Gastroesophageal Reflux Disease Symptoms In Patients Research Articles

Gastric Electrical Stimulation is an Effective Treatment Modality for Symptoms of GERD in Patients With Gastroparesis and VACTERL Association

Patients with VACTERL Association have multiple gastrointestinal comorbidities extending into adulthood. The term VACTERL stands for vertebral defects, anal atresia, cardiac defects, tracheo-esophageal fistula (TEF) with or without esophageal atresia (EA), renal anomalies, and limb abnormalities. Symptoms of gastroesophageal reflux disease (GERD), such as heartburn and acid regurgitation, are common in this population, and patients with EA have a higher risk. Multiple therapies have been suggested to treat symptoms of GERD in patients with gastroparesis and VACTERL Association, including acid suppression therapy and treating the underlying gastroparesis. If left untreated, patients who had EA can experience severe complications, including erosive esophagitis, Barrett’s esophagus (BE), peptic strictures, esophageal cancer, and decrease in quality of life. We present 2 cases of patients with VACTERL Association with prior EA, gastroparesis and underlying symptoms of GERD that were successfully treated with gastric electrical stimulation (GES).

Effectiveness of Rabeprazole and Other Proton Pump Inhibitors in Managing GERD with Varying Severity: A Retrospective, Real-world EMR-based Study (POWER GERD Study).

Purpose: To evaluate the effectiveness of rabeprazole and other proton pump inhibitors (PPIs) in providing symptomatic relief in patients with varying severity of gastroesophageal reflux disease (GERD). Methods: In this multicenter retrospective study, electronic medical records (EMRs) of GERD patients prescribed with PPIs at two Indian clinics/hospitals were reviewed (2016-2020). Rabeprazole's effectiveness was assessed at different follow-up visits and compared with other PPIs. Results: Overall, 269 patients (moderate and severe GERD: 84.39%) were included in three groups, viz rabeprazole, pantoprazole, and esomeprazole groups. A significant proportion of patients experienced quick and complete symptomatic relief at visit 1 with rabeprazole compared to the baseline visit, which gradually increased till visit 4 for both daytime [viz heartburn (38.78-93.88%; p < 0.001)] and nocturnal symptoms [viz sleep disturbances (62.92-97.75%; p < 0.001)]. Rabeprazole provided quick relief at visit 1 when compared with pantoprazole for daytime heartburn (38.78 vs 5.56%; p = 0.01), daytime epigastric pain (66.04 vs 12.12%; p = 0.049), and nocturnal water brash (60.71 vs 16.13%; p = 0.015), and when compared with esomeprazole for nocturnal nausea (82.61 vs 20.00%; p = 0.013). Further, the proportion of patients exhibiting complete treatment response was relatively higher in the rabeprazole group (83.33%) than in the pantoprazole (62.07%) and esomeprazole (65.67%) groups at visit 4. Conclusion: Rabeprazole was effective in providing quick and sustained relief for both daytime and nocturnal GERD symptoms in patients with moderate and severe GERD. Rabeprazole also demonstrated greater effectiveness when compared with pantoprazole and esomeprazole in reducing the severity of multiple GERD symptoms. How to cite this article: Lawate P, Jilawar N, Vyas K, et al. Effectiveness of Rabeprazole and Other Proton Pump Inhibitors in Managing GERD with Varying Severity: A Retrospective, Real-world EMR-based Study (POWER GERD Study). J Assoc Physicians India 2023;71(10):37-44.

Efficacy and safety of laparoscopic Roux-en-Y gastric bypass in symptomatic patients following fundoplication failure: a meta-analysis.

Revisional surgery may be required in a subset of patients who remain symptomatic despite undergoing laparoscopic fundoplication (LF) for gastroesophageal reflux disease (GERD). While revisional LF (RLF) is feasible in these patients, laparoscopic Roux-en-Y gastric bypass (LRYGB) may serve as an alternative, although its efficacy and safety remains unknown. This study aimed to determine the outcomes of LRYGB in symptomatic patients following failed LF for GERD. MEDLINE, EMBASE, and PubMed databases were systematically searched for studies reporting LRYGB outcomes in symptomatic adults despite undergoing LF for GERD. Postoperative symptom resolution, recurrence of heartburn and dysphagia, proton pump inhibitor (PPI) use, and body mass index (BMI) reduction were assessed to determine LRYGB efficacy. Postoperative morbidity and mortality were used to evaluate LRYGB safety. Twenty-two studies with 1523 patients were included. Pooled rates of symptom resolution, recurrence of heartburn and dysphagia, PPI use, morbidity, and mortality were 71.6% (95% CI 59.4-86.4), 15.6% (8.9-27.3), 20.7% (12.5-34.3), 29.6% (18.8-46.5), 39.5% (29.9-52.3), and 2.2% (1.2-4.0), respectively, following LRYGB. Similar rates were observed after RLF. However, BMI reduction was significantly greater after LRYGB compared with RLF (mean difference 6.1kg/m2, 4.8-7.4; p<0.0001). LRYGB resulted in symptom relief in a majority of patients, and proved comparable to RLF regarding symptom recurrence and PPI use. Morbidity and mortality following LRYGB also did not differ from RLF. However, LRYGB was associated with considerably greater weight loss relative to RLF. Therefore, LRYGB is efficacious and an acceptable revisional procedure in symptomatic GERD patients who have previously undergone LF.

The Effect of Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Meals on Transient Lower Esophageal Relaxations (TLESR) in Gastroesophageal Reflux Disease (GERD) Patients with Overlapping Irritable Bowel Syndrome (IBS).

A randomized crossover study in eight patients (6 F, age 57 ± 13) with overlapping GERD-IBS (non-constipation) was conducted to evaluate the effects of rice noodle vs. wheat noodle meals for breakfast and lunch on postprandial TLESR, intestinal gas production, and GERD/GI symptoms. Results: Wheat ingestion was significantly associated with more frequent TLESR after lunch than rice (5.0 ± 0.7 vs. 1.9 ± 0.3 times/2 h, p = 0.01). After lunch, wheat ingestion was significantly associated with higher H2 and CH4 levels compared to rice ingestion (p < 0.05), while H2 and CH4 levels before lunch were similar (p > 0.05). The area under curve of H2 concentration until 2 h after lunch significantly correlated with the TLESR number (r = 0.69, p = 0.04). Postprandial regurgitation (2.9 ± 1.2 vs. 0.4 ± 0.2), bloating (7.0 ± 0.4 vs. 3.1 ± 0.9), satiety (7.7 ± 0.4 vs. 3.5 ± 0.9), and belching (3.8 ± 1.2 vs. 1.1 ± 0.6) symptom scores were significantly greater after wheat compared to rice noodle ingestion (p < 0.05). Conclusion: Wheat noodle meals, part of a high FODMAP diet, induced a higher frequency of TLESRs, a higher GERD, and higher upper-GI symptom scores than rice noodle meals, part of a low FODMAP diet, in patients with overlapping IBS-GERD. These effects were associated with more intestinal gas production. Thus, a low FODMAP diet may relieve GERD symptoms in GERD patients with overlapping IBS.

Снижение риска рецидива симптоматики при применении эзофагопротектора у пациентов, которым требуется временная отмена антисекреторной терапии

Objective: to evaluate the effectiveness of an esophagoprotector in reducing the risk of recurrent symptoms of gastroesophageal reflux disease (GERD) in patients who requiring temporary cancellation of therapy with proton pump inhibitors (PPIs). Material and methods. For the prospective comparative study there were selectively chose patients who had been taking PPIs for a long time (at least one month) for the underlying disease and who required temporary discontinuation of antisecretory therapy due to objective medical reasons. The study included patients with endoscopically and/or pH-metrically verified GERD, as well as histologically verified Barrett's esophagus. In the process of randomization of patients, two equal groups were formed, depending on the therapy received at the time of PPI withdrawal: group 1 received antacids on demand, group 2 received antacids on demand, as well as the esophagoprotector Alfasoxx at a dose of 10 ml four times a day (after each meal and at night). The follow-up period was two weeks. The patients recorded episodes of heartburn in their personal diaries. Results. The study included 60 patients (28 men and 32 women). The average age of the examined patients was 43.1 ± 5.3 years. By the end of the two-week follow-up period, the frequency of recurrent symptoms in group 1 was 36.7%, while in group 2 it was 13.3%. The use of the esophagoprotector Alfasoxx contributed to the significant regression of the risk of heartburn recurrence (odds ratio 0.2657; 95% confidence interval (CI) 0.07328-0.9637; p = 0.0438) in comparison with the group of patients who received only antacids in the on-demand mode. When analyzing the population of patients who had relapsed symptoms, it was demonstrated that the average number of heartburn episodes in group 1 was 6.18 (95% CI 4,1930-8,1706), and in group 2 – 4.50 (95% CI 0,7121-8,2879). Conclusion. This prospective comparative study demonstrated that the use of the esophagoprotector Alfasoxx helps to reduce the risk of relapse of GERD symptoms in patients requiring temporary cancellation of PPI therapy.

Efficacy and tolerability of a novel galactomannan-based formulation for symptomatic treatment of gastroesophageal reflux disease: a randomized, double-blind, placebo-controlled study.

Proton Pump Inhibitors (PPIs) and traditional antacids are the common standard set of therapy for the management of gastroesophageal reflux disease (GERD) symptoms. The aim of the current study was to evaluate efficacy and safety of a novel galactomannan-based liquid formulation in reducing typical GERD symptoms in patients not taking PPIs. This was a single-center, randomized, double-blind, placebo-controlled study. Sixty patients met the eligibility criteria and were treated either with the investigational product (RefluG™) or placebo, one sachet three times per day for 14 consecutive days. Symptom intensity/frequency and quality of life were assessed over the course of the study by Reflux Disease Questionnaire (RDQ) and GERD-Health related Quality of life (HRQL) Questionnaire, respectively. The primary endpoint was to determine the number of subjects with at least 30% symptoms reduction from baseline to day 14 compared to placebo. RefluG™ was statistically superior to placebo (p <0.001) as 100% of subjects experienced at least 30% symptoms reduction at the end of the study while none achieved a 30% reduction in the placebo group. For all domains both after 7 and 14 days of treatment, significant improvement in HRQL was seen in the active group in comparison to placebo. Tolerability and safety were good and comparable between groups. The investigational product was safe and effective as mono-therapy in providing early resolution of troublesome GERD symptoms as well as for improving quality of life.

Long-term vonoprazan therapy is effective for controlling symptomatic proton pump inhibitor-resistant gastroesophageal reflux disease.

Vonoprazan, a novel potassium-competitive acid blocker, results in greater inhibition of gastric acid secretion than proton pump inhibitors (PPI). The aim of this study was to assess the long-term outcomes of patients with PPI-resistant gastroesophageal reflux disease (GERD) treated with vonoprazan. The medical records of patients with symptomatic GERD treated with vonoprazan for 1 year were retrospectively reviewed. Changes in abdominal symptoms were assessed using the Izumo scale, a self-reported questionnaire which is useful in evaluating the symptoms of GERD, epigastric pain, postprandial distress, constipation and diarrhea, and is commonly used in routine clinical practice. A total of 30 patients were included and stratified into a non-erosive (n=22) and erosive group (n=8). At baseline, postprandial distress symptoms were significantly greater in the non-erosive group compared with the erosive group (P=0.013). Even with vonoprazan therapy, symptoms of GERD in the non-erosive group were refractory compared with the erosive group, and required additional treatment in a larger proportion of patients (45 vs. 13%). GERD symptoms in the non-erosive group significantly improved from baseline and remained better after 1 year of vonoprazan therapy, similar to the erosive group. In addition, vonoprazan improved epigastric pain and postprandial distress symptoms in the non-erosive group, and 1 year of vonoprazan therapy did not aggravate constipation or diarrhea. In conclusion, 1 year of vonoprazan therapy improves GERD symptoms in patients with PPI-resistant GERD.

Sleeve Gastrectomy Is the Most Common Cause of Gastroesophageal Reflux Disease in Comparison with Other Bariatric Operations

Introduction: Gastroesophageal reflux disease (GERD) is one of the complications of bariatric operations that might affect the quality of life. We aim to perform a retrospective cohort study to determine the incidence of symptomatic GERD following different types of bariatric surgery and which operations are considered a contraindication of GERD. Besides, we are attempting to identify the risk factors of GERD after bariatric surgery. Methods: Medical records of 729 patients who had undergone bariatric operations between January 2010 and June 2019 at the Shamir (Assaf Harofeh) Medical Center were reviewed. Results: There was a significant difference between the type of bariatric procedure and the incidence of GERD symptoms after the operation. The incidence of symptomatic GERD in patients who underwent sleeve gastrectomy (SG) was 39.9% (p = 0.0131). This was significantly higher compared to 16.4% following Roux-en-Y gastric bypass, 23.4% following laparoscopic adjustable gastric band, and 11% following one anastomosis gastric bypass. 113 patients out of 718 had a positive swallow test, and of these patients, 71 developed GERD symptoms postoperatively without correlation to the degree of reflux at the swallow test but with statistically significant correlation to the type of operation especially for SG (p value < 0.001), and to our knowledge, this was never reported in the literature. Conclusion: SG is a good bariatric procedure option but should be considered carefully in asymptomatic patients with reflux at contrast swallow study and symptomatic GERD patients preoperatively because of high levels of symptomatic GERD postoperatively. Asymptomatic reflux at contrast swallow study preoperatively could be considered a risk factor for GERD after the operation. More studies are needed to be performed on this subject with the addition of postoperative contrast swallow test and pH monitoring preoperatively and postoperatively.

Effect of omeprazole on symptoms of gastroesophageal reflux disease in children with cystic fibrosis. A randomized, double-blind, placebo-controlled trial.

The incidence of gastroesophageal reflux disease (GERD) is higher in patients with cystic fibrosis (CF) than in the general population. While the relationship between GERD and its typical symptom, heartburn, is beyond doubt, its effect on cough or abdominal pain is unclear. In CF patients, in particular, it is often difficult to confirm the causal relationship between GERD and these symptoms. The aim of this trial was to evaluate the effect of omeprazole treatment of GERD on abdominal pain and cough, in children with CF. This was a multicentre, randomized, double-blind, placebo-controlled trial. All children aged 4-18 years underwent 24-hour multichannel intraluminal pH-impedance monitoring. The patients with diagnosed GERD were randomly assigned to receive omeprazole (20 mg twice daily for 12 weeks) or placebo. The severity of symptoms was assessed on visual analog scale. 22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled. A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups. However, there were no statistically significant differences between the groups in the degree of reduction. We did not observe any differences between the groups in terms of adverse reactions. Treatment of GERD in children with CF seems not to have a stronger effect than a placebo on the severity of cough and abdominal pain. Considering this, as well as the previously raised concerns about the impact of chronic proton pump inhibitor treatment on the course of CF, perhaps one should be more careful in intensively treating suspected atypical GERD symptoms in patients with CF.

Impact of adult spinal deformity corrective surgery in patients with the symptoms of gastroesophageal reflux disease: a 5-year follow-up report.

Gastroesophageal reflux disease (GERD) is reported as one of the symptoms of adult spinal deformity (ASD). Little is known about the mid- to long-term improvement in GERD symptoms after ASD surgery. Therefore, this retrospective study from prospectively collected database aimed to investigate GERD symptoms in patients for a minimum of 2years after ASD corrective surgery. Records from 230 patients (mean age: 64years) who underwent ASD surgery were examined using the frequency scale for the symptoms of GERD (FSSG) questionnaires for the diagnosis of GERD. FSSG scores and radiographic parameters were investigated preoperatively and postoperatively at 6months and 1, 2, and 5years. In total, 90 (39%) patients were preoperatively diagnosed with GERD defined by FSSG score ≥ 8 points. Radiographic results showed that the corrective surgeries improved local and global alignments. In the GERD patients, preoperative FSSG scores (16.1 ± 7.3 points) significantly improved to 7.7 ± 7.4 points within 6months postoperatively (p < 0.001), and postoperative FSSG scores maintained at 1year (9.9 ± 8.2 points, p = 0.061), 2years (9.7 ± 8.2 points, p = 0.086), and 5years (9.4 ± 8.0 points, p = 0.177). Among the GERD group, 62 patients (69%; improvement cases) showed improvement in GERD symptoms defined by FSSG score < 8 points within 6months postoperatively. Among ASD patients, 39% were diagnosed with GERD. In 69% of these patients, GERD symptoms improved within 6months of corrective surgery and maintained up to 5years postoperatively. These slides can be retrieved under Electronic Supplementary Material.

459 The Effect of Rebamipide in Patients With Gastroesophageal Reflux Disease, Including Non-Erosive Reflux Disease: A Multi-Center, Randomized, Single-Blind, Placebo-Controlled Study (RENERD Study)

INTRODUCTION: Gastroesophageal reflux disease (GERD) is a chronic and frequently relapsing disease. The etiology of non-erosive reflux disease (NERD) remains unclear, but it has been reported to manifest histologic changes such as dilated intercellular spaces (DIS) and inflammatory cells infiltration in the esophageal mucosa. In this study, we investigated the effect of rebamipide, a mucosal protective agent, in the recurrence of symptoms in GERD patients during proton pump inhibitor (PPI) and also examined histologic changes in the esophageal mucosa of NERD patients. METHODS: A total of 139 patients with GERD including 50 patients with NERD were enrolled in this study and were treated randomly with either PPI plus rebamipide (rebamipide group) or PPI plus placebo (placebo group) during 8 weeks. We compared the change of symptom score at 8 weeks in both groups using a GERD questionnaire. In addition, we analyzed histologic findings such as DIS, inflammatory cells infiltration, and basal cell hyperplasia in the esophageal mucosa of NERD patients, and we compared the histologic changes at 8 weeks in both groups. RESULTS: After 8 weeks, the mean decreases in the total symptom score in the rebamipide group were greater than those in the placebo group in GERD patients, but not statistically significant (-4.4 ± 2.7 vs. -3.9 ± 3.1, P = 0.382). However, the proportion of at least a 50% decrease in the total symptom score in the rebamipide group was significantly higher than that in the placebo group (74.1% vs. 51.7%, P = 0.020). With regard to histologic changes in NERD patients, the severity of DIS in the rebamipide group was significantly improved compared to that in the placebo group after 8 weeks (P = 0.024), and also the lymphocytes counts were more decreased in the rebamipide group compared to the placebo group (P = 0.026). CONCLUSION: Rebamipide, a mucosal protective agent, might be helpful in attenuating the recurrence of symptoms in GERD patients. It could also improve histologic abnormalities in the esophageal mucosa of NERD patients.

Transoral incisionless fundoplication with EsophyX for gastroesophageal reflux disease: clinical efficacy is maintained up to 10 years.

Background Transoral incisionless fundoplication with EsophyX is reported to be effective in patients with gastroesophageal reflux disease in short-medium term follow-up. Aim To examine clinical outcomes up to 10 years. Methods In total, 51 procedures were performed in 50 patients. All entered a yearly clinical follow-up schedule including gastroesophageal reflux disease health-related quality-of-life questionnaires, heartburn and regurgitation scores, and daily proton pump inhibitor consumption. Results The procedure was successfully performed in 49/50 patients. Severe complications occurred in 2/51 procedures. The remaining 49 patients were re-evaluated at 2 and 3 years, 41 after 5 years, 30 after 7 years, and 14 after 10 years. Eight patients were lost to follow-up between 3 and 5 years. Seven patients who were unresponsive to endoscopic fundoplication underwent surgical fundoplication. The mean scores at 2 years were significantly lower than before the procedure and did not change substantially during the follow-up. The rates of patients who had stopped or halved antisecretive therapy 2, 3, 5, 7, and 10 years after the procedure were 86.7 %, 84.4 %, 73.5 %, 83.3 %, and 91.7 %, respectively. Conclusions Transoral incisionless fundoplication with EsophyX is an effective therapeutic option for symptomatic gastroesophageal reflux disease patients, with Hill grades I – II or hiatal hernia < 2 cm, who refuse life-long medical therapy or surgery.

PATHOGENETIC ROLE OF NITROGEN MONOXIDE EFFICIENCY OF PHARMACOTHERAPY IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE AND STABLE ANGINA OF TENSION

Introduction: The search for new mechanisms of their interconnection and effective pharmacological correction of gastroesophageal reflux disease (GERD) for comorbidity with stable angina of tension (SAT). The aim: To establish the role of nitrogen monoxide (NO) in the pathogenesis of GERD in patients with SAT and to study the effectiveness of the correction of the basic therapy of SAT in order to eliminate the clinical manifestations of GERD and prevent its development. Materials and methods: 88 patients with SAT with a comorbid GERD were examined. We determined clinical symptoms, the level of stable NO metabolites, calculated the number of nitroglycerin tablets taken one week. All patients (2 groups) received baseline therapy for GERD and SAT. In this case, the patients of the 2nd group (45 persons) received therapy with the exception of long-acting nitrates and, in addition, meldonium for 30 days. Results:With the exception of the use of nitro-containing drugs and adding to the basic therapy of SAT the drug meldonium we faster (p<0,05) achieved a regression of clinical symptoms of GERD and decrease in the level of metabolites NO molecule in patients with SAT. Conclusion: In the case of the exclusion of the intake of long-acting nitrates with the adding of meldonium to the basal therapy of the SAT and the GERD the content of metabolites of nitrogen monoxide in the blood is more normalized, which correlates with a decrease in the frequency of GERD symptoms in patients with SAT and GERD.

Transoral fundoplication for gastroesophageal reflux disease

Transoral incisionless fundoplication (TIF) has recently been proved to be an effective therapeutic option as an alternative to medical and surgical therapy. TIF reconfigures the tissue to obtain a full-thickness gastro-esophageal valve from inside the stomach, through serosa-to-serosa plications including the muscle layers. Current issues about TIF refer to: (I) the capability of the procedure to effectively control gastroesophageal reflux disease (GERD)-related esophageal (heartburn and regurgitation) and extra-esophageal symptoms, heal esophagitis and reduce hiatal hernia; (II) the capability to control gastro-esophageal reflux, as measured by 24-h pH-impedance recording; (III) the long-term efficacy of the procedure, compared with surgery; (IV) the cost-effectiveness of the procedure, compared with surgery. Two recent meta-analyses showed that TIF performed either by EsophyX or MUSE is effective as surgery in controlling GERD symptoms, extra-esophageal symptoms, and gastro-esophageal reflux in the short-/medium-term period. Long-term results are still few; the 7 prospective observational studies reporting 3 to 6 years results showed that efficacy of TIF persists up to 6 years. The long-term post-TIF results are similar to those with surgical fundoplication, without any of the surgery-related persistent side effects such as dysphagia and gas bloat. TIF appears to be cost-effective compared to laparoscopic Nissen fundoplication. To date available findings confirm that TIF can offer an effective and safe therapeutic option for carefully selected symptomatic GERD patients, with Hill grade of the valve I and II or hiatal hernia not longer than 2 cm, who refuse life-long medical therapy or surgery, are intolerant to proton pump inhibitor (PPI), or have some risk of persistent post-surgical side effects.

Preoperative Esophageal Manometric Assessment of Severe Symptomatic Gastroesophageal Reflux Disease Patients

Preoperative Esophageal Manometric Assessment of Severe Symptomatic Gastroesophageal Reflux Disease Patients

Vonoprazan 10 mg daily is effective for the treatment of patients with proton pump inhibitor-resistant gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is commonly treated by primary care physicians. Although proton pump inhibitors (PPI) have been the mainstay of GERD treatment for two decades, in some patients GERD is refractory to standard dose PPI for more than eight weeks and is referred to as PPI-resistant GERD. Vonoprazan, a novel competitive acid blocker, became available in Japan for the treatment of patients with GERD, and has greater acid inhibition than existing PPIs. The aim of the present study was to determine the effect of vonoprazan 10 mg daily on PPI-resistant GERD. We retrospectively reviewed 24 patients with PPI-resistant GERD treated with vonoprazan 10 mg daily. The Izumo scale was used to evaluate the effect of vonoprazan before and one month after treatment, which reflects quality of life related to gastrointestinal symptoms. The overall rates of improvement and resolution of GERD symptoms were 88% (21/24) and 42% (10/24), respectively, and the score was significantly decreased (before 5.8±1.7, at one month 1.9±1.9, P<0.001). To evaluate the influence of esophageal erosions despite prior PPI treatment, the patients were divided into erosive (n=6) and non-erosive groups (n=18). Vonoprazan achieved 100% (6/6) improvement in the erosive group and 83% (15/18) in the non-erosive group. Patients in the erosive group had a significantly higher rate of resolution than in the non-erosive group [83% (5/6) vs 28% (5/18), P=0.017]. No adverse events occurred. Other GI symptoms in patients with PPI-resistant GERD were evaluated. The scores for epigastric pain, postprandial distress, constipation and diarrhea were unchanged during the treatment period. In conclusion, vonoprazan 10 mg daily is effective for the treatment of patients with PPI-resistant GERD. Vonoprazan resolves GERD symptoms in patients with erosions more than in those without erosions. This is the first report on the effect of vonoprazan 10 mg on PPI-resistant GERD.

A novel prostanoid EP1 receptor antagonist, ONO-8539, reduces acid-induced heartburn symptoms in healthy male volunteers: a randomized clinical trial.

Patients with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) have unmet clinical needs. Recently, we reported that esophageal prostaglandin E2 (PGE2) plays a crucial role in the generation of heartburn. In the present study, we focused on the PGE2 receptor, EP1, and investigated the effects of ONO-8539, a novel EP1 receptor antagonist, on heartburn symptoms in healthy male volunteers. This prospective, double-blind, placebo-controlled, two-period crossover study was performed in 20 healthy male subjects. The novel prostanoid EP1 receptor antagonist, ONO-8539 (450mg), was administered once 4h prior to acid perfusion test. During the test, hydrochloric acid (0.15moll-1) was perfused into the lower esophagus for 30min. Acid perception threshold was quantified by the time to first sensation of heartburn and intensity of GI symptoms determined using a validated categorical rating scale, and the area under the curve (AUC) as the total symptom score. ONO-8539 significantly reduced a total heartburn symptom score, not other upper GI symptom scores, during acid perfusion compared with placebo (AUC for heartburn, 85.0±10.6 for placebo and 56.5±7.2 for ONO-8539; P< 0.01), and significantly extended the time to first sensation of heartburn compared with placebo (5.7±4.3min for placebo and 9.7±7.2min for ONO-8539; P<0.05). ONO-8539 attenuated acid-induced heartburn in healthy male subjects, suggesting that EP1 receptors play a role in generation of heartburn symptoms. ONO-8539 is a potential novel therapeutic option for controlling heartburn symptoms in GERD patients. Clinical Trials Registry No: UMIN000015753.

COMPARISON OF ENDOSCOPIC FINDINGS WITH GERD SYMPTOMS SCORE IN ZAGAZIG UNIVERSITY HOSPITALS, EGYPT.

ABSTRACT Background : Gastroesophageal reflux disease (GERD) may need repeated endoscopy for diagnosis and follow up, this may concern psychological and financial burden on patient. Aim of the work: The aim of our work was to evaluate the benefit of the FSSG as a useful and a practical tool for diagnosing of GERD patients compared to the endoscopic results. This was mainly to avoid repeated uses of endoscopy for diagnosis and may reduce the medical costs and save the patients time Patients & Methods: This study was carried out at Zagazig University, Faculty of Medicine, Internal Medicine Department, Gastroenterology and endoscopy unit during the period from June 2015 to December 2015.The subjects were 131 Egyptian patients aged ≥18 year (mean 46.3± 16.8 year; male/female ratio 1.8/1) who presented with symptoms of heartburn, regurgitation and epigastric pain or discomfort. They were scheduled for esophagogastroduodenoscopy. It was done after approval of Local Ethics Committee and patient’s consent was obtained. Pre-endoscopy Procedure: Our study depends on a simplified questionnaire for evaluation of the symptoms of GERD called FSSG (Frequency Scale for Symptoms of GERD) which consists of 12 questions; all must be answered by all subjects Endoscopy Procedure: All subjects underwent esophagogastroduodenoscopy. The results of endoscopy were classified and graded according to Los Angeles classification into GERD A, B and C according to the severity of the endoscopic findings. After that the final endoscopic diagnosis was compared to the predicted diagnosis resulting from the Regression model and Equation. Results : Based on the endoscopic findings, the number of patients with GERD Los Angeles Class A, B and C was 18.3, 15.3 and 6.9 % respectively. Clinical obesity patients were 3 distributed as duodenal ulcer (DU) = 2 and GERD B = 1 patient. Overweight patients were 58 distributed as gastric ulcer (GU) = 13, DU = 7, functional dyspepsia (NUD) = 14, GERD A = 8, GERD B = 8 and GERD C = 8 patients. Normal weight patients were 63 distributed as GU = 14, DU = 11, NUD = 11, GERD A = 16, GERD B = 10 and GERD C = 1 patients. Underweight patients were 7 distributed as DU = 1, GU = 2, NUD = 3, GERD A = 0, GERD B = 1 and GERD C = 0 patients. Usage of the FSSG questionnaire with Regression Model help us to predict strongly GERD A by 95.8%, also GERD B by 95% and weakly predict DU by 81.8%, GERD C by 77.7%, GU by 60.7% and NUD by 50%. Conclusion: Noninvasive assessment tool FSSG questionnaire was useful for objective evaluation of symptoms in GERD patients and avoid repeated endoscopic examination which is undesirable in terms of medical costs and the burden on the patient and save our developing country efforts and resources.

Clinical characteristics and psychosocial impact of different reflux time in gastroesophageal reflux disease patients.

Gastroesophageal reflux disease (GERD) is an emerging disease, and can impair quality of life and sleep. This study aimed to investigate whether GERD patients with different timings of reflux symptoms have different clinical characteristics. This study prospectively enrolled individuals who underwent upper gastrointestinal endoscopy during a health checkup. Each participant completed all questionnaires including Reflux Disease Questionnaire, Nighttime GERD questionnaire, Pittsburg Sleep Quality Index, Taiwanese Depression Questionnaire, and State-Trait Anxiety Inventory. Combined reflux was defined as the timing of reflux symptoms occurring at both daytime and nighttime. A total of 2604 participants were enrolled. Of them, 651 symptomatic GERD patients, according to the Reflux Disease Questionnaire score, were recruited for final analysis. Of them, 224 (34.4%) had erosive esophagitis on endoscopy. According to the timing of reflux symptoms, 184 (28.3%) were assigned to the daytime reflux group, 71 (10.9%) to the nighttime reflux group, and 396 (60.8%) to the combined reflux group. In post hoc analysis, the combined reflux group had a significantly higher Reflux Disease Questionnaire score than the daytime reflux group (p<0.0001). Combined and nighttime reflux groups had higher body mass index and longer duration (> 12years) of education than the daytime reflux group (p<0.05). There was no difference in Pittsburg Sleep Quality Index, Taiwanese Depression Questionnaire, and State-Trait Anxiety Inventory scores among three groups. GERD patients with combined daytime and nighttime reflux of have more troublesome symptoms than those with daytime reflux. GERD patients with different timings of reflux symptoms have different clinical characteristics in terms of body mass index and duration of education, but not in terms of esophageal inflammation, quality of sleep, and psychosocial status.

Prevalence of Gastroesophageal Reflux Disease (GERD) Symptoms and Proton Pump Inhibitor (PPI) Use in Patients With Crohn Disease (CD) Treated at a Tertiary Care Inflammatory Bowel Disease Center

Introduction: GERD is commonly diagnosed by improvement of upper gastrointestinal (UGI) symptoms on PPI therapy. Similar symptoms are reported in patients with CD and whether this is a manifestation of UGI CD or GERD is unclear. Data on the prevalence of GERD in CD do not exist. A preliminary study of patients with CD has shown gastroduodenal histologic findings of granulomas and focally enhanced gastritis, which are more specific to UGI CD, in 12% of patients with upper endoscopy (Diaz et al, 2015). Given the potential long-term side effects of PPIs, our aim was to evaluate the prevalence of PPI use and reported GERD symptoms in patients with CD. Methods: We performed a retrospective chart review of 499 patients with CD seen between September 2009 to May 2015 and grouped them using the Montreal Classification (MC). Each encounter was evaluated for pyrosis, regurgitation, globus, dysphagia, odynophagia, chest pain, postprandial abdominal pain, early satiety, bloating, and nausea. Use of acid suppressive therapy prior to the first visit and current use were also recorded, as were gastric emptying and pH studies if available. Results: The mean age of our 499 patient cohort was 39 years (range: 17-80), 49% males, mean BMI= 24.7 (range: 13-52). By MC criteria, 186 (37%) were L1, 80 (16%) were L2, 218 (44%) were L3, and 15 (3%) had upper and lower GI CD. Less than 5% of patients had gastric emptying or pH studies. 108 (21.6%) patients were on medications prior to their first visit with indications unknown and 111 (22.2%) patients were on acid suppressive therapy. Of the patients on acid suppressive therapy, 61% were not assessed for pyrosis, 88% were not assessed for regurgitation, and 82% were not assessed for postprandial abdominal pain. Other classic GERD symptoms were not assessed at higher rates (Table 2). Bloating and nausea were reported in 43 and 45% of patients on acid suppressive therapy, respectively.Table 2: Upper GI Symptoms Assessed While on Acid Suppressive TherapyConclusion: Many patients with CD are on PPI therapy without proper symptom screening or existing indications. Nausea and bloating are commonly reported in these patients and whether that is related to UGI CD, dyspepsia, or true GERD is unknown. Given the potential side effects of PPIs and the complications of CD, appropriate screening should be done to minimize PPI use. Further studies should prospectively evaluate CD patients through validated GERD questionnaires and endoscopic biopsies to better analyze which CD patients would benefit from PPI use.Table 1: Baseline Characteristics