1
AGA Abstracts 11.0 ± 3.8), compared to non-CC genotypes (175 patients; mean score 10.4 ± 3.3; p= 0.007). There was no association of other dyspeptic symptoms with GNB3 genotypes. CONCLUSION: These results suggest a possible influence of genetic factors on the clinical presentation of FD in Brazilian patients. GNB3 genotyping may help to identify a subset of patients with specific dyspeptic symptoms. Mo1880 Prevalence of Organic Diseases in Uninvestigated Japanese Patients With GI Symptoms in Gastroenterological Clinic: Specific Symptoms Identifying Organic Causes Machi Tsukamoto, Noriaki Manabe, Tomoari Kamada, Naohito Yamashita, Hiroaki Kusunoki, Hiroshi Matsumoto, Ken-ichi Tarumi, Akiko Shiotani, Jiro Hata, Kazuhiko Inoue, Ken Haruma Background & Aims: The prevalence of clinically significant organic diseases (CSODs) in uninvestigated adult patients complaining of gastrointestinal (GI) symptoms, and its predictability based on their symptoms, is unknown, although there have been considerable changes in the epidemiology of GI diseases in the Asia-Pacific region over the past decade. Methods: From January 2010 to December 2011, a total of 1164 consecutive patients (519 males, 645 females; mean age 52.1 years) complaining of upper GI symptoms at least several times per week were recruited. To start, all patients completed a self-administered questionnaire about their symptoms. Subsequently, blood tests, ultrasonography and endos- copy procedures were carried out to attempt to exclude organic (local, systemic or metabolic) diseases that might be responsible for the patients symptoms. CSODs were defined as diseases which would develop into serious illness without further treatment and/or would need subsequent hospital treatment. Results: There were 255 patients with CSODs (21.9%) including peptic ulcer, gastric cancer and infectious diseases. There were several differences in symptoms between CSODs and non-CSODs (Table 1). Logistic regression analysis showed that heartburn was an independent symptom associated with non-CSODs (adjusted odds ratio (aOR): 1.61; 95% CI [1.02-2.54]) while dysphagia (aOR: 1.78; 95% CI [1.13-2.79]) and stomach ache (aOR: 1.60; 95% CI [1.17-2.20]) were independent symptoms associated with CSODs. Upper abdominal bloating, chest pain and nausea were not associated with either group of disorders. Conclusion: CSODs were present in 21.9% of Japanese uninvesti- gated adult patients complaining of GI symptoms. Heartburn, dysphagia and stomachache were found to be clinically important symptoms that were found to discriminate CSODs from non-CSODs. Further studies are needed in other centers in Japan to determine if our findings are generalizable. Differences in symptoms between CSODs and non- CSODs Mo1881 Onset of Action and Efficiency of STW 5 in the Clinical Setting in Patients With Functional Dyspepsia and Irritable Bowel Syndrome Bettina R. Vinson, Gerald Holtmann Introduction / background: STW 5 is an herbal preparation that has proven efficiency in placebo controlled trials for functional gastrointestinal disorders such as functional dyspepsia (FD) and irritable bowel syndrome (IBS). Mechanisms of action range from motility modulat- ing effects (Schemann et al., 2006), anti-nociceptive (Müller et al., 2006) and anti-inflamma- tory properties (Schempp et al., 2006). However, there are no data on the time-interval between the intake of study medication and onset of relief of symptoms. Aim: This study aimed to define time between the intake of STW5 and the onset of symptom relief in patients with functional or motility-related gastrointestinal diseases. Methods: 272 patients with functional dyspepsia, defined on basis of Rome III Criteria, were recruited by gastroenterolo- gists and GPs in private practice. Patients were treated for three weeks. The overall effect of treatment was measured utilizing the validated GIS. This instrument captures the intensity of 10 symptoms. In addition, the onset of a relevant symptom improvement was assessed after each dose, for duration of 8 days. Onset of relevant effect was documented by patients with a diary card by marking the moment of clearly perceptible global symptom improvement after intake. Furthermore, patients had to assess the general severity of symptoms on a 100- mm VAS scale 1, 5, 15, 30, 60 and 120 minutes after each single dose of STW 5. Results: As early as five minutes after the first dose of STW5 patients reported a detectable improvement of symptoms. In the course of the two-hour follow-up period most patients observed a clinically relevant reduction of the predominant gastrointestinal complaints within the time range of 15 to 30 minutes. During the 3 week treatment the average GIS score dropped from 12.5 ± 6.10 to 3.5 ± 3.84 points at end of therapy. No adverse effects were observed in this cohort of patients. Conclusion: This open-label study shows a clinically relevant improvement of symptoms as early as 15-30 minutes after intake of the medication. The rapid onset that is suggested by this study requires confirmation in properly controlled blinded studies. However, the data are consistent with effects that are observed in clinical practice. The rapid onset may suggest that the effect of STW5 is due to acute motor or sensory effects. S-682 AGA Abstracts Mo1882 Impairment of Health-Related Quality of Life (HR-QOL) in Functional Dyspepsia Might Be Based on the Mental Component of HR-QOL: Experience From Japanese Mega Study (JMMS) Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, Kei Matsueda, Motoyasu Kusano, Nobuyoshi N. Hanyu, Chikashi Shibata The impairment in health related-quality of life (HR-QOL) is common in functional dyspepsia (FD). However, the influence of patient background on HR-QOL and the effect of medical treatment on impaired HR-QOL in FD are poorly understood. Japan Mosapride Mega-Study (JMMS) showed significant symptom improvement with mosapride in FD patients. [Aim] To investigate the influence of patient background on HR-QOL and the effect of medical treatment on impaired HR-QOL in FD. [Subjects & Methods] A total of 1027 uninvestigated dyspepsia patients had screening endoscopies after informed consent. A total of 424 patients retired from the further study due to symptom resolution after assurance by negative endoscopy (n=264), any organic lesion in EGD regardless the possibility of symptom genera- tion (n=90) or voluntary decline (n=55). A total of 618 patients participated to pharmacologi- cal intervention either with mosapride 5 mg tid or teprenon 50 mg tid. Finally, 243 male patients and 293 female patients completed the study. Multiple regression analysis was conducted to examine the relationship of patient background (sex, age, symptoms duration, total symptom score [TSxS]) and HR-QOL measured by SF-36 (physical component sum- mary; PCS, mental component summary; MCS) at baseline. Therapeutic responses to HR- QOL were compared between mosapride and teprenon groups. [Results] PCS was significantly lower in older patients (Beta=.27, p ,.0001) or higher TSxS at baseline (Beta=.31, p ,.0001). MCS was significantly lower in female (Beta=.10, p ,.05) or younger patients (Beta=.13, p,.01) or longer symptom duration (Beta=.11, p ,.05) or higher TSxS at baseline (Beta= .25, p,.0001). Mosapride treatment significantly improved PCS (Cohen's d [d] =.10, p ,.05) and MCS (d=.41, p ,.0001), and teprenon treatment also improved PCS (d=.10, p ,.05) and MCS (d=.19, p ,.0001). The improvement of MCS were higher than PCS in either treatment. Therapeutic efficacy of mosapride in improving MCS is superior to teprenon (delta MCS; 4.0 and 2.0, respectively, p ,.005). [Conclusion] Prominent therapeutic effect of mosapride is reflected in MCS. Higher associations with MCS were found in female gender, younger age, severe and longer duration. Impairment of HR-QOL in dyspeptic patients seems to be based on the MCS. Mo1883 Differences on Esophageal Symptoms in Patients With Overlap of Gastroesophageal Reflux Disease and Postprandial Distress Syndrome: A Comparative Study Héctor J. Durán Arizaga, Brenda Ramos, Rosa P. Cruz Nieves, Paulina G. Briseño Sahagun, Alberto Ibarra Moedano, Nadia C. Arias Pena, Darhyana Lopez Gomez, Rodrigo I. Gonzalez Varela, Manuel J. Avendaño-Reyes, Ricardo Flores Rendon INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common disorder in Mexico. It is well known that GERD is often overlapped with functional dyspepsia.Nevertheless, only a few studies have analyzed the overlap of GERD and Postprandial distress syndrome (PDS); considering the latter could exacerbate GERD symptoms, based on the fact that delayed gastric emptying could worsen GERD. OBJECTIVES:To assess the clinical differences between subjects with GERD and those with overlap of GERD and PDS. METHODS:Prospec- tive evaluation between January-June 2012 in an open Mexican population. Subjects were interviewed by medical doctors .The standardized Gastroesophageal reflux disease question- naire (GERD-Q) was used to diagnose GERD patients,patients with 8 or more points were also submitted to ROME III questionnaire for functional dyspepsia and the PDS variant. Variables such as age, gender, anthropometric measures, comorbidities, esophageal symptoms and gastric symptoms were analyzed. The severity of symptoms was evaluated by a 7-point Likert scale.The data collected were expressed as percentage, median and standard deviation; comparisons with student's T test and chi-squared test with 95% confidence intervals were calculated, as well as a multivariate analysis. RESULTS: A total of 1004 subjects were interviewed of which 553 were studied, 275 (49.7%) had GERD and 278 had overlap of GERD and PDS.Female pts 412 (74.5%), age 41.3±13.3, BMI 29.6±6.3; 7.1% had diabetes mellitus, 29.8% had systemic arterial hypertension,179 (32.4%) with alcohol use and 70 (12.7%) reported smoking,331 pts searched medical attention, of which only 8% had gone to a gastroenterologist.Age (p= 0.02) and height (p= 0.004) were higher in subjects with just GERD, the BMI (p= 0.015) and the GERD-Q scores (p= 0.002) were higher in pts with overlap.The severity of nausea (2.4±1.5 vs 1.6±1.02), dysphagia (2.06±1.5 vs 1.56±1.0) and globus (2.29±1.65 vs 1.4±1.08) were higher in the overlap group (p ,0.001). Significant variables associated with the overlap of GERD and PDS were female gender, nausea, heart- burn, epigastric pain, belching, bloating and globus. Nevertheless, only bloating OR 1.5 (1.02-2.22, p= 0.035) and globus OR 1.7 (1.03-3.1, p= 0.037) were found to be indepen- dently associated with the overlap group, and to a lesser extent heartburn OR 0.5 (0.337- 0.743, p= 0.001) and belching OR 0.549 (0.353-0.852, p= 0.008). CONCLUSION: The overlap of symptoms in GERD and PDS often seems to worsen the reflux intensity measured by GERD Q, and is associated with troublesome esophageal symptoms such as dysphagia and globus .Although heartburn is frequent in pts with overlap ,it seems to be a less troublesome symptom and this could be due to presence of dyspepsia symptoms. Overlap of GERD and PDS symptoms is common and could alter the response to anti-reflux treatment

Mo1883 Differences on Esophageal Symptoms in Patients With Overlap of Gastroesophageal Reflux Disease and Postprandial Distress Syndrome: A Comparative Study

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Page 1: Mo1883 Differences on Esophageal Symptoms in Patients With Overlap of Gastroesophageal Reflux Disease and Postprandial Distress Syndrome: A Comparative Study

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s11.0 ± 3.8), compared to non-CC genotypes (175 patients; mean score 10.4 ± 3.3; p=0.007). There was no association of other dyspeptic symptoms with GNB3 genotypes.CONCLUSION: These results suggest a possible influence of genetic factors on the clinicalpresentation of FD in Brazilian patients. GNB3 genotyping may help to identify a subset ofpatients with specific dyspeptic symptoms.

Mo1880

Prevalence of Organic Diseases in Uninvestigated Japanese Patients With GISymptoms in Gastroenterological Clinic: Specific Symptoms IdentifyingOrganic CausesMachi Tsukamoto, Noriaki Manabe, Tomoari Kamada, Naohito Yamashita, HiroakiKusunoki, Hiroshi Matsumoto, Ken-ichi Tarumi, Akiko Shiotani, Jiro Hata, KazuhikoInoue, Ken Haruma

Background & Aims: The prevalence of clinically significant organic diseases (CSODs)in uninvestigated adult patients complaining of gastrointestinal (GI) symptoms, and itspredictability based on their symptoms, is unknown, although there have been considerablechanges in the epidemiology of GI diseases in the Asia-Pacific region over the past decade.Methods: From January 2010 to December 2011, a total of 1164 consecutive patients (519males, 645 females; mean age 52.1 years) complaining of upper GI symptoms at leastseveral times per week were recruited. To start, all patients completed a self-administeredquestionnaire about their symptoms. Subsequently, blood tests, ultrasonography and endos-copy procedures were carried out to attempt to exclude organic (local, systemic or metabolic)diseases that might be responsible for the patients symptoms. CSODs were defined as diseaseswhich would develop into serious illness without further treatment and/or would needsubsequent hospital treatment. Results: There were 255 patients with CSODs (21.9%)including peptic ulcer, gastric cancer and infectious diseases. There were several differencesin symptoms between CSODs and non-CSODs (Table 1). Logistic regression analysis showedthat heartburn was an independent symptom associated with non-CSODs (adjusted oddsratio (aOR): 1.61; 95% CI [1.02-2.54]) while dysphagia (aOR: 1.78; 95% CI [1.13-2.79])and stomach ache (aOR: 1.60; 95% CI [1.17-2.20]) were independent symptoms associatedwith CSODs. Upper abdominal bloating, chest pain and nausea were not associated witheither group of disorders. Conclusion: CSODs were present in 21.9% of Japanese uninvesti-gated adult patients complaining of GI symptoms. Heartburn, dysphagia and stomachachewere found to be clinically important symptoms that were found to discriminate CSODsfrom non-CSODs. Further studies are needed in other centers in Japan to determine if ourfindings are generalizable.Differences in symptoms between CSODs and non- CSODs

Mo1881

Onset of Action and Efficiency of STW 5 in the Clinical Setting in PatientsWith Functional Dyspepsia and Irritable Bowel SyndromeBettina R. Vinson, Gerald Holtmann

Introduction / background: STW 5 is an herbal preparation that has proven efficiency inplacebo controlled trials for functional gastrointestinal disorders such as functional dyspepsia(FD) and irritable bowel syndrome (IBS). Mechanisms of action range from motility modulat-ing effects (Schemann et al., 2006), anti-nociceptive (Müller et al., 2006) and anti-inflamma-tory properties (Schempp et al., 2006). However, there are no data on the time-intervalbetween the intake of study medication and onset of relief of symptoms. Aim: This studyaimed to define time between the intake of STW5 and the onset of symptom relief in patientswith functional or motility-related gastrointestinal diseases. Methods: 272 patients withfunctional dyspepsia, defined on basis of Rome III Criteria, were recruited by gastroenterolo-gists and GPs in private practice. Patients were treated for three weeks. The overall effectof treatment was measured utilizing the validated GIS. This instrument captures the intensityof 10 symptoms. In addition, the onset of a relevant symptom improvement was assessedafter each dose, for duration of 8 days. Onset of relevant effect was documented by patientswith a diary card by marking the moment of clearly perceptible global symptom improvementafter intake. Furthermore, patients had to assess the general severity of symptoms on a 100-mm VAS scale 1, 5, 15, 30, 60 and 120 minutes after each single dose of STW 5. Results: Asearly as fiveminutes after the first dose of STW5patients reported a detectable improvement ofsymptoms. In the course of the two-hour follow-up period most patients observed a clinicallyrelevant reduction of the predominant gastrointestinal complaints within the time range of15 to 30 minutes. During the 3 week treatment the average GIS score dropped from 12.5± 6.10 to 3.5 ± 3.84 points at end of therapy. No adverse effects were observed in thiscohort of patients. Conclusion: This open-label study shows a clinically relevant improvementof symptoms as early as 15-30 minutes after intake of the medication. The rapid onset thatis suggested by this study requires confirmation in properly controlled blinded studies.However, the data are consistent with effects that are observed in clinical practice. The rapidonset may suggest that the effect of STW5 is due to acute motor or sensory effects.

S-682AGA Abstracts

Mo1882

Impairment of Health-Related Quality of Life (HR-QOL) in FunctionalDyspepsia Might Be Based on the Mental Component of HR-QOL: ExperienceFrom Japanese Mega Study (JMMS)Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, KeiMatsueda, Motoyasu Kusano, Nobuyoshi N. Hanyu, Chikashi Shibata

The impairment in health related-quality of life (HR-QOL) is common in functional dyspepsia(FD). However, the influence of patient background on HR-QOL and the effect of medicaltreatment on impaired HR-QOL in FD are poorly understood. Japan Mosapride Mega-Study(JMMS) showed significant symptom improvement with mosapride in FD patients. [Aim]To investigate the influence of patient background on HR-QOL and the effect of medicaltreatment on impaired HR-QOL in FD. [Subjects & Methods] A total of 1027 uninvestigateddyspepsia patients had screening endoscopies after informed consent. A total of 424 patientsretired from the further study due to symptom resolution after assurance by negativeendoscopy (n=264), any organic lesion in EGD regardless the possibility of symptom genera-tion (n=90) or voluntary decline (n=55). A total of 618 patients participated to pharmacologi-cal intervention either with mosapride 5 mg tid or teprenon 50 mg tid. Finally, 243 malepatients and 293 female patients completed the study. Multiple regression analysis wasconducted to examine the relationship of patient background (sex, age, symptoms duration,total symptom score [TSxS]) and HR-QOL measured by SF-36 (physical component sum-mary; PCS, mental component summary; MCS) at baseline. Therapeutic responses to HR-QOLwere compared betweenmosapride and teprenon groups. [Results] PCSwas significantlylower in older patients (Beta=.27, p,.0001) or higher TSxS at baseline (Beta=.31, p,.0001).MCS was significantly lower in female (Beta=.10, p ,.05) or younger patients (Beta=.13,p,.01) or longer symptom duration (Beta=.11, p,.05) or higher TSxS at baseline (Beta=.25, p,.0001). Mosapride treatment significantly improved PCS (Cohen's d [d] =.10, p,.05)and MCS (d=.41, p,.0001), and teprenon treatment also improved PCS (d=.10, p ,.05)and MCS (d=.19, p,.0001). The improvement of MCS were higher than PCS in eithertreatment. Therapeutic efficacy of mosapride in improving MCS is superior to teprenon(delta MCS; 4.0 and 2.0, respectively, p,.005). [Conclusion] Prominent therapeutic effectof mosapride is reflected in MCS. Higher associations with MCS were found in femalegender, younger age, severe and longer duration. Impairment of HR-QOL in dyspepticpatients seems to be based on the MCS.

Mo1883

Differences on Esophageal Symptoms in Patients With Overlap ofGastroesophageal Reflux Disease and Postprandial Distress Syndrome: AComparative StudyHéctor J. Durán Arizaga, Brenda Ramos, Rosa P. Cruz Nieves, Paulina G. BriseñoSahagun, Alberto Ibarra Moedano, Nadia C. Arias Pena, Darhyana Lopez Gomez, RodrigoI. Gonzalez Varela, Manuel J. Avendaño-Reyes, Ricardo Flores Rendon

INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common disorder in Mexico.It is well known that GERD is often overlapped with functional dyspepsia.Nevertheless,only a few studies have analyzed the overlap of GERD and Postprandial distress syndrome(PDS); considering the latter could exacerbate GERD symptoms, based on the fact thatdelayed gastric emptying could worsen GERD. OBJECTIVES:To assess the clinical differencesbetween subjects with GERD and those with overlap of GERD and PDS. METHODS:Prospec-tive evaluation between January-June 2012 in an open Mexican population. Subjects wereinterviewed by medical doctors .The standardized Gastroesophageal reflux disease question-naire (GERD-Q) was used to diagnose GERD patients,patients with 8 or more points werealso submitted to ROME III questionnaire for functional dyspepsia and the PDS variant.Variables such as age, gender, anthropometric measures, comorbidities, esophageal symptomsand gastric symptoms were analyzed. The severity of symptoms was evaluated by a 7-pointLikert scale.The data collected were expressed as percentage, median and standard deviation;comparisons with student's T test and chi-squared test with 95% confidence intervals werecalculated, as well as a multivariate analysis. RESULTS: A total of 1004 subjects wereinterviewed of which 553 were studied, 275 (49.7%) had GERD and 278 had overlap ofGERD and PDS.Female pts 412 (74.5%), age 41.3±13.3, BMI 29.6±6.3; 7.1% had diabetesmellitus, 29.8% had systemic arterial hypertension,179 (32.4%) with alcohol use and 70(12.7%) reported smoking,331 pts searched medical attention, of which only 8% had goneto a gastroenterologist.Age (p= 0.02) and height (p= 0.004) were higher in subjects withjust GERD, the BMI (p= 0.015) and the GERD-Q scores (p= 0.002) were higher in pts withoverlap.The severity of nausea (2.4±1.5 vs 1.6±1.02), dysphagia (2.06±1.5 vs 1.56±1.0) andglobus (2.29±1.65 vs 1.4±1.08) were higher in the overlap group (p ,0.001). Significantvariables associated with the overlap of GERD and PDS were female gender, nausea, heart-burn, epigastric pain, belching, bloating and globus. Nevertheless, only bloating OR 1.5(1.02-2.22, p= 0.035) and globus OR 1.7 (1.03-3.1, p= 0.037) were found to be indepen-dently associated with the overlap group, and to a lesser extent heartburn OR 0.5 (0.337-0.743, p= 0.001) and belching OR 0.549 (0.353-0.852, p= 0.008). CONCLUSION: Theoverlap of symptoms in GERD and PDS often seems to worsen the reflux intensity measuredby GERD Q, and is associated with troublesome esophageal symptoms such as dysphagiaand globus .Although heartburn is frequent in pts with overlap ,it seems to be a lesstroublesome symptom and this could be due to presence of dyspepsia symptoms. Overlapof GERD and PDS symptoms is common and could alter the response to anti-reflux treatment