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Tu1430 Functional Dyspepsia Treatment Trial (FDTT): Effect of Antidepressants on Mood Response in Functional Dyspepsia
Tu1431
Functional Dyspepsia Treatment Trial (FDTT): Effect of Antidepressants on Mood Response in Functional Dyspepsia Ann E. Almazar, Yuri A. Saito, Linda M. Herrick, Giles Locke, Ernest P. Bouras, Colin W. Howden, Brian E. Lacy, John K. DiBaise, Charlene M. Prather, Bincy Abraham, Hashem B. El-Serag, Paul Moayyedi, Lawrence A. Szarka, Frank A. Hamilton, Katherine E. Tilkes, Cathy D. Schleck, Alan R. Zinsmeister, Nicholas J. Talley
Impaired Quality of Life in Patients With Belching. Which One Are the Determining Factors ELizabeth Perez, Claudia I. Blanco, Mercedes Amieva-Balmori, Arturo Meixueiro, Jose Remes-Troche Background: The real prevalence of excessive belching in the general population is unknown. However, belching is a common symptom reported by patients with dyspepsia and/or GERD and often is associated with excessive production of gas. However, information of which conditions (dyspepsia or GERD) are associated and impact the quality of life of patients is not known. Objective: To evaluate the prevalence of belching and associated symptoms in the general population in Mexico and determine which factors are associated with poorer quality of life. Materials and Methods: This study is part of a nationwide project named "SIGAME" (acronym for "SIntomas GAstrointestinales en MExico" in Spanish, or Gastrointestinal Symptoms in Mexicans, in English) which aim is to evaluate the prevalence of gastrointestinal symptoms in a representative population of subjects that lives in Mexico. A crosssectional study was conducted; and a face to face interview using a specific web application was performed by 73 interviewers, which were residents of one of the 8 geographic regions of the country. The 8 areas are: 1) Northeast (3 states), 2) Northwest (6 states), 3) West (4 states), 4) East (4 states), 5) Central north (5 states), 6) Central south (2 states and Federal district), 7) Southeast (4 states), and 8) Southwest (3 states). An authorized Spanish version of the Rome III questionnaire and PAGI-QOL were used. Sample size was calculated to include at least 500 subjects' residents for each of the 8 geographic areas. Patients with belching were divided into four groups: patients with belching and dyspeptic symptoms (Group 1), patients with belching and heartburn (Group 2), patients with belching, dyspepsia and heartburn (Group 3); and subjects with only belching (excessive) (Group 4). Results: 3,038 questionnaires were applied and the overall prevalence of subjects with belching was 5.3% (n = 161). Patients with belching were distributed in the following way: Group 1, 22.4% (n = 36), Group 2, 21.71% (n = 35), group 3, 20.5% (n = 33), Group 4, 35.4% (n = 57). Patients in group 1 were significantly younger than the other 3 groups (p <0.05). Patients in groups 1 and 3 (where there was overlap with dyspeptic symptoms) had lower scores overall and in the 5 dimensions of PAGI-QOL (Table). Conclusions: Belching as a symptom affects 5% of our population and the most common groups was patients with excessive belching. However. The presence of overlap with dyspeptic symptoms seems to be the most important factor associated with poor quality of life.
Background: The Functional Dyspepsia Treatment Trial (FDTT) demonstrated that amitriptyline improves functional dyspepsia (FD) symptoms. However, patients with FD frequently report comorbid depression and anxiety compared to healthy controls. The FDTT utilized antidepressant doses lower than typically used to for mood disorders. The impact of lowdose antidepressants on mood scores in patients with FD is unknown. Aim: To detect changes in psychological well-being in response to antidepressant therapy in patients with FD. Methods: The FDTT was a 12-week, multi-center, randomized, double-blind, placebocontrolled trial evaluating the efficacy of antidepressants on FD symptoms. Subjects were required to meet Rome II criteria for FD and were randomized to placebo (PLA), 50 mg amitriptyline (AMI), or 10 mg escitalopram (ESC). Subjects were excluded if they were receiving current antidepressant or psychotropic therapy, undergoing psychiatric treatment, had a current history of drug or alcohol abuse, or scored 11 or greater on the Hospital Anxiety Depression Scale (HADS). Subjects completed various psychological questionnaires including the 1) Symptom Check List 90 (SCL-90), 2) Symptom Somatic Checklist (SSC), 3) HADS, 4) Profile of Mood States (POMS), 5) State Trait Anxiety Inventory (STAI). The associations of baseline characteristics with treatment group were assessed using the KruskalWallis test. Post treatment differences were assessed using ITT analyses of covariance (based on ranks) with the baseline and balancing factors as covariates. Results: There were 292 subjects randomized: mean age was 44, 219 (75%) were female, 250 (86%) were Caucasian, while 207(70%) had dysmotility-like FD and 88 (30%) had ulcer-like FD. Psychological scores at baseline and post-treatment are shown in Table 1. Baselines scores for all 5 measures were similar between the three treatment arms. After 12 weeks of treatment, no differences for any of the psychological measures between treatment arms were observed. Importantly, post-treatment scores for depression (SCL-90, HADS), anxiety (SCL-90, HADS, STAI), somatization scores (SCL-90, SSC) were not better among those receiving amitriptyline and escitalopram compared to those receiving placebo (N.S.). Although most scores decreased pre-treatment to post-treatment, no significant mood changes (neither positive, nor negative) were observed. Conclusions: 50mg amitriptyline and 10mg escitalopram were not associated with changes in psychological traits such as depression, anxiety, or somatization in patients with FD.
*p<0.05 Tu1432 Dyspeptic Symptoms and Its Impact on Quality of Life in General Population in Mexico Claudia I. Blanco, Mercedes Amieva-Balmori, Ramon Carmona Sanchez, Arturo Meixueiro, Jose Remes-Troche Background: The global prevalence of uninvestigated dyspepsia (UD) is close to 20% but varies among countries and according to the criteria used to define its presence. The basic Mexican diet include corn, beans chili peppers, herbs and a lot of spices and a usually thinking is that Mexican diet induce more dyspeptic symptoms. In Mexico, some studies have reported that prevalence of UD range from 7% to 15.0%. Objective: Determine the prevalence of dyspeptic symptoms in Mexico and evaluate their impact on the quality of life of patients. Material and Methods: This study is part of a nationwide project named "SIGAME" (acronym for "SIntomas GAstrointestinales en MExico" in Spanish, or Gastrointestinal Symptoms in Mexicans, in English) which aim is to evaluate the prevalence of gastrointestinal symptoms in a representative population of subjects that lives in Mexico. A crosssectional study was conducted; and a face to face interview using a specific web application was performed by 73 interviewers, which were residents of one of the 8 geographic regions of the country. The 8 areas are: 1) Northeast (3 states), 2) Northwest (6 states), 3) West (4 states), 4) East (4 states), 5) Central north (5 states), 6) Central south (2 states and Federal district), 7) Southeast (4 states), and 8) Southwest (3 states). An authorized Spanish version of the Rome III questionnaire, PAGI SYM and PAGI-QOL were used. For this study, in the absence of alarm data subjects were classified as functional dyspepsia (FD) and divided into two categories: Postprandial distress syndrome (PD) and epigastric pain syndrome (ED). A group of healthy controls (n=1625) was used as controls. Results: 3,038 questionnaires were applied. 10% (303) had dyspeptic symptoms of which 68.6% (208) were women. The most common type of dyspepsia was ED with 57.8% (175) of the cases, followed by PD with 34.7% (105) and 7.6% (23) has overlap. When comparing the control group versus dyspeptic subjetcs, we found differences being more prevalent dyspepsia in higher education levels (45.2% vs 29.4%, p = 0.006) and in females (57.1% vs 68.6%, p = 0.003). Dyspeptic patients had lower scores in all components of PAGI-QOL than controls (p <0.0001). There were no demographic differences between subjects with PD and ED. When comparing subgroups (ED versus PD) we found a statistically significant difference in the daily activities score (74.40 ± 18.53 vs 82.21 ± 15.72, p <0.001) . However, overall, subjects who had
SCL-90= Symptom Check List 90, SSC=Symptom Somatic Checklist, HADS=Hospital Anxiety and Depression Scale, POMS= Profile of Mood States, STAI= State Trait Anxiety Inventory § Kruskal-Walli test for Baseline. ITT analyses (based on ranks) using ANCOVA for post
S-889
AGA Abstracts
AGA Abstracts
Tu1430
Functional Dyspepsia Treatment Trial (FDTT): Effect of Antidepressants on Mood Response in Functional Dyspepsia Ann E. Almazar, Yuri A. Saito, Linda M. Herrick, Giles Locke, Ernest P. Bouras, Colin W. Howden, Brian E. Lacy, John K. DiBaise, Charlene M. Prather, Bincy Abraham, Hashem B. El-Serag, Paul Moayyedi, Lawrence A. Szarka, Frank A. Hamilton, Katherine E. Tilkes, Cathy D. Schleck, Alan R. Zinsmeister, Nicholas J. Talley
Impaired Quality of Life in Patients With Belching. Which One Are the Determining Factors ELizabeth Perez, Claudia I. Blanco, Mercedes Amieva-Balmori, Arturo Meixueiro, Jose Remes-Troche Background: The real prevalence of excessive belching in the general population is unknown. However, belching is a common symptom reported by patients with dyspepsia and/or GERD and often is associated with excessive production of gas. However, information of which conditions (dyspepsia or GERD) are associated and impact the quality of life of patients is not known. Objective: To evaluate the prevalence of belching and associated symptoms in the general population in Mexico and determine which factors are associated with poorer quality of life. Materials and Methods: This study is part of a nationwide project named "SIGAME" (acronym for "SIntomas GAstrointestinales en MExico" in Spanish, or Gastrointestinal Symptoms in Mexicans, in English) which aim is to evaluate the prevalence of gastrointestinal symptoms in a representative population of subjects that lives in Mexico. A crosssectional study was conducted; and a face to face interview using a specific web application was performed by 73 interviewers, which were residents of one of the 8 geographic regions of the country. The 8 areas are: 1) Northeast (3 states), 2) Northwest (6 states), 3) West (4 states), 4) East (4 states), 5) Central north (5 states), 6) Central south (2 states and Federal district), 7) Southeast (4 states), and 8) Southwest (3 states). An authorized Spanish version of the Rome III questionnaire and PAGI-QOL were used. Sample size was calculated to include at least 500 subjects' residents for each of the 8 geographic areas. Patients with belching were divided into four groups: patients with belching and dyspeptic symptoms (Group 1), patients with belching and heartburn (Group 2), patients with belching, dyspepsia and heartburn (Group 3); and subjects with only belching (excessive) (Group 4). Results: 3,038 questionnaires were applied and the overall prevalence of subjects with belching was 5.3% (n = 161). Patients with belching were distributed in the following way: Group 1, 22.4% (n = 36), Group 2, 21.71% (n = 35), group 3, 20.5% (n = 33), Group 4, 35.4% (n = 57). Patients in group 1 were significantly younger than the other 3 groups (p <0.05). Patients in groups 1 and 3 (where there was overlap with dyspeptic symptoms) had lower scores overall and in the 5 dimensions of PAGI-QOL (Table). Conclusions: Belching as a symptom affects 5% of our population and the most common groups was patients with excessive belching. However. The presence of overlap with dyspeptic symptoms seems to be the most important factor associated with poor quality of life.
Background: The Functional Dyspepsia Treatment Trial (FDTT) demonstrated that amitriptyline improves functional dyspepsia (FD) symptoms. However, patients with FD frequently report comorbid depression and anxiety compared to healthy controls. The FDTT utilized antidepressant doses lower than typically used to for mood disorders. The impact of lowdose antidepressants on mood scores in patients with FD is unknown. Aim: To detect changes in psychological well-being in response to antidepressant therapy in patients with FD. Methods: The FDTT was a 12-week, multi-center, randomized, double-blind, placebocontrolled trial evaluating the efficacy of antidepressants on FD symptoms. Subjects were required to meet Rome II criteria for FD and were randomized to placebo (PLA), 50 mg amitriptyline (AMI), or 10 mg escitalopram (ESC). Subjects were excluded if they were receiving current antidepressant or psychotropic therapy, undergoing psychiatric treatment, had a current history of drug or alcohol abuse, or scored 11 or greater on the Hospital Anxiety Depression Scale (HADS). Subjects completed various psychological questionnaires including the 1) Symptom Check List 90 (SCL-90), 2) Symptom Somatic Checklist (SSC), 3) HADS, 4) Profile of Mood States (POMS), 5) State Trait Anxiety Inventory (STAI). The associations of baseline characteristics with treatment group were assessed using the KruskalWallis test. Post treatment differences were assessed using ITT analyses of covariance (based on ranks) with the baseline and balancing factors as covariates. Results: There were 292 subjects randomized: mean age was 44, 219 (75%) were female, 250 (86%) were Caucasian, while 207(70%) had dysmotility-like FD and 88 (30%) had ulcer-like FD. Psychological scores at baseline and post-treatment are shown in Table 1. Baselines scores for all 5 measures were similar between the three treatment arms. After 12 weeks of treatment, no differences for any of the psychological measures between treatment arms were observed. Importantly, post-treatment scores for depression (SCL-90, HADS), anxiety (SCL-90, HADS, STAI), somatization scores (SCL-90, SSC) were not better among those receiving amitriptyline and escitalopram compared to those receiving placebo (N.S.). Although most scores decreased pre-treatment to post-treatment, no significant mood changes (neither positive, nor negative) were observed. Conclusions: 50mg amitriptyline and 10mg escitalopram were not associated with changes in psychological traits such as depression, anxiety, or somatization in patients with FD.
*p<0.05 Tu1432 Dyspeptic Symptoms and Its Impact on Quality of Life in General Population in Mexico Claudia I. Blanco, Mercedes Amieva-Balmori, Ramon Carmona Sanchez, Arturo Meixueiro, Jose Remes-Troche Background: The global prevalence of uninvestigated dyspepsia (UD) is close to 20% but varies among countries and according to the criteria used to define its presence. The basic Mexican diet include corn, beans chili peppers, herbs and a lot of spices and a usually thinking is that Mexican diet induce more dyspeptic symptoms. In Mexico, some studies have reported that prevalence of UD range from 7% to 15.0%. Objective: Determine the prevalence of dyspeptic symptoms in Mexico and evaluate their impact on the quality of life of patients. Material and Methods: This study is part of a nationwide project named "SIGAME" (acronym for "SIntomas GAstrointestinales en MExico" in Spanish, or Gastrointestinal Symptoms in Mexicans, in English) which aim is to evaluate the prevalence of gastrointestinal symptoms in a representative population of subjects that lives in Mexico. A crosssectional study was conducted; and a face to face interview using a specific web application was performed by 73 interviewers, which were residents of one of the 8 geographic regions of the country. The 8 areas are: 1) Northeast (3 states), 2) Northwest (6 states), 3) West (4 states), 4) East (4 states), 5) Central north (5 states), 6) Central south (2 states and Federal district), 7) Southeast (4 states), and 8) Southwest (3 states). An authorized Spanish version of the Rome III questionnaire, PAGI SYM and PAGI-QOL were used. For this study, in the absence of alarm data subjects were classified as functional dyspepsia (FD) and divided into two categories: Postprandial distress syndrome (PD) and epigastric pain syndrome (ED). A group of healthy controls (n=1625) was used as controls. Results: 3,038 questionnaires were applied. 10% (303) had dyspeptic symptoms of which 68.6% (208) were women. The most common type of dyspepsia was ED with 57.8% (175) of the cases, followed by PD with 34.7% (105) and 7.6% (23) has overlap. When comparing the control group versus dyspeptic subjetcs, we found differences being more prevalent dyspepsia in higher education levels (45.2% vs 29.4%, p = 0.006) and in females (57.1% vs 68.6%, p = 0.003). Dyspeptic patients had lower scores in all components of PAGI-QOL than controls (p <0.0001). There were no demographic differences between subjects with PD and ED. When comparing subgroups (ED versus PD) we found a statistically significant difference in the daily activities score (74.40 ± 18.53 vs 82.21 ± 15.72, p <0.001) . However, overall, subjects who had
SCL-90= Symptom Check List 90, SSC=Symptom Somatic Checklist, HADS=Hospital Anxiety and Depression Scale, POMS= Profile of Mood States, STAI= State Trait Anxiety Inventory § Kruskal-Walli test for Baseline. ITT analyses (based on ranks) using ANCOVA for post
S-889
AGA Abstracts
AGA Abstracts
Tu1430