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1.  Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients 
Background
Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d.
Methods
Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change.
Results
This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA’s Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors.
Conclusions
We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that the IBS-QOL items demonstrate very good construct validity and ability to detect changes due to treatment effects. Furthermore, our analyses suggest that the IBS-QOL items measure a univariate construct and we believe further modeling of the IBS-QOL from an item response theory (IRT) approach under both non-treatment and treatment conditions would greatly further our understanding as item-based methods could be used to develop a short form.
doi:10.1186/1477-7525-11-208
PMCID: PMC3895767  PMID: 24330412
IBS-QOL; Patient-reported Outcomes; Psychometrics; HRQOL; Irritable Bowel Syndrome; Diarrhea; Eluxadoline
2.  Validation of Symptom-Based Diagnostic Criteria for Irritable Bowel Syndrome: A Critical Review 
The American journal of gastroenterology  2010;105(4):10.1038/ajg.2010.56.
Aims
Critically review the validity of symptom-based criteria (Manning, Rome I, Rome II, and Rome III) for irritable bowel syndrome (IBS).
Methods
Two kinds of validation are reported: (1) studies testing whether symptom criteria discriminate patients with structural disease at colonoscopy from patients without structural disease; and (2) studies testing whether symptom criteria discriminate patients presumed to have IBS by positive diagnosis from healthy subjects or patients with other functional and structural disorders.
Results
The first study type addresses an important clinical management question but cannot provide meaningful information on sensitivity or positive predictive value because IBS is defined only by exclusion of structural disease. Specificity is modest (about 0.7), but can be improved to 0.9 by addition of red flag signs and symptoms. The second type of study judges validity by whether the symptom criteria consistently perform as predicted by theory. Here factor analysis confirms consistent clusters of symptoms corresponding to IBS; symptom-based criteria agree reasonably well (sensitivity 0.4–0.9) with clinical diagnoses made by experienced clinicians; patients with a clinical diagnosis of IBS who fulfill Rome II criteria have greater symptom severity and poorer quality of life than patients with a clinical diagnosis of IBS who do not fulfill Rome criteria; and (4) somatization does not explain endorsement of the symptom-based criteria for IBS. There are no consistent differences in sensitivity or specificity between Manning, Rome I, and Rome II.
Conclusions
Both study types support the validity of symptom-based IBS criteria. Tests of Rome III are needed.
doi:10.1038/ajg.2010.56
PMCID: PMC3856202  PMID: 20179688
3.  Small Intestinal Bacterial Overgrowth in Irritable Bowel Syndrome: Association with Colon Motility, Bowel Symptoms, and Psychological Distress 
Background
Small intestinal bacterial overgrowth (SIBO) has been implicated in the pathogenesis of irritable bowel syndrome (IBS), although with significant controversy.
Aims
To determine the prevalence of SIBO in IBS and its association with colonic motility, bowel symptoms and psychological distress.
Methods
Sucrose hydrogen and methane breath tests were performed in 158 IBS and 34 healthy controls (HC). Thresholds for pain and urgency were tested by barostat in the descending colon. The motility index (MI) was calculated as the average area under the curve for all phasic contractions. Questionnaires assessed psychological distress, IBS symptom severity (IBSSS), IBS Quality of Life (IBS-QOL) and self reported bowel symptoms.
Results
52/158 (32.9%) IBS patients had abnormal breath tests compared with 6/34 (17.9%) HC (χ2=0.079). SIBO (SIBO+) and Non-SIBO (SIBO−) did not differ in the prevalence of IBS-subtypes, IBS-SS, IBS-QOL and psychological distress variables. IBS had a greater post-distension increase in MI than HC, but there was no difference between SIBO+ and SIBO−. Predominant methane producers had higher urge thresholds (28.4 vs. 18.3, p<0.05) and higher baseline MI (461 vs. 301.45, p<0.05) than SIBO− IBS, and they reported more “hard or lumpy stools” when compared to predominant hydrogen producers (p<0.05) and SIBO− IBS (p< 0.05).
Conclusions
SIBO is unlikely to contribute significantly in the pathogenesis of IBS. Methane production is associated with constipation.
doi:10.1111/j.1365-2982.2008.01142.x
PMCID: PMC3856223  PMID: 18482250
Small intestinal bacterial overgrowth; Irritable bowel syndrome; Breath test; Methane; Constipation; Visceral hypersensitivity; Psychological
4.  Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits 
The American journal of gastroenterology  2008;103(10):10.1111/j.1572-0241.2008.02066.x.
Objectives
Irritable bowel syndrome (IBS) patients show pain hypersensitivity and hypercontractility in response to colonic or rectal distention. Aims were to determine whether predominant bowel habits and IBS symptom severity are related to pain sensitivity, colon motility, or smooth muscle tone.
Methods
129 patients classified as IBS with diarrhea (IBS-D, n=44), IBS with constipation (IBS-C, n=29), mixed IBS (IBS-M, n=45) and unspecified IBS (IBS-U, n=11) based on stool consistency, and 30 healthy controls (HC) were studied. A manometric catheter containing a 600-ml capacity plastic bag was positioned in the descending colon. Pain threshold was assessed using a barostat. Motility was assessed for 10 min with the bag minimally inflated (individual operating pressure or IOP), 10 min at 20 mmHg above the IOP, and for 15-min recovery following bag inflation. Motility was also recorded for 30 min following an 810-kcal meal.
Results
Compared to HC, IBS patients had lower pain thresholds (medians: 30 vs. 40 mmHg, p<0.01), but IBS subtypes were not different. IBS symptom severity was correlated with pain thresholds (rho=-0.36, p<0.001). During distention, the motility index (MI) was significantly higher in IBS compared to HC (909±73 vs. 563±78, p<0.01). Average barostat bag volume at baseline was higher (muscle tone lower) in HC compared to IBS-D and IBS-M but not compared to IBS-C. The baseline MI and bag volume differed between IBS-D and IBS-C and correlated with symptoms of abdominal distention and dissatisfaction with bowel movements. Pain thresholds and MI during distention were uncorrelated.
Conclusions
Pain sensitivity and colon motility are independent factors contributing to IBS symptoms. Treatment may need to address both and to be specific to predominant bowel habit.
doi:10.1111/j.1572-0241.2008.02066.x
PMCID: PMC3855425  PMID: 18684175
irritable bowel syndrome; visceral hypersensitivity; colonic motility; symptom severity; subtypes of bowel habit
5.  Randomized Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-type Constipation 
Diseases of the colon and rectum  2009;52(10):10.1007/DCR.0b013e3181b55455.
Purpose
To determine whether biofeedback is more effective than diazepam or placebo in a randomized controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented biofeedback is necessary for successful training.
Methods
One hundred seventeen patients participated in a 4-week run-in (education and medical management). The 84 who remained constipated were randomized to Biofeedback (n=30); Diazepam (n=30); or Placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during 6 biweekly 1-hour sessions, but only Biofeedback patients received electromyography feedback. All other patients received pills 1-2 hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly.
Results
Before treatment, the groups did not differ on demographic (average age 50, 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention to treat analysis (70 percent vs. 23 percent reported adequate relief of constipation 3 months after treatment, χ2 = 13.1, p < 0.001), and also superior to placebo (38 percent successful, χ2 = 5.7, p = 0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared to Placebo (p = .005), with a trend favoring biofeedback over diazepam (p = .067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (p < 0.001).
Conclusions
This investigation provides definitive support for the efficacy of biofeedback for pelvic floor dyssynergia and shows that instrumented biofeedback is essential to successful treatment.
doi:10.1007/DCR.0b013e3181b55455
PMCID: PMC3855426  PMID: 19966605
biofeedback; constipation; dyssynergia; dyssynergic defecation; electromyography
6.  Narcotic Use for Inflammatory Bowel Disease and Risk Factors During Hospitalization 
Inflammatory bowel diseases  2011;18(5):10.1002/ibd.21806.
Background and Aims
Growing evidence demonstrates adverse effects of narcotics in inflammatory bowel disease (IBD). We sought to study the relationship between narcotic use, objective measures of disease activity and other associated factors in hospitalized patients with IBD.
Methods
We performed a retrospective cohort study of all adult IBD patients admitted to a general medical or surgical ward service at a United States tertiary care center over a 1 year period. We collected demographic and disease specific information, inpatient narcotic use and disease activity measurements from endoscopic and radiologic reports. Bivariate comparisons were made between characteristics and narcotic use. Logistic regression was used to evaluate the independent effects of characteristics on narcotic use.
Results
A total of 117 IBD patients were included. Narcotics were given to 70.1% of hospitalized patients. Factors significantly associated with any inpatient narcotic use: Crohn’s disease (CD); p=<0.01, duration of IBD, p=0.02, prior psychiatric diagnosis, p=0.02, outpatient narcotic use, p=<0.01, current smoking, p=<0.01, prior IBD-specific surgery, p<0.02, and prior IBD-IBS diagnosis, p=0.02. Narcotic use was not significantly associated with disease severity on computed tomography (CT) scan or endoscopy. On multivariate analysis, smoking (OR 4.34, 95% CI 1.21–15.6) and prior outpatient narcotic use (OR 5.41, 95% CI 1.54–19.0) were independently associated with inpatient narcotic use.
Conclusions
A majority of patients with IBD are prescribed narcotics during hospitalization in spite of data on increased complications. Risk factors for narcotic use include CD and associated factors (disease duration, surgeries), substance abuse (outpatient narcotics and smoking), psychiatric diagnoses and IBD-IBS.
doi:10.1002/ibd.21806
PMCID: PMC3813953  PMID: 21739533
8.  Anti-Enteric Neuronal Antibodies and the Irritable Bowel Syndrome 
Background/Aims
Functional gastrointestinal disorders are those in which no abnormal metabolic or physical processes, which can account for the symptoms, can be identified. The irritable bowel syndrome (IBS) is a significant functional disorder, which affects 10-20 percent of the population worldwide. Predominant symptoms of IBS are abnormal defecation associated with abdominal pain, both of which may be exacerbated by psychogenic stress. Our study was designed to test a hypothesis that symptoms in a subset of patients with a diagnosis of IBS are associated with an autoimmune degenerative neuropathy in the enteric nervous system.
Methods
Serum was collected from Rome II-IBS patients and controls at the University of North Carolina Functional Gastrointestinal Diseases Center. Assay procedures were immunohistochemical localization of antibody binding to enteric neurons and human protein microarray assay for antigens recognized by antibodies in the sera.
Results
Eighty-seven percent of IBS sera and 59% of control sera contained anti-enteric neuronal antibodies. Antibody immunostaining was seen in the nucleus and cytoplasm of neurons in the enteric nervous system. Protein microarray analysis detected antibody reactivity for autoantigens in serum with anti-enteric neuronal antibodies and no reactivity for the same autoantigens in samples not containing anti-enteric neuronal antibodies in our immunostaining assay. Antibodies in sera from IBS patients recognized only 3 antigens out of an 8,000 immunoprotein array. The 3 antigens were: (1) a nondescript ribonucleoprotein (RNP-complex); (2) small nuclear ribonuclear polypeptide A; and (3) Ro-5,200 kDa.
Conclusions
Results of the present study suggest that symptoms in a subset of IBS patients might be a reflection of enteric neuronal damage or loss, caused by circulating anti-enteric autoimmune antibodies.
doi:10.5056/jnm.2012.18.1.78
PMCID: PMC3271258  PMID: 22323991
Autoimmune neuropathy; Enteric nervous system; Gastrointestinal disorders
9.  Biopsychosocial Model of Irritable Bowel Syndrome 
Irritable bowel syndrome (IBS) is a common chronic disorder seen in gastroenterology and primary care practice. It is characterized by recurrent abdominal pain or discomfort associated with disturbed bowel function. It is a heterogeneous disorder with varying treatments, and in this regard physicians sometimes struggle with finding the optimal approach to management of patients with IBS. This disorder induces high health care costs and variably reduces health-related quality of life. IBS is in the class of functional gastrointestinal disorders, and results from dysregulation of central and enteric nervous system interactions. Psychosocial factors are closely related to their gut physiology, associated cognitions, symptom manifestations and illness behavior. Therefore, it is important for the physician to recognize the psychosocial issues of patients with IBS and in addition to build a good patient-physician relationship in order to optimize treatment. This review focuses on the interaction between psychological and physiological factors associated with IBS by using a biopsychosocial model. In this article, we describe (1) the predisposing psychological features seen in early life; (2) the psychological factors associated with life stress, the symptom presentation, and their associated coping patterns; (3) gut pathophysiology with emphasis on disturbances in motility, visceral hypersensitivity and brain-gut interactions; and finally (4) the clinical outcomes and effective treatments including psychotherapeutic methods.
doi:10.5056/jnm.2011.17.2.131
PMCID: PMC3093004  PMID: 21602989
Irritable bowel syndrome; Pathophysiology; Psychology
11.  Increased colonic pain sensitivity in irritable bowel syndrome is the result of an increased tendency to report pain rather than increased neurosensory sensitivity 
Gut  2007;56(9):1202-1209.
Objective
The aim was to determine whether lower visceral pain thresholds in irritable bowel syndrome (IBS) primarily reflect physiological or psychological factors.
Methods
Firstly, 121 IBS patients and 28 controls underwent balloon distensions in the descending colon using the ascending methods of limits (AML) to assess pain and urge thresholds. Secondly, sensory decision theory analysis was used to separate physiological from psychological components of perception: neurosensory sensitivity (p(A)) was measured by the ability to discriminate between 30 mm Hg vs 34 mm Hg distensions; psychological influences were measured by the report criterion—that is, the overall tendency to report pain, indexed by the median intensity rating for all distensions, independent of intensity. Psychological symptoms were assessed using the Brief Symptom Inventory (BSI).
Results
IBS patients had lower AML pain thresholds (median: 28 mm Hg vs 40 mm Hg; p<0.001), but similar neurosensory sensitivity (median p(A): 0.5 vs 0.5; p = 0.69; 42.6% vs 42.9% were able to discriminate between the stimuli better than chance) and a greater tendency to report pain (median report criterion: 4.0 (“mild” pain) vs 5.2 (“weak” pain); p = 0.003). AML pain thresholds were not correlated with neurosensory sensitivity (r = −0.13; p = 0.14), but were strongly correlated with report criterion (r = 0.67; p<0.0001). Report criterion was inversely correlated with BSI somatisation (r = −0.26; p = 0.001) and BSI global score (r = −0.18; p = 0.035). Similar results were seen for the non‐painful sensation of urgency.
Conclusion
Increased colonic sensitivity in IBS is strongly influenced by a psychological tendency to report pain and urge rather than increased neurosensory sensitivity.
doi:10.1136/gut.2006.117390
PMCID: PMC1954968  PMID: 17483191
hypersensitivity; hypervigilance; perceptual response bias; irritable bowel syndrome
12.  INTERNATIONAL SURVEY OF PATIENTS WITH IBS 
Background
While clinicians generally make treatment decisions in 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 (IFFGD) or the UNC Center for Functional GI Disorders filled out questionnaires to address the study aims.
Results
The 1,966 respondents (83% female, 91% Caucasian, 78% USA/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor HRQOL 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 years) 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.
doi:10.1097/MCG.0b013e318189a7f9
PMCID: PMC2700202  PMID: 19384249
13.  A Very Low-carbohydrate Diet Improves Symptoms and Quality of Life in Diarrhea-Predominant Irritable Bowel Syndrome 
Background & Aims
Patients with diarrhea-predominant IBS (IBS-D) anecdotally report symptom improvement after initiating a very low-carbohydrate diet (VLCD). This is the first study to prospectively evaluate 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 grams of carbohydrates/day). A responder was defined as having adequate relief (AR) of gastrointestinal symptoms for 2 or more weeks during the VLCD. Changes in abdominal pain, stool habits, and quality of life (QOL) were also measured.
Results
Of the 17 participants enrolled, 13 completed the study and all met the responder definition, with 10 (77%) reporting AR for all 4 VLCD weeks. Stool frequency decreased (2.6 ± 0.8/day to 1.4 ± 0.6/day; p<0.001). Stool consistency improved from diarrheal to normal form (Bristol Stool Score: 5.3 ± 0.7 to 3.8 ± 1.2; p<0.001). Pain scores and QOL measures significantly improved. Outcomes were independent of weight loss.
Conclusion
A VLCD provides adequate relief, and improves abdominal pain, stool habits, and quality of life in IBS-D.
doi:10.1016/j.cgh.2009.02.023
PMCID: PMC2693479  PMID: 19281859
14.  Not All “Side Effects” of Tricyclic Antidepressants are True Side Effects 
Objectives
Patients with functional gastrointestinal (GI) disorders treated with tricyclic antidepressants may report non-GI symptoms. It is unclear whether these symptoms are side effects of the medication or reflect a general behavioral tendency to report symptoms. This study 1) evaluated whether a checklist of symptoms reported by patients prior to taking desipramine increased in number or worsened in severity after being on a tricyclic antidepressant (desipramine), and 2) assessed baseline factors that predispose patients to report symptoms.
Methods
Female patients in the drug arm of a multi-center NIH treatment trial for functional bowel disorders completed a 15 item symptom questionnaire at baseline before randomization and at 2 weeks after starting Desipramine (n=81), or placebo (n=40) and at study completion 12 weeks later. Patients were asked on each occasion if they experienced any of 15 Symptoms and its level of severity and frequency, and the results were compared.
Results
A total of 57 patients in the desipramine arm who completed the questionnaire at both week 0 and week 2 comprised the study sample. Certain symptoms reported as side effects: dizziness, dry mouth/thirstiness, lightheadedness, feeling jittery or tremors and flushing not only were reported more often but also worsened at week 2 indicating a drug effect. Conversely, other symptoms that were also reported as side effects: feeling tired in AM, nausea, blurred vision, headaches, decreased appetite, and trouble sleeping either did not change in severity or showed improvement at week 2 (tiredness). All these symptoms except trouble sleeping were reported less often at Week 2 than at baseline (Week 2). Psychological distress but not desipramine level significantly correlated with symptom reporting.
Conclusions
The majority of symptoms often attributed to side effects of desipramine were present prior to treatment, and only a few related to its anticholinergic effects worsened 2 weeks after beginning treatment, suggesting that most symptoms considered as side effects were not related to drug per se. Clinicians should consider that “Side effects” may relate more to psychological distress than to drug effects.
doi:10.1016/j.cgh.2008.11.014
PMCID: PMC2702777  PMID: 19167522
15.  Adequate Relief in a Treatment Trial with IBS Patients: A Prospective Assessment 
Background
Adequate relief of IBS symptoms (IBS-AR) has been used as a primary endpoint in many randomized controlled trials of IBS and is considered by the Rome III Committee to be an acceptable primary endpoint. However, controversy exists on whether baseline severity confounds the effect of this treatment patient outcome.
Aims
In a randomized controlled treatment trial (1) to compare subjective report of IBS-AR to global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS) and IBS Quality of Life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the sensitivity of these outcome measures; (3) to determine whether psychological symptoms influence the sensitivity of these measures.
Methods
289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<150), moderate (150-300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or waitlist control.
Results
IBS baseline severity significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (p<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant of effect patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (p=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity.
Conclusions
These data suggest that IBS-AR as an endpoint is confounded with initial IBS symptom severity as measured by baseline reporting of adequate relief. The confounding effects of adequate relief can be eliminated if patients who report adequate relief at screening are excluded from study participation.
doi:10.1038/ajg.2009.13
PMCID: PMC2707022  PMID: 19293784
16.  Complementary and alternative medicine use and cost in functional bowel disorders: A six month prospective study in a large HMO 
Background
Functional Bowel Disorders (FBD) are chronic disorders that are difficult to treat and manage. Many patients and doctors are dissatisfied with the level of improvement in symptoms that can be achieved with standard medical care which may lead them to seek alternatives for care. There are currently no data on the types of Complementary and Alternative Medicine (CAM) used for FBDs other than Irritable Bowel Syndrome (IBS), or on the economic costs of CAM treatments. The aim of this study is to determine prevalence, types and costs of CAM in IBS, functional diarrhea, functional constipation, and functional abdominal pain.
Methods
1012 Patients with FBD were recruited through a health care maintenance organization and followed for 6 months. Questionnaires were used to ascertain: Utilization and expenditures on CAM, symptom severity (IBS-SS), quality of life (IBS-QoL), psychological distress (BSI) and perceived treatment effectiveness. Costs for conventional medical care were extracted from administrative claims.
Results
CAM was used by 35% of patients, at a median yearly cost of $200. The most common CAM types were ginger, massage therapy and yoga. CAM use was associated with female gender, higher education, and anxiety. Satisfaction with physician care and perceived effectiveness of prescription medication were not associated with CAM use. Physician referral to a CAM provider was uncommon but the majority of patients receiving this recommendation followed their physician's advice.
Conclusion
CAM is used by one-third of FBD patients. CAM use does not seem to be driven by dissatisfaction with conventional care. Physicians should discuss CAM use and effectiveness with their patients and refer patients if appropriate.
doi:10.1186/1472-6882-8-46
PMCID: PMC2499988  PMID: 18652682
17.  Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome 
BMJ : British Medical Journal  2008;336(7651):999-1003.
Objective To investigate whether placebo effects can experimentally be separated into the response to three components—assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship—and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.
Design A six week single blind three arm randomised controlled trial.
Setting Academic medical centre.
Participants 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale.
Interventions For three weeks either waiting list (observation), placebo acupuncture alone (“limited”), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence (“augmented”). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.
Main outcome measures Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.
Results At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus “limited” versus “augmented,” respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01).Results were similar at six week follow-up.
Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.
Trial registration Clinical Trials NCT00065403.
doi:10.1136/bmj.39524.439618.25
PMCID: PMC2364862  PMID: 18390493
18.  The Narcotic Bowel Syndrome: Clinical Features, Pathophysiology and Management 
Narcotic bowel syndrome (NBS) is a subset of opioid bowel dysfunction that is characterized by chronic or frequently recurring abdominal pain that worsens with continued or escalating dosages of narcotics. This syndrome is under recognized and may be becoming more prevalent. This may be due in the United States to increases in using narcotics for chronic non-malignant painful disorders, and the development of maladaptive therapeutic interactions around its use. NBS can occur in patients with no prior gastrointestinal disorder who receive high dosages of narcotics after surgery or acute painful problems, among patients with functional GI disorders or other chronic gastrointestinal diseases who are managed by physicians unaware of the hyperalgesic effects of chronic opioids. The evidence for the enhanced pain perception is based on: a) activation of excitatory anti-analgesic pathways within a bimodal opioid regulation system, b) descending facilitation of pain at the Rostral Ventral Medulla and pain facilitation via dynorphin and CCK activation, and c) glial cell activation that produces morphine tolerance and enhances opioid induced pain. Treatment involves early recognition of the syndrome, an effective physician patient relationship, graded withdrawal of the narcotic according to a specified withdrawal program and the institution of medications to reduce withdrawal effects.
doi:10.1016/j.cgh.2007.06.013
PMCID: PMC2074872  PMID: 17916540
19.  Translation and validation of a Japanese version of the irritable bowel syndrome-quality of life measure (IBS-QOL-J) 
Aims
To compare quality of life (QOL) for patients with irritable bowel syndrome (IBS) between the U.S. and Japan, it is indispensable to develop common instruments. The IBS-QOL, which is widely used in Western countries, was translated into Japanese as there has been a lack of Japanese disease-specific QOL measures for IBS.
Methods
The original 34 items of the IBS-QOL were translated from English into Japanese through two independent forward translations, resolution, back translation, and resolution of differences. Forty nine patients who had GI symptoms but did not have any organic diseases (including 30 IBS patients diagnosed by Rome II criteria) were recruited from Tohoku University Hospital in Sendai, Japan and completed a Japanese version of the IBS-QOL (IBS-QOL-J) concomitant with a Japanese version of the IBS severity index (IBSSI-J) twice within 7–14 days.
Results
The IBS-QOL-J demonstrated high internal consistency (Cronbach's alpha; 0.96) and high reproducibility (intraclass correlation coefficient; 0.92, p < 0.001). Convergent analyses confirmed that the overall score of IBS-QOL-J was significantly correlated with overall severity of IBS symptoms on the IBSSI-J (r = -0.36, p = 0.01) and with the individual items on the IBSSI-J that assess interference with life in general (r = -0.47, p = 0.001) and dissatisfaction with bowel habits (r = -0.32, p < 0.05). Eight patients who reported continuous abdominal pain in the past 6 months had significantly lower scores in the IBS-QOL-J than those who did not (53.7 +- 12.7 vs. 73.6 +- 19.5, p < 0.01). Age, sex, education or marital status did not affect scores on the measure.
Conclusion
The IBS-QOL-J is a reliable instrument to assess the disease-specific QOL for IBS. Considering cross-cultural comparison, this measure is likely to be a valuable tool to investigate the QOL in Japanese patients with IBS.
doi:10.1186/1751-0759-1-6
PMCID: PMC1832201  PMID: 17371576
20.  A Randomized Comparison of Alternative Formats for Clinical Simulations 
Computer-based clinical simulations for medical education exhibit wide variation in structure and format, yet few studies have examined which formats are optimal for particular educational settings. This study is a randomized comparison of the same simulated case offered in three formats: a “pedagogic” format offering explicit educational support, a “high fidelity” format attempting to model clinical reasoning in the real world, and a “problem solving” format that required students to express specific diagnostic hypotheses. Data were collected from rising third year medical students using a posttest, attitudinal questionnaire, students' writeups of the case, and log files of students' progress through the simulation. Student performance on all measures differed significantly by format. In general, students using the pedagogic format were more proficient but less efficient. They acquired more information but were able to do proportionately less with it. Students at this level had difficulty generating queries for clinical information using natural language. The results suggest that the format of computer-based simulations is important educationally; a format that works well for one learner population may not work as well for another population with different characteristics.
PMCID: PMC2245724

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