Global Overall Symptom Research Articles

Functional Abdominal Pain of Children: Therapy with Bacillus Coagulans GBI-30, 6086 and Insight into Its Probiotic Properties

Background: Probiotics are effective in the treatment of functional gastrointestinal disorders in adults but there is lack of enough clinical evidence in children.
 Aim: To evaluate effectiveness of Bacillus Coagulans GBI-30, 6086 along with digestive enzymes in the treatment of childhood functional abdominal pain (FAP).
 Methods: Children with FAP, based on the Rome IV criteria (n = 95, aged 5-16 years), received Bacillus Coagulans GBI-30, 6086 along with digestive enzymes from a commercially available preparation - Tummysoft® for three weeks. Treatment response was assessed by improvement in the Quality of Life in Reflux and Dyspepsia Questionnaire (QOLRAD) score and Global Overall Symptom (GOS) scale.
 Results: Patients diagnosed with FAP upon receiving a 3-week treatment with Bacillus Coagulans GBI-30, 6086 along with digestive enzymes, registered statistically significant improvement in both QOLRAD (Baseline, 30.27 ± 5.95; 10th Day: 108.39 ± 7.06; 21st day: 173.71 ± 6.71, P=0.00) and GOS scale (Baseline, 3.10 ± 0.37; 10th Day: 2.15 ± 0.73; 21st day: 1.00 ± 0.00, P = 0) signifying the efficacy of the probiotic in FAP.
 Conclusion: Bacillus Coagulans GBI-30, 6086 along with digestive enzymes from a commercially available preparation - Tummysoft® was found to be effective in the treatment of childhood functional abdominal pain (FAP).

The effectiveness of the ferula asafoetida in the treatment of dyspeptic disorders

Background and Objective: Dyspepsia is a common condition observed in daily clinical practice. Traditionally, for many centuries, Ferula Asafoetida has been used for various gastric disturbances in physiological doses. This study is an effort to understand its effectiveness in Dyspeptic disorders on a homoeopathic basis. Methods: A prospective, observational, non-randomised, and non-controlled study was conducted at Government Homoeopathic Medical College, Kadapa, Andhra Pradesh, from 2018 to 2019. A purposive sampling technique was used to enroll 30 patients (15 males and 15 females) complaining of heartburn and regurgitation of food of all age groups by the Esophagogastroduodenoscopy diagnosis and differentiating the other causes of illness to fit in the study. Ferula Asafoetida was prescribed in 30cH and 200cH high dilution in repeated doses according to the Homoeopathic posology. The assessment was done by establishing the Dyspepsia questionnaire and Global Overall Symptom (GOS) scale before and after the intervention at baseline and after the one year. Results: At 29 degrees of freedom, the 5% significant limit of ‘t’ is 2.05. The observed‘t’ value is 14.62. Hence, Asafoetida yielded a significant effect in the treatment of Dyspeptic disorders. Limitations: It includes that we could not perform the urea breath test, stool and biopsy of the stomach tissue to diagnose the H.pylori infection, a lack of control arm and used purposive sampling method for enrolling patients to prescribe Asafoetida. Conclusion: This study has shown optimistic results regarding the usefulness of Ferula Asafoetida in the treatment of Dyspeptic disorders. However, further randomised controlled trials with long-term follow-ups need to be conducted for definite conclusions.

Changes of Dyspeptic Symptom after Successful Eradication in Helicobacter pylori-Associated Dyspepsia

Background: Helicobacter pylori (H. pylori) gastritis could cause dyspepsia, and eradication is recommended as the first-line treatment. Patients who continuously have their symptoms under control > 6 months after eradication are defined as having H. pylori-associated dyspepsia (HPD), whereas patients who do not benefit from successful eradication are defined as having functional dyspepsia. Objectives: We assessed changes in dyspeptic symptoms after successful eradication of H. pylori by using a questionnaire. Methods: We studied H. pylori-infected dyspeptic participants with abdominal symptom scores > 4 points on the Global Overall Symptom (GOS) scoring items and received eradication therapy. We evaluated their symptoms using the GOS questionnaire before their eradications, at 1-month and at 1-year check-ups after eradication therapy. Results: Thirty dyspeptic participants (mean age 59.6 ± 15.3 years) answered every questionnaire. Fourteen participants (46.7%) had HPD, whereas 16 participants (53.3%) were non-HPD patients. The questionnaire at 1 month showed sensitivity of 64.3% (9/14) and specificity of 56.3% (9/16) for HPD. Approximately 60% of H. pylori-infected dyspepsia participants were identified as having HPD or non-HPD within 1 month after their eradications. Conclusions: Approximately 60% of HPD participants improved at 1 month after eradication. The questionnaire at 1 month helped diagnose HPD in advance and guided next treatment choice.

Short-Term Symptomatic Relief in Gastroesophageal Reflux Disease: A Comparative Study of Esomeprazole and Vonoprazan

Background and AimProton pump inhibitors and vonoprazan (a potassium-competitive acid blocker) are recommended as first-line treatments for gastroesophageal reflux disease (GERD). However, few reports have investigated the onset of action of these agents for GERD symptom relief. The present study compared the symptom relief of esomeprazole with that of vonoprazan via monitoring self-reported GERD symptoms after treatment initiation.MethodsThis was a prospective, multicenter, randomized, open-label, parallel group, comparative clinical study between esomeprazole (20 mg/day) and vonoprazan (20 mg/day) administered for 4 weeks to patients with GERD symptoms. Patients who had scores ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (GerdQ) were defined as having GERD and enrolled in this study. Sixty patients were randomly assigned to either the esomeprazole group (n = 30) or the vonoprazan group (n = 30). Treatment response rates in each drug group were evaluated according to the GerdQ. The Frequency Scale for the Symptoms of GERD (FSSG) scores from the 1st day after treatment initiation and the Global Overall Symptom (GOS) scale scores during treatment were also evaluated.ResultsAt 4 weeks, the treatment response rates for symptom relief according to the GerdQ were 88.0% in the esomeprazole group and 81.8% in the vonoprazan group. The GOS scales, which reflect the impact of GERD symptoms, were similar for both groups. The FSSG scores decreased from the 1st to the 14th day in both groups.ConclusionsThere were no substantial differences in the symptom relief between the two groups at any time point in this short-term study.

Su1071 - Efficacy of a Potassium-Competitive Acid Blocker for Improving Symptoms in Patients with Reflux Esophagitis, Non-Erosive Reflux Disease, and Functional Dyspepsia

The aim of the present study was to investigate the efficacy of a potassium-competitive acid blocker (PCAB) named vonoprazan (VPZ) for improving symptoms in patients with reflux esophagitis (RE), non-erosive reflux disease (NERD), and functional dyspepsia (FD). A hospital-based, retrospective study of outpatients in our department (Department of Gastroenterology, University of Juntendo, Tokyo, Japan) between March 2015 and August 2016 was performed. The patients who were experiencing heartburn, acid regurgitation, gastric pain, and/or a heavy feeling in the stomach of at least moderate severity at baseline were treated with 20 mg VPZ once daily for 4 weeks. The patients completed the global overall symptom (GOS) scale to determine their symptom severity at baseline and after the 4 week treatment period. The proportions of patients with RE, NERD, and FD achieving improvement of their symptoms, defined as a GOS scale score of 1 (‘no problem’) or 2 (‘minimal problem’), were evaluated. During 4 weeks of VPZ therapy, changes in the gastroesophageal reflux disease (GERD) score, which was defined as the total points for heartburn and acid regurgitation on the GOS scale in patients with RE and NERD, and in the FD score, which was defined as the total points for gastric pain and a heavy feeling in the stomach on the GOS scale in patients with FD, were also evaluated. A total of 88 eligible cases were included in the present study, comprising 20 patients with RE, 25 patients with NERD, and 43 patients with FD. The rates of symptomatic improvement in patients with RE, NERD, and FD were 75.0, 60.0, and 48.8%, respectively. For the patients who were first administered VPZ, the rates of symptomatic improvement were 90.9, 66.7, and 58.8% in patients with RE, NERD, and FD, respectively. For those patients who were resistant to 8 weeks of proton pump inhibitor therapy, the rates of symptomatic improvement were 55.6, 53.8, and 42.3% in patients with RE, NERD, and FD, respectively. The GERD score in patients with RE and NERD, and the FD score in FD patients, were decreased after 4 weeks of VPZ therapy (P<0.01). In patients with RE, NERD and FD, the possibility that PCAB may be used as a novel therapeutic drug was suggested. However, the number of study subjects was small; therefore, further, larger and prospective studies are required.

Efficacy of a potassium-competitive acid blocker for improving symptoms in patients with reflux esophagitis, non-erosive reflux disease, and functional dyspepsia.

The aim of the present study was to investigate the efficacy of a potassium-competitive acid blocker (PCAB) named vonoprazan (VPZ) for improving symptoms in patients with reflux esophagitis (RE), non-erosive reflux disease (NERD), and functional dyspepsia (FD). A hospital-based, retrospective study of outpatients in our department (Department of Gastroenterology, University of Juntendo, Tokyo, Japan) between March 2015 and August 2016 was performed. The patients who were experiencing heartburn, acid regurgitation, gastric pain, and/or a heavy feeling in the stomach of at least moderate severity at baseline were treated with 20 mg VPZ once daily for 4 weeks. The patients completed the global overall symptom (GOS) scale to determine their symptom severity at baseline and after the 4 week treatment period. The proportions of patients with RE, NERD, and FD achieving improvement of their symptoms, defined as a GOS scale score of 1 (‘no problem’) or 2 (‘minimal problem’), were evaluated. During 4 weeks of VPZ therapy, changes in the gastroesophageal reflux disease (GERD) score, which was defined as the total points for heartburn and acid regurgitation on the GOS scale in patients with RE and NERD, and in the FD score, which was defined as the total points for gastric pain and a heavy feeling in the stomach on the GOS scale in patients with FD, were also evaluated. A total of 88 eligible cases were included in the present study, comprising 20 patients with RE, 25 patients with NERD, and 43 patients with FD. The rates of symptomatic improvement in patients with RE, NERD, and FD were 75.0, 60.0, and 48.8%, respectively. For the patients who were first administered VPZ, the rates of symptomatic improvement were 90.9, 66.7, and 58.8% in patients with RE, NERD, and FD, respectively. For those patients who were resistant to 8 weeks of proton pump inhibitor therapy, the rates of symptomatic improvement were 55.6, 53.8, and 42.3% in patients with RE, NERD, and FD, respectively. The GERD score in patients with RE and NERD, and the FD score in FD patients, were decreased after 4 weeks of VPZ therapy (P<0.01). In patients with RE, NERD and FD, the possibility that PCAB may be used as a novel therapeutic drug was suggested. However, the number of study subjects was small; therefore, further, larger and prospective studies are required.

A Multicenter, Randomized, Open-Label Trial: Efficacy of Once-Daily Versus Twice-Daily Double-Dose Rabeprazole on Refractory Gastroesophageal Reflux Disease-Related Symptoms and Quality of Life

BackgroundApproximately 20% to 40% of patients with gastroesophageal reflux disease (GERD) are refractory to standard-dose proton-pump inhibitor (PPI) treatment. ObjectiveWe compared the efficacy and quality-of-life effects of 20 mg once daily (QD) versus 10 mg twice daily (BID) rabeprazole (RPZ) in patients with refractory GERD-related symptoms and sleep disturbances. MethodsThis multicenter, prospective, randomized, open-label study included patients in whom PPI treatment >4 weeks was ineffective. According to the Global Overall Symptom (GOS) scale, PPI-refractory GERD was defined as ≥1 category with >3 points among 10 specific upper gastrointestinal symptoms. Seventy-eight patients were randomly assigned to 20 mg QD and 10 mg BID RPZ groups for 8 weeks. Efficacy was evaluated using self-reported questionnaires, including the GOS scale and Pittsburg Sleep Quality Index (PSQI), whereas quality of life was assessed using the Short-Form 8 Health Survey (SF-8), at 4 and 8 weeks. Patients showing improvement at 8 weeks received follow-up every 4 to 8 weeks. ResultsGOS scale scores were significantly improved at 8 weeks in both groups, with no significant intergroup differences. Although SF-8 scores showed an increasing trend over 8 weeks in both groups, the physical component summaries in the 10 mg BID group significantly improved. The mental component summaries clearly improved in the 10 mg BID group. Of the 74 cases (4 missing), 51 (68.9%) had PSQI scores ≥5.5. PSQI scores remained unchanged during follow-up in both groups. The recurrence rate was not significantly different (46.1% vs 47.1% in the 20 mg QD and 10 mg BID groups, respectively) during the follow-up period at median (interquartile range) 24.0 (30.5) months. ConclusionsIn patients with refractory GERD, there was no significant difference in GOS scale score, PSQI, or recurrence rate between the groups. With regard to subscores of the SF-8, the 10 mg BID group might be potentially effective.

Prevalence of gastroesophageal reflux disease symptoms and effects of esomeprazole on the quality of life related to reflux and dyspepsia in patients on maintenance hemodialysis.

The prevalence of gastroesophageal reflux disease (GERD) symptoms has not been investigated in patients on maintenance hemodialysis in Japan, and few studies have reported the effect of proton pump inhibitors (PPIs) in hemodialysis patients with GERD symptoms. Here, we investigated the prevalence of GERD symptoms and the effects of the PPI esomeprazole on the quality of life related to reflux and dyspepsia in patients on maintenance hemodialysis. This was a cross-sectional/cohort study of hemodialysis outpatients implemented in 10 Japanese medical facilities from October 2012 to March 2014. The trial was registered in the UMIN Clinical Trial Registry (UMIN000009124). Forty-one of 385 patients (11%) reported GERD symptoms on the Global Overall Symptom (GOS) questionnaire. Multivariate logistic regression analysis identified the independent prognostic factors for GERD symptoms as a history of gastric ulcer and use of sevelamer hydrochloride or calcium polystyrene sulfonate. Participants with GERD symptoms completed the Quality of Life in Reflux and Dyspepsia, Japanese version (QOLRAD-J) questionnaire and were assigned to receive 4-week esomeprazole treatment (20 mg/day). This PPI therapy significantly improved all QOLRAD-J domains in the full analysis set (n = 28) and improved the GERD symptoms listed in the GOS questionnaire. Significantly impaired disease-specific quality of life (QOL) in the QOLRAD-J domains was observed in 44.4-74.1% of patients who had symptoms before treatment. The mean GOS and QOLRAD-J scores correlated significantly. Therapy with 20 mg/day esomeprazole appears to be efficacious for improving disease-specific QOL and GERD symptoms in Japanese patients on maintenance hemodialysis.

Sociodemographic profile of Helicobacter pylori positive functional dyspepsia patients in central India

Background: Dyspepsia is one of the common complaints in all sectors of the Indian population. It is diagnosed in the presence of symptoms thought to originate from gastroduodenal region and if there is no organic cause to explain dyspeptic symptoms on upper gastrointestinal endoscopy, the patient is labeled as functional dyspepsia (FD). Helicobacter pylori , a Gram-negative bacilli harboring in the acidic gastric environment has been said to be the causative agent, but this association has not been proved in Indian population. Hence, this study was conducted to find out the prevalence of H. pylori in FD. Methods: After the approval from Institutional Ethics Committee, patients presenting with symptoms of dyspepsia of both sex, within age group of 18-60 years and any dietary habit were enrolled in the study. After a detailed history and complete general and systemic examination, patients were subjected to gastroduodenoscopy. On endoscopy, if no lesion was observed, then the patient was labeled as FD. The severity of dyspepsia symptoms was assessed by seven-point global overall symptom (GOS) scale. Patients were then screened for H. pylori infection by both invasive (rapid urease, Gram staining, and culture) and non-invasive tests (C-14 urea breath test). Results: The prevalence of H. pylori in FD was found to be 63.38%. Among 90 H. pylori positive FD patients, 56% were male, 58.89% were below the age of 40 years, and 53.33% belonged to middle income group. The average GOS score for dyspepsia symptoms was 6.01±0.64. Epigastric pain and mild gastritis were the most common presenting symptom and endoscopic finding, respectively. Conclusion: Our results suggest that H. pylori is an important causative factor for dyspeptic symptoms in patients of FD. Hence, all the FD patients must be investigated for H. pylori and treated promptly.

A randomized prospective study comparing the efficacy of on-demand therapy versus continuous therapy for 6 months for long-term maintenance with omeprazole 20 mg in patients with gastroesophageal reflux disease in Japan

Aim. To assess the efficacy of continuous therapy (cont) and on-demand therapy (on-demand) as maintenance therapy for gastroesophageal reflux disease (GERD). Methods. Patients with upper GI endoscopy (EGD)-proven GERD who completed 8 weeks of initial therapy were randomized to cont (omeprazole 20 mg od) or on-demand (omeprazole 20 mg on-demand) group. Assessments by the Global Overall Symptom (GOS) scale at baseline (at the start of maintenance therapy) and at 8-week, 16–week, and 24-week visits were made and EGD was performed at 24 weeks. Symptom relief was defined as percentages of patients whose GOS score of 1 or 2. Results. Of the 117 enrolled patients, cont/on-demand was 59/58 and nonerosive reflux disease (NERD)/reflux esophagitis (RE) before the initial therapy was 35/82. Symptom relief in cont/on-demand were 57.6%/48.3% at baseline (n.s.), 66.7%/54.7% at 8 week (n.s.), 64.6%/54.7% at 16 weeks (n.s.), and 66.7%/74.0% at 24 weeks (n.s.). When subjects were divided into NERD and RE, symptom relief in cont/on-demand were 33.3%/41.2% at baseline (n.s.), 43.8%/64.3% at 8 weeks (n.s.), 50.0%/42.9% at 16 weeks (n.s.), and 50.0%/69.2% at 24 weeks (n.s.) in NERD, while those were 68.3%/51.2% at baseline (n.s.), 76.3%/51.3% at 8 weeks (p < 0.05), 70.6%/59.0% at 16 weeks (n.s.), and 72.7%/75.7% at 24 weeks (n.s.) in RE, respectively. At 24-week EGD, all patients in NERD remained as NERD but number of healed patients was significantly higher in cont (85.3%) than in on-demand (44.4%) (p < 0.01) in RE. Conclusions. Since NERD is defined by symptoms, as a result of the limited efficacy of continuous therapy, on-demand therapy would be sufficient as maintenance therapy in NERD patients. Regarding RE, continuous therapy would be recommended in terms of reduced symptoms and maintaining mucosal healing.

Mo1074 A Multicenter Randomized Trial to Compare the Efficacy of Omeprazole Versus Rabeprazole on Early Symptom Relief in Reflux Esophagitis

INTRODUCTION: The pharmacokinetics of PPI differs by the kind and this may lead the difference of therapeutic effect, especially symptom relief in early phase. Since genetic polymorphism of CYP2C19 is different in ethnic group and the standard dose of PPI in Japan differs from Western countries, efficacy of PPIs should be verified in each area. However, there is no study so far regarding early symptom relief by administrating standard dose of PPI in patient with reflux esophagitis (RE) in Japan. This prospective trial was performed to compare the efficacy of omeprazole and rabeprazole on early symptom relief in patients with RE. AIMS & METHODS: The patients who had been endoscopically diagnosed with RE within the past 12 months and who had moderate to severe reflux symptom of heartburn or gastric acid regurgitation. The severity was defined as score 4 and above in patient's reported symptom questionnaire with Global Overall Symptom (GOS) scale which have a seven point Likert scale. Subjects were randomized to either omeprazole 20mg od(O) or rabeprazole 10 mg od (R) for four weeks. The primary endpoint was to compare sustained

Mo1076 Comparison of Night-Time Acid-Suppressive Efficacies of Different Proton Pump Inhibitors in Helicobacter pylori-Negative CYP2C19 Homozygous Extensive Metabolizers: Effect of Rabeprazole at High and Twice Daily Doses

INTRODUCTION: The pharmacokinetics of PPI differs by the kind and this may lead the difference of therapeutic effect, especially symptom relief in early phase. Since genetic polymorphism of CYP2C19 is different in ethnic group and the standard dose of PPI in Japan differs from Western countries, efficacy of PPIs should be verified in each area. However, there is no study so far regarding early symptom relief by administrating standard dose of PPI in patient with reflux esophagitis (RE) in Japan. This prospective trial was performed to compare the efficacy of omeprazole and rabeprazole on early symptom relief in patients with RE. AIMS & METHODS: The patients who had been endoscopically diagnosed with RE within the past 12 months and who had moderate to severe reflux symptom of heartburn or gastric acid regurgitation. The severity was defined as score 4 and above in patient's reported symptom questionnaire with Global Overall Symptom (GOS) scale which have a seven point Likert scale. Subjects were randomized to either omeprazole 20mg od(O) or rabeprazole 10 mg od (R) for four weeks. The primary endpoint was to compare sustained

Lafutidine 10 mg versus Rabeprazole 20 mg in the Treatment of Patients with Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial

Background. Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia. Aim. The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H2-RA, and rabeprazole and to compare their efficacy. Methods. This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS) scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks. Results. A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P < .01) and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P < .01). Both the drugs were well tolerated. Conclusion. Both lafutidine and rabeprazole provide symptom relief in patients with heartburn-dominant uninvestigated dyspepsia. The present study confirms the appropriateness of lafutidine as an empiric treatment and superior efficacy for primary care practice patients with dyspepsia.

Esomeprazole 40 mg Once a Day in Patients with Functional Dyspepsia: The Randomized, Placebo-Controlled “ENTER” Trial

The etiologies of functional dyspepsia (FD) are unclear, but in some studies, treatment with a proton pump inhibitor has been beneficial. The objective of this study was to evaluate the efficacy of esomeprazole 40 mg once a day compared to placebo in achieving symptom relief in primary care patients with FD. This was a randomized, placebo-controlled trial in adult FD patients, who had at least moderate severity of symptoms, defined as a score of > or =4 on a 7-point Global Overall Symptom (GOS) scale. Patients were excluded if they had predominant symptoms of heartburn or regurgitation; after a normal baseline endoscopy, patients were randomized to esomeprazole 40 mg once daily or placebo for 8 wk. The primary outcome measure was symptom relief (GOS < or =2) at 8 wk. Of the 502 enrolled patients, 224 were randomized. The main reasons for exclusion were abnormal endoscopic findings, especially esophagitis. A significantly greater proportion of patients in the esomeprazole group achieved symptom relief at 4 but not at 8 wk compared to placebo: 4 wk esomeprazole 50.5% versus placebo 32.2%, p= 0.009; 8 wk esomeprazole 55.1% versus placebo 46.1%, p= 0.16. A similar relationship at 4 and 8 wk was seen for symptom resolution (GOS = 1) and improvement (DeltaGOS > or =2). For the primary outcome measure of symptom relief at 8 wk, there was no statistically significant difference between esomeprazole 40 mg once a day and placebo. However, at 4 wk, esomeprazole was significantly more effective than placebo for symptom relief. The difference in therapeutic gain between 4 and 8 wk was largely due to a higher placebo response rate at 8 wk.

Symptom Scale for Dyspepsia

Quantifying the severity of dyspepsia in clinical trials has been problematic, because patients in whom dyspepsia is diagnosed have varied predominant symptoms. Investigators in Canada developed a 7-point Global Overall Symptom (GOS) scale to grade overall symptoms of dyspepsia, defined as upper abdominal symptoms located between the sternum and the umbilicus, retrospectively during a defined period of either …