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Sa1072 Symptom Control, Quality of Life, and Treatment Satisfaction in Patients Treated With Lubiprostone vs. Other Treatments for Irritable Bowel Syndrome-Constipation (IBS-C)
food avoidance subscales were not statistically significantly different. More patients in LUB reported a positive (Agree to very strongly agree) treatment satisfaction (LUB: 92.3%; NonLUB: 71.0% satisfied; p<0.001) (Table 1). Conclusions: In this cohort of IBS-C patients with a previous inadequate response to other therapies, LUB improved patient-reported symptom control, treatment satisfaction, and HRQL. Table 1. Overall Treatment PAC-SYM, IBS-QoL, and Satisfaction Scores
AGA Abstracts
prevalence of obesity (15.2% vs. 4.7%, p=0.01). 16.5% of patients had mild to severe symptoms. Conclusions: Prevalence of GERD symptoms is similar to those reported in other countries (7.7-12.6%) and there were no differences among the 8 geographic regions of our country. GERD symptoms in Mexico are frequent independently of the geographic, diet and cultural factors. This study was supported by research grants of Asofarma Mexico Heartburn prevalence
* Adjusted results are from inverse probability of treatment weighted data, thus N differs.
Sa1071 Efficacy of Caraway Oil Poultices in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Cross-Over Trial Jost Langhorst, Romy Lauche, Anke Janzen, Rainer Lüdtke, Holger Cramer, Gustav J. Dobos
Sa1073 Intensive Treatment of Adolescent Rumination Syndrome (ARS) - Predictors of Treatment Outcome Anthony Alioto, Heather Yardley, Desale Yacob, Carlo Di Lorenzo
Background: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, with a worldwide prevalence between 5% and 20%in the general population. Caraway oil is known for its spasmolytic and carminative potential. Poultices are frequently used for self-management, but no evidence exists to support such use. This study tested the efficacy of a caraway oil poultice for treating IBS. Methods: This randomized controlled cross-over trial had three treatment periods. The intervention consisted of a hot poultice made with caraway oil; control interventions were either hot or cold poultices made with olive oil. Patients applied each intervention daily for three weeks, followed by two week ‘wash-out' phases. The primary outcome measure was symptom severity; secondary outcomes included quality of life, psychological distress and patient safety. Results: 48 patients with IBS (diarrhea predominant or alternators) were included in this study (40 females, 53.9±14.4 years). Compliance was good, with more than two thirds of patients applying the poultices as prescribed. After adjustment for expectations statistically significant difference was found in favor of the caraway poultices for symptom severity (difference -38.4; 95%CI: -73.6,3.1; p=0.033), compared to the cold, but not to the hot olive oil poultices (difference -24.3; 95%CI: -56.5,7.9; p=0.139). Response rates were significantly higher for the caraway oil, compared to the hot olive oil and cold olive oil poultices (43.9%, 20.0% and 18.9% respectively, p=0.019). Significant group differences in favor of the caraway poultices were also found for the IBS-QOL total score and subscales health worry and dysphoria, as well as the Bristol stool scale, at least for highly compliant patients. Perceived subjective benefit was highest for use of the caraway poultices. No adverse events were reported. Conclusion: The use of hot caraway poultices to treat IBS appears effective and safe, although these effects may be partly due to the application of heat. Patients reported highest levels of subjective benefit from caraway poultices, making their use appropriate in the self-management of IBS.
Background Adolescent Rumination Syndrome (ARS) is a functional GI disorder in which the patient constantly regurgitates food or drink after soon after ingestion. Several approaches to treatment have been shown to provide benefit in the literature. However, most of the literature describes either case studies implementing a particular treatment approach, or involves a chart review where multiple nonspecific treatments have been provided to the patients. Objectives The purpose of the current project was twofold; first, to examine the outcomes of a sizeable sample of adolescents, all receiving an interdisciplinary medical and behavioral approach to treatment; and second, to determine if any factors predicted treatment outcome. Methods Chart reviews were conducted on the first 50 adolescent patients (mean age = 15.8 years, 90% female) in an intensive inpatient program for rumination at a large Midwestern pediatric hospital. Data obtained included demographics (patient age, gender), illness (duration of rumination prior to treatment, percentage of patients on enteral feeds prior to treatment, duration of admission), mental health (presence of a mental health diagnosis, score on the MMPI-A Hysteria scale), and outcome (if the patient reached criteria of keeping down at least 80% of their estimated energy needs (EEN)). Results Average duration of rumination prior to admission was 21.4 months (SD = 17.3), with 52% of patients receiving enteral feeds upon admission. Of all MMPI-A scales, only Hysteria was found to be clinically elevated (i.e., t > 65), with a mean of 65.9 (SD = 13.4). The four mental health issues present in the sample were diagnoses of anxiety, depression, and/or eating disorder, and a history of abuse. Fifty two percent of the sample had one of these four mental health issues present, with 30% having one, and 22% having more than one mental health challenge. Average duration of admission was 10.1 days (SD = 5.3). At the end of treatment, 86% of the sample were considered treatment successes meeting PO intake and retention criteria. While most variables did not predict outcome (e.g., duration of illness prior to admission, need for enteral feeds, age, duration of admission), mental health variables were highly predictive of the patient's ability to reach PO intake and retention criteria. Conclusions The current study demonstrates the effectiveness of an intensive, interdisciplinary approach to treating ARS. In addition, findings stress the importance of mental health factors in the maintenance and treatment of ARS. Future research will examine if mental health factors are equally predictive of long-term outcome in these patients.
Sa1072 Symptom Control, Quality of Life, and Treatment Satisfaction in Patients Treated With Lubiprostone vs. Other Treatments for Irritable Bowel Syndrome-Constipation (IBS-C) Caitlyn T. Solem, Haridarshan Patel, Sonam Mehta, Reema Mody, Monica Katyal, Cynthia Macahilig, Xin Gao
Sa1074
Background: This study aimed to compare patient-reported symptom control, health-related quality of life (HRQL), and treatment satisfaction between patients with IBS-C treated with lubiprostone (LUB) and without LUB (non-LUB). Methods: A US observational retrospective chart review along with a patient survey (via computer assisted telephone interview) recruited IBS-C patients from March-August 2013 who were ≥18 years had a physician confirmed IBS-C diagnosis, initiated a new treatment due to inadequate relief (i.e. <3 spontaneous complete bowel movements per week, hard or lumpy stools and/or straining during a bowel movement) by the previous treatments and had been on the new treatment for ≥3 months. Patients were defined as LUB if it was initiated ≥3 months ago and as non-LUB if a different treatment was initiated. Patients in either group could be taking multiple IBS-C treatments. Self-reported symptoms were assessed by the Patient Assessment of Constipation Symptoms (PAC-SYM; scored 0-4; higher scores indicate more severe symptoms); HRQL was measured by the IBS quality of life instrument (IBS-QOL; 0-100; higher scores indicate better HRQL), and overall satisfaction with current treatment by a single item (6-level scale, from very strongly disagree to very strongly agree). Severity of IBS-C was also measured in patient charts. IBS-C severity, time since diagnosis, age, and race were controlled for using inverse probability of treatment weighting. Unweighted and weighted outcomes were compared using t-tests for continuous and chi-squared tests for categorical outcomes. Results: Of 162 patients (mean±SD age 45.9±15.3 years; 71% white, 61.1% moderate IBS-C), 76 switched to LUB and 86 to non-LUB. There was no difference between groups in clinical or demographic characteristics or in IBS-C treatment used prior to the current regimen. Patients reported using osmotic laxatives (LUB: 27.6%, Non-LUB: 53.5%), bulk forming laxatives (LUB: 27.6%, Non-LUB: 38.4%), and probiotics (LUB: 13.2%, Non-LUB: 26.7%) in the 30 days prior to survey. After weighting, all PAC-SYM scores (abdominal, rectal, stool, total) were significantly lower for LUB vs. non-LUB (p<0.05). All IBS-QOL subscales were higher for LUB, with overall, dysphoria, social reaction, sexual, and relationship scores significantly higher for LUB vs. non-LUB (p<0.05); while interference with activity, body image, health worry and
AGA Abstracts
Nurse-Led, Interactive Group Sessions for Dyspepsia and GERD Referrals: A Prospective Controlled Study of the "Nurse Navigator" Clinic Kerri L. Novak, Barb Kathol, Mark G. Swain, Colleen Johnston, Joe Kwan, Lorraine Bucholtz, Danica Hignell, Willem S. Schoombee, Michelle C. Buresi, Christopher N. Andrews Background: Routine referrals for functional dyspepsia (FD) and gastroesophageal reflux (GERD) are common in general gastroenterology (GI) practice with lengthy wait times often exceeding a year. The need for endoscopic evaluation in these individuals is low. Nurseled ("nurse navigator", NN) clinics for care of functional gut disorders can focus on patient education, optimization of therapy, and may mitigate the significant demand for access to GI consultation and endoscopy. Methods: Prospective, controlled, REB-approved study with identification of patients through a centralized triage system for GI referrals in a city of 1M people. Patients referred for FD or GERD from a defined primary care area were contacted by a nurse for a telephone consultation. All patients with alarm features were excluded and separately triaged urgently. Patients then consented to participate in a 1 hour interactive group session (groups of 8) with a dietician, pharmacist, and expert nurse. A brief physician visit followed the group session with prescription of medication and/or endoscopic evaluation where indicated. Referrals from outside the defined primary care area were used as controls (routine care). Validated symptoms score (GOS scale, 1 (no symptoms)-7 (very severe symptoms)) and patient satisfaction were evaluated prior to intervention with repeat score at 6 months post-intervention. Results: 247 subjects (55% female; mean age 47±1 years, range 17-80) were assigned to the NN pathway and 112 (similar demographics) were assigned to routine care. Median time to NN group session from referral date was 2.5 months, while only 11/112 (10%) of control patients had GI consultation by 6 months. 32/ 247 (13%) went directly to endoscopy before NN group session (findings: 2 Barrett's; one
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AGA Abstracts
prevalence of obesity (15.2% vs. 4.7%, p=0.01). 16.5% of patients had mild to severe symptoms. Conclusions: Prevalence of GERD symptoms is similar to those reported in other countries (7.7-12.6%) and there were no differences among the 8 geographic regions of our country. GERD symptoms in Mexico are frequent independently of the geographic, diet and cultural factors. This study was supported by research grants of Asofarma Mexico Heartburn prevalence
* Adjusted results are from inverse probability of treatment weighted data, thus N differs.
Sa1071 Efficacy of Caraway Oil Poultices in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Cross-Over Trial Jost Langhorst, Romy Lauche, Anke Janzen, Rainer Lüdtke, Holger Cramer, Gustav J. Dobos
Sa1073 Intensive Treatment of Adolescent Rumination Syndrome (ARS) - Predictors of Treatment Outcome Anthony Alioto, Heather Yardley, Desale Yacob, Carlo Di Lorenzo
Background: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, with a worldwide prevalence between 5% and 20%in the general population. Caraway oil is known for its spasmolytic and carminative potential. Poultices are frequently used for self-management, but no evidence exists to support such use. This study tested the efficacy of a caraway oil poultice for treating IBS. Methods: This randomized controlled cross-over trial had three treatment periods. The intervention consisted of a hot poultice made with caraway oil; control interventions were either hot or cold poultices made with olive oil. Patients applied each intervention daily for three weeks, followed by two week ‘wash-out' phases. The primary outcome measure was symptom severity; secondary outcomes included quality of life, psychological distress and patient safety. Results: 48 patients with IBS (diarrhea predominant or alternators) were included in this study (40 females, 53.9±14.4 years). Compliance was good, with more than two thirds of patients applying the poultices as prescribed. After adjustment for expectations statistically significant difference was found in favor of the caraway poultices for symptom severity (difference -38.4; 95%CI: -73.6,3.1; p=0.033), compared to the cold, but not to the hot olive oil poultices (difference -24.3; 95%CI: -56.5,7.9; p=0.139). Response rates were significantly higher for the caraway oil, compared to the hot olive oil and cold olive oil poultices (43.9%, 20.0% and 18.9% respectively, p=0.019). Significant group differences in favor of the caraway poultices were also found for the IBS-QOL total score and subscales health worry and dysphoria, as well as the Bristol stool scale, at least for highly compliant patients. Perceived subjective benefit was highest for use of the caraway poultices. No adverse events were reported. Conclusion: The use of hot caraway poultices to treat IBS appears effective and safe, although these effects may be partly due to the application of heat. Patients reported highest levels of subjective benefit from caraway poultices, making their use appropriate in the self-management of IBS.
Background Adolescent Rumination Syndrome (ARS) is a functional GI disorder in which the patient constantly regurgitates food or drink after soon after ingestion. Several approaches to treatment have been shown to provide benefit in the literature. However, most of the literature describes either case studies implementing a particular treatment approach, or involves a chart review where multiple nonspecific treatments have been provided to the patients. Objectives The purpose of the current project was twofold; first, to examine the outcomes of a sizeable sample of adolescents, all receiving an interdisciplinary medical and behavioral approach to treatment; and second, to determine if any factors predicted treatment outcome. Methods Chart reviews were conducted on the first 50 adolescent patients (mean age = 15.8 years, 90% female) in an intensive inpatient program for rumination at a large Midwestern pediatric hospital. Data obtained included demographics (patient age, gender), illness (duration of rumination prior to treatment, percentage of patients on enteral feeds prior to treatment, duration of admission), mental health (presence of a mental health diagnosis, score on the MMPI-A Hysteria scale), and outcome (if the patient reached criteria of keeping down at least 80% of their estimated energy needs (EEN)). Results Average duration of rumination prior to admission was 21.4 months (SD = 17.3), with 52% of patients receiving enteral feeds upon admission. Of all MMPI-A scales, only Hysteria was found to be clinically elevated (i.e., t > 65), with a mean of 65.9 (SD = 13.4). The four mental health issues present in the sample were diagnoses of anxiety, depression, and/or eating disorder, and a history of abuse. Fifty two percent of the sample had one of these four mental health issues present, with 30% having one, and 22% having more than one mental health challenge. Average duration of admission was 10.1 days (SD = 5.3). At the end of treatment, 86% of the sample were considered treatment successes meeting PO intake and retention criteria. While most variables did not predict outcome (e.g., duration of illness prior to admission, need for enteral feeds, age, duration of admission), mental health variables were highly predictive of the patient's ability to reach PO intake and retention criteria. Conclusions The current study demonstrates the effectiveness of an intensive, interdisciplinary approach to treating ARS. In addition, findings stress the importance of mental health factors in the maintenance and treatment of ARS. Future research will examine if mental health factors are equally predictive of long-term outcome in these patients.
Sa1072 Symptom Control, Quality of Life, and Treatment Satisfaction in Patients Treated With Lubiprostone vs. Other Treatments for Irritable Bowel Syndrome-Constipation (IBS-C) Caitlyn T. Solem, Haridarshan Patel, Sonam Mehta, Reema Mody, Monica Katyal, Cynthia Macahilig, Xin Gao
Sa1074
Background: This study aimed to compare patient-reported symptom control, health-related quality of life (HRQL), and treatment satisfaction between patients with IBS-C treated with lubiprostone (LUB) and without LUB (non-LUB). Methods: A US observational retrospective chart review along with a patient survey (via computer assisted telephone interview) recruited IBS-C patients from March-August 2013 who were ≥18 years had a physician confirmed IBS-C diagnosis, initiated a new treatment due to inadequate relief (i.e. <3 spontaneous complete bowel movements per week, hard or lumpy stools and/or straining during a bowel movement) by the previous treatments and had been on the new treatment for ≥3 months. Patients were defined as LUB if it was initiated ≥3 months ago and as non-LUB if a different treatment was initiated. Patients in either group could be taking multiple IBS-C treatments. Self-reported symptoms were assessed by the Patient Assessment of Constipation Symptoms (PAC-SYM; scored 0-4; higher scores indicate more severe symptoms); HRQL was measured by the IBS quality of life instrument (IBS-QOL; 0-100; higher scores indicate better HRQL), and overall satisfaction with current treatment by a single item (6-level scale, from very strongly disagree to very strongly agree). Severity of IBS-C was also measured in patient charts. IBS-C severity, time since diagnosis, age, and race were controlled for using inverse probability of treatment weighting. Unweighted and weighted outcomes were compared using t-tests for continuous and chi-squared tests for categorical outcomes. Results: Of 162 patients (mean±SD age 45.9±15.3 years; 71% white, 61.1% moderate IBS-C), 76 switched to LUB and 86 to non-LUB. There was no difference between groups in clinical or demographic characteristics or in IBS-C treatment used prior to the current regimen. Patients reported using osmotic laxatives (LUB: 27.6%, Non-LUB: 53.5%), bulk forming laxatives (LUB: 27.6%, Non-LUB: 38.4%), and probiotics (LUB: 13.2%, Non-LUB: 26.7%) in the 30 days prior to survey. After weighting, all PAC-SYM scores (abdominal, rectal, stool, total) were significantly lower for LUB vs. non-LUB (p<0.05). All IBS-QOL subscales were higher for LUB, with overall, dysphoria, social reaction, sexual, and relationship scores significantly higher for LUB vs. non-LUB (p<0.05); while interference with activity, body image, health worry and
AGA Abstracts
Nurse-Led, Interactive Group Sessions for Dyspepsia and GERD Referrals: A Prospective Controlled Study of the "Nurse Navigator" Clinic Kerri L. Novak, Barb Kathol, Mark G. Swain, Colleen Johnston, Joe Kwan, Lorraine Bucholtz, Danica Hignell, Willem S. Schoombee, Michelle C. Buresi, Christopher N. Andrews Background: Routine referrals for functional dyspepsia (FD) and gastroesophageal reflux (GERD) are common in general gastroenterology (GI) practice with lengthy wait times often exceeding a year. The need for endoscopic evaluation in these individuals is low. Nurseled ("nurse navigator", NN) clinics for care of functional gut disorders can focus on patient education, optimization of therapy, and may mitigate the significant demand for access to GI consultation and endoscopy. Methods: Prospective, controlled, REB-approved study with identification of patients through a centralized triage system for GI referrals in a city of 1M people. Patients referred for FD or GERD from a defined primary care area were contacted by a nurse for a telephone consultation. All patients with alarm features were excluded and separately triaged urgently. Patients then consented to participate in a 1 hour interactive group session (groups of 8) with a dietician, pharmacist, and expert nurse. A brief physician visit followed the group session with prescription of medication and/or endoscopic evaluation where indicated. Referrals from outside the defined primary care area were used as controls (routine care). Validated symptoms score (GOS scale, 1 (no symptoms)-7 (very severe symptoms)) and patient satisfaction were evaluated prior to intervention with repeat score at 6 months post-intervention. Results: 247 subjects (55% female; mean age 47±1 years, range 17-80) were assigned to the NN pathway and 112 (similar demographics) were assigned to routine care. Median time to NN group session from referral date was 2.5 months, while only 11/112 (10%) of control patients had GI consultation by 6 months. 32/ 247 (13%) went directly to endoscopy before NN group session (findings: 2 Barrett's; one
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