Gastroesophageal Reflux Disease Symptom Assessment Scale Research Articles

Comparison of efficacy of daily and alternate day maintenance treatment of GERD with Vonoprazan 10-mg using Gastroesophageal Reflux Disease Symptom Assessment Scale.

To compare efficacy of 10-mg of vonoprazan daily & on alternate days by Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). This prospective interventional cohort was done at Department of Medicine/Gastroenterology Dow Medical College, Karachi, Pakistan during the period August 2022 & January 2023. Potential participants fulfilling inclusion and exclusion criteria were asked to fill out GSAS questionnaires after their written consent. Patients were allocated in to two groups using random tables. Group-A was given Tab Vonoprazan 10-mg daily for two weeks. Group-B was given Tab Vonoprazan 10-mg on alternate day. GSAS was scored by totaling scores across symptoms and then they are divided by the total number of non-missing symptom scores. Both groups were assessed week-0 & week-2. Only 90 proformas that were completely filled were included, Group-A had 30 males and 15 females while Group-B had 29 males and 16 females. No significant difference in score was found in GSAS score at week-0 except that in item 'gurgling' while at week two there was no significant difference between any of the items. Total GSAS score were significantly lower at Week-2 than at week-0 (p = <.001). Vonoprazan of 10-mg on alternate day is equally effective as 10-mg daily in maintenance of GERD patients at two weeks.

Efficacy and safety of pantoprazole and itopride in patients with overlap of gastroesophageal reflux disease and dyspepsia: A prospective, open-label, single-arm pilot study.

Combining proton pump inhibitors (PPIs) with prokinetics can provide synergistic action in patients with gastroesophageal reflux disease (GERD) and overlapping dyspepsia, but data regarding this is lacking. This single-center, prospective study evaluated the efficacy and safety of 6-week treatment with fixed-drug combination (FDC) of pantoprazole (PPI) and itopride (prokinetic) in 50 patients with ≥3 month history of GERD and overlapping dyspepsia refractory to pantoprazole. Efficacy was assessed as reduction in GERD symptom assessment scale (GSAS) distress score for 15 symptoms from baseline to week 6. Adverse events (AEs) were monitored up to week 6. Although heartburn was the most common symptom at week 6 (26.8%), its frequency significantly decreased from baseline (84.0%; P <0.01). A similar trend was observed for other symptoms: pressure/discomfort inside chest (19.5%), belching (14.6%), regurgitation (12.2%), bloating (9.8%), flatulence (9.8%), early satiety (7.3%), acidic/sour taste in mouth (7.3%), nausea (7.3%), frequent gurgling in stomach/belly (4.9%), and pressure/lump in throat (2.4%). Mean distress scores of all symptoms markedly decreased at week 6. Three AEs (n = 2) of moderate intensity were reported. The FDC of pantoprazole and itopride showed favorable efficacy and safety in patients with GERD and overlapping dyspepsia refractory to pantoprazole monotherapy. Nevertheless, further studies are warranted.

The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial.

INTRODUCTION:This is the first randomized controlled diet intervention trial to investigate both the amount and type of carbohydrate on symptomatic gastroesophageal reflux disease (GERD).METHODS:Ninety-eight veterans with symptomatic GERD were randomly assigned to high total/high simple, high total/low simple, low total/high simple, or low total/low simple carbohydrate diet for 9 weeks. The primary outcomes were esophageal acid exposure time (AET) and total number of reflux episodes derived from 24-hour ambulatory pH monitoring. Secondary outcomes were esophageal reflux symptoms rated using the Gastroesophageal Reflux Disease Questionnaire (GERDQ) and GERD Symptom Assessment Scale (GSAS).RESULTS:Half of the subjects were White and half African American (mean age, 60.0 ± 12.5 years; mean body mass index, 32.7 ± 5.4 kg/m2). There was a significant main effect of diet treatment on AET (P = 0.001) and on the total number of reflux episodes (P = 0.003). The change in AET in the high total/low simple group (−4.3% ± 3.8%) differed significantly from the high total/high simple control group (+3.1% ± 3.7%), (P = 0.04). The reduction in simple sugar intake averaged 62 g less per day. Subjects' ratings of symptoms improved in all carbohydrate modification groups, including significant reductions in heartburn frequency, heartburn severity, acid taste in the mouth, lump/pain in the throat or chest, and sleep disturbance.DISCUSSION:A modification of dietary carbohydrate intake that targeted a substantial reduction in the intakes of simple sugars improved pH monitoring outcomes and symptoms of GERD that profoundly affect daily life. These findings provide a feasible and clinically applicable contribution to the limited objective data existing for efficacious dietary recommendations in the routine treatment and management of GERD.

A standardized extract of Opuntia ficus-indica (L.) Mill and Olea europaea L. improves gastrointestinal discomfort: A double-blinded randomized-controlled study.

Gastrointestinal discomfort (GD), which often includes gastroesophageal reflux disease (GERD), is a common disorder in healthy adults affecting 40% of the worldwide population. The symptoms related to GD can have a negative impact on the quality of life (QoL). Current treatments for GERD are associated with side effects. We conducted a randomized double-blind placebo-controlled trial to assess the effect of a standardized extract of Opuntia ficus-indica L. cladodes and Olea europaea L. leaves on the symptoms and QoL of healthy adults with GD. One hundred healthy participants with GD were enrolled in the study and divided into two groups: 60 participants taking verum (400 mg/day) and 40 taking the placebo for 8 weeks. The Gastrointestinal Quality of Life index (GIQLI) and GERD Symptom Assessment Scale (GSAS) questionnaires were administered at the beginning of the study and after 4 and 8 weeks. The group treated with verum experienced a statistically significant improvement of GIQLI and GSAS scores (p < .001). Moreover, the effect size measured revealed a clinical significance. A day-dependent improvement of symptoms was also observed. The standardized extract represents a fast, effective, and well-tolerated treatment for improving symptoms related to GD and GERD.

High-resolution impedance manometry and 24-hour multichannel intraluminal impedance with pH testing before and after sleeve gastrectomy: de novo reflux in a prospective series.

Laparoscopic sleeve gastrectomy (SG) is increasingly popular but concern regarding its effect on gastroesophageal reflux disease remain. The current literature is conflicting, and there have been little objective data. To objectively and more accurately assess the impact of SG on esophago-gastric physiology. Centre of Excellence in Metabolic and Bariatric Surgery, Private Hospital, Australia. Prospective cohort study of 31 patients undergoing SG with high-resolution impedance manometry (HRM), 24-hour multichannel intraluminal impedance combined with pH testing (MII-pH), and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) questionnaire 1 month before and 6 months after SG. There were 31 patients that underwent SG, 20 with synchronous hiatal repair and fixation, and 6 that were excluded. HRM demonstrated significantly increased intragastric pressures (15.5-29.6 mm Hg) and failed swallows (3.1-7.5%) but no other change in esophageal motility. MII-pH did not demonstrate significant changes in acid exposure time (8.5%-7.5%) or number of reflux episodes, although the numbers of long reflux episodes (2.3-4.7) and weak acid reflux episodes were significantly increased (15.4-55.2). DeMeester and GSAS scores were not significantly changed. There was no significant difference in patients with preexisting reflux. However, for patients without preexisting reflux, acid exposure time increased significantly (1.3%-6.7%), as did DeMeester scores (5.8-24.5) and the numbers of long reflux episodes (.1-4.4) and weakly acidic episodes (22.1-89.2). SG was associated with increased intragastric pressures, without changes in esophageal motility or acid exposure. For patients without preexisting reflux, there were increases in acid exposure time, long reflux episodes, weakly acidic reflux episodes, and DeMeester score.

Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial)

Introduction: Proton pump inhibitors (PPIs) are potent inhibitors of acid secretion and are the mainstay of therapy for gastroesophageal reflux disease (GERD). Initially designed to be taken 30 minutes before the first daily meal for optimal benefit, these agents are commonly used suboptimally, which adversely affects symptom relief. No study to date has, however, assessed whether correcting dosing regimens would improve symptom control. The objective of this study was to determine whether patients with persistent GERD symptoms on suboptimal omeprazole dosing experience symptomatic improvement when randomized to an optimal dosing regimen, and to evaluate the economic impact of suboptimal PPI dosing in GERD patients. Methods: Patients with heartburn symptoms ≥3 times per wk treated with omeprazole 20 mg were enrolled and observed for 2 wks on their current regimen. They were then randomized to optimal dosing (n=24) or continued suboptimal dosing (n=40) of omeprazole for 4 wks. Patients randomized to optimal dosing completed the study, while the remaining patients were further randomized to optimal (n=17) or continued suboptimal (n=23) dosing for an additional 4 wks. The primary endpoints were changes in symptom, frequency, and severity as determined using the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) at 6 and 10 wks. Baseline descriptive statistics were calculated and compared between study arms. The primary outcomes were changes in symptom, frequency, and severity, as determined using the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) 4 wks after the intervention was administered. In a secondary analysis, an alternative measure of symptom load was used to infer potential costs. Results: Sixty-four patients were enrolled with no differences in baseline demographic data (Table 1). GSAS symptom, frequency, and severity scores were significantly improved when dosing was optimized for overall and heartburn specific symptoms (P < 0.01 for all parameters) (Figure 1). Cost savings resulting from reduced medical care and workplace absenteeism were estimated to be $159.60 per treated patient, with cost savings potentially exceeding $4 billion annually in the U.S.Figure: Comparison of mean GSAS (a) symptom scores, (b) frequency scores, and (c) severity scores.Table: Baseline data.Conclusion: Patients administered a brief intervention to promote optimal PPI dosing demonstrated significant overall symptom improvement. Proper education and PPI dosing should serve to reduce the burden of persistent GERD symptoms and related healthcare costs of uncontrolled disease.

The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study.

There is a bidirectional relationship between gastroesophageal reflux disease (GERD) and sleep. It has been demonstrated that antireflux treatment can improve sleep quality in GERD patients with nighttime reflux. Patients with heartburn and/or regurgitation ≥3 times/week and insomnia for ≥3 months were included. Patients were assessed at baseline with the demographic, GERD symptom assessment scale, Epworth sleepiness scale, Berlin sleep apnea, Pittsburgh sleep quality index, and the Insomnia severity index questionnaires. Subjects underwent an upper endoscopy followed by pH testing. Subsequently, subjects were randomized, in a double-blind, placebo-controlled trial, to receive either ramelteon 8 mg or placebo before bedtime for 4 weeks. During the last week of treatment, subjects completed a daily GERD symptom and sleep diary and underwent actigraphy. Sixteen patients completed the study, 8 in each arm (mean age and M/F were 48.5 vs. 57.8 y, and 8/0 vs. 6/2, respectively). Patients who received ramelteon demonstrated a statistically significant decrease in symptom score as compared with those who received placebo for daytime heartburn (-42% vs. -29%), nighttime heartburn (-42% vs. 78%), 24-hour heartburn (-42% vs. -3%), and 24-hour acid regurgitation (-26% vs. 19%) (all P<0.05). Insomnia severity index score was significantly reduced in patients receiving ramelteon as compared with placebo (-46% vs. -5%, P<0.05). Ramelteon group also demonstrated a significant improvement in sleep efficiency and sleep latency, as compared with placebo, P<0.05). No significant adverse events were observed with ramelteon. Ramelteon significantly improved symptoms in patients with GERD. In addition, ramelteon significantly improved patients' sleep experience. Further studies are needed in the future (NCT01128582).

Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study.

Gastroesophageal reflux (GER) is a common, chronic, relapsing symptom. Often people self-diagnose and self-treat it even though health-related quality of life is significantly impaired. In the lack of a valid alternative approach, current treatments focus on suppression of gastric acid secretion by the use of proton pump inhibitors (PPIs), but people with GER have a significantly lower response rate to therapy. We designed a randomized double-blinded controlled clinical study to evaluate the efficacy and the safety of a formulation based on sodium alginate/bicarbonate in combination with extracts obtained from Opuntia ficus-indica and Olea europaea associated with polyphenols (Mucosave®; verum), on GER-related symptoms. Male/female 118 (intention to treat) subjects with moderate GER and having at least 2 to 6 days of GER episodes/week were treated with verum (6 g/day) or placebo for two months. The questionnaires Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQoL) and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) were self-administered by participants before the treatment and at the end of the treatment. Verum produced statistically significant reduction of GERD-HRQoL and GSAS scores, −56.5% and −59.1%, respectively, in comparison to placebo. Heartburn and acid regurgitation episodes for week were significantly reduced by verum (p < 0.01). Results indicate that Mucosave formulation provides an effective and well-tolerated treatment for reducing the frequency and intensity of symptoms associated with gastroesophageal reflux.

Systematic review of patient-reported outcome instruments for gastroesophageal reflux disease symptoms

Gastroesophageal reflux disease (GERD) symptoms are best assessed using patient-reported outcome (PRO) instruments. Guidance on developing well-defined and reliable instruments that capture optimal information from the patient's perspective was recently published by the US Food and Drug Administration and the European Medicines Agency. The aim of this systematic review was to identify and evaluate existing PRO instruments for GERD symptoms with regard to regulatory requirements. Systematic literature searches were conducted in PubMed and Embase to identify PRO instruments for GERD symptoms that have undergone psychometric evaluation. Content, construct and test-retest reliability, internal consistency, and responsiveness were evaluated in relation to regulatory recommendations. Supplementary searches were conducted to assess whether identified instruments had been used as clinical trial endpoint measures. The systematic literature searches identified 15 PRO instruments for GERD symptoms that have undergone psychometric evaluation. Eight were designed to evaluate GERD symptoms, two were to diagnose GERD, four were designed for both evaluative and diagnostic purposes, and one was designed for screening purposes. Five instruments were developed and reported to include most steps recommended by the Food and Drug Administration and European Medicines Agency, and have also been used as endpoint measures in clinical trials: the GERD Symptom Assessment Scale, the Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire, the Reflux Questionnaire, the Reflux Disease Questionnaire, and the Proton pump inhibitor Acid Suppression Symptom test. Existing PRO instruments for GERD do not meet all the regulatory requirements for an outcome instrument in reflux trials and may need further validation.

Gastroesophageal Reflux Disease as an Etiology of Sleep Disturbance in Subjects with Insomnia and Minimal Reflux Symptoms: A Pilot Study of Prevalence and Response to Therapy

Gastroesophageal reflux disease (GERD) is a well-recognized cause of impaired sleep in patients with frequent GERD symptoms, as well as those with sleep apnea. GERD's role in sleep disturbance of minimally symptomatic patients with poor sleep quality is less clear. We aimed to define the prevalence of GERD-related sleep disturbance in minimally-symptomatic subjects with demonstrated insomnia, and to assess the changes in sleep efficiency in these subjects after vigorous acid suppression. We recruited subjects aged 18-75 years reporting at least 6 months of insomnia, and sleep difficulty at least three nights per week. Subjects with a BMI > 30, a history of snoring or ongoing use of proton pump inhibitor or H2 receptor antagonist were excluded. Subjects underwent concurrent sleep study with dual channel 24-h pH study. Sleep efficiency, defined as the percentage of time after sleep initiation that the subject actually slept, and spontaneous arousal index, defined as the number of arousals per hour, were calculated. Those with a sleep study demonstrating poor sleep quality (sleep efficiency of < 83%, and > 10 arousals/h for those aged < 45, and > 15 for those who were 45 or older) and no obstructive sleep apnea were treated with rabeprazole 20 mg PO BID x 14 days. After 14 days, the subjects underwent repeat sleep study with pH monitoring. The GERD Symptom Assessment Scale (GSAS), the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) were administered to subjects at study inception and after 2 weeks of therapy. Twenty-four subjects reporting insomnia were enrolled, and 20 met criteria for disordered sleep and no OSA. Seventeen completed both the first and second studies, and 16 were adequate for analysis. Baseline GSAS demonstrated trivial or no reflux symptoms in the cohort (no subject scored > 8 out of 45 on GSAS, corresponding to a median rating of reflux symptoms of "not at all"). Four of 16 subjects (25%) demonstrated abnormal pH studies at baseline. All four had normalization of acid exposures on PPI. After 2 weeks of treatment, three of these four subjects had normalization of sleep efficiency, compared to 4 of 12 of the subjects with normal Johnson-DeMeester scores. Repeated measures analysis showed significant improvement in spontaneous arousal index between the first and second study for the whole group (P < 0.0035). Pre- and post-therapy ESS and FOSQ scores were not significantly different. Despite the lack of GERD symptoms, a significant minority of subjects with sleep disturbance have abnormal acid exposures. These preliminary data suggest that aggressive treatment of GERD in such patients may result in improvement in sleep efficiency.

Tradução e validação para a língua portuguesa (Brasil) de instrumentos específicos para avaliação de qualidade de vida na doença do refluxo gastroesofágico

Gastroesophageal reflux disease has been shown patients to alter quality of life and working productivity. Most of the instruments available for this type of assessment come from English or French speaking countries. To use these instruments in Brazil requires a judicious process of translation and validation. Translating to Portuguese the questionnaires GSAS (Gastroesophageal Reflux Disease Symptom Assessment Scale), GERD-HRQL (Gastroesophageal Reflux Disease - Health Related Quality of Life) and HBQOL (Heartburn Specific Quality of Life Instrument) specific for quality of life assessment in gastroesophageal reflux disease. Testing the psychometric properties of reliability and validity of the referred disease specific instruments. One hundred and thirty two gastroesophageal reflux disease patients (mean age 54.9 years and +/- SD 13.9) from the Digestive Disease Motility Outpatient Clinic, Federal University of São Paulo, SP, Brazil and the Department of Surgical Gastroenterology "São José do Rio Preto" School of Medicine, São José do Rio Preto, SP, Brazil, accepted to participate and signed the informed consent form. Forty of these patients took part in the pre-test phase (28 females and 12 males, mean age 55.3 years +/- SD 14.7) and the remaining 92 part in the validation phase (64 females and 28 males, mean age 54.7 years and +/- SD 13.7). The translation and cultural adaptation processes were carried out accordingly us to the method of Guillemin et al (1993). The validation processes of the disease specific translated questionnaires (GSAS, GERD-HRQL and HBQOL) was performed in relation to a generic (SF-36) and a symptomatic (SQGERD) instrument. Nine words of the GSAS, four of the GERD-HRQL and six of the HBQOL were replaced during the cultural adaptation phase. The GSAS questionnaire was discontinued after this phase because of scoring problems. Therefore reliability and validity were tested only for the two remaining questionnaires. These questionnaires proved to be reproducible for both inter and intra-observer relationships (0.980 and 0.968 values for the GERD-HRQL and varying values of 0.868 to 0.972 for the HBQOL). The HBQOL questionnaire demonstrated high internal consistency (>0.70) for three of the four dimensions tested (physical aspect, pain, sleep). Good correlations levels with the SF-36 and SQGERD questionnaires were demonstrated during the validation phase. The cross cultural adaptation of the Portuguese (Brazil) versions of the GERD-HRQL and HBQOL instruments proved to be reliable and valid options with low burden level for assessment of quality of life in gastroesophageal reflux disease our country. The HBQOL is the only multidimensional questionnaire for quality of life assessment in gastroesophageal reflux disease currently available in Brazil. The Portuguese (Brazil) version of the GSAS instrument proved inadequate for quality of life assessment in our country.

A Very Low-Carbohydrate Diet Improves Gastroesophageal Reflux and Its Symptoms

Obese patients with gastroesophageal reflux disease (GERD) may experience resolution of symptoms utilizing a very low-carbohydrate diet. The mechanism of this improvement is unknown. This studied aimed to prospectively assess changes in distal esophageal acid exposure and GERD symptoms among obese adults initiating a very low-carbohydrate diet. We studied obese individuals with GERD initiating a diet containing less than 20 g/day of carbohydrates. Symptom severity was assessed using the GERD Symptom Assessment Scale--Distress Subscale (GSAS-ds). Participants underwent 24-hr esophageal pH probe testing and initiated the diet upon its completion. Within 6 days, a second pH probe test was performed. Outcomes included changes in the Johnson-DeMeester score, percentage total time with a pH<4 in the distal esophagus, and GSAS-ds scores. Eight participants were enrolled. Mean Johnson-DeMeester score decreased from 34.7 to 14.0 (P=0.023). Percentage time with pH<4 decreased from 5.1% to 2.5% (P=0.022). Mean GSAS-ds score decreased from 1.28 to 0.72 (P=0.0004). These data suggest that a very low-carbohydrate diet in obese individuals with GERD significantly reduces distal esophageal acid exposure and improves symptoms.

Development and Validation of the Gastroesophageal Reflux Disease Treatment Satisfaction Questionnaire

There is growing recognition of the importance of assessing patient perceptions of treatment, especially patient satisfaction. The Gastroesophageal Reflux Disease (GERD) Treatment Satisfaction Questionnaire (GTSQ) was developed to assess satisfaction with GERD medication. A web-based survey, which included the GTSQ and the GERD Symptom Assessment Scale (GSAS), was administered in September 2003 to 2511 subjects taking prescription GERD medication, identified as H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). Results showed excellent reliability of the GTSQ subscales (from 0.82-0.95) and validity with respect to two GSAS subscales. Rabeprazole (Aciphex) subjects taking 1 pill per day were statistically more satisfied than those taking 2 pills per day for all subscales except "Daytime Relief" and "Quick and Long-Lasting." Those who stayed on rabeprazole therapy longer showed statistically significant greater satisfaction on the "Daytime Relief" and "Health-Related Quality of Life" scales. The GTSQ has high reliability and can be used to assess aspects of satisfaction with GERD medication.

PGI8: RAPID IMPACT OF RABEPRAZOLE ON SYMPTOM DISTRESS AMONG PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

OBJECTIVES: Gastroesophageal reflux disease (GERD) is a common condition associated with a variety of symptoms, particularly heartburn. The purpose of this study was to assess patient-reported symptom distress in a randomized trial of rabeprazole (RAB), a proton pump inhibitor. METHODS: Symptom distress was measured using the Distress subscale of the GERD Symptom Assessment Scale (GSAS) that asks patients about the degree of bother they experience for 15 symptoms. Patients completed the GSAS at baseline and week 4. We evaluated the impact of treatment (RAB 10mg, RAB 20mg, or placebo) on mean change in GSAS Distress scores using an ANCOVA model. We also conducted a relative variability analysis using ANOVA models to determine which of 5 clinical indicators are most useful to explain changes in GSAS Distress scores. Mean change was assessed as a function of baseline daytime heartburn severity, baseline nighttime heartburn severity, time to first 24 hours without heartburn symptoms, complete daytime heartburn relief, and complete nighttime heartburn relief. RESULTS: The sample consisted of 169 patients (RAB10mg = 55, RAB 20mg = 56, placebo = 58). Overall, a significant difference in mean change in GSAS Distress scores was observed across treatment groups (p = 0.0007). Both the RAB 10mg and RAB 20mg groups reported significantly greater improvements in GSAS Distress scores than the placebo group (p = 0.0036 and p = 0.0004, respectively). Of the 5 clinical indicators examined, time to first 24 hours without heartburn explained the greatest amount of variability in GSAS Distress scores. Achieving complete daytime and complete nighttime heartburn relief also were significant factors. CONCLUSIONS: In clinical studies, RAB provided fast and consistent (both daytime and nighttime) heartburn relief. Given that speed of heartburn relief as well as achieving complete heartburn relief were significant factors explaining variability in patient-reported symptom distress, the positive impact of RAB on the GSAS distress scale was consistent with its clinical efficacy.