Project description:BACKGROUND/AIMS:To compare gastroesophageal reflux disease (GERD) symptoms and response to proton pump inhibitor (PPI) in patients with erosive esophagitis (EE), non-erosive reflux disease (NERD) or functional heartburn (FH) using GERD impact scale (GIS) questionnaire. METHODS:Total 126 patients with GERD symptoms were diagnosed as EE (n = 62), NERD (n = 34) and FH (n = 30) by endoscopy, 24-hour esophageal pH testing and Bernstein test, prospectively. Analysis of risk factors and GIS questionnaire for GERD symptoms and quality of life were performed before and 8 weeks after PPI treatment. RESULTS:EE group had a higher proportion of men, frequent alcohol consumption, smoking, hiatal hernia, body mass index ? 25 kg/m(2) and triglyceride levels (? 150 mg/dL) than the other groups (all P < 0.05). On the other hand, both psychiatric treatment and psychopharmacotherapy were more frequent in patients with FH than in those with EE and NERD (both P < 0.05). Among GERD symptoms, chest pain was more frequent in FH group than in EE and NERD groups (P < 0.05). Eating problems and limitation of productive daily activities occurred frequently in FH group and NERD group, respectively. GIS after 8 week PPI treatment showed improvement in all of the GERD symptoms in EE (all P < 0.05) and in acid regurgitation, epigastric pain and hoarseness in NERD group (all P < 0.05). In terms of quality of life, PPI treatment improved sleep disturbance in EE (P = 0.031) and limitation of productive activity in the NERD group (P = 0.001). CONCLUSIONS:GIS questionnaire showed that different characteristics and symptoms improved after PPI therapy among patients with EE, NERD and FH, demonstrating the usefulness of the GIS questionnaire.
Project description:Background/aimsTo evaluate the usefulness of gastroesophageal reflux disease questionnaire (GerdQ) and reflux symptom index (RSI) for diagnosis of gastroesophageal reflux disease (GERD) in patients with suspected laryngopharyngeal reflux (LPR) symptoms (cough, hoarseness, globus, and throat pain).MethodsA total of 98 patients with LPR symptoms were incorporated from either gastroenterology or otorhinolaryngology clinic. Patient's laryngoscopic findings were graded by reflux finding score (RFS), and RFS ≥ 7 was considered as positive LPR. Erosive esophagitis on endoscopy or abnormal results on ambulatory impedance-pH monitoring were used as diagnostic criteria for GERD. Esophageal motor function was evaluated using high-resolution esophageal manometry.ResultsNinety-three (94.9%) of the 98 subjects were diagnosed as LPR by RFS, but only 15 (15.3%) had GERD. For GerdQ, the cutoff value of 9 showed the highest area under curve (AUC) to diagnose GERD by receiver operating curve analysis (AUC = 0.565); the sensitivity, specificity, positive predictive value, and negative predictive value were unsatisfactory (50.0%, 70.7%, 22.6%, and 89.2%, respectively.) RSI also showed poor performance in diagnosing GERD; the cutoff value of 25 showed the highest yield (AUC = 0.581); the sensitivity, specificity, positive predictive value, and negative predictive value were 42.9%, 79.3%, 26.1%, and 89.0%, respectively. Ineffective esophageal motility was frequently observed (69 of 98, 70.4%), but there was no difference in esophageal motility parameters between GERD and non-GERD patients.ConclusionsIn patients with LPR symptoms, significant discrepancies are observed between laryngoscopic diagnosis and GERD. In this population, neither GerdQ nor RSI is useful in diagnosing GERD.
Project description:BackgroundThere is a need to find a simple, non-invasive and effective diagnostic tool for diagnosing gastroesophageal reflux-induced chronic cough (GERC) in clinic. This study aimed to evaluate the predictive diagnostic value of Hull airway reflux questionnaire (HARQ) and its combination with gastroesophageal reflux disease questionnaire (GerdQ) for GERC.MethodsChronic cough patients were enrolled and the diagnosis of GERC was established according to the chronic cough diagnosis and treatment process. The diagnostic value of HARQ and GerdQ alone or the combination of HARQ and GerdQ was analyzed.ResultsA total of 402 patients with chronic cough were eventually enrolled, including 166 GERC patients. When the HARQ score was used to predict the diagnosis of GERC, the area under the ROC curve was 0.796. The sensitivity and specificity were 77.19% and 77.06%, respectively. When the GerdQ was used to predict the diagnosis of GERC, the area under the ROC curve was 0.763. The sensitivity and specificity were 70.18% and 76.15%, respectively. When HARQ combined with GerdQ were used to predict the diagnosis of GERC, the area under the ROC curve was 0.848. The sensitivity and specificity were 77.19% and 79.82%, respectively.ConclusionsHARQ used to evaluate the cough hypersensitivity has a certain predictive diagnostic value for GERC. The diagnosis of GERC should be considered when the HARQ score is ≥24. The predictive diagnostic value of the combination of HARQ and GerdQ is significantly higher, which makes the diagnosis of GERC simpler, quicker and more effective.
Project description:Several specific foods are known to precipitate gastroesophageal reflux disease (GERD) symptoms and GERD patients are usually advised to avoid such foods. However, foods consumed daily are quite variable according to regions, cultures, etc. This study was done to elucidate the food items which induce typical GERD symptoms in Korean patients.One hundred and twenty-six Korean patients with weekly typical GERD symptoms were asked to mark all food items that induced typical GERD symptoms from a list containing 152 typical foods consumed daily in Korea. All patients underwent upper gastrointestinal endoscopy followed by 24-hour ambulatory esophageal pH monitoring. The definition of "GERD" was if either of the 2 studies revealed evidence of GERD, and "possible GERD" if both studies were negative.One hundred and twenty-six cases (51 GERD and 75 possible GERD) were enrolled. In 19 (37.3%) of 51 GERD cases and in 17 (22.7%) of 75 possible GERD cases, foods inducing typical GERD symptoms were identified. In the GERD group (n = 19), frequent symptom-inducers were hot spicy stews, rice cakes, ramen noodles, fried foods, and topokki. In the possible GERD group (n = 17), frequent symptom-inducers were hot spicy stews, fried foods, doughnuts, breads, ramen noodles, coffee, pizza, topokki, rice cakes, champon noodles, and hotdogs.In one-third of GERD patients, foods inducing typical symptoms were identified. Hot spicy stews, rice cakes, ramen noodles, fried foods, and topokki were the foods frequently inducing typical symptoms in Korea. The list of foods frequently inducing typical GERD symptoms needs to be modified based on their own local experiences.
Project description:The Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) is used to score and evaluate gastroesophageal reflux (GER) related symptoms such as regurgitation, irritability and crying. A cut-off of ≥ 16 has been suggested to discriminate between GER and GER-disease. However, age-specific normal values were not assessed. Aim of this study was to determine age-specific normal values in healthy infants. Cross-sectional survey in healthy infants aged 0-24 months during their regular check-ups at well-baby clinics and through an online questionnaire using the I-GERQ-R. Infants with a history of (suspected) GER-disease were excluded. Spearman's correlation coefficient was calculated to explore age-related trends. A total of 979 healthy infants (47% male, median age 6 [0-24] months) were included. Median I-GERQ-R score, regardless of age, was 6 (range: 0-27). I-GERQ-R scores significantly decreased with age (rs = -0.569, p < 0.001). Of all infants, 49 (5%) had a score of ≥ 16 which previously has been considered 'suggestive of GER-disease'. Scores of ≥ 16 were most frequently seen in newborns aged 0-4 months (16% in 0-1 months to 4% in 3-4 months) and disappeared after the age of 16 months. High scores in the first months of life were caused by a high prevalence of regurgitation, colic-associated symptoms and hiccup frequency. Conclusion: Age-dependent normal values for the I-GERQ-R show that reflux symptoms decrease in the first 24 months of life in healthy infants. Scores of ≥ 16 should not necessarily be considered abnormal in young infants. Validation as a diagnostic tool for GER-disease using age-appropriate normal values is needed. What is Known: • The Infant Gastro Esophageal Reflux Questionnaire Revised (I-GERQ-R) was developed to objectively score and evaluate GER-related symptoms in infants. • Previously a cut off of ≥ 16 has been suggested to differentiate between gastro esophageal reflux (GER) and GER-disease. What is New: • We present age-specific normal values of the I-GERQ-R in healthy infants. • I-GERQ-R scores clearly decrease with age and up to 16% of young healthy infants have a score that is above the previously suggested cut-off score of 16 for GER-disease.
Project description:Background & aimsThere are few data on the prevalence of gastroesophageal reflux disease (GERD) in the United States. We performed a population-based study to determine the prevalence of GERD symptoms and persistent GERD symptoms despite use of proton pump inhibitors (PPIs).MethodsWe conducted the National Gastrointestinal Survey in 2015 using MyGiHealth, an app that guides participants through National Institutes of Health gastrointestinal Patient-Reported Outcomes Measurement Information System surveys. Primary outcomes were prevalence of GERD symptoms in the past and persistence of GERD symptoms (heartburn or regurgitation 2 or more days in past week) among participants taking PPIs. Population weights were applied to the data and multivariable regression was used to adjust for confounding.ResultsAmong 71,812 participants, 32,878 (44.1%) reported having had GERD symptoms in the past and 23,039 (30.9%) reported having GERD symptoms in the past week. We also found that 35.1% of those who had experienced GERD symptoms were currently on therapy (55.2% on PPIs, 24.3% on histamine-2 receptor blockers, and 24.4% on antacids). Among 3229 participants taking daily PPIs, 54.1% had persistent GERD symptoms. Younger individuals, women, Latino individuals, and participants with irritable bowel syndrome or Crohn's disease were more likely to have continued symptoms, even when taking PPIs.ConclusionsUsing a population-based survey, we found GERD symptoms to be common: 2 of 5 participants have had GERD symptoms in the past and 1 of 3 had symptoms in the past week. We also found that half of PPI users have persistent symptoms. Given the significant effect of GERD on quality of life, further research and development of new therapies are needed for patients with PPI-refractory GERD symptoms.
Project description:ObjectivesThis study aimed to examine the validity of the modified Reflux Symptom Questionnaire-electronic Diary (mRESQ-eD) through patient input and psychometric testing of the questionnaire to support use in clinical trials in patients with persistent gastroesophageal reflux disease (GERD) and in accordance with Food and Drug Administration guidance on patient-reported outcome instruments.MethodsCognitive interviews were conducted with patients (n = 30) to evaluate the interpretability and content validity of draft mRESQ-eD items. Patient data from a phase 2b clinical study (ClinicalTrials.gov identifier: NCT02637557) on persistent GERD served to aid in the construction of weekly scores for heartburn severity, regurgitation severity, and total GERD severity. These scores' psychometric properties were also evaluated.ResultsMinor modifications were made to the draft mRESQ-eD based on patient feedback to improve interpretability and clarity of the instrument. Psychometric analysis suggested that an 8-item version of the mRESQ-eD was best suited to the clinical data. The internal consistency was found to be high (Coefficient ω = 0.95). Retest reliability and convergent validity were strong for a heartburn weekly severity score, regurgitation weekly severity score, and total GERD severity score.DiscussionThe final 8-item mRESQ-eD is a reliable and valid instrument with good psychometric properties for use in clinical trials in patients with persistent GERD. The mRESQ-eD may be considered for inclusion in clinical trials for persistent GERD and potentially positioned, in consultation with Food and Drug Administration, as endpoints to characterize treatment benefit.
Project description:Background/aimsThere is uncertainty about how to measure outcomes reported by patients in gastroesophageal reflux disease (GERD). This study was conducted to develop an instrument and to determine of the definition of respondent for a patient reported outcomes to assess the efficacy of a treatment used for GERD treatment.MethodsA structural process has developed a self-evaluation questionnaire for GERD (SEQ-GERD); health-related quality of life questionnaire for GERD (GERD-QOL) was translated through cross-cultural validation. Two-week reproducibility was evaluated and construct validity was assessed by correlating the SEQ-GERD with the Patient Assessment of Gastrointestinal Disorders (PAGI-SYM), the reflux disease questionnaire (RDQ), and GERD-QOL. Changes in SEQ-GERD scores were compared to assess the discriminative validity following 4 weeks of proton pump inhibitor administration.ResultsA total of 83 Korean patients were included (mean age 46 ± 14 years, females 61.4%). The internal consistency of the 19-item SEQ-GERD was good (alpha = 0.60-0.94) and the test-retest reliability was high (intra-class correlation coefficient = 0.67-0.95). The SEQ-GERD highly correlated with the GERD domain of the PAGI-SYM (correlation coefficient r = 0.894, P < 0.001), the RDQ-GERD (r = 0.877, P < 0.001), and GERD-QOL (r = -0.536, P < 0.05). SEQ-GERD scores significantly varied according to the overall treatment effectiveness scale of drug responsiveness and significantly decreased after drug treatment (mean differences according to the overall treatment effectiveness scale, P = 0.020).ConclusionThis study supports that SEQ-GERD is reliable and valid, and can be used to evaluate the treatment response in patients with GERD.
Project description:BackgroundEmpiric therapy with multichannel intraluminal impedance-pH monitoring (MII-pH) has been used for the initial treatment of gastroesophageal reflux-induced chronic cough (GERC). However, an algorithm based on the gastroesophageal reflux disease questionnaire (GerdQ) has the potential to achieve a simple, structured, and effective treatment approach for patients with GERC.ObjectivesThis study compared the efficacy of anti-reflux therapy based on GerdQ (new structured pathway, NSP) with medical treatment after MII-pH examination (ordinary clinical pathway, OCP) in the management of GERC.DesignFor the NSP, we adapted the GerdQ score to establish the basis for a treatment algorithm. For the OCP, treatment was determined using the MII-pH examination results.MethodsThe non-inferiority (NI) hypothesis was used to evaluate NSP versus OCP.ResultsOverall, the NSP and OCP-based therapeutic algorithms have similar efficacy for GERC [NI analysis: 95% confidence interval (CI), -4.97 to 17.73, p = 0.009; superiority analysis: p = 0.420]. Moreover, the cough symptom scores and cough threshold improved faster in the NSP group than in the OCP group at week 8 (p < 0.05). In the subgroup analyses using the GerdQ and GerdQ impact scale (GIS) scores, patients with low-likelihood GERC (GerdQ < 8) were more likely to benefit from OCP (NI analysis: 95% CI, -19.73 to 18.02, p = 0.213). On the other hand, in patients with high-likelihood and low-reflux impact GERC patients (GerdQ > 8 and GIS < 4), the NSP arm was not inferior to the standard treatment of OCP (NI analysis: 95% CI, -8.85 to 28.21%, p = 0.04; superiority analysis: p = 0.339), indicating that GerdQ- and GIS-guided diagnosis and management of patients with GERC could be an alternative to MII-pH management, especially in settings with reduced medical resources.ConclusionsThe use of the GerdQ algorithm should be considered when handling patients with GERC in the primary care setting.Trial registrationThis research was registered in the Chinese Clinical Trials Registry (ChiCTR-ODT-12001899).
Project description:Background and aimsProton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. Although a proportion do not require ongoing PPI therapy, a diagnostic approach to identify candidates appropriate for PPI cessation is not available. This study aimed to examine the clinical utility of prolonged wireless reflux monitoring to predict the ability to discontinue PPIs.MethodsThis double-blinded clinical trial performed over 3 years at 2 centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response. Participants underwent prolonged wireless reflux monitoring (off PPIs for ≥7 days) and a 3-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPIs). Symptom burden was quantified using the Reflux Symptom Questionnaire electronic Diary (RESQ-eD).ResultsOf 128 enrolled, 100 participants met inclusion criteria (mean age, 48.6 years; 41 men). Thirty-four participants (34%) discontinued PPIs. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET) > 4.0% (odds ratio, 1.82; P < .001). Participants with 0 days of AET > 4.0% had a 10 times increased odds of discontinuing PPI than participants with 4 days of AET > 4.0%. Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD, -43.7% vs -5.3%; P = .04).ConclusionsAmong patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted the ability to discontinue PPIs without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management. (ClinicalTrials.gov, Number: NCT03202537).