Stephan R. Weinland

International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit.

Background Although clinicians generally make treatment decisions in irritable bowel syndrome (IBS) related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood. Objective To describe among patients with IBS their symptoms and severity, quality of life and health status, medications taken, and the risk that they would take to continue medications for optimal relief. Methods Adult patients diagnosed with IBS who accessed the websites of the International Foundation for Functional GI Disorders or the University of North Carolina Center for Functional GI Disorders filled out questionnaires to address the study aims. Results The 1966 respondents (83% female, 91% white, 78% US/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor health-related quality of life particularly with dietary restrictions, mood disturbance, and interference with daily activity, and 35% reported their symptoms as severe defined primarily as pain, bowel difficulties, bloating, and eating/dietary restrictions). These symptoms were reported in some combination by over 90%, and 35.1% endorsed all 4 items. To receive a treatment that would make them symptom free, patients would give up 25% of their remaining life (average 15 y) and 14% would risk a 1/1000 chance of death. Most of the medications being taken were for pain relief and 18% were taking narcotics. Complementary and alternative treatments were used by 37%. Conclusions Patients accessing IBS informational websites report moderate-to-severe impairments in health status, and would take considerable risk to obtain symptom benefit. There is an unmet need to find effective treatments for patients with IBS and regulatory agencies might consider raising risk-benefit ratios when approving new medications for IBS.

A Very Low-Carbohydrate Diet Improves Symptoms and Quality of Life in Diarrhea-Predominant Irritable Bowel Syndrome

BACKGROUND & AIMS Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) anecdotally report symptom improvement after initiating a very low-carbohydrate diet (VLCD). This study prospectively evaluated a VLCD in IBS-D. METHODS Participants with moderate to severe IBS-D were provided a 2-week standard diet, then 4 weeks of a VLCD (20 g carbohydrates/d). A responder was defined as having adequate relief of gastrointestinal symptoms for 2 or more weeks during the VLCD. Changes in abdominal pain, stool habits, and quality of life also were measured. RESULTS Of the 17 participants enrolled, 13 completed the study and all met the responder definition, with 10 (77%) reporting adequate relief for all 4 VLCD weeks. Stool frequency decreased (2.6 +/- 0.8/d to 1.4 +/- 0.6/d; P < .001). Stool consistency improved from diarrheal to normal form (Bristol Stool Score, 5.3 +/- 0.7 to 3.8 +/- 1.2; P < .001). Pain scores and quality-of-life measures significantly improved. Outcomes were independent of weight loss. CONCLUSIONS A VLCD provides adequate relief, and improves abdominal pain, stool habits, and quality of life in IBS-D.

Diagnosis, characterization, and 3-month outcome after detoxification of 39 patients with narcotic bowel syndrome.

OBFECTIVES:Narcotic bowel syndrome (NBS) is characterized by a paradoxical increase in abdominal pain associated with continued or escalating dosages of narcotics. This study evaluated the clinical and psychosocial features of patients with NBS and the response to detoxification treatment.METHODS:For 2 years, 39 patients seen by the GI consult service at the University of North Carolina at Chapel Hill (UNC) with presumed NBS were placed on a detoxification program. Clinical, psychosocial, health status, and outcome data were obtained before and after detoxification. Our aims were to: (i) clinically characterize patients with presumed NBS, (ii) assess the clinical response and adverse effects to detoxification, (iii) identify clinical and psychosocial predictors of treatment response, and (iv) determine the clinical outcome at 3 months after detoxification and the time frame for patients who revert back to narcotics.RESULTS:Of the 39 patients detoxified, 89.7% met predefined criteria. Patients were mostly well educated (14.5±2.3 years of school), female (92.3%), and with a variety of diagnoses (21% irritable bowel syndrome IBS/functional, 37% inflammatory bowel disease and other structural, 29% fibromyalgia and other functional somatic, or orthopedic, and 13% postoperative or other). They reported high health-care use (15.3±10.1 MD visits/6 months; 6.5±6.1 hospitalizations/2 years, 6.4±2.0 surgeries/lifetime), and 82.1% were jobless. Despite high dosages of narcotics (total intravenous (IV) morphine equivalent 75.3±78.0 mg/day), pain scores were rated severe (52.9±28.8 visual analog scale (VAS); 257.1±139.6 functional bowel disorder severity index (FBDSI); 17.2±10.2 (McGill Pain and greater than labor or postoperative pain). Multiple symptoms were reported (n=17.8±9.2) and rated as moderate to severe. Psychosocial scores showed high catastrophizing (19.9±8.6); poor daily function (Short Form-36 (SF-36) physical 28.3±7.7, mental 34.3±11.0; worse than tetraplegia); 28.2% were clinically depressed and 33.3% anxious (Hospital Anxiety and Depression Scale (HADS)). Detoxification was successfully completed by 89.7%; after detoxification, abdominal pain was reduced by 35% (P<0.03) and nonabdominal pain by 42% (P<0.01) on VAS, and catastrophizing significantly improved (P<0.01). Responder status was met in 56.4% with 48.7% achieving a ≥30% reduction in pain. By 3 months after detoxification, 45.8% had returned to using narcotics. For those who remained off narcotics at 3 months, the VAS abdominal pain score was 75% lower than pretreatment when compared with those who went back on narcotics (24% lower). Successful detoxification and a good clinical response was associated with low abuse potential (Current Opioid Misuse Measure (COMM) score <9).CONCLUSIONS:Despite severe pain, poor coping, and poor health status, almost all patients with NBS undergoing detoxification were able to stop using narcotics and have significant improvement in pain and coping. However, almost ½ reverted to narcotic use at 3 months. Those who stayed off narcotics showed greater improvement in pain scores. This study provides a rationale for treating patients with NBS by detoxification in order to improve their clinical status. Further work is needed to understand the reasons for the high recidivism rate.

Atypical Antipsychotic Quetiapine in the Management of Severe Refractory Functional Gastrointestinal Disorders

Management of severe refractory functional gastrointestinal disorders (FGIDs) is difficult. Quetiapine, an atypical antipsychotic, may benefit patients by mitigating associated anxiety and sleep disturbances, augmenting the effect of antidepressants, and providing an independent analgesic effect. Outpatient records from a university-based FGID clinic were reviewed, and 21 patients with refractory symptoms who received quetiapine were identified and interviewed. Outcomes included global relief of symptoms, treatment efficacy questionnaire, and change in gastrointestinal (GI) and psychological symptoms. Eleven of 21 patients continued therapy at the time of interview. Six of 11 demonstrated global relief of symptoms, and 9 were satisfied with treatment. The remaining 10 of 21 discontinued therapy because of somnolence and lack of GI benefits. Quetiapine in low doses appeared beneficial in more than half of the adults with severe FGIDs who stayed on treatment. This response in otherwise refractory patients suggests quetiapine might augment the effectiveness of antidepressants in severe FGIDs.

Characterization of Episodes of Irritable Bowel Syndrome Using Ecological Momentary Assessment

OBJECTIVES:Patients with irritable bowel syndrome (IBS) report that symptoms occur as episodes. The nature and frequency of episodes have not been well studied.METHODS:Using modified ecological momentary assessment (EMA), we examined clinical factors attributed to IBS symptom episodes and compared them with nonsymptom episode periods in patients with IBS-D (N=21), IBS-C (N=18), or IBS-M (N=19), and healthy controls (N=19). Symptoms were rated over 14 days on a visual ordinal scale (VOS: 0–10) randomly in morning, midday, and evening, and at wake up, bedtime, prebowel movement, and postbowel movement. Scores were evaluated for total group and across subgroups and between EMA and daily diary cards on the same day.RESULTS:Subjects (n=57/59) reported symptom episodes 34% of the time. Episodes showed significantly higher pain levels (3.6 vs. 1.64, P<0.0001), bloating (4.57 vs. 3.02, P<0.0001), stress (3.54 vs. 2.59, P<0.0001), and decreased well-being (5.29 vs. 6.16, P<0.0001). Episode frequency/2 weeks was greatest for IBS-D (10.7±7.05) than IBS-C (8.4±5.76) and IBS-M (7.1±4.45) (P=nonsignificant). IBS-D also had shorter episodes (9 h 23 min) compared with IBS-M (15 h 01 min) and IBS-C (15 h 25 min) (P<0.04). Stool frequency and looser consistency were greater with IBS-D and similar between IBS-C and IBS-M. Abdominal pain was the greatest predictor of episode status. Diary card ratings of pain and stool frequency overestimate levels reported by EMA.CONCLUSIONS:Episodes of IBS are associated with greater pain (strongest relationship), bloating, and stress scores, and poorer global well-being. Compared with IBS-D, IBS-C and IBS-M are similar in clinical features. Patients overreport pain and stool frequency by diary compared with EMA.

Cognitive Factors Affect Treatment Response to Medical and Psychological Treatments in Functional Bowel Disorders

OBJECTIVES:For clinical trials in functional bowel disorders (FBD), the definition of a responder, one who meets the predefined criteria for a clinical response, is needed. Factors that determine clinical response aside from treatment itself are unknown. The aim of this study was to determine what baseline and post-treatment factors affect treatment response.METHODS:Females (n=397) with FBD entering a 12-week, four-arm, randomized NIH treatment trial (desipramine (DES), CBT, pill placebo, and education) were studied at baseline and after treatment. Demographic, clinical, psychosocial, and physiological variables were considered in the analysis. A responder was defined as a patient obtaining a score >3.5 on an averaged eight-item, five-point satisfaction-with-treatment questionnaire. Baseline and post-treatment logistic regressions were performed for each treatment condition to predict the responder outcome variable.RESULTS:Similar cognitive features predisposed participants to treatment response across the treatment conditions: sense of control over the condition, positive relationship with therapist or study coordinator, confidence in treatment, improvement in maladaptive cognitions, and quality of life during treatment. Demographic and clinical variables studied were not predictive. Some treatment-specific effects predicting responder status were noted, including a reduction in stool frequency with DES treatment and lack of abuse history in the placebo group.CONCLUSIONS:For medication, psychological, and placebo treatment in FBD, satisfaction with treatment depends on cognitive factors of confidence in treatments, perceived control over illness and symptoms, and reduction in negative cognitions related to symptom experience. Addressing these issues among patients with FBD may enhance treatment response to a variety of treatments.

Commentary: sociocultural factors in medicine and gastrointestinal research.

Table. No caption available The authors examine the work by Gerson et al., with respect to the role of cultural factors in clinical gastrointestinal practice and research. These often underappreciated factors play an important role in the diverse populations that clinicians work with in westernized countries and internationally. This study argues for the importance of addressing culture when examining the perception of symptoms and the roles of physician and patient. Research questions as well as treatment decisions can be compromised if a patients cultural belief systems are not accommodated. Sociocultural factors affect physician–patient interactions and particularly affect how symptoms are reported and treated. An understanding of specific cultural contributions to symptom experience can enhance the clinicians ability to engage in more effective research and treatment.

Diagnosing anxiety and depression among patients in referral GI practices: help or hindrance?

I t is commonly reported that symptoms of anxiety and depression are underrecognized and poorly addressed in primary care. Several studies have found that psychologic diagnoses frequently coexist with and may exacerbate physical symptom presentation, yet physicians continue to have difficulty in addressing their association and influence on the clinical presentation. Furthermore, as demonstrated within gastroenterology, merely making a diagnosis of a functional gastrointestinal (GI) disorder compared with an organic GI disorder can influence physician attitudes, behaviors, and clinical judgment. In this study, Keefer et al are to be commended for bringing these important clinical issues to light and to encourage psychosocial assessments to improve patient care. Using the Hospital Anxiety and Depression Scale (HADS) among patients seen in 2 gastroenterology referral clinics, the authors found that anxiety, more than depression, were common, though were not different between the functional and organic disorders. However, the treating gastroenterologists often missed these diagnoses, and when they did diagnose anxiety or depression, the results correlated poorly with, and had a low-positive predictive value to the standardized psychologic test. Furthermore, it seems that physicians were more likely to diagnose a functional GI disorder (FGID) when anxiety is perceived or vice versa. In effect, the authors found that the physician’s ability to diagnosis anxiety and depression is poor when compared with standard measures and that their diagnostic accuracy may be biased by the perceived association of anxiety with a FGID. So, is the recommendation for medical physicians to use psychologic tests to make psychologic diagnoses going to be helpful? To fully understand and apply the recommendations into clinical practice, it is important to know (a) whether physicians are able to identify psychologic comorbidities, or whether they interpret and respond to them differently, (b) whether psychosocial screening instruments are clinically relevant and appropriate to use in medical settings, and finally (c) whether gastroenterologists need to provide a different type of care for their patients with psychosocial comorbidities. Are Physicians able to identify psychologic comorbidities or do they see them differently? The identification of psychologic diagnoses and distress can be difficult even for psychiatrists and psychologists. The risk of missing important factors in patient presentation, whether medical or psychologic, likely represents a larger trend within medical practice; the pressure to reduce the time spent with the patient because of increased financial pressures—to ‘‘increase throughput’’ to counter decreasing revenues. Thus, medical physicians may not believe it to be valuable to put in additional time to assess psychologic diagnoses. To complicate this further, patients referred to gastroenterologists maybe reluctant to acknowledge symptoms of anxiety or depression because of the risk of social stigma or the belief that they

Narcotic Bowel Syndrome: Characterization of 30 Patients and Preliminary Results After Detoxification

Proof CONTROL ID: 1019563 CURRENT CATEGORY: Neurogastroenterology and Motility PRESENTATION TYPE: AGA Institute Oral or Poster PRESENTER: Douglas Drossman PRESENTER (E-MAIL ONLY): drossman@med.unc.edu

Development and Validation of the Irritable Bowel Syndrome Satisfaction With Care Scale (IBS-SAT)

BACKGROUND & AIMS: Satisfaction with care is an important measure of quality, from the patients’ perspective, and could also affect outcomes. However, there is no standard measure of patient satisfaction for irritable bowel syndrome (IBS) care; a multi-item, condition-specific instrument is needed. METHODS: Using standard qualitative methods, we conducted focus groups to identify items that patients associated with satisfaction in their care for IBS. These and additional items identified by experts were placed into a preliminary questionnaire, which was refined through pilot testing and cognitive debriefing by additional patients, as well as standard statistical methods. The resulting instrument and several external validation measures were administered to 300 adult US patients with IBS. Factor analysis was performed to identify clinically relevant subscales and then psychometric properties were assessed. RESULTS: We developed an IBS satisfaction with care scale (IBS-SAT) that has 38 items from 5 clinically relevant subscales (connection with provider, education, benefits of visit, office attributes, and access to care). This IBS-SAT had a high level of internal consistency (Crohnbach’s .96). Convergent validity was established by correlations between the IBS-SAT and a single, global satisfaction with care question (r 0.68; P .001), and a generic, multi-item satisfaction scale (physician satisfaction questionnaire-18) (r 0.75, P .001). Discriminant validity (among known groups) was established across groups that were stratified based on IBS-quality of life (r 0.34; P .0001), IBS severity (functional bowel disorders severity index) (r 0.21; P .001), and number of unmet expectations (r 0.38; P .0001). CONCLUSIONS: The IBSSAT is a validated measure of patient satisfaction with IBS care. As a new, condition-specific instrument, it is likely to be a useful tool for quality measurement, health services research, and clinical trials.