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S1075 One Week Acid Suppression Trial of Rabeprazole, Lansoprazole and Omeprazole in the Treatment of Functional Dyspepsia with or Without Heartburn: A Randomized Controlled Trial
NERD and control groups but was significantly higher in the FD group (FD: NERD: control= 0.26±0.12: 0.22±0.1: 0.22±0.1 mmHg●s-1; P<0.05). Discussion In this study of responses to a gastric air insufflation stimulus, the time to threshold was shorter in FD and NERD patients than healthy controls, suggesting visceral hypersensitivity. The initial gradient was also high, indicating impaired fundal relaxation. These results demonstrate that visceral hypersensitivity and impaired fundal relaxation are characteristic of FD and NERD as seen from the gastric side using this method. The only difference observed between the FD and NERD groups was compliance of the entire stomach. Gastric tension was confirmed to be stronger in the FD group than the NERD group, suggesting a difference in gastric function between the two groups. S1075 One Week Acid Suppression Trial of Rabeprazole, Lansoprazole and Omeprazole in the Treatment of Functional Dyspepsia with or Without Heartburn: A Randomized Controlled Trial Ryoichi Nishiki, Hajime Kuwayama Aims: Earlier studies have reported that the symptomatic response to proton pump inhibitors (PPIs) was greatest in patients with functional dyspepsia (FD) with reflux and ulcer-like syndrome, but undetectable in those with dysmotility-like symptoms. Symptomatic improvement with PPI therapy in FD patients was seen only in those with heartburn. In this study, we compared the efficacy of therapy with 3 PPIs for 1 week in subjects with FD with or without heartburn. Methods: We randomly assigned 87 subjects with FD (age 55.3±15.9 years, male/female 37/50) to treatment with either rabeprazole 20 mg daily (RPZ n=27), lansoprazole 30 mg daily (LPZ n=23), omeprazole 20 mg (OPZ n=21), or a non acid suppressive agent 1 g daily as control (Cont n=16) for 1 week. EPS was defined as ‘burning' or ‘epigastric pain', and PDS as ‘postprandial fullness', ‘upper abdominal bloating' or ‘postprandial nausea' related to meals. Subjects recorded symptom score(0-4 points) in a diary. Heartburn was recognized using a structured questionnaire. Results: 1. EPS scores decreased significantly from day 1 with all PPIs, with no significant differences seen between the 3 PPIs. 2. A significant difference in PDS was observed from day 1, with a greater improvement with RPZ (1.2±0.2) than with LPZ (2.2±0.4, P=0.04) and OPZ (2.4±0.5, P=0.02). 3. EPS and PDS improvement rates on day 7 were higher in subjects with heartburn than in those without heartburn. No difference in EPS improvement rates was seen between PPIs in subjects with or without heartburn. PDS improvement rates on day 7 in subjects with heartburn were higher with RPZ (65.2±10.7%) than with LPZ (45.5±16.2%, P=0.004), and higher with LPZ than with OPZ (30.6±16.3%, P=0.05). However, no significant differences were seen between the 3 PPIs in PDS improvement rates in subjects without heartburn. Conclusions: Significant differences were seen between the effect of PPIs in PDS, but not in EPS. The influence of the effect on heartburn by PPIs effect was detected in both EPS and PDS. Differences between PPIs were seen in PDS in subjects with heartburn.
S1073 How the Subgroups in Functional Dyspepsia Affect the Quality of Life and Therapeutic Approaches. Experience from Japanese Mega Study (JMMS) Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, Kei Matsueda, Motoyasu Kusano, Nobuyoshi Hanyuu, Chikashi Shibata The subgroups differentiated by symptom (Sx) categories by Rome III may affect therapeutic response, however, the knowledge for these are limited. To study this concern, we analyzed the characteristics of the patients enrolled to clinical trials for dyspeptic patients conducted in Japan, Japan Mosapride Mega-Study (JMMS). A total of 618 patients having feeling of gastrifc stasis Sxs (GSS) and/or epigastric pain Sxs (EPS) with negative endoscopy were allocated to two treatment groups; mosapride (5HT4 agonist) 5mg tid and teprenon (gastric mucosa protectant) 50mg tid. Each group had pharmacotherapy for 2 weeks. [Methods] GSS and EPS were evaluated as Sx scores (SS); by the severity (0-3) and the frequency (03). Patients were classified into 3 groups; GSS as SS for GSS > 2 (n=294), EPS as SS for EPS > 2 (n=90) and Mixed as SS for both GSS and EPS > 2. (n=152). The responder rates with mosapride and with teprenon in each subgroup were compared. The responder criterions were defined as (I) satisfactory relief of GSS and/or EPS (patients' impression with “much improved” or “improved”), and (II) at least a 50% decrease in total (GSS SS + EPS SS). [Results] Distribution of age, gender were statistically similar each other. Total SS scores in GSS, EPS and Mix were 3.7, 3.8 and 6.2*, respectively (* p<0.0001 vs. GSS and EPS). The QOL assessed by SF-36 was statistically different; GSS > Mix in all domain, GSS > EPS and EPS > Mix in some domains (p<0.05). Reduction in total SS were 2.5, 2.1 and 4.0 with mosapride, and 1.6, 2.1 and 2.6 with teprenon in GSS, EPS and Mix, respectively. Reductions in GSS SS were 2.0 and 2.0 with mosapride, and 1.4 and 1.3 with teprenon in GSS and Mix, respectively. Reductions in EPS SS were 1.9 and 2.0 with mosapride, and 1.7 and 1.3 with teprenon in EPS and Mix, respectively. Significant difference between mosapride and teprenon was found in GSS and Mix (p<0.0001). In criterion (I), responder rate was 63, 73 and 57% with mosapride, and 22, 32 and 38% with tepurenon in GSS, EPS and Mix, respectively, and in criterion (II), responder rate was 75, 65 and 72% with mosapride, and 42, 57 and 47% with tepurenon in GSS, EPS and Mix, respectively. Significant difference between mosapride and teprenon was found in GSS, EPS and Mix (I), and in GSS and Mix (II) (p<0.0001). [Conclusion] In Mix, they had higher total SS and lower QOL than in GSS and EPS, this implies more serious impact on daily life exist in Mix. The therapeutic responses were different by subgroups, the efficacy of mosapride was superior to teprenon in GSS and Mix, while which was limited in EPS. Altered or combination treatment may be required in EPS.
S1076 How the Gender Difference Affect the Therapeutic Approaches for the Dyspeptic Patients. Experience from Japanese Mega Study (JMMS) Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, Kei Matsueda, Motoyasu Kusano, Nobuyoshi Hanyuu, Chikashi Shibata There are some sex difference in some FGID in their pathophysiology and responses to medical interventions. Little is known on sex and age differences in functional dyspepsia (FD) in medical interventions, especially in the subgroups of FD. [Aim] To investigate sex differences in response to pharmacotherapy in patients with functional dyspepsia. [Subjects & Methods] A total of 1027 uninvestigated dyspepsia patients were endoscoped after informed consent. After endoscopies, 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 generation (n=90) or voluntary decline (n=55). A total of 618 patients participated to pharmacological intervention either with mosapride 5 mg tid or teprenon 50 mg tid. 243 male patients and 293 female patients completed the study. Distribution of dominant symptoms, either gastric stasis symptom or epigastric pain symptom or both, were not different between male and female patients. Mean age, symptom scores for two symptoms with a sum of intensity and frequency (both 0 to 3) and health-related QOL in SF-36 were not different between the sex. Therapeutic responses were evaluated by; HR-QOL, patients' impression, and responder rate, defines as reduction of symptom scores >50% or patients' impression with improved or better. [Results] Male to female ratio among the patients with symptom resolution after endoscpies was 1:1.9. Male to female ratio who had pharmacotreatment was 1:1.2. Mosapride treatment improved all scales both in male and female. Therapeutic gain is bigger in male than female in all scales. In teprenon treatment, therapeutic gain is bigger in female than male in all parameters (p<0.05). [Summary] Though the therapeutic effect of mosapride is found both in male and female patients, there were some differences between male and female. Mosapride is more effective in male patients and teprenon is more effective in female patients. [Conclusion] Female patients is more vulnerable assurance by negative endoscopy and pharmacotherapy to teprenon (as placebo), suggesting female patients may have more psychological influence, which reduced the effect of mosapride over teprenon.
S1074 Characteristics of Response to Intragastric Pressure (IGP) Measurement Following Air Insufflation in Patients with Functional Dyspepsia (FD) and Patients with Non-Erosive Gastroesophageal Reflux Disease (NERD) Tsuyoshi Suzuki, Fumitaka Kira, Shuji Nishimura, Yuki Suyama Aims We previously measured changes in IGP following air insufflation during gastroscopy, thereby assessing visceral perception and gastric tone (Gastroenterology 2007;132(4): A373). In this study, we used the same method to compare responses to a gastric distension stimulus caused by air insufflation in patients with FD, patients with NERD and healthy subjects. Subjects The subjects were 38 FD patients (9 male, 29 female; average age, 50 years), 25 NERD patients (16 male, 9 female; average age, 51 years) and 34 healthy volunteers (9 male, 25 female; average age, 56 years). Methods During endoscopic examination (no anticholinergic premedication), air was insufflated at 20 mL●s-1, and changes in IGP were measured over time. The parameters calculated were basal IGP (mmHg), IGP at symptom appearance (ie, threshold pressure, mmHg), time to threshold pressure (s), rate of increase in IGP (initial gradient, mmHg●s-1; 0-5 mmHg gradient), and IGP gradient up to threshold pressure (hereafter gastric tone, mmHg●s-1). Results 1) The initial gradient was significantly higher in the FD and NERD groups than the control group (FD: NERD: control (mean±SD)= 0.56±0.42: 0.50±0.38: 0.34±0.18 mmHg●s-1; P<0.05). Time to threshold pressure was significantly shorter in the FD and NERD groups than the control group (FD: NERD: control= 45.6±20.2: 53.5±13.9: 66.5±19.3 s; P<0.05). 2) There was no significant difference between groups in basal IGP (FD: NERD: control=14.4±3.0: 13.4±6.0: 12.7±2.9 mmHg), or threshold pressure (25.8±5.7:24.9±7.8:26.6±3.9 mmHg). Gastric tone was almost equivalent in the
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AGA Abstracts
Significant findings were defined as erosive esophagitis, stricture, Barrett's esophagus, PUD, active gastritis, dysplasia, or cancer. Results: The 1010 identified cases had a mean age of 50 ± 14 and included 618 (61%) women, 549 (54%) Hispanics, 283 (28%) Asians, 68 (7%) Blacks, and 55 (5%) Whites. Significant esophageal pathology (EP) was uncovered in 186 (18%) individuals and significant gastric pathology (GP) in 114 (11%), including PUD in 35 (3.5%). More men had EP than women (22% vs 16%; p=0.008). However, women born in the US were more likely to have EP than those who immigrated to the US (36% vs 14%; p=0.004). Hispanic women were more likely to have EP than non-Hispanics (17% vs 11%; p=0.046). Men had more GP than women (15% vs 9%; p=0.001). Blacks were more likely to have GP than non-Blacks (21% vs 11%; p=0.013), including a higher rate of PUD (8.8% vs 3.2%; p=0.03), despite no difference in H. pylori prevalence (47% vs 45%; p=0.47). Asians were also more likely to have GP than non-Asians (17% vs 9%; p<0.001), despite no difference in H. pylori prevalence (43% vs 48%; p=0.47). In particular, Asian men were more likely to have GP than non-Asian men (22% vs 12%; p=0.008). Overall, men were significantly more likely to have both EP and GP than women (35% vs 23%; p<0.001). In multivariate logistic regression analysis controlling for age, H. pylori status, ethnicity, and country of birth, male gender remained a significant predictor of esophageal pathology (OR 2.0 CI 1.2-3.2; p=0.006). In a similar multivariate logistic regression model, both male gender (OR 1.8 CI 1.0-3.0; p=0.049) and Asian ethnicity (OR 2.8 CI 1.5-5.2; p=0.001) remained significant predictors of gastric pathology. Conclusion: In this ethnically diverse cohort with dyspepsia, EGD revealed significant pathology independent of H. pylori status. Male gender and Asian ethnicity remained significant independent predictors for pathology. Further studies assessing predictors of endoscopic findings in ethnically diverse cohorts are warranted.
S1073 How the Subgroups in Functional Dyspepsia Affect the Quality of Life and Therapeutic Approaches. Experience from Japanese Mega Study (JMMS) Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, Kei Matsueda, Motoyasu Kusano, Nobuyoshi Hanyuu, Chikashi Shibata The subgroups differentiated by symptom (Sx) categories by Rome III may affect therapeutic response, however, the knowledge for these are limited. To study this concern, we analyzed the characteristics of the patients enrolled to clinical trials for dyspeptic patients conducted in Japan, Japan Mosapride Mega-Study (JMMS). A total of 618 patients having feeling of gastrifc stasis Sxs (GSS) and/or epigastric pain Sxs (EPS) with negative endoscopy were allocated to two treatment groups; mosapride (5HT4 agonist) 5mg tid and teprenon (gastric mucosa protectant) 50mg tid. Each group had pharmacotherapy for 2 weeks. [Methods] GSS and EPS were evaluated as Sx scores (SS); by the severity (0-3) and the frequency (03). Patients were classified into 3 groups; GSS as SS for GSS > 2 (n=294), EPS as SS for EPS > 2 (n=90) and Mixed as SS for both GSS and EPS > 2. (n=152). The responder rates with mosapride and with teprenon in each subgroup were compared. The responder criterions were defined as (I) satisfactory relief of GSS and/or EPS (patients' impression with “much improved” or “improved”), and (II) at least a 50% decrease in total (GSS SS + EPS SS). [Results] Distribution of age, gender were statistically similar each other. Total SS scores in GSS, EPS and Mix were 3.7, 3.8 and 6.2*, respectively (* p<0.0001 vs. GSS and EPS). The QOL assessed by SF-36 was statistically different; GSS > Mix in all domain, GSS > EPS and EPS > Mix in some domains (p<0.05). Reduction in total SS were 2.5, 2.1 and 4.0 with mosapride, and 1.6, 2.1 and 2.6 with teprenon in GSS, EPS and Mix, respectively. Reductions in GSS SS were 2.0 and 2.0 with mosapride, and 1.4 and 1.3 with teprenon in GSS and Mix, respectively. Reductions in EPS SS were 1.9 and 2.0 with mosapride, and 1.7 and 1.3 with teprenon in EPS and Mix, respectively. Significant difference between mosapride and teprenon was found in GSS and Mix (p<0.0001). In criterion (I), responder rate was 63, 73 and 57% with mosapride, and 22, 32 and 38% with tepurenon in GSS, EPS and Mix, respectively, and in criterion (II), responder rate was 75, 65 and 72% with mosapride, and 42, 57 and 47% with tepurenon in GSS, EPS and Mix, respectively. Significant difference between mosapride and teprenon was found in GSS, EPS and Mix (I), and in GSS and Mix (II) (p<0.0001). [Conclusion] In Mix, they had higher total SS and lower QOL than in GSS and EPS, this implies more serious impact on daily life exist in Mix. The therapeutic responses were different by subgroups, the efficacy of mosapride was superior to teprenon in GSS and Mix, while which was limited in EPS. Altered or combination treatment may be required in EPS.
S1076 How the Gender Difference Affect the Therapeutic Approaches for the Dyspeptic Patients. Experience from Japanese Mega Study (JMMS) Koji Nakada, Michio Hongo, Shigeru Harasawa, Tetsuya Mine, Iwao Sasaki, Kei Matsueda, Motoyasu Kusano, Nobuyoshi Hanyuu, Chikashi Shibata There are some sex difference in some FGID in their pathophysiology and responses to medical interventions. Little is known on sex and age differences in functional dyspepsia (FD) in medical interventions, especially in the subgroups of FD. [Aim] To investigate sex differences in response to pharmacotherapy in patients with functional dyspepsia. [Subjects & Methods] A total of 1027 uninvestigated dyspepsia patients were endoscoped after informed consent. After endoscopies, 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 generation (n=90) or voluntary decline (n=55). A total of 618 patients participated to pharmacological intervention either with mosapride 5 mg tid or teprenon 50 mg tid. 243 male patients and 293 female patients completed the study. Distribution of dominant symptoms, either gastric stasis symptom or epigastric pain symptom or both, were not different between male and female patients. Mean age, symptom scores for two symptoms with a sum of intensity and frequency (both 0 to 3) and health-related QOL in SF-36 were not different between the sex. Therapeutic responses were evaluated by; HR-QOL, patients' impression, and responder rate, defines as reduction of symptom scores >50% or patients' impression with improved or better. [Results] Male to female ratio among the patients with symptom resolution after endoscpies was 1:1.9. Male to female ratio who had pharmacotreatment was 1:1.2. Mosapride treatment improved all scales both in male and female. Therapeutic gain is bigger in male than female in all scales. In teprenon treatment, therapeutic gain is bigger in female than male in all parameters (p<0.05). [Summary] Though the therapeutic effect of mosapride is found both in male and female patients, there were some differences between male and female. Mosapride is more effective in male patients and teprenon is more effective in female patients. [Conclusion] Female patients is more vulnerable assurance by negative endoscopy and pharmacotherapy to teprenon (as placebo), suggesting female patients may have more psychological influence, which reduced the effect of mosapride over teprenon.
S1074 Characteristics of Response to Intragastric Pressure (IGP) Measurement Following Air Insufflation in Patients with Functional Dyspepsia (FD) and Patients with Non-Erosive Gastroesophageal Reflux Disease (NERD) Tsuyoshi Suzuki, Fumitaka Kira, Shuji Nishimura, Yuki Suyama Aims We previously measured changes in IGP following air insufflation during gastroscopy, thereby assessing visceral perception and gastric tone (Gastroenterology 2007;132(4): A373). In this study, we used the same method to compare responses to a gastric distension stimulus caused by air insufflation in patients with FD, patients with NERD and healthy subjects. Subjects The subjects were 38 FD patients (9 male, 29 female; average age, 50 years), 25 NERD patients (16 male, 9 female; average age, 51 years) and 34 healthy volunteers (9 male, 25 female; average age, 56 years). Methods During endoscopic examination (no anticholinergic premedication), air was insufflated at 20 mL●s-1, and changes in IGP were measured over time. The parameters calculated were basal IGP (mmHg), IGP at symptom appearance (ie, threshold pressure, mmHg), time to threshold pressure (s), rate of increase in IGP (initial gradient, mmHg●s-1; 0-5 mmHg gradient), and IGP gradient up to threshold pressure (hereafter gastric tone, mmHg●s-1). Results 1) The initial gradient was significantly higher in the FD and NERD groups than the control group (FD: NERD: control (mean±SD)= 0.56±0.42: 0.50±0.38: 0.34±0.18 mmHg●s-1; P<0.05). Time to threshold pressure was significantly shorter in the FD and NERD groups than the control group (FD: NERD: control= 45.6±20.2: 53.5±13.9: 66.5±19.3 s; P<0.05). 2) There was no significant difference between groups in basal IGP (FD: NERD: control=14.4±3.0: 13.4±6.0: 12.7±2.9 mmHg), or threshold pressure (25.8±5.7:24.9±7.8:26.6±3.9 mmHg). Gastric tone was almost equivalent in the
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AGA Abstracts
AGA Abstracts
Significant findings were defined as erosive esophagitis, stricture, Barrett's esophagus, PUD, active gastritis, dysplasia, or cancer. Results: The 1010 identified cases had a mean age of 50 ± 14 and included 618 (61%) women, 549 (54%) Hispanics, 283 (28%) Asians, 68 (7%) Blacks, and 55 (5%) Whites. Significant esophageal pathology (EP) was uncovered in 186 (18%) individuals and significant gastric pathology (GP) in 114 (11%), including PUD in 35 (3.5%). More men had EP than women (22% vs 16%; p=0.008). However, women born in the US were more likely to have EP than those who immigrated to the US (36% vs 14%; p=0.004). Hispanic women were more likely to have EP than non-Hispanics (17% vs 11%; p=0.046). Men had more GP than women (15% vs 9%; p=0.001). Blacks were more likely to have GP than non-Blacks (21% vs 11%; p=0.013), including a higher rate of PUD (8.8% vs 3.2%; p=0.03), despite no difference in H. pylori prevalence (47% vs 45%; p=0.47). Asians were also more likely to have GP than non-Asians (17% vs 9%; p<0.001), despite no difference in H. pylori prevalence (43% vs 48%; p=0.47). In particular, Asian men were more likely to have GP than non-Asian men (22% vs 12%; p=0.008). Overall, men were significantly more likely to have both EP and GP than women (35% vs 23%; p<0.001). In multivariate logistic regression analysis controlling for age, H. pylori status, ethnicity, and country of birth, male gender remained a significant predictor of esophageal pathology (OR 2.0 CI 1.2-3.2; p=0.006). In a similar multivariate logistic regression model, both male gender (OR 1.8 CI 1.0-3.0; p=0.049) and Asian ethnicity (OR 2.8 CI 1.5-5.2; p=0.001) remained significant predictors of gastric pathology. Conclusion: In this ethnically diverse cohort with dyspepsia, EGD revealed significant pathology independent of H. pylori status. Male gender and Asian ethnicity remained significant independent predictors for pathology. Further studies assessing predictors of endoscopic findings in ethnically diverse cohorts are warranted.