Comparación del efecto de omeprazol como monoterapia y su combinación con bicarbonato de sodio en el tratamiento de la pirosis moderada a severa: ensayo clínico controlado, aleatorizado y doble ciego / Comparison of the effect of omeprazole monotherapy and its combination with sodium bicarbonate in the treatment of moderate to severe heartburn: a double-blind, randomized controlled clinical trial

Heartburn occurs in 75% of patients with digestive discomfort of any origin and is one of the main symptoms of gastroesophageal reflux disease. Treatment focuses on lifestyle modification and symptomatology management with various drugs; when heartburn is moderate to severe, a proton pump inhibitor is more suitable. Omeprazole (OMZ) combined with sodium bicarbonate (BC) has demonstrated significant and sustained suppression of acid secretion. The objective was to compare the effect of sequential OMZ/BC therapy compared to OMZ monotherapy for the improvement of heartburn in Mexican individuals. The study was a double-blind, randomized, controlled, multicenter clinical study including 277 subjects with moderate to severe heartburn. Patients received 7 days of OMZ/BC and 7 days of OMZ (OMZ/BC7) or 14 days of OMZ (OMZ14). The primary endpoint was defined as the change in the number of days a week that the patient has heartburn, it was evaluated at 14 days. Both treatments reduced time (days) with heartburn by less than 4 days (OMZ14 3.9 vs. 4.2 days OMZ/BC7), as well as duration, number of events and intensity of heartburn. The treatments improved the quality of life, and the control of the symptoms. The proportion of adverse events was lower with OMZ/BC. The non-inferiority of OMZ/BC7 with respect to OMZ14 was verified.

La pirosis se presenta en el 75% de los pacientes con molestias digestivas de cualquier origen y es uno de los principales síntomas de la enfermedad por reflujo gastroesofágico. El tratamiento se enfoca en la modificación del estilo de vida y el manejo de la sintomatología con diversos fármacos; cuando la pirosis es moderada a severa, un inhibidor de la bomba de protones es más adecuado. El omeprazol (OMZ) combinado con bicarbonato de sodio (BC) ha demostrado supresión significativa y sostenida de la secreción ácida. El objetivo fue comparar el efecto de la terapia secuencial de OMZ/BC en comparación con el tratamiento continuo de OMZ para la mejoría de la pirosis en individuos mexicanos. Estudio clínico multicéntrico, doble ciego, controlado, aleatorizado que incluyó 277 sujetos con pirosis moderada a severa. Los pacientes recibieron 7 días de OMZ/BC y 7 días de OMZ (OMZ/BC7) o 14 días de OMZ (OMZ14). La variable primaria fue definida como el cambio del número de días a la semana que el paciente presenta pirosis, se evaluó a los 14 días. Ambos tratamientos redujeron los días con pirosis en menos 4 días (OMZ14 3,9 vs. 4,2 días OMZ/BC7), así como la duración, el número de eventos e intensidad de la pirosis. Los tratamientos mejoraron los indicadores de calidad de vida, y el control del padecimiento. La proporción de eventos adversos fue menor con OMZ/BC. Se comprobó la no-inferioridad de OMZ/BC7 respecto OMZ14.

Distúrbios funcionais esofágicos na avaliação pré-operatória de cirurgia bariátrica / Esophageal functional disorders in the pre-operatory evaluation of bariatric surgery

ABSTRACT BACKGROUND: Obesity is an independent risk factor for esophageal symptoms, gastroesophageal reflux disease (GERD), and motor abnormalities. When contemplating bariatric surgery, patients with obesity type III undergo esophagogastroduodenoscopy (EGD) and also esophageal manometry (EMN), and prolonged pHmetry (PHM) as part of their pre-operative evaluation. OBJECTIVE: Description of endoscopy, manometry and pHmetry findings in patients with obesity type III preparing for bariatric surgery, and correlation of these findings with the presence of typical GERD symptoms. METHODS: Retrospective study in which clinical symptoms of GERD were assessed, focusing on the presence of heartburn and regurgitation. All patients underwent EMN, PHM and most of them EGD. RESULTS: 114 patients (93 females-81%), average age 36 years old, average BMI of 45.3, were studied. Typical GERD symptoms were referred by 43 (38%) patients while 71 (62%) were asymptomatic. Eighty two patients (72% of total) underwent EGD and 36 (42%) evidenced esophageal abnormalities. Among the abnormal findings, hiatal hernia was seen in 36%, erosive esophagitis (EE) in 36%, and HH+EE in 28%. An abnormal EMN was recorded in 51/114 patients (45%). The main abnormality was a hypotensive lower esophageal sphincter (LES) in 32%, followed by ineffective esophageal motility in 25%, nutcracker esophagus in 19%, IEM + hypotensive LES in 10%, intra-thoracic LES (6%), hypertensive LES (4%), aperistalsis (2%) and achalasia (2%). Among the 43 symptomatic patients, 23 (53%) had abnormal EMN and 31/71 asymptomatic cases (44%) also presented this finding (P=0.30). PHM showed abnormal reflux in 60/114 patients (53%), with a predominance of bi-positional reflux (42%), followed by supine reflux (33%) and upright reflux (25%). Abnormal PHM was found in 26/43 symptomatic cases (60%) and also among 34/71 asymptomatic cases (48%) (P=0.19). CONCLUSION: Manometric abnormalities were common in obesity type III patients, the most frequent being hypotensive LES, followed by IEM. Most patients were asymptomatic. There was no correlation between the finding of motor abnormalities and the presence of symptoms. More than half the patients had abnormal reflux at PHM. We found no significant correlation between abnormal reflux and the presence of symptoms.

RESUMO CONTEXTO: A obesidade é fator de risco independente para sintomas esofagianos, doença do refluxo gastroesofágico (DRGE) e alterações motoras. Pacientes com obesidade tipo III, candidatos à cirurgia bariátrica foram submetidos a endoscopia digestiva alta (EDA) e também realizaram esofagomanometria (EMN) e pHmetria prolongada (PHM) como parte da avaliação pré-operatória. OBJETIVO: Em um grupo de pacientes com obesidade tipo III em pré-operatório de cirurgia bariátrica, descrever os achados endoscópicos, manométricos e pHmétricos, correlacionando-os com a presença de sintomas típicos de DRGE. MÉTODOS: Estudo retrospectivo, de pacientes com obesidade tipo III, candidatos a cirurgia bariátrica. A avaliação clínica focalizou a presença de sintomas típicos de DRGE (pirose/regurgitação); todos foram submetidos a EMN, PHM e a maior parte à EDA, realizada previamente. RESULTADOS: Foram incluídos 114 pacientes, 93 (81%) do sexo feminino, média de idade de 36 anos e IMC médio de 45,3. Sintomas típicos de refluxo foram referidos por 43 (38%) pacientes e 71 (62%) eram assintomáticos. EDA foi realizada por 82 (72%) pacientes, havendo anormalidades esofagianas em 36 (42%). Entre os anormais, havia hérnia hiatal (HH) em 36%, esofagite erosiva (EE) em 36% e HH + EE em 28%. A EMN foi anormal em 51/114 (45%). Entre os anormais, predominou o esfíncter esofagiano inferior (EEI) hipotenso em 32%, seguido por motilidade esofagiana ineficaz (MEI) em 25%, esôfago em quebra-nozes (19%), EEI hipotenso + MEI (10%), EEI intra-torácico (6%), EEI hipertenso (4%), aperistalse (2%) e acalasia (2%). Dentre os 43 sintomáticos, 23 (53%) apresentavam EMN anormal, sendo que em 31 dos 71 (44%) assintomáticos a EMN também era anormal (P=0,30). A PHM revelou refluxo anormal em 60 (53%) pacientes. Predominou o refluxo anormal biposicional (42%) seguido do refluxo supino (33%) e refluxo ereto (25%). Dentre os 43 pacientes sintomáticos, 26 (60%) apresentavam PHM anormal, sendo que em 34 dos 71 assintomáticos a PHM também era anormal (48%) - P=0,19. CONCLUSÃO: Alterações manométricas foram comuns em obesidade tipo III, sendo as mais frequentes o EEI hipotenso, seguida de motilidade ineficaz. A maioria dos pacientes era assintomática. Mais da metade dos pacientes apresentou refluxo anormal à PHM. Não houve diferença significativa entre o achado de refluxo anormal e a presença de sintomas. Não houve relação entre o achado de alterações motoras e a presença de sintomas.

Impacto da pirose e regurgitação no bem-estar de indivíduos da população geral: um inquérito nacional brasileiro / Impact of heartburn and regurgitation on individuals' well-being in the general population: a brazilian national survey

ABSTRACT BACKGROUND: Heartburn and acid regurgitation are typical symptoms usually associated with gastroesophageal reflux disease (GERD). GERD is one of the gastrointestinal diagnosis with higher prevalence worldwide, significantly impairing patients' quality of life. OBJECTIVE: The objective of this study was to analyze the impact of GERD-related symptoms in the Brazilian urban population. METHODS: National telephone survey with community-dwelling Brazilian individuals. Self-reported prevalence and frequency of symptoms (heartburn / regurgitation) were assessed. Individuals rated the impact of symptoms in their general well-being using a numeric scale from 1 to 10 (1 = no impact; 10 = very intense, preventing the person to eat and perform daily routine activities). Descriptive and bivariate statistical analyses were performed. RESULTS: The final sample was comprised of 1,773 subjects, 935 (52.7%) females, an average of 40 years old. The prevalence of heartburn and regurgitation in the past 6 months was 26.2% (n=466) and 11.0% (n=196), respectively. Women presented higher prevalence (heartburn n=266, 28.5% and regurgitation n=119, 12.7%) than men (n=200, 23.1% and n=78, 8.9%, respectively) (P<0.05). Heartburn in the past week was reported by 175 individuals (9.8%), while regurgitation episodes by 67 (3.8%). Absence of impact of the symptom in the overall well-being was observed for 82 subjects (17.6%) with heartburn and 18 individuals (9.2%) with regurgitation. Very intense impact was reported by 46 subjects (9.8%) with heartburn and 41 (20.9%) with regurgitation. Women's well-being was more affected than men's (mean score 5.45 vs 4.71, P<0.05). CONCLUSION: Heartburn and regurgitation were frequent symptoms, women with higher prevalence. These symptoms led to a substantial impact on individuals' well-being, women being more affected.

RESUMO CONTEXTO: Pirose e regurgitação ácida são sintomas típicos usualmente relacionados à doença do refluxo gastroesofágico (DRGE). A DRGE é um dos diagnósticos gastrointestinais com maior prevalência mundial, afetando significativamente a qualidade de vida dos pacientes. OBJETIVO: Analisar o impacto de sintomas relacionados à DRGE em uma amostra da população brasileira urbana. MÉTODOS: Inquérito nacional via telefone com indivíduos brasileiros em contexto comunitário. O inquérito foi conduzido entre 6 de agosto e 12 de setembro de 2018. A prevalência autorrelatada e a frequência dos sintomas foram avaliadas. Os respondentes classificaram o impacto dos sintomas no seu bem-estar geral utilizando uma escala numérica de 1 a 10 (1 = ausência de impacto; 10 = impacto muito grave, impedindo a pessoa de comer ou realizar atividades da vida diária). Análises estatísticas descritivas e bivariadas foram conduzidas. RESULTADOS: A amostra final foi constituída por 1.773 indivíduos, 935 (52,7%) mulheres, com idade média de 40 anos. A prevalência de pirose e regurgitação nos últimos 6 meses foi de 26,2% (n=466) e 11,0% (n=196), respectivamente. Sexo feminino (pirose n=266, 28,5% e regurgitação n=119, 12,7%) apresentou prevalência mais alta do que o masculino (n=200, 23,1% e n=78, 8,9%, respectivamente) (P<0,05). Pirose na última semana foi relatada por 175 indivíduos (9,8%), enquanto episódios de regurgitação por 67 (3,8%). Ausência de impacto dos sintomas no bem-estar geral dos indivíduos foi observada para 82 respondentes (17,6%) com pirose e 18 (9,2%) daqueles com regurgitação. Impacto muito grave foi reportado por 46 (9,8%) indivíduos com pirose e 41 (20,9%) com regurgitação. Sexo feminino foi mais afetado pelos sintomas do que o masculino. CONCLUSÃO: Pirose e regurgitação foram bastante frequentes sendo o sexo feminino mais afetado. Tais sintomas levaram a impacto no bem-estar dos indivíduos, com maior prejuízo para mulheres.

Trânsitos oral e faríngeo na pirose funcional / Oral and pharyngeal transit in functional heartburn

ABSTRACT BACKGROUND: Gastroesophageal reflux disease is associated with slower transit of the bolus through the pharynx and upper esophageal sphincter. Functional heartburn has similar symptoms to gastroesophageal reflux disease, however, the symptoms are not caused by reflux. OBJECTIVE: The aim of this investigation was to evaluate oral and pharyngeal transit in patients with functional heartburn, with the hypothesis that, similar to patients with gastroesophageal reflux disease, they have changes in pharyngeal and upper esophageal sphincter transit time. METHODS: Oral and pharyngeal transit was evaluated by videofluoroscopy in eight women with functional heartburn, five with mild dysphagia for solid foods, and 12 female controls. Controls and patients swallowed in duplicate 5 mL and 10 mL of liquid and paste boluses. RESULTS: No difference in the oral or pharyngeal transit time was found between patients and controls. No aspiration of bolus into the airways was detected in any individual. Pharyngeal residues were detected in the same proportion of swallows, in patients (12.5%) and controls (15.0%), after swallows of 10 mL paste bolus. CONCLUSION: Oral, pharyngeal and upper esophageal sphincter transit time are similar in patients with functional heartburn to healthy controls.

RESUMO CONTEXTO: A doença do refluxo gastroesofágico está associada ao trânsito mais lento do bolo deglutido pela faringe e esfíncter superior do esôfago. Pirose funcional tem sintomas similares aos de doença do refluxo gastroesofágico, entretanto eles não são consequência de refluxo. OBJETIVO: Como na pirose funcional os sintomas são semelhantes aos da doença do refluxo gastroesofágico, o objetivo desta investigação foi avaliar a duração do trânsito do bolo deglutido pela boca, faringe e esfíncter superior do esôfago em pacientes com pirose funcional, com a hipótese de que esses pacientes também apresentem alteração no trânsito. MÉTODOS: Pelo método videofluoroscópico foi avaliado o trânsito oral e faríngeo de oito pacientes do sexo feminino com pirose funcional, cinco com disfagia leve para alimentos sólidos, e 12 indivíduos controles do sexo feminino. Controles e pacientes deglutiram em duplicata 5 mL e 10 mL de bolos com a consistências líquida e pastosa. RESULTADOS: Com bolo líquido e pastoso não houve diferença na duração do trânsito oral, faríngeo e pelo esfíncter superior do esôfago entre controles e pacientes. Não houve aspiração do bolo para as vias aéreas em nenhum indivíduo. Os resíduos faríngeos foram observados na mesma proporção das deglutições em pacientes (12,5%) e controles (15%), com a deglutição de 10 mL de bolo pastoso. CONCLUSÃO: A duração do trânsito oral, faríngeo e pelo esfíncter superior do esôfago foi semelhante nos pacientes com pirose funcional e controles.

Prevalence of non-obstructive dysphagia in patients with heartburn and regurgitation

OBJECTIVE: Heartburn and regurgitation are the most common gastroesophageal reflux symptoms, and dysphagia could be a possible symptom. This investigation aimed to evaluate the prevalence of non-obstructive dysphagia in patients with heartburn and regurgitation. METHODS: A total of 147 patients (age, 20-70 years; women, 72%) complaining of heartburn and regurgitation, without esophageal stricture, previous esophageal surgery, or other diseases, were evaluated. Twenty-seven patients had esophagitis. The Eating Assessment Tool (EAT-10) was employed to screen for dysphagia; EAT-10 is composed of 10 items, and the patients rate each item from 0 to 4 (0, no problems; 4, most severe symptom). Results of the 147 patients were compared with those of 417 healthy volunteers (women, 62%; control group) aged 20-68 years. RESULTS: In the control group, only two (0.5%) had an EAT-10 score ≥5, which was chosen as the threshold to define dysphagia. EAT-10 scores ≥5 were found in 71 (48.3%) patients and in 55% of the patients with esophagitis and 47% of the patients without esophagitis. This finding indicates a relatively higher prevalence of perceived dysphagia in patients with heartburn and regurgitation and in patients with esophagitis. We also found a positive correlation between EAT-10 scores and the severity of gastroesophageal reflux symptoms based on the Velanovich scale. CONCLUSION: In patients with heartburn and regurgitation symptoms, the prevalence of dysphagia was at least 48%, and has a positive correlation with the overall symptoms of gastroesophageal reflux.

Erradicación de Helicobacter pylori en pacientes con dispepsia funcional / Helicobacter pylori eradication in patients with functional dyspepsia

La dispepsia constituye un motivo de consulta frecuente en atención primaria. A propósito de un paciente con diagnóstico de dispepsia funcional, la autora se plantea si el tratamiento de erradicación del Helicobacter pylori podría mejorar los síntomas. Luego de una búsqueda rápida se encontró evidencia que señala que el tratamiento de la infección por este germen podría ser beneficiosa para aliviar los síntomas de la dispepsia funcional a largo plazo, aunque con mayor riesgo de efectos adversos, por lo que otros tratamientos alternativos continúan siendo ser una opción válida en el manejo de los pacientes con este problema de salud. (AU)

Esophageal pH-impedance monitoring of reflux patterns in non-erosive reflux disease, reflux hypersensitivity and functional heartburn / 南方医科大学学报

OBJECTIVE@#To analyze the differences in reflux patterns in 24-hour esophageal pH-impedance monitoring in patients with non-erosive reflux disease (NERD), reflux hypersensitivity (RH) and functional heartburn (FH) and explore the possible mechanism of symptoms in patients with heartburn and negative endoscopic findings.@*METHODS@#Seventy-nine patients with heartburn as the main symptoms but negative endoscopic findings, including 35 with NERD, 16 with RH and 28 with FH, were enrolled in this study.All the patients underwent 24-h esophageal pH-impedance monitoring and esophagogastroscopy, and the results were compared among the 3 groups.@*RESULTS@#Acid reflux episode was significantly increased and weakly alkaline reflux episode was significantly decreased in NERD group in comparison with RH group and FH group (@*CONCLUSIONS@#Patients with NERD, RH and FH had different reflux patterns.Acid reflux is predominant in the NERD, while weakly alkaline reflux is significantly increased RH and FH.In patients with normal esophageal acid exposure but without symptoms or without recorded symptoms during esophageal pH-impedance monitoring, analysis of the total reflux episode, mixed reflux episode, proximal acid reflux episode and percentage can help in the differential diagnosis between RH and FH.

Role of Esophageal Mean Nocturnal Baseline Impedance and Post-reflux Swallow-induced Peristaltic Wave Index in Discriminating Chinese Patients With Heartburn

BACKGROUND/AIMS: Recently, esophageal mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic wave (PSPW) index have been proposed, which can increase the diagnostic role of multichannel intraluminal impedance and pH recording (MII/pH) for differentiating patients with heartburn. Therefore, our aim is to investigate the role of esophageal proximal MNBI, distal MNBI, and PSPW index in differentiating Chinese patients with heartburn. METHODS: Patients with heartburn from the Beijing Anzhen Hospital, who underwent upper gastrointestinal endoscopy and 24-hour MII/pH, were enrolled in this study. RESULTS: In all, 24 erosive esophagitis (EE), 46 non-erosive reflux disease (NERD), 52 reflux hypersensitivity (RH), and 78 functional heartburn (FH) patients were recruited. The respective median values for the EE, NERD, RH, and FH groups were as follows: proximal MNBI 1858.0, 2147.5, 2374.3, and 2329.0 Ω (P = 0.053); distal MNBI 1243.4, 1506.5, 2451.2, and 2477.3 Ω (P < 0.001); and PSPWI 15.0%, 25.0%, 25.0%, and 45.0% (P < 0.001). Spearman correlation analysis showed that distal MNBI and PSPW index were significantly negatively correlated with acid and bolus exposure time and acid reflux events. Receiver operating characteristic analyses showed that distal MNBI and PSPW index significantly discriminated FH from EE, NERD, and RH (P < 0.001), with cut-off values of 1890.6 Ω and 27.5% and areas under the curve of 0.721 and 0.779, respectively. CONCLUSION: Esophageal distal MNBI and PSPW index could increase the diagnostic role of MII/pH, especially for differentiating Chinese patients with heartburn.

An Increasing Trend of Eosinophilic Esophagitis in Korea and the Clinical Implication of the Biomarkers to Determine Disease Activity and Treatment Response in Eosinophilic Esophagitis

BACKGROUND/AIMS: The epidemiology and pathogenesis of eosinophilic esophagitis (EoE) remain unclear in Asian countries. We investigated clinicopathological characteristics and diagnostic trends of EoE, and evaluated 3 tissue biomarkers for correlation with disease activity and treatment response in Korean patients with EoE. METHODS: We retrospectively reviewed 25 271 esophageal biopsies performed during upper endoscopies between 2006 and 2017. We diagnosed EoE based on ≥ 15 eosinophils/high-power field (HPF) and, symptoms of esophageal dysfunction. We performed immunohistochemical analysis for tryptase, eosinophilic derived neurotoxin (EDN), and eotaxin-3. RESULTS: We diagnosed EoE in 72 patients (53 men and 19 women; mean age, 46.2 years) with presenting symptoms of, dysphagia (15.3%), epigastric pain (31.9%), and heartburn (30.6%). The diagnostic rate of EoE considerably increased between 2006 and 2017, from 0.29 diagnoses to 7.99 diagnoses per 1000 esophageal biopsies (P < 0.001). The mean peak eosinophil count (PEC) was 56.0 (± 77.8)/HPF. Whereas the EDN (rho = 0.667, P < 0.001) and eotaxin-3 levels (rho = 0.465, P < 0.001) correlated with PEC, tryptase and PEC were weakly correlated (rho = 0.291, P = 0.013). EDN (rho = 0.279, P = 0.017), and tryptase (rho = 0.279, P = 0.033) correlated with the inflammatory score of Eosinophilic Esophagitis Endoscopic Reference Score. Immunohistochemical analysis and changes in tryptase, EDN, and eotaxin-3 levels were associated with histologic and endoscopic improvements. CONCLUSIONS: EoE incidence considerably increased during the 12-year period, regardless of endoscopic esophageal biopsy rate. Tryptase, EDN, and eotaxin-3 levels in esophageal biopsy specimens could be promising biomarkers for disease activity, symptom, and endoscopic response in Korea.

Multicenter Prospective Study of Laparoscopic Nissen Fundoplication for Gastroesophageal Reflux Disease in Korea

BACKGROUNDS/AIMS: This multicenter study aims to evaluate the effect and feasibility of anti-reflux surgery compared with medical treatment for gastroesophageal reflux disease (GERD). METHODS: Patients with GERD who were undergoing medical treatment with proton pump inhibitors for more than 8 weeks and those who were scheduled to undergo anti-reflux surgery were enrolled. Efficacy of pre-operative medical treatment was evaluated retrospectively and effect of anti-reflux surgery was prospectively evaluated at 1 week and 3 months after surgery. Quality of life (QOL) was also investigated before and after surgery. RESULTS: Between February and October 2018, 51 patients underwent laparoscopic Nissen fundoplication for treating GERD at 5 hospitals in Korea. Thirty-four patients (66.7%) showed poor proton pump inhibitor response. At 3 months after surgery, heartburn was completely resolved in 87.9% patients and partially improved in 9.1%. Acid regurgitation was completely resolved in 82.9% and partially improved in 11.4%. Atypical extraesophageal symptoms were completely controlled in 45.5% and partially controlled in 36.4%. GERD-related QOL scores at 1 week after surgery significantly improved compared with pre-operative scores. There was no difference in GERD-related QOL scores between 1 week and 3 months after surgery. General QOL measured with European QOL-5 dimensions and health-related QOL instrument with 8 items significantly improved after anti-reflux surgery. Satisfaction with treatment was significantly higher after surgery than before surgery (72.5% vs 11.8%, P < 0.001). CONCLUSION: Anti-reflux surgery improved GERD symptoms and QOL in patients. Anti-reflux surgery is an effective treatment option compared with medical treatment for GERD patients selected for surgical treatment.

Efficacy and Safety of AlbisD Compared With Omeprazole 20 mg in Patients With Non-erosive Reflux Disease: A Randomized, Open-label, Active-controlled, Pilot Study

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.

The Clinical Efficacy of a Pure Alginate Formulation (Lamina G) for Controlling Symptoms in Individuals with Reflux Symptoms: A Randomized Clinical Study

BACKGROUND/AIMS: Bicarbonate-containing alginate formulations are reported to be effective for controlling reflux symptoms. However, the efficacy of Lamina G alginate without gas production has not been reported. The aim is to evaluate the efficacy of a non-bicarbonate alginate in individuals with reflux symptoms without reflux esophagitis. METHODS: Participants who had experienced heartburn or regurgitation for 7 consecutive days were randomized to one of the following treatment groups: proton pump inhibitors (PPI) plus alginate (combination) or PPI plus placebo (PPI only). In addition, as a reference group, patients received placebo plus alginate (alginate only). The primary endpoint compared the percentage of patients with complete resolution of symptoms for the final 7 days of the treatment. Secondary endpoints compared changes in symptom score, symptom-free days during the treatment period, the Reflux Disease Questionnaire, Patient Assessment of Upper Gastrointestinal Disorders (PAGI)-Quality of Life and PAGI-Symptoms Severity Index scores, the investigator's assessment of symptoms, and incidence of adverse events. RESULTS: Complete resolution of heartburn or regurgitation was not significantly different between the combination and PPI only groups (58.7% vs 57.5%, p=0.903). The secondary endpoints were not significantly different between the two groups. Complete resolution of heartburn or regurgitation, did not differ between the alginate only reference group and the PPI only group (75.0% vs 57.5%, p=0.146). CONCLUSIONS: The addition of non-bicarbonate alginate to PPI was no more effective than PPI alone in controlling reflux symptoms.

Cough related to swallowing in asthma patients

BACKGROUND: Occurrence of cough during swallowing is common among asthma patients, but has not been investigated in detail. OBJECTIVE: We conducted an observational study to determine the prevalence of swallowing-related cough (SRC) and its characteristics in asthma patients. METHODS: Asthma patients attending our outpatient department between May 2005 and April 2007 were interviewed to investigate if they had ever experienced SRC, as well as postnasal drip or heartburn and cough related to these conditions. RESULTS: Among 417 patients who completed the questionnaire, 121 patients (29.0%) had experienced SRC. Spicy and sour foods were the most frequent tussigenic foods, causing cough in 76.0% and 53.7% of the 121 patients, respectively. In patients without SRC, the prevalence rates of postnasal drip and postnasal drip-induced cough were 35.8% (106 of 296) and 7.8% (23 of 296), respectively. The corresponding prevalence rates in patients with SRC were 50.4% (61 of 121) and 37.2% (45 of 121), which were both significantly higher than in patients without cough (p = 0.006 and p < 0.001 respectively). In patients without SRC, the prevalence rates of heartburn and heartburn-induced cough were 22.2% (66 of 296) and 2.4% (7 of 296), respectively. The corresponding prevalence rates in patients with SRC were 45.5% (55 of 121) and 16.5% (20 of 121), with both being significantly higher than in patients without cough (p = 0.002 and p < 0.001, respectively). CONCLUSION: SRC was frequent in asthma patients, and was closely related to postnasal drip and heartburn. Irritable larynx is one of the possible underlying mechanisms of SRC. This study was registered with the University Hospital Medical Information Network clinical trials registry (registration number: UMIN000017426).

Thoracic Splenosis after Splenic and Diaphragmatic Injury / 대한흉부외과학회지

Thoracic splenosis is a rare disease that develops as a result of autotransplantation of splenic tissue into the thoracic cavity following splenic and diaphragmatic injury. We report the case of a 53-year-old man with a chief complaint of heartburn and cough. He had a history of traumatic diaphragmatic rupture treated with surgical repair and splenectomy 15 years ago. Imaging studies revealed a paraesophageal mass, and surgical resection was performed considering the possibility of Castleman disease or an esophageal submucosal tumor. Pathologic results showed findings of normal splenic tissue. The patient was discharged on postoperative day 5 without any complications.

The Gastroesophageal Reflux Disease Questionnaire in Adolescents: What Is the Best Cutoff Score? / 대한소아소화기영양학회지

BACKGROUND: A self-assessment questionnaire, the GERD-Questionnaire (GERD-Q) was used to determine the prevalence of GERD in adolescents, describe the related factors, and determine the impact on quality of life (QoL). METHODS: The incidence of GERD was evaluated using the GERD-Q in adolescents aged 12–18 years. The Pediatric Gastroesophageal Reflux Disease Symptom Questionnaire and Quality of Life Questionnaire (PGSQ-A) for adolescents were additionally administered. Some factors considered related to GERD were also evaluated. RESULTS: The 520 adolescents were included. The prevalence of suspected GERD, according to a GERD-Q cutoff score of ≥7 was 32.9%, and those drinking soda were 1.7 times more likely to have GERD (95% confidence interval, 1.3–2.2; p<0.001). However, soda consumption was not a risk factor for development of GERD symptoms. Applying a cutoff score of ≥8, only 10.9% of the participants had a positive GERD score, but the association with soda consumption persisted. The median PGSQ-A score in subjects suspected of GERD was 8 (range 0–37) on weekends and 1 (range 0–17) during weekdays (p<0.001) compared to those not suspected of GERD, with a median of 2 (range 0–27) during weekends and 0 (range 0–10) during weekdays. Heartburn, regurgitation, and extraesophageal symptoms correlated significantly with QoL (p<0.001). CONCLUSION: The prevalence of suspected GERD in adolescents was 32.9% or 10.9%, depending on the cutoff score used. There was a statistically significant difference in PGSQ-A scores between the subjects suspected or not of GERD, indicating an impaired QoL.

Eficacia diagnóstica de la impedancia basal nocturna media, un nuevo parámetro para el estudio de la enfermedad por reflujo gastroesofágico / Diagnostic efficacy of mean nocturnal basal impedance, a new parameter for the study of gastroesophageal reflux disease

Resumen Introducción y objetivos: el análisis de la impedancia basal nocturna media (IBNM) se ha propuesto para incrementar la precisión diagnóstica de enfermedad por reflujo erosiva (ERGE). Nuestro objetivo fue evaluar el rendimiento diagnóstico de esta prueba en un grupo de pacientes con ERGE conocida. Materiales y métodos: incluimos 123 individuos (58 con ERGE y 65 controles sanos) a quienes se les realizó pH-impedanciometría (pH-IMM) consecutiva entre enero de 2015 y junio de 2017. Todos los pacientes tenían endoscopia tomada en los 6 meses previos. El tiempo de exposición ácida (TEA) anormal (>4,2%) y la presencia de pirosis y/o regurgitación en los 6 meses previos fueron los criterios para el diagnóstico de ERGE. Se encontraron 58 pacientes con ERGE, 24 con enfermedad por reflujo erosiva (ERE) y 34 con enfermedad por reflujo no erosiva (ERNE). Los 65 restantes fueron controles sanos (CS) asintomáticos con EGD y pH-IMM normales. Todos los trazos de pH-IMM se reanalizaron para medir la IBNM por un segundo observador que desconocía los datos previos. El análisis estadístico incluyó pruebas múltiples de Bonferroni para comparar los grupos; regresión lineal para variables continuas; y análisis de curva ROC para buscar valor IBNM con mayor rendimiento. Para los diferentes parámetros de precisión diagnóstica se utilizó el punto de corte de la IBNM. Se usó significancia estadística con valor de p <0,01 e intervalos de confianza de 95% (IC 95%) para todos los cálculos. Resultados: los pacientes con ERE y ERNE presentaron valores de IBNM significativamente más bajos que el grupo control (p <0,01). Se observó una correlación negativa entre los valores de la IBNM y TEA (r = 0,59; p = <0,001), y también entre la IBNM y número de eventos de reflujo (r = 0,37; p = <0,001). En el análisis de curva ROC, el área bajo la curva de la IBNM fue de 0,941 (IC 95%: 0,894-0,987) y el punto de corte con mayor eficiencia 1102 ohms (sensibilidad 98,5%; especificidad 84,5%). Usando este valor (<1,102), la IBNM tuvo una sensibilidad para detectar ERGE de 91% (ERNE 86% y ERE 100%) y una especificidad de 98%. Conclusión: la IBNM tiene alta sensibilidad y especificidad para el diagnóstico de la ERGE. Adicionar esta prueba al análisis convencional de la pH-impedancia y a los métodos actuales de estudio de la ERGE puede mejorar significativamente nuestra capacidad para diagnosticar la enfermedad.

Abstract Introduction and Objectives: Analysis of nocturnal basal impedance (IBNM) has been proposed as a way to increase accuracy of GERD diagnosis. Our objective was to evaluate the diagnostic performance of this test in a group of patients known to have GERD. Materials and methods: We included 123 individuals: 58 with GERD and 65 healthy controls. They underwent consecutive pH-impedance monitoring between January 2015 and June 2017. All had undergone endoscopy in the 6 months prior to testing. Criteria used for diagnosis of GERD were abnormal acid exposure time (AET > 4.2%), pyrosis and/or regurgitation in the previous 6 months. We found 58 patients with GERD of whom 24 had erosive reflux disease (ERE) and 34 had non-erosive reflux disease (NERD). The remaining 65 were asymptomatic healthy controls with normal endoscopic results and pH impedance monitoring. A second observer who did not know the previous data measurements analyzed all pH impedance monitoring traces for IBMN. Statistical analysis included multiple Bonferroni tests for comparison between groups, linear regression for continuous variables, and receiver operating characteristic (ROC) curve analysis to find high performance IBNM values. The IBNM cutoff point was used for diagnostic precision parameters. Statistical significance was set at p <0.01, and 95% confidence intervals were used for all calculations. Results: IBNM measures were significantly lower for patients with ERE and NERD than for the control group (p <0.01). A negative correlation was observed between IBNM and acid exposure time values ​​(r = 0.59, p = <0.001) and also between IBNM and number of reflux events (r = 0.37, p = <0.001). ROC curve analysis found that the area under the curve for IBNM was 0.941 (95% CI: 0.894-0.987), and the cutoff point with the highest efficiency was 1,102 ohms (sensitivity 98.5%, specificity 84.5%). Using this value (<1.102), the IBNM had a sensitivity for detecting GERD of 91% (NERD 86% and ERE 100%) and a specificity of 98%. Conclusion: IBNM has high sensitivity and specificity for diagnosis of GERD. Addition of this test to conventional pH-impedance analysis and current methods for studying GERD can significantly improve our ability to diagnose this disease.

Doença ulcerosa péptica: realmente é possível identificá-la por meio das características da dor epigástrica? / Peptic ulcer disease: is it really possible to identify it through the characteristics of epigastric pain?

OBJETIVO: Determinar se características da dor epigástrica são capazes de identificar pacientes com doença ulcerosa péptica. MÉTODOS: Estudo caso-controle, com coleta de dados de setembro de 2014 a junho de 2016. Foram incluídos pacientes com mais de 18 anos com dispepsia que realizaram endoscopia digestiva alta ambulatorialmente. Os pacientes foram abordados antes de realizar a endoscopia digestiva alta, verificando, em suas guias, a presença de dispepsia, tendo sido convidados a responder um questionário, e, posteriormente, o prontuário de cada entrevistado foi avaliado para verificação do diagnóstico, sendo, então, divididos entre o Grupo Doença Ulcerosa Péptica (casos), com 32 pacientes, e o Grupo Controle, com 44 pacientes com dispepsia atribuída a outras causas. RESULTADOS: Dos pacientes com dispepsia não ulcerosa, 52,27% caracterizaram a dor como em queimação, sendo 47,72% moderada e que piorava com alimentação. Dentre os demais sintomas, 45,45% relataram náuseas e 25% desconforto pós-prandial, com 52,27% relatando histórico familiar negativo de doença ulcerosa péptica. Em contrapartida, dos pacientes com doença ulcerosa péptica, 53,12% referiram dor em queimação e de moderada intensidade, e 50% relataram piora com alimentação. Dentre os demais sintomas, prevaleceram também náuseas (53,12%) e desconforto pós-prandial (40,62%). A maioria (81,25%) relatou histórico familiar de doença ulcerosa péptica. Observou-se diferença estatística em dor noturna, predominando na doença ulcerosa péptica (p=0,0225) e dor em cólica na dispepsia não ulcerosa (p=0,0308), assim como na ausência de histórico familiar entre os pacientes com dispepsia não ulcerosa (p=0,0195). CONCLUSÃO: A dispepsia relacionada à doença ulcerosa péptica relaciona-se, principalmente, à piora noturna, sendo que a intensidade da dor, a relação com alimentação e os sintomas associados não auxiliaram na diferenciação da dispepsia não ulcerosa, diferentemente do que a literatura tradicionalmente informa. (AU)

To determine whether it is possible to identify Peptic Ulcer Disease through the characteristics of epigastric pain. METHODS: This is a case-control study with data collected between September 2014 and June 2016 including patients over 18 years of age with dyspepsia who underwent upper gastrointestinal endoscopy as outpatients. The patients were approached before the upper gastrointestinal endoscopy when their test requisition form indicated the presence of dyspepsia. The subjects were invited to answer a questionnaire and, afterwards, the records of all interviewees were evaluated to check for the diagnosis. Then, they were divided into a peptic ulcer disease group (cases), with 32 patients, and a control group, with 44 patients with dyspepsia from other causes. RESULTS: Among non-ulcer dyspepsia patients, 52.27% described the pain as a "burning pain", with 47.72% reporting it as moderate and aggravated by food intake. As for other symptoms, 45.45% of subjects reported nausea, and 25% reported postprandial discomfort; 52.27% had no family history of peptic ulcer disease. In contrast, 53.12% of peptic ulcer disease patients reported "burning" and moderate pain, and 50% said the pain was aggravated by eating. As for the other symptoms, nausea (53.12%) and postprandial discomfort (40.62%) prevailed; most of the patients (81.25%) had family history of peptic ulcer disease. There was a statistical difference in night pain, which was more prevalent in peptic ulcer disease (p=0.0225), and colicky pain, which was more frequent in nonulcer dyspepsia (p=0.0308), as well as absence of family history in non-ulcer dyspepsia patients (p=0.0195). CONCLUSION: Dyspepsia caused by peptic ulcer disease is mainly related to night worsening, and pain intensity, the relationship with food intake, and associated symptoms did not help differentiate nonulcer dyspepsia, differently from what the medical literature traditionally suggests. (AU)

Analysis of Relationship between Reflux Symptom Index and Psychiatric Problems / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: This study investigated the relationship between reflux symptom index (RSI) and psychiatric problems such as depression, somatization, and anxiety. SUBJECTS AND METHOD: We prospectively analyzed 231 patients with symptoms with laryngopharyngeal reflux (LPR) using the RSI and the reflux finding score. RESULTS: Seventy nine patients (34.2%) were diagnosed with LPR. A significant correlation was detected between the RSI and depression (18.4±8.3 vs. 12.3±7.0, p < 0.001), anxiety (19.5±8.5 vs. 13.0±7.3, p < 0.001), and somatization (19.2±9.1 vs. 13.6±7.5, p < 0.001). A multivariate analysis confirmed a significant association between heartburn and depression [odds ratio (OR): 1.241, 95% confidence interval (CI): 1.003–1.537, p=0.047], choking and anxiety (OR: 1.747, 95% CI: 1.297–2.352, p < 0.001), and choking and somatization (OR: 1.707, 95% CI: 1.248–2.336, p=0.001). CONCLUSION: Our preliminary results suggest that patients with high RSI may need to be carefully evaluated for psychiatric problems.

Prevalence of Eosinophilic Esophagitis in Adult Patients with Upper Gastrointestinal Symptoms in a Locality in Upper Egypt

BACKGROUND/AIMS: Eosinophilic esophagitis (EoE) is gaining importance in the diagnosis of upper gastrointestinal (UGI) symptoms. Diagnosis is based on the clinical presentation of esophageal dysfunction and pathological findings in the absence of other causes of tissue eosinophilia. Our study was designed to evaluate EoE prevalence in patients with UGI symptoms in our locality (El-Minia, Egypt). METHODS: This single-center, cross-sectional study recruited all patients with UGI symptoms who agreed for endoscopic evaluation. Esophageal biopsy samples were obtained and histological evaluation for the presence of eosinophils was performed for every patient. EoE was defined when at least 15 eosinophils were present in a single high-power field, in the absence of other causes of esophageal eosinophilia. RESULTS: Between 2013 and 2015, 218 of 476 adult patients with UGI symptoms underwent upper endoscopy after giving consent. Among the 218 patients, only 4 (1.87%) had the diagnosis of EoE based on the presence of eosinophils in esophageal biopsies and exclusion of other causes of esophageal eosinophilia. Three patients with EoE presented mainly with dysphagia (75%) and/or other UGI symptoms, such as heartburn. CONCLUSIONS: We observed a low prevalence of EoE in our locality. The diagnosis of EoE should be considered in patients with dysphagia and/or heartburn.

A Single-center Experience of Esophageal Eosinophilia / 대한소화기학회지

BACKGROUND/AIMS: Esophageal eosinophilia occurs in many conditions, including eosinophilic esophagitis (EoE) and proton pump inhibitor-responsive esophageal eosinophilia (PPI-REE), which have been increasingly recognized in Western countries. There have been only a few reports in Korea. Here, we evaluated the clinical and endoscopic characteristics of patients with esophageal eosinophilia from our experience. METHODS: Nineteen patients were diagnosed with esophageal eosinophilia based on typical symptoms, endoscopic features, esophageal eosinophilia with ≥15 eosinophils/high power field, and response to medication by PPI. Symptoms, endoscopic and pathological findings were evaluated. RESULTS: Of the 19 patients, 2 patients were diagnosed with EoE, 7 patients were diagnosed with PPI-REE, and 10 patients were undetermined due to loss to follow-up. Among these 19 patients, dysphagia was present in 11, and heartburn, dyspepsia and reflux in 8. Sixteen patients had common endoscopic features, such as longitudinal furrows, concentric rings, strictures, and white plaques; however, 3 patients had normal findings. Nine patients underwent endoscopy at the time of follow-up. Two patients had complete resolution, and 3 had partial resolution. However, 4 patients showed no endoscopic changes. All patients showed symptom improvements. CONCLUSIONS: The clinical and endoscopic characteristics of both groups in Korea were undistinguishable. However, after treatment, endoscopic findings were different between the two groups. Large-scale studies are warranted to confirm our findings.