BACKGROUND:There is a need for safe and effective IBS treatments that provide immediate and sustained improvement of IBS symptoms, particularly among more severe patients. The aim was to assess long-term clinical response of cognitive behavioral therapy (CBT) with reference to IBS education. METHODS:A total of 436 Rome III-diagnosed IBS patients (80% F, M age = 41 years) were randomized to: 4 session home-based CBT (minimal contact (MC-CBT)), 10 session clinic-based CBT (standard (S-CBT)), or 4 session IBS education (EDU). Follow-up occurred at 2 weeks and 3, 6, 9, and 12 months following treatment completion. Treatment response was based a priori on the Clinical Global Improvement Scale (global IBS symptom improvement) and IBS Symptom Severity Scale (IBS-SSS). RESULTS:Post-treatment CGI gains were generally maintained by MC-CBT patients at quarterly intervals through 12-month follow-up with negligible decay. For MC-CBT and S-CBT, 39 and 33% of respondents maintained treatment response at every follow-up assessment. The corresponding percent for EDU was 19%, which was significantly lower (p < 0.05) than for the CBT groups. On the IBS-SSS, therapeutic gains also showed a pattern of maintenance with trends towards increased efficacy over time in all conditions, with the mean unit reductions between baseline and follows-up being approximately -76 at immediate and approximately -94 at 12 months (-50 = clinically significant). CONCLUSIONS:For treatment-refractory IBS patients, home- and clinic-based CBT resulted in substantial and enduring relief of multiple IBS symptoms that generally extended to 12-month post treatment.

Introduction: IBS is a chronic, oftentimes disabling, GI disorder for which there is no satisfactory medical or dietary treatment. As such, there is an urgent need for efficacious, safe, and efficient treatments that help IBS patients' self-manage unresolved GI symptoms. Methods: 438 Rome III-diagnosed IBS patients (86% female, Mean age=41 yrs.) with moderate to severe symptoms were recruited from local physicians and the community at two academic sites, completed baseline assessment as part of an NIH clinical trial, and randomized to either 2 versions of cognitive behavior therapy (10-session, therapist-administered CBT: Standard-CBT vs. 4-session, self-administered CBT: Minimal Contact-CBT) or 4 session IBS education (EDU) that was designed to exclude CBT techniques but focused on treatment goals (patient education, support) critical to IBS management (Drossman, 1999). Efficacy assessment occurred 2 weeks after the 10-week treatment phase and at 3 and 6 months post-treatment. Primary outcome was global improvement of IBS symptoms (CGI-Improvement) with responder status defined a priori as IBS symptom ratings of “moderately improved” or “substantially improved”. Results: Minimal contact-CBT (MC-CBT) produced a statistically significant (p <.05) larger percent of treatment responders than EDU at immediate post-treatment (67.8% vs. 46.2%) and 3-month (63.8% vs. 49.2%) and a near-significant difference at 6-month follow-up (63.2% vs 50.5%, p <.07) for both per protocol and ITT analyses. Patterns of results were similar for IBS symptom improvement ratings completed by study gastroenterologists blind to treatment assignment (immediate post treatment MC-CBT= 62.8% vs. EDU=43.4% vs S-CBT=59.7%). Improvement ratings were not significantly associated with concomitant use/nonuse of IBS medications (r=.05 -.10-, ns). MC-CBT and Standard-CBT (S-CBT) equivalence was evaluated through formal equivalence testing methods. Equivalence generally was found across contrasts, suggesting MC-CBT is at least as efficacious as S-CBT in improving IBS symptoms. Conclusion: In this multisite study, CBT, whether self- or clinician-administered, tended to be more effective in improving overall IBS symptoms in IBS patients than IBS education. IBS symptom improvement was maintained up to 6 months after treatment was discontinued and not solely due to education, support or other non-specific factors. Acknowledgement: NIH/NIDDK Grant 77738.

Objective: This study assessed the relative magnitude of associations between IBS outcomes and different aspects of social relationships (social support, negative interactions).Method: Subjects included 235 Rome III diagnosed IBS patients (M age = 41 yrs, F = 78%) without comorbid GI disease. Subjects completed a testing battery that included the Interpersonal Support Evaluation List (Social Support or SS), Negative Interaction (NI) Scale, IBS Symptom Severity Scale (IBS-SSS), IBS-QOL, BSI Depression, STAI Trait Anxiety, SOMS-7 (somatization), Perceived Stress Scale, and a medical comorbidity checklist.Results: After controlling for demographic variables, both SS and NI were significantly correlated with all of the clinical variables (SS r's =.20 to.36; NI r's =.17 to.53, respectively; ps <.05) save for IBS symptom severity (IBS-SSS). NI, but not SS, was positively correlated with IBS-SSS. After performing r-to-z transformations on the correlation coefficients and then comparing z-scores, the correlation between perceived stress, and NI was significantly stronger than with SS. There was no significant difference between the strength of correlations between NI and SS for depression, somatization, trait anxiety, and IBSQOL. A hierarchical linear regression identified both SS and NI as significant predictors of IBS-QOL.Conclusions: Different aspects of social relationships - support and negative interactions - are associated with multiple aspects of IBS experience (e.g. stress, QOL impairment). Negative social relationships marked by conflict and adverse exchanges are more consistently and strongly related to IBS outcomes than social support. (C) 2013 Elsevier Inc. All rights reserved.

BACKGROUND: While irritable bowel syndrome (IBS) is associated with significant mental and physical comorbidity, little is known about the day to day burden (e.g., quality of life [QOL], physical and mental functioning, distress, IBS symptoms) that comorbidity imposes. METHOD: 175 Rome III-diagnosed IBS patients (M age = 41 yrs, 78% Female, 91% Caucasian) completed psychiatric assessments (MINI International Neuropsychiatric Interview), a physical comorbidity checklist as well as the IBS Symptom Severity Scale, IBSQOL, Brief Symptom Inventory (distress, BSI), abdominal pain intensity scale, and the physical (PCS) and mental (MCS) functioning scales of the SF-12 as part of baseline assessment of an NIH clinical trial. RESULTS. IBS patients in this cohort reported an avg. of 5 diagnosed comorbidities (1 mental, 4 physical). Partial correlations indicated that subjects with more comorbidities reported worse QOL after adjusting for confounding variables. The number of physical comorbidities was more strongly associated with the physical aspects of QOL, while the number of mental comorbidities was more strongly correlated with mental aspects of QOL. The number of comorbidities was unrelated to either the intensity of abdominal pain or global severity of IBS symptoms. Multiple linear regression analyses indicated that comorbidity type was more consistently and strongly associated with illness burden indicators than simple disease counts after confounding variables were held constant. Of 10, 296 possible physicalmental comorbidity pairs, 6 of the 10 most frequent dyads involved a combination of conditions (generalized anxiety disorder, major depression, back pain, agoraphobia, tension headache, insomnia) that were consistently associated with illness (QOL, mental and physical functioning, distress) and symptom (IBS symptom severity, abdominal pain intensity) burden indicators. A comorbidity dyad with consistently large effect sizes was low back pain and major depression. For these patients, scores were expected to decrease by 22 points on the IBS QOL, 10.24 on the PCS, 11.76 on the MCS, and increase by 20.61 points on the BSI in comparison to patients who are not diagnosed with MDD and LBP. For the IBS-SSS, the regression coefficient was 89.67. This means that a patient diagnosed with MDD-LBP had IBS symptom severity scores on the IBS-SSS score that, on average, are 89.67 units higher than a patient undiagnosed with MDD and LBP. CONCLUSIONS. Physical-mental comorbidity in IBS is common, associated with increased distress and QOL impairment and, for patients with specific comorbidity profiles, more severe IBS symptoms. The type of reported comorbidities, rather than their number, may be a more useful way of understanding the full scope of their impact in more severely affected IBS patients. This study was funded by NIH Grant DK77738

BACKGROUND & AIMS:Irritable bowel syndrome (IBS) has significant mental and physical comorbidities. However, little is known about the day-to-day burden these comorbidities place on quality of life (QOL), physical and mental function, distress, and symptoms of patients. METHODS:We collected cross-sectional data from 175 patients with IBS, which was diagnosed on the basis of Rome III criteria (median age, 41 years; 78% women), who were referred to 2 specialty care clinics. Patients completed psychiatric interviews, a physical comorbidity checklist, the IBS Symptom Severity Scale, the IBS-QOL instrument, the Brief Symptom Inventory, the abdominal pain intensity scale, and the Short Form-12 Health Survey. RESULTS:Patients with IBS reported an average of 5 comorbidities (1 mental, 4 physical). Subjects with more comorbidities reported worse QOL after adjusting for confounding variables. Multiple linear regression analyses indicated that comorbidity type was more consistently and strongly associated with illness burden indicators than disease counts. Of 10,296 possible physical-mental comorbidity pairs, 6 of the 10 most frequent dyads involved specific conditions (generalized anxiety, depression, back pain, agoraphobia, tension headache, and insomnia). These combinations were consistently associated with greater illness and symptom burdens (QOL, mental and physical function, distress, more severe symptoms of IBS, and pain). CONCLUSIONS:Comorbidities are common among patients with IBS. They are associated with distress and reduced QOL. Specific comorbidities are associated with more severe symptoms of IBS.

Introduction. Because factors are strongly related to IBS symptom severity, there is a need to identify high risk patients before their condition worsens. This study assessed the ability of seven psychosocial alarm to predict IBS symptom severity. Methods. Eighty two Rome-diagnosed IBS patients (Mean age = 46 yrs, Female = 84%) completed a psychological testing battery that assessed Rome alarm variables: anxiety, suicide ideation, depression, abuse, impaired coping, functional impairment, and pain severity. Results. Pain and functional impairment were highly correlated with IBS symptom severity (IBS symptom severity scale, IBS-SSS); coping and depression were moderately correlated with the IBS- SSS. Regression analyses indicated that alarm variables accounted for 46% of the variance in the IBS-SSS. The alarm variable that independently predicted symptom severity was pain severity. Discussion. Data lend empirical validation to the Rome Foundation alarm variables, which appear most useful in flagging patients whose IBS profile is dominated by pain intensity.

questionnaires including the Zarit Burden Interview (ZBI), Relationship Satisfaction Scale (RSS) and questions on sexual relationships.IBS patients were rated on disease severity using the Functional Bowel Disease Severity Index (FBDSI).39 healthy volunteers and their partners were also recruited as the control group.Results: Comparing between the partners of IBS patients and healthy volunteers, there were no significant demographic differences.Relationship burden was significantly higher in IBS partners, with a mean ZBI score of 22.1 compared to 11.5 in healthy volunteer partners (p=0.0002).Those rating their relationship as more burdensome (ZBI) had IBS partners with worse disease severity (FBDSI; p<0.0001).Both the IBS and control partners' ratings of burden (ZBI) were negatively correlated with quality of the relationship (as measured by the RSS) and sexual relationship.When compared, there was no difference in the RSS scores (4.25 vs. 4.19, p=0.78) and sexual relationship (6.47 vs. 6.21,p=0.64), between the partners of IBS patients and healthy volunteers respectively.Conclusions: IBS poses a significant degree of partner burden, when compared to a healthy control population.Perceived burden is increased with worsening IBS severity, poorer sexual and relationship satisfaction.The fact that relationship satisfaction and sexual relationship were no worse in the IBS partners show that their increased perceived burden was primarily attributable to the IBS.

BACKGROUND & AIMS: Patient-reported outcomes (PROs) are used to gauge the benefit of treatments for functional gastrointestinal disorders, including irritable bowel syndrome (IBS). Commonly used end points derived from scales of symptom severity differ in their structure, format, and the extent to which they are based on established psychometric fundamentals. We evaluated the overlap between 2 measures of IBS symptom severity, documented their association with different symptoms (pain, bloating, altered defecation), and identified psychological factors that might bias PRO ratings, by affecting how patients interpret IBS symptom severity. METHODS: Ninety-eight patients diagnosed with IBS, based on Rome III criteria, completed the multicomponent IBS Symptom Severity Scale and the single-item, UCLA Symptom Severity Scale. Data were collected on pain, bloating, and bowel habits, as well as somatization, sensitivity to arousal symptoms (anxiety sensitivity), and a negative thinking style called pain catastrophizing. RESULTS: The 2 global scales were correlated with one another (r = 0.56); each scale was associated most strongly with variation in abdominal pain. Data were consistent with a model in which pain catastrophizing and somatization influenced 1 or more of patients' judgments of pain, bloating, and/or bowel habits, which then affected the PROs. CONCLUSIONS: Depending on their structure and format, PROs can have different levels of sensitivity to core IBS symptoms and be influenced by psychological and somatic complaints that are beyond the aim of therapy and labeling claim. PROs that rely on patients' perspectives to index symptom severity can be improved by consideration of psychometric principles that influence self-report.

Background: Obstructed defecation syndrome (ODS) is recognized as both a functional (e.g., anismus or anal dyssynergia) and anatomic (e.g., rectocele and internal rectal intussusception) defecatory disorder of the pelvic floor.The purpose of this study was to determine outcomes and patient satisfaction following stapled transanal rectal resection (STARR) for the surgical treatment of ODS.Methods: Between May 2006 and July 2009, 1,580 patients were evaluated for constipation or rectocele-related symptoms.A subset with ODS was assessed with anal physiology studies and defecography.Thirty-seven of these patients were offered STARR procedure for rectocele and internal intussusception and comprise the cohort of this study.Demographic data and surgical complications were tabulated.Long-term outcomes were assessed by comparing pre-and post-operative subsets of the Wexner constipation scoring system (paired two-tailed Student's t-test) as well as patient satisfaction surveys.Results: A total of 37 patients (100% female) with a mean age of 52.9 years (range: 31-74 years) underwent STARR procedure.All patients had clinically significant rectocele as evidenced on defecography and 82% had concomitant intussusception.Postoperative complications occurred in 13 patients (35.1%) during 90-day follow-up (table).Two of these patients (5.4%) required reintervention: dilation of stricture in one and transanal excision of staple granuloma in another.Long-term follow-up was achieved at a mean of 19.3 months (range: 3-36 months) in 84% of patients.Mean pre-and post-operative constipation scores were 11.1±3.6 (range: 0-17) and 4.0±3.4(range: 0-11), respectively (p<1.3x10^-9).Overall outcome was reported as excellent or good in 71% of patients, adequate in 22.5%, and poor in 6.5%.When asked in retrospect if they would undergo the procedure again, 77% responded affirmatively.Of note, 42% of these patients experienced postoperative complications.Conclusions: The STARR procedure for ODS may result in significantly improved patient outcomes and satisfaction.Most complications were minor and did not require reoperative interventions.In appropriately selected patients, the STARR procedure was a beneficial option for the anatomical correction of ODS secondary to rectocele and intussusception.Surgical complications following STARR during 90-day follow up (note: some patients experienced more than one complication).

BACKGROUND & AIMS: Cognitive behavior therapy (CBT) is an empirically validated treatment for irritable bowel syndrome (IBS), yet it is unclear for whom and under what circumstances it is most effective. We investigated whether patients who achieved a positive response soon after CBT onset (by week 4), termed rapid responders (RRs), maintain treatment gains compared with non-rapid responders. We also characterized the psychosocial profile of RRs on clinically relevant variables (eg, health status, IBS symptom severity, distress). METHODS: The study included 71 individuals (age, 18-70 y) whose IBS symptoms were consistent with Rome II criteria and were of at least moderate severity. Patients were assigned randomly to undergo a wait list control; 10 weekly 1-hour sessions of CBT; or four 1-hour CBT sessions over 10 weeks. RRs were classified as patients who reported adequate relief of pain, adequate relief of bowel symptoms, and a decrease in total IBS severity scores of 50 or greater by week 4. RESULTS: Of patients undergoing CBT, 30% were RRs; 90% to 95% of the RRs maintained gains at the immediate and 3-month follow-up examinations. Although the RRs reported more severe IBS symptoms at baseline, they achieved more substantial, sustained IBS symptom reduction than non-rapid responders. Both dosages of CBT had comparable rates of RR. CONCLUSIONS: A significant proportion of IBS patients treated with CBT have a positive response within 4 weeks of treatment; these patients are more likely to maintain treatment gains than patients without a rapid response. A rapid response is not contingent on the amount of face-to-face contact with a clinician.