asthma), were reported by 37 of the patients (53%). Fourteen patients (20%) had elevated specific IgE levels in serum for common food and inhalant allergens and 4 patients (6%) had elevated total IgE levels. Neither elevated IgE levels, total or specific, nor a history of atopic disease were correlated with food-related symptoms. Conclusion: The severity of food-related GI symptoms in IBS seems to be more related to poor quality of life and high symptom burden in general, than to the presence of atopic disease. However, further investigations evaluating the relevance of local allergic factors in the gut for food-related symptoms in IBS are warranted.
M1343 A Prospective Comparative Study of Quality of Life (QOL) in Patients With Fecal Incontinence, Constipation, Mixed Symptoms and Healthy Controls Bhavya Akhauri, Pauline Day, Carrie Phillips, Ashok Attaluri, Jessica Valestin, Carl K. Brown, Satish S. Rao Background: QOL has been reported to be impaired in patients with bowel disorders, but whether some domains are more affected in one group is not known. Also, there has been no comparative assessment of these features between patients with common defecation disorders. Aims: To prospectively assess the QOL in subjects with chronic constipation, fecal incontinence, and a mixed group - incontinence and constipation and compare these traits between the three groups as well as with healthy controls. Methods: We surveyed subjects with constipation (Rome III), fecal incontinence (>1 episode/week), mixed symptoms and healthy controls. All subjects completed a standard SF-36 questionnaire, one week stool diary, and disease specific questionnaires. The impact of QOL was analyzed for 8 domains and data were compared using ANOVA, Dunnett's and Tukey Kramer adjusted probabilities. Results: We enrolled 531 subjects, of whom 278 had constipation (m/f=33/245 mean age= 43), 154 had fecal incontinence m/f=19/135, mean age=62), 24 had mixed symptoms (m/ f= 4/20, mean age= 51), and 75 healthy controls (m/f=17/58, mean age=35). All three groups of patients had significantly lower (p<0.03) QOL as assessed by each of the 8 domains when compared to healthy controls [Table, mean ± SEM, * = p<0.03 vs. controls; # = p≤0.03 incontinence vs. constipation], except for mental health (incontinence). QOL domains tended to be lower with increasing BMI and was significant (p =0.015) for physical function. Although many domains were equally affected in all 3 groups, physical function was more impaired in incontinence group compared to constipation (p=0.03) and bodily pain more impaired in the constipated group compared to incontinence (p=0.003). Conclusions: This large prospective study shows significant and severe impairment of QOL in patients with chronic constipation, fecal incontinence and those with mixed symptoms. The mean difference in domain scores were >20 compared to healthy subjects. Bodily pain and physical functioning differed between patient groups. QOL issues should be inquired and addressed in order to provide optimal health care for these patients.
M1341 Characterization and Comparison of Patients Versus Non-Patients With Functional Bowel Symptoms in the General Population. Tamar Ringel-Kulka, Danielle M. Maier, Olafur S. Palsson, Yehuda Ringel Functional bowel (FB) symptoms are highly prevalent in the general population. However it is estimated that about 75% of individuals with IBS symptoms do not seek medical care and are referred to as “non-patients”. The available data on non-patients is limited and the difference between patients and non-patients with FB symptoms has not been adequately investigated. Aim: To characterize and compare demographics, psychosocial and clinical data between FB patients and non-patient subjects with FB symptoms. Methods: Subjects who met the Rome III criteria for one of the FB disorders and had active mild-to-moderate FB symptoms (by IBS-SS scale) were investigated. Non-patients were defined as subjects who did not see a physician or took prescribed medications for their GI symptoms. All subjects were recruited from the general population by advertising. Validated questionnaires were used to collect demographics, psychosocial (Beck Depression Inventory, IBS-QOL) and clinical (abdominal pain/discomfort, bloating/distention, bowel frequency, stool consistency, other GI symptoms) variables. Subjects were specifically asked about their satisfaction with bowel habits, satisfaction with current treatments, effects of stress on symptoms, impact of symptoms on everyday life, physician visits, and hospitalizations. Results: A total of 172 subjects (n=61 patients; n=111 non-patients) were investigated. Study population included 68% females, 74% white, mean age 36 years, 49% married, and 61% had a college degree or higher. There was a significantly higher female ratio in the non-patients group (p=0.02) but no other differences in demographic variables between the groups. Compared to FB patients, non-patients had significantly less days with abdominal pain (p<0.0001), less severe abdominal pain (p<0.0001), less severe bloating/distention (p<0.0001) and they were more satisfied with their bowel habits (p=0.022). Non-patients reported significantly less physicians' visits (p<0.001) and hospitalizations (p<0.0001), and better QOL (p<0.0001). Nonpatients were also less likely to participate in any type of treatments (p<0.0001). However, there were no significant differences in depression scores, perceived effect of stress on health, and satisfaction with current treatments between the patients and non-patients groups. Conclusions: Clinical variables rather than demographic and psychosocial factors differentiate FB patients from non-patients with FB symptoms in the general population. Education and non-prescribed treatment to reduce severity of symptoms may reduce healthcare utilization. Supported by grants DK07562 (YR), M01RR00046 and UL1RR025747 M1342 Pain Associated With Irritable Bowel Syndrome is a Major Unmet Need Among IBS Sufferers Daniel W. Gil, Rozalina Dimitrova, Simon Daggett, Peter Sissins, Wayne Lam, John E. Donello
M1344 Comparison of GI Symptom Survey Between Electronic Survey and Mail Survey in Japan (JFGID Survey) Michio Hongo, Tsutomu Chiba, Shigeru Harasawa, Ken Haruma, Kei Matsueda, Hiroto Miwa, Kentaro Sugano, Naomi Uemura
Pain is an important symptom in Irritable Bowel Syndrome (IBS) which predicts illness severity, health related quality of life and physician visits (1). However, there is relatively little data on the pain experience and use of medication for pain in IBS patients. Objective: Quantify the pain experience and unmet need of IBS patients. Methods: An internet quantitative questionnaire utilized the National Health and Wellness Survey panel to characterize pain and other symptoms of IBS, healthcare use, medication use, attitudes about pain medications and demographics. Respondents who were either self-identified or diagnosed with IBS were screened to ensure they met the ROME III IBS diagnostic criteria. In order to validate patient recall, the questionnaire ratings were compared to 2-week baseline pain ratings from a recent IBS clinical trial in which Rome III+ IBS patients rated their daily pain severity on a 0-10 numeric rating scale using electronic diaries (ediary). Results: 22% out of 2,736 questionnaire respondents met Rome criteria (n=602; mean age 48.2; 73% female). In 43%, pain is the most bothersome symptom of IBS and approximately half completely or somewhat agree that without the pain, their bowel problems would not bother them so much. 18% of sufferers have continuous pain, 35% have pain at least 4 days per week and 72% have pain >1 day per week. This compares with the IBS clinical trial in which 18% and 55% of 283 female patients experienced average pain severity of 4 or more on >6 and >4 days per week, respectively. 35% of the clinical trial subjects had a mean daily average pain score >5 over the 14-day baseline. Sufferers in the survey have pain on average more than half the year. The pain associated with an IBS event typically lasts for more than an hour in 38% of sufferers and lasts 30 minutes to 1 hour in 28%. Pain severity ranges from 6.5 at its worst to 5.3 on average to 3.2 at its least severe (0-10 scale). Only about a third of surveyed sufferers currently use prescription or over-the-counter medication for pain and of those utilizing medications only 23% are satisfied. Willingness to take a daily chronic pain medication is high (>47%) across all sufferers relatively independent of how frequently they suffer pain. Conclusions: Pain associated with IBS is the most bothersome symptom. Approximately half the IBS sufferers have moderate to severe pain the majority of the time with similar results obtained by survey or ediary. Receptivity to new treatments specific to the treatment of pain associated with IBS is high. Reference: 1. Drossman DA, Chang L, Schneck S, Blackman C, Norton WF, Norton NJ. Dig Dis Sci. 2009; 54(7):1532-41.
Epidemiological study on GI symptoms can be conducted in various ways. Electronic survey using internet might be simple and rapid, with a lack of responding rate, while paper survey using postal mail might be slow with a data of responding rate. Cost for the survey is much cheaper in electronic survey with no printing cost nor postal charges. However, reliability of the data obtained in electronic survey is not clear. [Aim] We explored the difference of electronic survey and mail survey studies in the characteristics of the epidemiologic data of GI symptoms. [Method] GI symptom survey questionnaires were sent to the registered panel subjects; one to the internet registered group, and one to the mail survey group. Subjects were selected according to the age, gender, and residential areas, to become homogenous, for both studies. Those who have reflux symptoms, dyspeptic symptoms, and abnormal bowel movement with abdominal symptoms, twice or more in a month were classifies as GERD, FD and IBS, respectively. [Results] Responses to the electronic survey and to mail survey were 2125 and 11020, respectively. Age and gender distribution were similar in both groups. Those who have any of the symptoms of GERD, FD or IBS were 47.3% in net survey and 24.8% in mail survey. Proportion of subtypes among the symptomatic subjects were similar for GERD and IBS, and less in mail survey for GERD symptoms. Proportion of subtype overlap was similar for FD & IBS, but other combination of overlaps, namely overlap with GERD symptoms, were lower in mail survey. [Conclusion] Electronic survey showed higher prevalence of specific symptoms than mail survey, suggesting selection bias. However, proportion of symptom subtypes are similar for FD and IBS. GERD subjects seems to show some kind of interest for this kind of survey. Electronic survey shows biased data, but some of the characteristics of the respondents seems to be common to mail survey. Electronic survey might be useful for epidemiological survey of GI symptoms under certain condition, with some limitations. Proportion of symptom subtypes among the symptomatic subjects
OBJECTIVE: Irritable Bowel syndrome (IBS) is a common gastrointestinal disease and found in 10-31% of Japanese. Several studies report that IBS have negative impact on Health related quality of Life (HR-QOL) compared with other chronic diseases. However, the prevalence, risk factors and impact on HR-QOL of IBS in general population has not been well established. The purpose of this study was to examine the prevalence and risk factor of IBS in the general population, and impact on HR-QOL compared with health controls. METHOD: We performed a cross-sectional study of Japanese workers who visited a clinic for a routine health check-up, and asked them to fill out a self-report questionnaire including age, gender, height, weight, smoking and drinking habit, past history, presence of allergic diseases (athma, atopy, allergic rhinitis, eczema and pollinosis), key questions based on ROME III for IBS diagnosis and SF-8 to access HR-QOL. A logistic regression model was used to identify risk factors for IBS. RESULT: IBS was found in 367 (13.5%) of 2717 eligible subjects; 79 had IBS with constipation (IBS-C); 102 had IBS with diarrhea (IBS-D); 89 had mixed IBS (IBS-M); 97 had unsubtyped IBS (IBS-U). Subjects with IBS were significant younger, female dominant, had lower BMI, and higher presence of allergic diseases compared with controls. IBS was significantly associated with younger age [OR=1.16, 95%CI 1.061.26], female [OR=1.67, 95%CI 1.31-2.12], lower BMI [OR=1.05, 95%CI 1.01-1.09], allergic disease [OR= 2.16, 95%CI 1.33-3.53] by multivariate logistic regression analyses. IBS-C was notably associated with younger age [OR=1.23, 95%CI 1.03-1.49] and female [OR= 3.63, 95%CI 2.17-6.05], IBS-D with lower BMI [OR=1.09, 95%CI 1.01-1.16], IBS-M with female [OR=1.79, 95%CI 1.14-2.83] and allergy [OR=3.45, 95%CI 1.64-7.23] and IBS-U with younger age [OR=1.23, 95%CI 1.05-1.47] and female [OR=2.05, 95%CI 0.32-3.27]. IBS sufferers reported significantly poorer HR-QOL across all domains compared with controls. CONCLUSION: The prevalence of IBS in Japanese general population is high. IBS worsened HR-QOL and is associated with younger age, female, lower BMI and allergic diseases. There are several differences of risk factors among IBS subtypes.
numbers of proportion include other overlaps. M1345 Assessing Treatment Response in Chronic Constipation Clinical Trials: Concepts Elicited Through Qualitative Interviews With Patients Sheri Fehnel, Claire Ervin, Steven J. Shiff, Jeffrey M. Johnston, Caroline B. Kurtz, Robyn T. Carson INTRODUCTION The assessment of treatment response in CC trials has historically focused on bowel symptoms; however, the FDA guidance on patient reported outcome (PRO) measures recommends that selection of appropriate endpoints for clinical trials be based upon direct patient input obtained through open-ended patient interviews or focus groups. AIMS and METHODS The study aimed to identify a comprehensive set of CC symptoms important to patients and optimal terminology to measure those symptoms. Twenty-eight in-depth qualitative interviews were conducted in two geographic locations in patients meeting modified Rome II criteria for CC. A semi-structured interview guide was used, beginning with a series of open-ended questions to ascertain all relevant symptoms. Participants were subsequently probed to identify their most bothersome CC symptoms as well as other symptoms not mentioned spontaneously. RESULTS Patients spontaneously reported bowel symptoms including infrequent stools (28/28), hard stools (22/28) straining (20/28), unsuccessful attempts to have a BM (18/28), stools too small or too large (18/28), and incomplete BMs (13/28). In addition, patients frequently reported abdominal symptoms including bloating (22/28), abdominal pain (22/28), abdominal discomfort (15/28), stomach pains/aches (14/28), abdominal cramping (13/28), and feeling of fullness/feeling stuffed (13/ 28). Other symptoms elicited were predominantly the consequence of severe bowel or abdominal symptoms. For example, patients reported rectal pain, hemorrhoids, and rectal bleeding secondary to straining and hard stools. The symptoms reported most frequently by patients as their most bothersome included bloating, rectal pain, infrequent BMs, and abdominal pain. CONCLUSIONS This study is the first published report of symptoms spontaneously identified by CC patients through open-ended interviews using the methods outlined in FDA's guidance on PROs. Although patients identified a wide variety of symptoms, symptom assessment in a clinical trial should be focused on the most relevant symptoms reported by patients. These interview results suggest that in addition to bowel symptoms, abdominal symptoms are important and bothersome to CC patients and should be considered for inclusion in the assessment of treatment response in CC clinical trials.
M1348 Prevalence of Overlaps Between Gastroesophageal Reflux Disease, Functional Dyspepsia and Irritable Bowel Syndrome and Impact on Health-Related Quality of Life Makiko Kaji, Yasuhiro Fujiwara, Yukie Kohata, Hirohisa Machida, Hirotoshi Okazaki, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Kazunari Tominaga, Tetsuo Arakawa OBJECTIVE: Gastroesophageal reflux disease (GERD), functional dyspepsia (FD), and irritable bowel syndrome (IBS) are common gastrointestinal diseases, and have negative impacts on health-related quality of life (HR-QOL). Several studies demonstrated a significant overlap between two of these three diseases. However, the prevalence of overlaps among the three diseases (GERD, FD, and IBS) and their risk factors in the general population have not been well established. Specifically, there has been no study based on Rome III criteria. The purpose of this study was to examine the prevalence of GERD, FD, and IBS, their overlap rates, their risk factors, and HR-QOL for each disease and each overlap compared with healthy controls in the Japanese general population. METHODS: We performed a cross-sectional study of Japanese workers who visited a clinic for a routine health check-up, and asked them to fill out a self-report questionnaire. Prevalence and overlap rate of GERD defined as heartburn and/or acid regurgitation at least weekly, FD and IBS based on Rome III criteria, and HRQOL by SF-8 were examined. RESULTS: Of the 2,680 eligible subjects, 207 (7.7%) were diagnosed as having GERD, 269 (10.0%) as FD, and 381 (14.2%) as IBS. FD and IBS, but not GERD, were significantly younger and female predominant compared with control. Of the 2,680 subjects, 668 subjects (25.7%) had at least one disease of GERD, FD, or IBS. Of those, no overlap (one disease only) was found in 508 (76.0%) subjects, and overlaps were found in 160 (24.0%). There were no differences in gender or age between the not overlapping and overlapping groups. Prevalence of overlaps in subjects with IBS (34.3%) was significantly lower compared with those among GERD (46.9%) or FD (47.6%). The common risk factor of each overlaps were smoking [GERD+FD+IBS: OR=4.08, 95% CI 1.66-10.07]. GERD, FD, or IBS sufferers reported significantly poorer HR-QOL across all domains compared with controls. Overlaps significantly worsened HR-QOL in most domains except in the role emotional. HR-QOL was particularly poor in the physical component summary for overlapping GERD and in the mental component summary for overlapping IBS. CONCLUSIONS: Overlaps among GERD, FD and IBS were common and worsened HR-QOL in Japanese general population. The common risk factor of overlaps were smoking.
M1346 High Prevalence of Lower Gastrointestinal (GI) Symptoms in Functional Dyspepsia: A Factor and Cluster Analysis in the General Population Hidekazu Suzuki, Juntaro Matsuzaki, Keiko Asakura, Yasushi Fukushima, Yoshimasa Saito, Toru Takebayashi, Toshifumi Hibi Background. Dyspepsia and lower GI symptoms such as diarrhea and constipation are common conditions that often coexist. A recent meta-analysis reported the prevalence of irritable bowel syndrome (IBS) among subjects of dyspepsia was 37% compared with 7% in those without dyspepsia (Odds Ratio 8.00 for IBS in subjects with dyspepsia. Clin. Gastroenterol. Hepatol. 2009). However, the association between dyspepsia and lower GI symptoms has not been fully examined in the general population. The aim of this study was to determine the prevalence and overlap of dyspepsia and lower GI symptoms in Japanese population. Methods. Web interview questionnaires comprised of Gastrointestinal Symptom Rating Scale (GSRS), Rome III criteria of functional dyspepsia (FD), and demographic information were sent to 177,615 subjects (20-75 years old) registered for clinical trial programs in Tokyo Station Center Building Clinic with informed consent. FD was diagnosed by the presence of ≥ 3 months postprandial fullness, early satiety, epigastric pain, or epigastric burning without structural disease based on Rome III. Results. 8,039 subjects (male 3,463; female 4,576; mean age 40.8) completed the survey. 1,403 met criteria for uninvestigated dyspepsia; among these, 563 met criteria for FD. Factor analysis revealed a three-component structure with factors of upper GI symptoms (Factor-EGD), diarrheal symptoms (Factor-D) and constipation symptoms (Factor-C). Since gastroesophageal reflux (GER) symptoms were highly correlated with Factor-EGD, GER symptoms could not be separated as independent factor. According to the cluster analysis based on the results of Factor analysis, 8,039 subjects were categorized in 3 major clusters: cluster 1 associated with Factor-D, cluster 2 associated with Factor-C, and cluster 3 associated neither with Factor-D nor with Factor-C. FD subjects were distributed 33.0% to cluster 1, 28.4% to cluster 2 and 38.5% to cluster 3. Multivariable logistic regression analysis revealed that older age (p<0.01) was associated with FD in cluster 1, older age (p<0.001) and lower BMI (p<0.01) was associated with FD in cluster 2, and older age (p<0.05), female gender (p<0.05), and higher alcohol consumption (p<0.001) was associated with FD in cluster 3. FD symptom was significantly stronger in cluster 1 and 2 than in cluster 3 (p<0.001), suggesting that FD with lower GI symptoms would have more severe dyspeptic symptoms. Conclusions. FD highly overlapped with the lower GI symptoms such as diarrhea or constipation. Such FD subjects with lower GI symptoms have stronger symptoms for FD. Subjects with FD also had almost complete overlap with subjects with GER symptoms.
M1349 ROME II Versus ROME III; Impact on Subtyping and Prevalence of Psychiatric Co-Morbidity in Irritable Bowel Syndrome (IBS) Orla F. Craig, Timothy G. Dinan, Fergus Shanahan, Eamonn M. Quigley Background: The Rome II criteria sub-typed IBS on the basis of reported symptoms, Rome III uses stool consistency. Considerable data exist on various aspects of IBS, as defined by Rome II; less is known of the impact of Rome III. Aim: To determine the level of agreement between Rome II and Rome III in defining IBS subtypes and to compare psychological comorbidity amongst subtypes so defined. Methods: 160 subjects with a functional GI disorder were recruited from a specialty clinic. Each completed the Rome III diagnostic questionnaire, an abridged version of the Rome II modular questionnaire and the patient health questionnaire. IBS was defined and subclassified by Rome III criteria as IBS with constipation (IBSC), IBS with diarrhea (IBS -D), mixed IBS (IBS-M) and unsubtyped IBS (IBS-U) and by Rome II as constipation predominant IBS (CP -IBS), diarrhea predominant IBS (DP-IBS) and alternating IBS (A- IBS). Co-morbid psychiatric conditions were defined by the patient health questionnaire. Results: 118/160 subjects fulfilled Rome III criteria for diagnosis of
Differences of Risk Factors Among Irritable Bowel Syndrome Subtypes in Japanese Population Makiko Kaji, Yasuhiro Fujiwara, Yukie Kohata, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Kazunari Tominaga, Tetsuo Arakawa