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1.
Measurement of Salivary Pepsin to Detect Gastroesophageal Reflux Disease Is Not Ready for Clinical Application.
Woodland, P, Singendonk, MMJ, Ooi, J, Nikaki, K, Wong, T, Lee, C, Glasinovic, E, Koning, R, Lutter, R, Benninga, MA, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2019;(3):563-565
Abstract
A noninvasive test for gastroesophageal reflux disease (GERD) is desirable for adults and children. Salivary pepsin measurement has been proposed as such a test.1-3 A previous study from our group demonstrated that a maximal salivary pepsin cutoff of >210 ng/mL using the PepTest device (RD Biomed, Hull, United Kingdom) had excellent specificity of 96% but modest sensitivity of 44% to diagnose GERD,4 leading to optimism about its potential use. In this study, we aimed to confirm the previously reported sensitivity and specificity in healthy volunteers and patients with heartburn, evaluate the association between a positive PepTest and response to proton pump inhibitor (PPI) therapy, assess if test-sensitivity can be improved for GERD when samples are taken over a 72-hour sampling period, and establish normal values of salivary pepsin in infants.
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2.
Oral esomeprazole in Japanese pediatric patients with gastric acid-related disease: Safety, efficacy, and pharmacokinetics.
Shimizu, T, Nakayama, Y, Ishii, E, Ida, S, Satou, T, Tokuhara, D, Arai, K, Nii, M, Rydholm, H, Yajima, T, et al
Pediatrics international : official journal of the Japan Pediatric Society. 2019;(1):87-95
Abstract
BACKGROUND Proton pump inhibitors (PPI) are widely used for the treatment of gastric acid-related disease, but they are not approved for use in children in Japan. To assess the safety, pharmacokinetics, pharmacodynamics, and efficacy (gastrointestinal symptom improvement) of PPI in Japanese pediatric patients with gastric acid-related disease, we conducted an 8 week, open-label, parallel-group, multicenter, phase I/III study of once-daily oral esomeprazole use. METHODS Japanese children, aged 1-14 years with gastric acid-related disease, were stratified by weight and age into five groups (10 patients/group) to receive esomeprazole as granules for suspension (10 mg) or capsules (10 mg or 20 mg) once daily. RESULTS Esomeprazole was absorbed and eliminated rapidly in all groups, with a median time to reach maximum plasma concentration of 1.47-1.75 h, an arithmetic mean terminal elimination half-life of 0.80-1.37 h, and a weight-correlated apparent total body clearance of 0.216-0.343 L/h/kg. Area under the plasma concentration-time curve during a dosage interval and maximum plasma drug concentration were generally higher in groups given a higher dose (20 mg) or with a lower age/weight, but also in patients identified as poor metabolizers on cytochrome P450 2C19 genotype. Most patients who had any upper gastrointestinal symptoms at baseline were asymptomatic at the end of the study. Thirty-three patients (66%) reported ≥1 adverse events, including three patients who reported serious adverse events not judged to be causally related to esomeprazole. CONCLUSIONS Oral esomeprazole, at 10 mg or 20 mg once daily, had a similar safety, efficacy, and pharmacokinetic profile in Japanese pediatric patients to that previously seen in adults and Caucasian children.
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3.
BARIATRIC SURGERY IMPACT ON GASTROESOPHAGEAL REFLUX AND DENTAL WEAR: A SYSTEMATIC REVIEW.
Castilho, AVSS, Foratori-Junior, GA, Sales-Peres, SHC
Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery. 2019;(4):e1466
Abstract
INTRODUCTION Several oral problems may be perceived in individuals who were submitted to bariatric surgery, due to metabolic and behavioral changes relative to diet and oral hygiene. Tooth wear appears to suffer impact after bariatric surgery, because there may be an increase in gastroesophageal reflux. OBJECTIVE To systematically review the literature regarding the impact of bariatric surgery on gastroesophageal reflux and tooth wear. METHOD The following databases were accessed by two independent, calibrated examiners: PubMed, Medline, Lilacs, Scielo and Cochrane using the following descriptors: "bariatric surgery" AND "dental erosion" OR "bariatric surgery" AND "dental erosion" AND "gastroesophageal reflux disease". After excluding duplicate studies, 12 studies were initially evaluated by the title and abstract. The excluded studies were those without relevance to the present research, literature review studies and case reports. Thus, four articles were included in this study. All the articles evaluated indicated high association between gastroesophageal reflux and tooth wear in patients submitted to bariatric surgery. Association of these outcomes was more evident six months after the surgical procedure. CONCLUSION Patients submitted to bariatric surgery showed higher prevalence of gastroesophageal reflux and tooth wear.
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4.
Effect of Gastric Acid Suppressants on Response to a Physical Activity Intervention and Major Mobility Disability in Older Adults: Results from the Lifestyle Interventions for Elders (LIFE) Study.
Squires, PJ, Pahor, M, Manini, TM, Brown, JD
Pharmacotherapy. 2019;(8):816-826
Abstract
OBJECTIVES Proton pump inhibitors (PPIs) and histamine2 receptor antagonists (H2 RAs) are associated with pharmacologic effects that may be detrimental to mobility and response to physical activity. Mobility disability and injurious fall outcomes in PPI and H2 RA users were compared with nonusers in this secondary analysis of data from the Lifestyle Interventions for Elders (LIFE) study. METHODS Participants ages 70-89 years were randomized to a physical activity (PA) or successful aging intervention and evaluated by medication use. Confounders included baseline demographic characteristics, physical function, cognitive function, sleep quality, and acid reflux symptoms that were adjusted via propensity score weighting. Outcomes were incident and persistent major mobility disability (MMD and pMMD) and injurious falls. Weighted proportional hazard models evaluated independent and interaction effects of PPIs and H2 RAs. RESULTS No interaction was found between PPIs and H2 RAs and the PA intervention. Drug use associations were significant for H2 RAs (hazard ratio [HR] 1.74 [95% confidence interval [CI] 1.12-2.68]) and PPIs (HR 1.32 [95% CI 1.02-1.70]) compared with nonusers for pMMD. PPIs were associated with increased injurious falls compared with nonusers (HR 1.44 [95% CI 1.06-1.96]). Pooling of data from the H2 RA and PPI exposure groups showed a 26% increase in MMD (HR 1.26 [95% CI 1.07-1.48]), a 44% increase in pMMD (HR 1.44 [95% CI 1.16-1.77]), and a 48% increase in injurious falls (HR 1.48 [95% CI 1.15-1.91]) compared with nonusers. All direct comparisons between PPIs and H2 RAs were nonsignificant. CONCLUSIONS Compared with nonusers, participants using either PPIs or H2 RAs had an increased risk of MMD, pMMD, and injurious falls. It is not known if these effects are related to the individual pharmacology of each medication, reduced acid secretion, or the underlying disease state. Further study is required to determine causality.
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5.
Comparison of tube feeding in stroke patients: Nasogastric tube feeding versus oroesophageal tube feeding-A pilot study.
Park, JW, Park, KD, Kim, TH, Lee, JY, Lim, OK, Lee, JK, Choi, C
Medicine. 2019;(30):e16472
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Abstract
BACKGROUNDS Patients with central nervous system injuries present with dysphagia and may require non-oral feeding methods, like percutaneous endoscopic gastrostomy, nasogastric (NG) tube, or oroesophageal (OE) tube. The prevalence of pneumonia in patients with gastroesophageal reflux (GER) is significantly higher than that in patients without GER. We aimed to determine the most appropriate tube feeding with low risk of GER by comparing the results of 24-hour pH monitoring studies in patients who were administered 2 types of feeding: NG tube and OE tube. METHODS In this pilot study, 6 stroke patients underwent 24-hour esophageal pH monitoring during NG tube feeding and OE tube feeding, sequentially. Parameters collected included acid exposure time, mean esophageal pH, number of reflux episode, time of bolus reflux for both total 24-hour pH study data and postprandial data, and deMeester composite score. RESULTS Total acid reflux time (minutes) decreased more with OE tube feeding than that with NG tube feeding in the total 24-hour pH study. The number of reflux episodes decreased in both total and postprandial data with OE tube feeding versus NG tube feeding (P < .05). There were no significant differences in mean esophageal pH and total time of bolus reflux between the 2 groups. CONCLUSIONS Although we could not definitively conclude that OE tube feeding decreased the severity of GER compared with NG tube feeding, there were significant differences in 4 out of 9 parameters. OE tube can be a substitute for NG tube in patients with dysphagia after stroke leading to GER disease.
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HISTORICAL PERSPECTIVE OF GASTROESOPHAGEAL REFLUX DISEASE CLINICAL TREATMENT.
Zaterka, S, Marion, SB, Roveda, F, Perrotti, MA, Chinzon, D
Arquivos de gastroenterologia. 2019;(2):202-208
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases. GERD generates significant impairment in patients' quality of life and it is associated to relevant medical resources utilization. A better understanding of GERD pathophysiology in the past five decades has favored the evolution of therapeutic strategies from non-drug interventions and antacids to more efficacious and safer alternatives. OBJECTIVE To summarize data about the historical evolution of GERD management in Brazil, focusing on medical therapy and addressing evidence on efficacy and safety of drug classes currently recommended. METHODS A narrative review was conducted by systematizing information about discoveries on GERD pathophysiology. We also addressed efficacy and safety of medications currently used to reduce symptoms and improve endoscopic healing of esophageal lesions. A structured search on Pubmed was performed to identify systematic reviews and meta-analysis investigating GERD outcomes positively impacted by proton pump inhibitors (PPIs), the first choice of pharmacotherapy for the disease. RESULTS The chronological development of therapeutic measures for GERD in Brazil evolved from lifestyle interventions with relative poor effect on symptoms related to esophageal acid exposure, particularly heartburn, to effective and safe pharmacological interventions such as histamine H2-receptor antagonists and PPIs. In the present days, some drug classes play a minor role in disease management, namely prokinetics and antacids, due to their reduced efficacy and relevant safety concerns (particularly with prokinetics). The main challenge for prescribers and researchers seems to be finding long-acting acid suppressants strategies able to ameliorate patients' symptoms and quality of life, thereafter, reducing medical resource consumption. The dual delayed-release PPI dexlansoprazole seems to respond for some of the limitations other PPIs have. CONCLUSION Recognizing the historical evolution of GERD management can help care providers to better understand therapeutic options for their patients, as well as focus on unmet needs that deserve further attention. PPIs are still the first choice therapy, with good evidence in favor of their efficacy, despite some safety concerns. However, as with any medical intervention, it is recommended to prescribe PPIs for patients with clear indication, using adequate dosing and monitoring for adverse events.
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Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk: A Randomized Controlled Trial.
Uygur, O, Yalaz, M, Can, N, Koroglu, OA, Kultursay, N
Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2019;(3):154-158
Abstract
PURPOSE Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, we aimed to examine the effects of feeds with warm milk versus room temperature milk in preterm infants. MATERIALS AND METHODS Infants with a birth weight ≤1,500 g or gestational age ≤34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusively breast milk-fed, and some received breast milk and artificial milk (mixed feeding). Feeding tolerance of infants in both groups and the consequences were evaluated. RESULTS In total, 80 preterm infants (group 1 fed with milk at 22-24°C, n = 40; group 2 fed with milk at 32-34°C, n = 40) were prospectively included in the study. There was a slight decrease in gastric residual frequency in infants fed with breast milk in group 2. Apnea was significantly more frequent in group 1 (p = 0.006), and these infants needed more anti-reflux treatment (p = 0.013). CONCLUSION According to our results, warming enteral feeds close to body temperature are encouraging especially due to the decrease in gastric residual frequency, apnea of prematurity, and need for anti-reflux treatment. More studies may confirm the positive effect of warm enteral feeds on feeding tolerance in preterm infants.
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8.
Effect of wu chu yu tang on gastroesophageal reflux disease: Randomized, double-blind, placebo-controlled trial.
Shih, YS, Tsai, CH, Li, TC, Yu, CJ, Chou, JW, Feng, CL, Wang, KT, Lai, HC, Hsieh, CL
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2019;:118-125
Abstract
BACKGROUND The main symptoms of gastroesophageal reflux disease GERD are heartburn and acid regurgitation. Proton-pump inhibitors (PPI) are considered to be safe and effective for the treatment of GERD. In traditional Chinese medicine, wu chu yu tang (WCYT) is used to treat nausea after eating, vomiting, and diarrhea. PURPOSE We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic effect of WCYT on GERD using omeprazole as a PPI for the positive control. METHODS Ninety patients with GERD were randomly assigned to the 1) control group (CG), who received an oral administration of omeprazole (20 mg) once per day and given WCYT placebo (3.0 g) three times per day for 4 weeks continuously; or the 2) treatment group (TG), who received oral administration of omeprazole (20 mg) placebo once per day and WCYT (3.0 g) three times per day for 4 weeks continuously. RESULTS Seventy-seven patients (37 in CG, 40 in TG) completed the trial. Both Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores was less in the second assessment (V2) and in the third assessment (V3) than those in V1 (first assessment; baseline) in the CG and TG groups (all p < 0.001); the score difference of both RDQ and GERDQ between V2 and V1 was similar between CG and TG (p = 1.00, p = 0.54, respectively). The score difference of both RDQ and GERD between V3 and V1 was less in the CG group than those of the TG group (both p = 0.004). CONCLUSION WCYT has an effect similar to omeprazole for GERD treatment. Furthermore, this effect resulting from WCYT appeared to be maintained for a longer period of time than did that of omeprazole. A study with a larger sample size and longer study period is needed to corroborate our findings.
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Systematic review and meta-analysis of prevalence and risk factors for Barrett's esophagus.
Qumseya, BJ, Bukannan, A, Gendy, S, Ahemd, Y, Sultan, S, Bain, P, Gross, SA, Iyer, P, Wani, S
Gastrointestinal endoscopy. 2019;(5):707-717.e1
Abstract
BACKGROUND AND AIMS Although screening for Barrett's esophagus (BE) is recommended in individuals with multiple risk factors, the type and number of risk factors necessary to trigger screening is unclear. In this systematic review and meta-analysis, we aimed to assess the relationship between number of risk factors and prevalence of BE. METHODS Through October 17, 2018 we searched studies that described the prevalence of BE in the general population and based on presence of risk factors that included GERD, male gender, age >50 years, family history of BE and esophageal adenocarcinoma, and obesity (defined as body mass index >35). Risk of BE based on number of risk factors was assessed using meta-regression while controlling for potential confounders. RESULTS Of 2741 studies, 49 were included in the analysis (307,273 individuals, 1948 with biopsy specimen-proven BE). Indications varied by study. The prevalence of BE for various populations was as follows: low-risk general population, .8% (95% confidence interval [CI], .6%-1.1%); GERD, 3% (95% CI, 2.3%-4%); GERD plus presence of any other risk factor, 12.2% (95% CI, 10.2%-14.6%); family history, 23.4% (95% CI, 13.7% -37.2%); age >50, 6.1% (95% CI, 4.6%-8.1%); obesity, 1.9% (95% CI, 1.2%-3%); and male sex, 6.8% (95% CI, 5.3%-8.6%). Prevalence of BE varied significantly between Western and non-Western populations. In a meta-regression, controlling for the region of the study, age, and gender, there was a positive linear relationship between the number of risk factors and the prevalence of BE. CONCLUSIONS Results of this study provide estimates of BE prevalence based on the presence and the number of risk factors. These results add credence to current guidelines that suggest screening in the presence of multiple risk factors.
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Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects.
Kim, E, Kim, A, Yi, S, Kim, YK, Jang, SB, Byun, HM, Yoon, SH, Cho, JY, Jang, IJ, Yu, KS, et al
European journal of clinical pharmacology. 2018;(10):1261-1272
Abstract
PURPOSE YH4808 is a potassium-competitive acid blocker, developed for the treatment of acid-related disorders. Two clinical studies in healthy male subjects were conducted to evaluate the effect of food on the pharmacokinetics of YH4808. METHODS The first study, a randomized, three-treatment, three-period, crossover study, compared pharmacokinetics of YH4808 (300 mg) after a single dose at fed state with a standard or a high-fat meal to those at fasted state. The second study, a randomized, two-treatment, two-period, crossover study, investigated pharmacokinetics at fasted or fed state with a standard meal after twice daily dose of YH4808 (100 mg) for 7 days. Bloods for pharmacokinetic evaluation were sampled up to 48 h post-dose and 24 h post-dose at steady state, respectively. The pharmacokinetic parameters were estimated by non-compartmental method. RESULTS After single dosing, the geometric means of maximum plasma concentration increased by 1.2 and 2.1 times in the fed states with a standard meal and a high-fat meal, respectively, of that in fasted state. Corresponding values of area under the plasma concentration-time curve (AUC) from time 0 to the last measurable time point increased by 1.8 and 2.8 times, respectively. After multiple dosing, the geometric mean for 24-h AUC at steady state slightly increased in fed state by 1.1 times of that in fasted state. CONCLUSIONS As fat content of the food increased, the systemic exposure of YH4808 after single dosing increased. However, systemic exposures at steady state after multiple dosing between fasted and fed states were similar. TRIAL REGISTRATION ClinicalTrials.gov registry no.: NCT01520012.