Gastroesophageal Reflux Disease Symptom Score Research Articles

Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease

BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P < 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.

The Impact of Intermittent Fasting on Patients With Suspected Gastroesophageal Reflux Disease.

The aim was to investigate the short-term impact of time restricted feeding on patients with suspected gastroesophageal reflux disease (GERD). Lifestyle modifications are often suggested, but the role of diet in GERD is unclear. Intermittent fasting is popular in the media and has demonstrated potential benefits with weight loss and inflammatory conditions as well as alterations in gastrointestinal hormones. Patients who were referred for 96-hour ambulatory wireless pH monitoring off proton pump inhibitor to investigate GERD symptoms were screened for eligibility. Patients were instructed to maintain their baseline diet for the first 2 days of pH monitoring and switch to an intermittent fasting regimen (16 consecutive hour fast and 8h eating window) for the second 2 days. Objective measures of reflux and GERD symptom severity were collected and analyzed. A total of 25 participants were analyzed. 9/25 (36%) fully adhered to the intermittent fasting regimen, with 21/25 (84%) demonstrating at least partial compliance. Mean acid exposure time on fasting days was 3.5% versus 4.3% on nonfasting days. Intermittent fasting was associated with a 0.64 reduction in acid exposure time (95% CI: -2.32, 1.05). There was a reduction in GERD symptom scores of heartburn and regurgitation during periods of intermittent fasting (14.3 vs. 9.9; difference of -4.46, 95% CI: -7.6,-1.32). Initial adherence to time restricted eating may be difficult for patients. There is weak statistical evidence to suggest that intermittent fasting mildly reduces acid exposure. Our data show that short-term intermittent fasting improves symptoms of both regurgitation and heartburn.

Correlation between Psychosomatic Assessment, Heart Rate Variability, and Refractory GERD: A Prospective Study in Patients with Acid Reflux Esophagitis.

Gastroesophageal reflux disease (GERD) affects a significant proportion of individuals, with life stress being a contributing factor. This study aimed to investigate the correlation between psychosomatic evaluations, heart rate variability (HRV), and GERD in a cohort of individuals. Additionally, the study aimed to analyze the sequencing changes following proton pump inhibitor (PPI) treatment and identify predictive factors associated with refractory GERD. A prospective cohort of 105 individuals with reflux esophagitis and a control group of 50 participants without acid reflux symptoms were enrolled. Psychosomatic evaluations, including GERDQ, GERDQLQ, RSI, BAI, BDI, and SSS-8, were assessed at baseline and during treatment. HRV parameters were also evaluated. Multivariate analysis was used to identify predictive factors for refractory GERD. PPIs were administered regularly for the initial 2 months and then used on-demand. Refractory GERD was defined as less than 50% improvement in symptom relief or GERDQLQ score ≥ 20 after 8 weeks of PPI treatment. The GERD group had higher scores in all psychosomatic evaluations compared to the control group (all p-values < 0.001). There were no significant changes in any parameters of HRV before and after treatment in the GERD group. Strong and consistent correlations were observed between GERD symptoms and psychological scores (BAI, BDI, and SSS-8) across all time points (W0, W4, and W8). Sequential reductions in GERD symptom scores and psychosomatic evaluations were observed during the initial eight weeks of treatment. Higher GERDQ (≥10) and SSS-8 (≥12) scores were predictive of refractory GERD (p = 0.004 and p = 0.009, respectively). This study emphasizes the importance of considering physiological and psychological factors in the management of GERD. Psychosomatic evaluations provide valuable insights for assessing and treating GERD patients. Integrating stress management and comprehensive assessments into personalized treatment strategies is crucial.

Overlap Between Constipation and Gastroesophageal Reflux Disease in Japan: Results From an Internet Survey.

Background/AimsDetailed evaluations of overlapping constipation and gastroesophageal reflux disease (GERD) have not been conducted in Japan. The REACTION-J2 study examined the overlap of these diseases in Japan.MethodsThis internet-based survey recruited participants from general public survey panels. Questions included demographic and medical data and assessments based on validated measures for constipation and GERD. Associations between background factors affecting constipation/GERD overlap, disease measures, and treatment were also evaluated.ResultsAmong 10 000 survey responses received, functional constipation (Rome IV diagnostic criteria) was reported by 439 participants; chronic constipation (Japanese guidelines) by 3804 participants; and subjective constipation symptoms by 2563 participants. The number of participants with constipation/GERD overlap ranged from 73 to 1533 depending on the criteria used. Regardless of the definition used, all GERD groups had significantly higher odds of being constipated than non-GERD participants the OR (95% CI) for all 9 combinations of definitions ranged between 1.56 (1.21, 2.01) and 2.67 (2.44, 2.92) (all P ≤ 0.001). Straining, hard stools, and sensations of incomplete evacuation and anorectal obstruction/blockage, according to chronic constipation criteria, were common. Participants with constipation/GERD overlap had poorer quality of life (P < 0.001) and worse GERD symptom scores (P < 0.001). The frequency of abnormal stools was highest (P < 0.001) in the constipation/GERD overlap group. In the overlap group, 52.4% and 26.0% used gastric and constipation medication, respectively.ConclusionIndividuals with constipation/GERD overlap tend to have worsened symptoms and quality of life.

S485 The Effects of Intermittent Fasting on Gastroesophageal Reflux Disease

Introduction: The role of diet in gastroesophageal reflux disease (GERD) is not clear. Intermittent fasting has been popularized in the media and has demonstrated potential benefits with weight loss and inflammatory conditions, as well as alterations in GI hormones. We aim to evaluate the impact of intermittent fasting on esophageal acid exposure time (AET) and GERD symptoms. Methods: Patients referred for 96-hour wireless pH monitoring off PPI for diagnostic evaluation of GERD symptoms were screened for eligibility. Consented patients were instructed to maintain their baseline diet for the first 2 days of pH monitoring and switch to an intermittent fasting regimen (consisting of a 16-hour consecutive fast with 8-hour eating window) for the second 2 days. A mixed effects model was used to analyze the impact of intermittent fasting on AET and GERD symptom severity (adapted from GERD-HRQL survey, up to 25 points each for regurgitation and heartburn). Results: A total of 25 participants were analyzed, averaging 43.5 years of age and about equally split among men and women. 9/25 (36%) fully adhered to the intermittent fasting regimen, with 21/25 (84%) demonstrating at least partial compliance (1 out of last 2 days). A total of 35 successful intermittent fasting days were identified and was associated with 6 additional hours of fasting before first meal and 0.6 less meals per day than days without intermittent fasting (p < 0.05 between groups for both). Mean AET on fasting days was 3.5% vs 4.3% on non-fasting days. Intermittent fasting was associated with a 0.64 reduction in AET (95% CI -2.32, 1.05). Post prandial acid exposure and reflux events were not increased in those who underwent intermittent fasting. Stratified analysis of those with at least borderline reflux at baseline demonstrated a stronger trend toward benefit with intermittent fasting. There was a reduction in GERD symptom scores of heartburn and regurgitation during periods of intermittent fasting (14.3 vs 9.9; difference of -4.46, 95% CI -7.6, -1.32). Conclusion: Initial adherence to time restricted eating may be difficult for patients. There is weak statistical evidence to suggest that intermittent fasting reduces esophageal acid exposure. Our data suggests that intermittent fasting can improve symptoms of both regurgitation and heartburn. Randomized controlled trials with larger sample sizes and longer follow up times will be needed to determine if intermittent fasting has a role in the non-pharmacologic management of GERD.Figure 1.: (A) Change in AET by intermittent fasting status. (B) Change in GERD symptom severity score following day 2 (baseline diet) and day 4 (intermittent fasting) of pH monitoring.Table 1.: Intermittent Fasting Adherence and Characteristics

Gastro-esophageal reflux disease (GERD) after peroral endoscopic myotomy (POEM)

Peroral endoscopic myotomy (POEM) is gaining traction as a minimally invasive treatment of achalasia. Increased reflux is reported after POEM but the incidence, type and severity of reflux are not fully understood. We aimed to study the prevalence and nature of reflux after POEM and correlate reflux with endoscopy and pH-impedance findings. This is a prospective cohort study of achalasia patients undergoing POEM since 2014. Data from Eckardt and GERD symptom scores, high-resolution oesophageal manometry (HRM) and gastroscopy were performed pre-procedure and repeated at 1-year follow-up. Data from 24-h pH-impedance, if performed, were also recorded. A standardized questionnaire was used to determine the severity and frequency of heartburn symptoms and the composite score for each patient was calculated. 58 patients underwent POEM between January 2014 and October 2018. The efficacy of POEM at 1year was 93.0%. We observed reduction of median Integrated Relaxation Pressure (IRP) from 23.5 ± 33.1mmHg to 13.4 ± 7.71mmHg (p = 0.005) and mean Eckardt score improved from 6.09 ± 2.43 points to 1.16 ± 1.70 points (p < 0.001). At 1year, 43.1% (n = 25) had symptomatic reflux. Of the 40 patients who underwent repeated gastroscopy, 60.0% (n = 24) had endoscopic evidence of oesophagitis with seven patients (18%) diagnosed with Grade C or D oesophagitis. 43.1% (n = 25) of patients had pH-impedance done post-POEM off PPIs. 14 patients (56%) had increased acid exposure. Sixteen percent of reflux episodes were acidic and 77.3% were weakly acidic. POEM was an effective treatment for achalasia. However, GERD was common after POEM with incidence of 43% on symptom score, 60% on endoscopy and 56% on pH-impedance test. Post-POEM reflux appeared to be predominantly acidic in nature. Routine surveillance for GERD after POEM is recommended.

Effect of laparoscopic novel W-H fundoplication in patients with proton pump inhibitor dependent gastroesophageal reflux disease

Objective: To investigate the effect of a novel laparoscopic W-H fundoplication in the treatment of proton pump inhibitor (PPI) dependent gastroesophageal reflux disease (GERD). Methods: The clinical data of PPI dependent GERD patients who underwent laparoscopic W-H fundoplication in PLA Rocket Force Characteristic Medical Center from October 1st, 2018 to April 30th, 2019 were analyzed retrospectively. The GERD symptom score, subjective symptom relief, PPI withdrawal, efficacy satisfaction and postoperative complications were followed up and analyzed by a questionnaire. Results: A total of 80 GERD patients were included in this study, and 49 were male and 31 were female, with a median age of 58 years. Among all patients, 85% (68/80) are with esophagitis and 77.5% (62/80) with hiatal hernia. The operation time was 67 (52, 73) minutes, without intraoperative complications and conversion to laparotomy. The postoperative follow-up period was 16 (14, 18) months. The postoperative GERD symptom scores were significantly lower than those before surgery, with an statistical difference (all P<0.05). The subjective remission degree of the overall digestive and respiratory symptoms were 100 (90, 100)% and 100 (80, 100)%, respectively. During the follow-up period, the PPI discontinuation rate was 83% (69/80), and the satisfactory rate was 93% (75/80). Postoperative complications included dysphagia, flatulence, increased exhaust and diarrhea, and the incidence was 61% (49/80), 8% (6/80), 5% (4/80) and 4% (3/80), respectively, and 16% (13/80) of the patients had prolonged occasional mild dysphagia. There was no death, symptomatic recurrence or reoperation. Conclusions: The novel W-H fundoplication has a good medium-term efficacy, with significant GERD symptom control rate and PPI discontinuation rate. The postoperative dysphagia is common, but it is self-limiting and does not affect the satisfaction of the surgical effect.

Estimate of Refractory Reflux Disease in the United States: Economic Burden and Associated Clinical Characteristics.

To update the estimate of the prevalence of refractory gastroesophageal reflux disease (GERD) in the United States, and to assess the clinical and economic differences between patients with and without refractory GERD. GERD affects 18% to 28% of the US population, with nearly 40% of GERD patients presenting with refractory symptoms despite ongoing therapy. Retrospective analysis of the IBM MarketScan databases between January 2011 and June 2018. Inclusion criteria were prescription fill and subsequent refill of a proton pump inhibitor or H2-receptor antagonist (earliest claim=index date), diagnosis of GERD 60 days preceding and/or following index, continuous insurance enrolment for 12 months preceding/following index, and absence of prior GERD diagnosis or GERD medication. We derived refractory GERD symptom scores for all patients on the basis of a previously published algorithm. Health care costs and comorbidities were assessed for all patients and compared between those with and without refractory GERD. In total, 399,017 GERD patients qualified for the study; 103,654 (26%) met our definition of having indications of refractory GERD symptoms. Patients with refractory GERD symptoms reported significantly higher rates of hiatal hernia (25.1% vs. 5.9%), esophagitis (37.3% vs. 11.8%), esophageal stricture (11.3% vs. 1.5%), and dysphagia (26.8% vs. 7.1%; P<0.01 for each). The refractory GERD symptoms cohort incurred ~$10,000 greater health care costs per patient per year compared with patients without refractory GERD symptoms ($26,057±$58,948 vs. $15,285±$39,307; P<0.01). Refractory GERD symptoms were associated with a substantial increase in health care costs. Treatments aimed at improving refractory GERD symptoms may mitigate symptom burden, potentially reducing health care expenditure.

Advanced Endoscopic Evaluation of Gastroesophageal Reflux Disease in Morbidly Obese Patients in a Rural Setting.

Obesity is a known risk factor for gastroesophageal reflux disease (GERD). Morbidly obese patients in rural areas are usually referred to the local surgeon for endoscopic evaluation. This situation poses significant challenges given the increased risk for perioperative complications due to anatomical and metabolic factors. This study aims to evaluate the safety of performing GERD diagnostic workup studies in a rural setting. Institutional review board approval was obtained for a retrospective chart review of patients who presented with GERD symptoms to a rural antireflux clinic between August 2015 and October 2020. Patients were included if their body mass index (BMI) was over 35 with comorbidities or over 40kg/m2 who underwent upper gastrointestinal endoscopy with or without concomitant placement of wireless pH probe and/or functional luminal imaging probe. A total of 117 patients met the inclusion criteria. There were 94 (80.3%) females and 23(19.7%) males. The average age was 56.0 ± 13.4years. The average BMI was 40.4 (35-66.4). Proton pump inhibitor use was noted in 97/117 (82.9%) with an average duration of 12.0 ± 9.2years. The average GERD-Health Related Quality of Life, Reflux Symptom Index and GERD Symptom Score (GERSS) were 29.8 ± 20, 24.5 ± 14.2 and 21.3 ± 15.4 respectively. There were no procedural complications. All the endoscopic examinations were successfully completed and patients were discharged. Performing diagnostic studies for GERD for morbidly obese patients in critical access hospitals is safe. Patient selection, proper training and adequate preparation are critical prerequisites for good outcomes.

Derangement of esophageal anatomy and motility in morbidly obesepatients: a prospective study based on high-resolution impedancemanometry.

Morbidly obese patients often suffer from gastroesophageal reflux disease (GERD). High-resolution impedance manometry (HRIM) allows a comprehensive evaluation of esophageal motility and esophagogastric junction (EGJ) morphology and helps to clarify GERD pathophysiology. To evaluate the esophageal function and EGJ anatomy in morbid obesity by HRIM. University Hospital, Taiwan. We consecutively enrolled 57 morbidly obese patients planning to undergo bariatric surgery and 58 healthy volunteers in this prospective study. All patients responded to validated symptom questionnaires and underwent fasting blood tests, HRIM, and esophagogastroduodenoscopy. We compared anthropometric and HRIM parameters between the 2 groups, and analyzed correlations between the GERD symptom scores and clinical variables in the obese patients. The obese patients, comprising 30 males (53%), had a median age of 35 years and body mass index of 40.5 kg/m2. The 4-second integrated relaxation pressure in the lower esophageal sphincter was significantly higher in the patients than the volunteers (median: 10.8 versus 5.6 mm Hg; P < .001). EGJ outflow obstruction and ineffective esophageal motility were diagnosed in 16% and 11% of the patients, respectively, versus 5% and 28% of the volunteers (P = .022). Manometric hiatal hernia (m-HH) was present in 19 (33%) of the patients and none of the volunteers; all m-HH were associated with erosive esophagitis. Most of the patients were considered as no GERD by the validated questionnaires, regardless of the presence of m-HH and erosive esophagitis. The obese patients had a higher lower esophageal sphincter 4-second integrated relaxation pressure and higher prevalence of EGJ outflow obstruction and m-HH than the healthy volunteers. The presence of m-HH was strongly associated with erosive esophagitis. The absence of GERD symptoms in morbid obesity was not necessarily suggestive of negative esophagogastroduodenoscopy and HRIM findings, and the discrepancy existed between esophagogastroduodenoscopy and HRIM for diagnosing HH. A comprehensive evaluation of the EGJ anatomy and esophageal function may be considered before bariatric surgery.

Clinical Study on the Efficacy of Pantoprazole Combined with Mosapride on Gastroesophageal Reflux Chest Pain

To analyze the efficacy of pantoprazole combined with mosapride on gastroesophageal reflux chest pain. A total of 74 patients with gastroesophageal reflux chest pain treated in the Hospital of Shaanxi from June 2016 to June 2017 were enrolled in the study and divided into 2 groups, the combined group and the reference group (n=37) according to the order of admission. The combined group received treatment of pantoprazole and mosapride while the reference group was treated with pantoprazole. Curative effect, recurrence rate and gastroesophageal reflux disease symptom frequency scale were compared between the two groups. The total effective rate of the reference group was 83.78 %, significantly lower than that of the combined group (97.3 %, p>0.05). Besides, there were 2 cases of recurrence in the combined group, while there were 7 cases in the reference group and this difference is statistically significant (p<0.05). Meanwhile, after treatment the gastroesophageal reflux disease symptom scores of patients in the combined group were significantly better than those in the reference group. The combined treatment of pantoprazole and mosapride has significant curative effect on gastroesophageal reflux chest pain with relatively high effective rate, thus worthy of recommendation in clinical trials.

Esophageal motility and reflux characteristics in gastroesophageal reflux disease patients with or without extra-esophageal symptoms

Objective: To investigate esophageal motility and reflux characteristics in gastroesophageal reflux disease (GERD) with and without extra-esophageal symptoms by high-resolution manometry and 24 h esophageal multichannel intraluminal impedance combined pH (MII-pH) monitoring. Methods: From February 2016 to June 2017, GERD patients with and without extra-esophageal symptoms were enrolled in this prospective controlled study. Esophageal HRM and 24 h MII-pH monitoring were performed. The differences in esophageal motility and reflux parameters were further analyzed between 30 GERD patients with extra-esophageal symptoms and 30 simple GERD patients. Results: The GERD symptom scores didn't show statistical difference between two groups. The GERD symptom scores didn't show statistical difference between two groups. The relaxation pressure of lower esophageal sphincter(LES), the integrated relaxation pressure, and the recovery time of upper esophageal sphincter(UES) of GERD patients with extra-esophageal symptoms were all lower than those of patients without extra-esophageal symptoms [(15±7) vs (21±11)mmHg, (8±3) vs (10±5)mmHg, (388±168) vs (492±170)ms, 1 mmHg=0.133 kPa], and the differences were statistically significant(all P<0.05). The main classification of esophageal motility type of GERD patients with extra-esophageal symptoms was mild esophageal motility disorders (27%, 8/30), and the occurrence of ineffective esophageal motivation was 20% (6/30), which were similar with simple GERD patients. The proximal reflux percentages of weak acid reflux and nonacid reflux, abnormal nonacid reflux in GERD patients with extra-esophageal symptoms were significantly higher than those in simple GERD patients [84.6% (73.2%, 100.0%) vs 75.0% (60.0%, 87.65%), P=0.048; 90.0% (45.8%, 100.0%) vs 0(0, 100.0%), P=0.017; 46.7% vs 3.3%, P=0.03]. Conclusions: The pathogenesis of GERD with extra-esophageal symptoms may be different from typical GERD. Increase of proximal esophageal reflux and abnormal nonacid reflux may all participate in the mechanisms of GERD with extra-esophageal symptoms.

A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease.

Background/AimsWe aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride.MethodsA total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment.ResultsEndoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (−13.4 ± 14.7 vs −8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively).ConclusionsThe combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients.

An open-label pilot study to explore usefulness of Homoeopathic treatment in nonerosive gastroesophageal reflux disease

Background and Aim: Nonerosive gastroesophageal reflux disease or nonerosive reflux disease (NERD) is characterized by troublesome reflux-related symptoms in the absence of esophageal erosions/breaks at conventional endoscopy. There are a number of medicines cited in homoeopathic literature which can be used for treatment of symptoms such as heartburn and regurgitation. A pilot study was undertaken to explore usefulness of homoeopathic medicines in treatment of NERD. Methodology: In this study, 78 patients were screened and 34 were enrolled, having symptoms of heartburn and/or regurgitation at least twice a week, having a gastroesophageal reflux disease (GERD) symptom score of more than 4. Homoeopathic medicine was prescribed on the basis of presenting symptoms. Response to treatment was assessed on GERD symptom score, visual analog scale (VAS) for heartburn, and World Health Organization quality of life-BREF (WHO-QOL) questionnaire evaluated at baseline and at end of 8 weeks of treatment . Results: Significant difference was found in pre- and post-treatment GERD symptom score (8.79 ± 2.7 vs. 0.76 ± 1.8; P = 0.001) and VAS for heartburn (47.47 ± 19.6 vs. 5.06 ± 11.8; P = 0.001). Statistically significant improvement was seen in three domains of WHO-QOL score, i.e. psychological health, social relationship, and environmental domain. Conclusion: The findings are encouraging to open avenues for further studies on reflux disease.

Efficacy of proton pump inhibitors and H2 blocker in the treatment of symptomatic gastroesophageal reflux disease in infants.

PurposeGastroesophageal reflux disease (GERD) occurs in pediatric patients when reflux of gastric contents presents with troublesome symptoms. The present study compared the effects of omeprazole and ranitidine for the treatment of symptomatic GERD in infants of 2-12 months.MethodsThis study was a clinical randomized double-blind trial and parallel-group comparison of omeprazole and ranitidine performed at Children Training Hospital in Tabriz, Iran. Patients received a standard treatment for 2 weeks. After 2 weeks, the patients with persistent symptoms were enrolled in this randomized study.ResultsWe enrolled 76 patients in the present study and excluded 16 patients. Thirty patients each were included in group A (ranitidine) and in group B (omeprazole). GERD symptom score for groups A and B was 47.17±5.62 and 51.93±5.42, respectively, with a P value of 0.54, before the treatment and 2.47±0.58 and 2.43±1.15, respectively, after the treatment (P=0.98). No statistically significant differences were found between ranitidine and omeprazole in their efficacy for the treatment of GERD.ConclusionThe safety and efficacy of ranitidine and omeprazole have been demonstrated in infants. Both groups of infants showed a statistically significant decrease in the score of clinical variables after the treatment.

Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease.

To evaluate safety, tolerability, and symptom improvement with once-daily esomeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD). In this 8-week, multicenter, randomized, uncontrolled, double-blind study, children ages 1 to 11 years were stratified by weight to receive esomeprazole 5 or 10 mg (children < 20 kg) or 10 or 20 mg (children ≥ 20 kg) once daily. Safety and tolerability was assessed by evaluating adverse events (AEs; both treatment- and non-treatment-related AEs) and changes from baseline in medical history, physical examinations, and clinical laboratory tests. Investigators scored symptom severity every 2 weeks using the Physician's Global Assessment (PGA). Patients' parents rated GERD symptoms of heartburn, acid regurgitation, and epigastric pain (none to severe, 0-3) at baseline (based on past 72 hours) and daily (from past 24 hours). Of 109 patients randomized, 108 had safety data. AEs were experienced by 68.0% and 65.2% of children < 20 kg receiving esomeprazole 5 and 10 mg, respectively, and 83.9% and 82.8% of children ≥ 20 kg receiving esomeprazole 10 and 20 mg, respectively, regardless of causality. Overall, only 9.3% of patients reported 13 treatment-related AEs; the most common were diarrhea (2.8% [3/108]), headache (1.9% [2/108]), and somnolence (1.9% [2/108]). Vomiting, a serious AE in 2 patients, was not judged by the investigator to be related to treatment. At the final visit, PGA scores improved significantly from baseline (P < 0.001). Of 58 patients with moderate to severe baseline PGA symptom scores, 91.4% had lower scores by the final visit. GERD symptom scores were significantly improved from baseline to the final week of the study in all of the treatment groups (P < 0.01) CONCLUSIONS: In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD-related symptoms were significantly reduced during the active treatment period.

Factors affecting response to proton pump inhibitor therapy in patients with gastroesophageal reflux disease: a multicenter prospective observational study

Proton pump inhibitor (PPI) therapy, the first-line treatment for gastroesophageal reflux disease (GERD), is not always effective. This study aimed to examine the effect of pretreatment patient characteristics on response to PPI therapy. Japanese outpatients with symptomatic GERD scheduled to receive endoscopy and PPI therapy were enrolled in this multicenter prospective observational study. The patients' characteristics, including GERD and dyspeptic symptoms, anxiety, depression, and quality of life, were assessed using questionnaires before and 2 and 4weeks after the start of PPI therapy. Factors affecting therapeutic response were examined by simple and multiple regression analyses using three patient-reported outcome measures as objective variables. Data from 182 patients were analyzed. In multiple regression analysis using the residual symptom rate as an objective variable, lower GERD symptom score (p<0.05), absence of erosive esophagitis (p<0.05), higher epigastric pain/burning symptom score (p<0.05), and higher depression subscale score (p<0.05) accompanied poorer therapeutic response. In analyses using the patient's impression of therapy, lower GERD symptom score (p<0.05) and absence of erosive esophagitis (p<0.05) accompanied poorer therapeutic response. In analyses using the relative GERD symptom intensity evaluated using a numeric rating scale, lower GERD symptom score (p<0.05), higher epigastric pain/burning symptom score (p<0.1), and lower body mass index (p<0.05) accompanied poorer therapeutic response. Patients who complained of milder GERD symptoms before treatment were likely to have poorer response to PPI therapy. Association of absence of erosive esophagitis, severer epigastric pain/burning symptoms, lower body mass index, and severer depression with poorer therapeutic response was also suggested.

Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial

Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Maintenance of Efficacy and Safety of Rabeprazole in Children With Endoscopically Proven GERD

The aim of the present study was to evaluate 24-week maintenance of efficacy and safety of rabeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD). Children ages 1 to 11 years who achieved endoscopic/histologic healing (defined as grade 0 of the Hetzel-Dent Classification scale and/or grade 0 of the Histological Features of Reflux Esophagitis scale) in a 12-week treatment phase were continued on the same dose for an additional 24 weeks during the maintenance phase. The dose was determined by weight: children weighing 6 to 14.9 kg (low-weight cohort) received 5 or 10 mg and children weighing ≥ 15 kg (high-weight cohort) received 10 or 20 mg. Healing was maintained in 90% of children (100% [low-weight cohort]; 89% [10 mg, high-weight cohort]; 85% [20 mg, high-weight cohort]). The Total GERD Symptom and Severity score continued to improve slightly in all of the children across all dose groups (P = 0.026) during the maintenance phase, except the 10-mg dose group (low-weight cohort), which experienced a slight worsening of 3.6 points. Overall, 71% children felt better on the GERD Symptom Relief score (P < 0.001); 95% of investigators and 92% of parent/caregivers rated "Good to Excellent" on the Global Treatment Satisfaction scale and Clinical Global Impressions Improvement scale, respectively. Overall incidence of treatment-emergent adverse events was 63%; upper respiratory tract infections (13%) and vomiting (11%) were the most commonly reported (>10%). Rabeprazole was effective in maintaining endoscopic/histologic healing during a 24-week maintenance period in children with endoscopically proven GERD. The clinical effect and safety profile were largely similar across dose groups.

Safety and Efficacy of Delayed Release Rabeprazole in 1‐ to 11‐Month‐Old Infants With Symptomatic GERD

: The efficacy and safety of rabeprazole, a proton pump inhibitor, were studied in infants with gastroesophageal reflux disease (GERD). Infants ages 1 to 11 months, with symptomatic GERD resistant to conservative therapy and/or previous exposure to acid-suppressive medications, were screened. After scoring >16 on a GERD symptom score (Infant Gastroesophageal Reflux Questionnaire-Revised [I-GERQ]), 344 infants were enrolled in a 1- to 3-week open-label (OL) phase and received rabeprazole 10 mg/day. Following caregiver-rated clinical improvement during the OL phase, patients were randomized to placebo, rabeprazole 5 mg, or rabeprazole 10 mg in the ensuing 5-week double-blind (DB) withdrawal phase. Primary endpoints evaluated from DB baseline to the end of the DB withdrawal phase included frequency of regurgitation, weight-for-age z score, and daily and weekly GERD symptom scores. Overall, 231 (86%) of the 268 randomized infants (placebo: 90; rabeprazole 5 mg: 90; rabeprazole 10 mg: 88) completed the study. Efficacy endpoints were similarly improved during the OL phase in all of the groups, and continued improving during the DB withdrawal phase with no difference between the placebo and combined rabeprazole groups. Mean decrease in frequency of regurgitation (-0.79 vs -1.20 times per day; P = 0.168), in I-GERQ-Revised scores (-3.6 [-25%] vs -3.9 points [-27%]; P = 0.960), in I-GERQ-Daily Diary scores (-1.87 [-19%] vs -1.85 [-19%]; P = 0.968), and increase in weight-for-age z scores (mean [standard deviation]: 0.11 [0.329] vs 0.14 [0.295]; P = 0.440) indicated equal improvement. Equal percentages (47%) reported adverse events in placebo and combined rabeprazole groups, with no new safety signals emerging. In those infants with GERD who improved with rabeprazole during the OL phase, improvements in symptoms and weight were similar in those who continued rabeprazole and those withdrawn to placebo during a 5-week DB phase.