidly eliminated with a mean half-life of 42.3 minutes, mean clearance of 5.6 mL/min/kg, and volume of distribution of 0.33 L/kg. Average steady state plasma concentrations ranged from 1.69 to 5.55 ng/mL and increased proportionally with increasing dose. Three (50.0%) patients reported treatment-related adverse events, but none were serious. Conclusion. Continuous terlipressin IV infusion improved control of refractory ascites with an acceptable safety and predictable PK profile. Further evaluation of terlipressin is warranted in a randomized controlled trial for treating refractory ascites and related complications of cirrhosis.

Background and Aims. In very early-onset IBD patients (VEO-IBD), studies have shown an incidence ranging from 0.4 to 2.1/100,000, extensive disease location, and a corresponding difficult and debatable treatment. We therefore aimed to investigate the incidence and medical and surgical treatment of VEO-IBD in a well-defined Danish population-based cohort. Methods. All VEO-IBD patients, defined as an IBD diagnosis before 6 years of age, were included from the Capital Region and the Zealand Region in 2015-2020. Demographic and clinical data including medical and surgical treatment were systematically extracted from the patient files. Results. Forty VEO-IBD patients were identified, 11 diagnosed with CD, 23 UC, and 6 IBD-U. The incidence rate of VEO-IBD was 2.0/100,000 (95% CI 0.8-5.9). All VEO-IBD patients except one had extensive colonic involvement or pancolitis. A total of 34 (85.0%) and 23 (57.5%) of the VEO-IBD patients received immunomodulators and/or biologicals, respectively. The cumulative risks of receiving immunomodulators and/or biologicals after 1/3/5 years was 55.3%/86.8%/90.1% and 36.8%/45.9%/57.0%, respectively. During follow-up, six VEO-IBD patients (15.0%) were treated with vedolizumab—although off-label for this age group—as second-line biological therapy. Four patients (17.4%) with UC had a colectomy. Two colectomised patients were treated with vedolizumab. Conclusion. Our population-based study showed an incidence of VEO-IBD comparable with the incidence in other countries. The population were treated intensively with immunomodulators and biologicals—including off-label vedolizumab—and compared to other studies had the same risk of undergoing IBD-related surgeries.

Background. Recent epidemiological studies in inflammatory bowel disease (IBD) indicate that paediatric onset of IBD (pIBD) more often requires biological therapy compared to adult onset of IBD (aIBD). Whether this is due to a more aggressive disease phenotype or lower threshold of prescribing biologicals is unknown. In order to expand these findings in a clinical setting, we compared the inflammatory burden in pIBD and aIBD patients requiring biological therapy. Methods. We retrospectively included 70 pIBD and 83 aIBD patients initiating biological therapy. Symptoms and biomarker levels were recorded prior to and 6, 14, 22, and 52 weeks after initiation of biological therapy. Results. In Crohn’s disease (CD), the baseline levels of faecal calprotectin and C-reactive protein (CRP) were increased in paediatric CD patients compared to adult CD patients (p < 0.0001 and p = 0.01, respectively). No significant differences were seen in ulcerative colitis (UC). In CD, baseline vitamin D levels ≥ 75 nmol/L and baseline CRP levels < 5 mg/L were associated with higher remission rate (p = 0.02) at the end of follow-up. Moreover, aIBD patients had a higher risk of loss of response to biological therapy and treatment discontinuation compared to pIBD patients (HR = 4.7 [1.6-13.4], p = 0.004). Conclusions. pCD patients had increased inflammation markers compared to aCD patients prior to biological treatment. In addition to this, vitamin D < 75 nmol/L and high CRP levels predicted poor response to treatment in IBD patients.

The Edinburgh Dysphagia Score (EDS) was previously developed to identify patients referred to secondary care with dysphagia, who were most likely to have oesophageal cancer. The aim of this study was to use the EDS prospectively during the COVID pandemic to risk stratify patients to either urgent or routine investigation of dysphagia. Between 1^st April and 1^st July 2020, 283 patients were referred to NHS Lothian with dysphagia. An EDS score was calculated utilizing information in the GP referral letter or information gained in a “HOT clinic.” Patients with a score ≥ 3.5 were prioritized for investigation under the “urgent suspicion of cancer” pathway. 243 patients underwent investigations. 18 patients were diagnosed with oesophageal cancer, all of whom had an EDS ≥ 3.5 (range 4-10). Approximately one third of patients with dysphagia had a score of <3.5. Using this cut-off, sensitivity was 100% and negative predictive value 100%. This study shows that the EDS can be used prospectively when triaging patients referred to secondary care with dysphagia. The high negative predictive value using the EDS means that patients who have an EDS < 3.5 can be downgraded to a routine waiting list without leading to delays in diagnosing oesophageal malignancy. This will enable faster investigations for patients who remain on the “urgent suspicion of cancer” waiting list. In the age of COVID-19, with increasingly long waiting lists, the EDS is a useful scoring system to identify patients with the greatest need for urgent endoscopy.

Background. The number of gastrointestinal endoscopies in children is rapidly increasing without evidence of a parallel increase in disease burden. The positive yield of paediatric endoscopies outside certain conditions is small but the impact of normal “negative” results on clinical management is poorly studied. Routine mucosal biopsy in all paediatric endoscopies is common practice. We aimed to assess the impact of normal endoscopy on patient care, defined by symptom improvement and discharge from hospital follow-up, and calculate the correlation between endoscopic and histological findings. Methods. Retrospective analysis of the first diagnostic endoscopy in children (2015–2019) from Evelina London Children’ Hospital, in London, UK. Endoscopy and histology findings were recorded. Symptoms and follow-up were reviewed up to six months after the endoscopy. Results. 362 children were included; 46.7% were female. Mean age 10.5 (±4.1) years, 66.3% underwent OGDs, and 33.7% underwent combined OGD and colonoscopies. 72.9% of endoscopies and 57.2% of all biopsies were normal. There was a strong positive correlation between endoscopic findings and biopsy results (phi 0.68 p < .001). 31.2% of children reported symptom improvement and were discharged from further follow-up after undergoing endoscopy after 1.9 (±1.5) clinics, phi 0.2 p < 0.001 between normal endoscopy and discharge. Conclusion. Negative endoscopy appears to influence clinical management and discharge from hospital follow-up in about a third of children undergoing endoscopy. The practice of routine biopsies in all paediatric endoscopies should be considered due to a strong positive correlation between normal endoscopies and normal biopsies.