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1.  Clinical trial: Probiotic Bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 Versus Placebo for the Symptoms of Bloating in Patients with Functional Bowel Disorders - a Double-Blind Study 
Recent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders (FBD). Probiotic studies in FBD generated inconsistent results suggesting a strain and product specific effect.
To investigate the clinical efficacy of Lactobacillus acidophilus NCFM (L-NCFM) and Bifidobacterium lactis Bi-07 (B-LBi07) in non-constipation FBD.
A double-blind, placebo-control clinical trial of the probiotic bacteria L-NCFM and B-LBi07 bid (2×1011cfu/day) vs. placebo over 8-weeks. Primary endpoints: global relief of GI symptoms and satisfaction with treatment. Secondary endpoints: Change in symptoms severity, well being, and quality of life. Microbiology effect was assessed by qPCR on fecal samples.
Sixty subjects (probiotic n=31; placebo n=29), 72% females, 84% whites, mean age 37 years. Abdominal bloating improved in the probiotics compared to the placebo group at 4 weeks (4.10 vs. 6.17, p=0.009; change in bloating severity p=0.02) and 8 weeks (4.26 vs. 5.84, p=0.06; change in bloating severity p<0.01). Analyses on the IBS subgroup (n=33) showed similar results.
L-NCFM and B-LBi07 BID improve symptoms of bloating in patients with FBD. This data supports the role of intestinal bacteria in the pathophysiology of FBD and the role for probiotic bacteria in the management of these disorders.
PMCID: PMC4372813  PMID: 21436726
Functional bowel disorders; Irritable Bowel Syndrome; Probiotics; Intestinal microbiota
2.  Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis 
Psychotherapy is not routinely recommended for in ulcerative colitis (UC). Gut-directed hypnotherapy (HYP) has been linked to improved function in the gastrointestinal tract and may operate through immune-mediated pathways in chronic diseases.
To determine the feasibility and acceptability of hypnotherapy and estimate the impact of hypnotherapy on clinical remission status over a 1 year period in patients with an historical flare rate of 1.3 times per year.
54 patients were randomized at a single site to 7 sessions of gut-directed hypnotherapy (N = 26) or attention control (CON; N = 29) and followed for 1 year. The primary outcome was the proportion of participants in each condition that had remained clinically asymptomatic (clinical remission) through 52 weeks post-treatment.
One-way ANOVA comparing hypnotherapy and control subjects on number of days to clinical relapse favored the hypnotherapy condition [F = 4.8 (1, 48), p = .03] by 78 days. Chi square analysis comparing the groups on proportion maintaining remission at 1 year was also significant [X2(1) = 3.9, p = .04], with 68% of hypnotherapy and 40% of control patients maintaining remission for 1 year. There were no significant differences between groups over time in quality of life, medication adherence, perceived stress or psychological factors.
This is the first prospective study that has demonstrated a significant effect of a psychological intervention on prolonging clinical remission in patients with quiescent UC.
Clinical Trial # NCT00798642
PMCID: PMC4271841  PMID: 23957526
ulcerative colitis; hypnotherapy; remission; inflammatory bowel disease; psychological treatment
3.  Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: A randomized trial 
Pain  2013;154(11):10.1016/j.pain.2013.07.028.
Omega-3 and n-6 fatty acids are biosynthetic precursors to lipid mediators with antinociceptive and pronociceptive properties. We conducted a randomized, single-blinded, parallel-group clinical trial to assess clinical and biochemical effects of targeted alteration in dietary n-3 and n-6 fatty acids for treatment of chronic headaches. After a 4-week preintervention phase, ambulatory patients with chronic daily headache undergoing usual care were randomized to 1 of 2 intensive, food-based 12-week dietary interventions: a high n-3 plus low n-6 (H3-L6) intervention, or a low n-6 (L6) intervention. Clinical outcomes included the Headache Impact Test (HIT-6, primary clinical outcome), Headache Days per month, and Headache Hours per day. Biochemical outcomes included the erythrocyte n-6 in highly unsaturated fatty acids (HUFA) score (primary biochemical outcome) and bioactive n-3 and n-6 derivatives. Fifty-six of 67 patients completed the intervention. Both groups achieved targeted intakes of n-3 and n-6 fatty acids. In intention-to-treat analysis, the H3-L6 intervention produced significantly greater improvement in the HIT-6 score (−7.5 vs −2.1; P < 0.001) and the number of Headache Days per month (−8.8 vs −4.0; P = 0.02), compared to the L6 group. The H3-L6 intervention also produced significantly greater reductions in Headache Hours per day (−4.6 vs −1.2; P = 0.01) and the n-6 in HUFA score (−21.0 vs −4.0%; P < 0.001), and greater increases in antinociceptive n-3 pathway markers 18-hydroxy-eicosapentaenoic acid (+118.4 vs +61.1%; P < 0.001) and 17-hydroxy-docosahexaenoic acid (+170.2 vs +27.2; P < 0.001). A dietary intervention increasing n-3 and reducing n-6 fatty acids reduced headache pain, altered antinociceptive lipid mediators, and improved quality-of-life in this population.
PMCID: PMC3850757  PMID: 23886520
Omega-3; Omega-6; Headache; Migraine; Clinical trial
4.  Which psychological factors exacerbate Irritable Bowel Syndrome? Development of a comprehensive model 
Journal of psychosomatic research  2013;74(6):486-492.
There is evidence that psychological factors affect the onset, severity and duration of Irritable Bowel Syndrome (IBS). However, it is not clear which psychological factors are the most important and how they interact. The aims of the current study are to identify the most important psychological factors predicting IBS symptom severity and to investigate how these psychological variables are related to each other.
Study participants were 286 IBS patients who completed a battery of psychological questionnaires including neuroticism, abuse history, life events, anxiety, somatization and catastrophizing. IBS severity measured by the IBS Severity Scale was the dependent variable. Path analysis was performed to determine the associations among the psychological variables, and IBS severity.
Although the hypothesized model showed adequate fit, post hoc model modifications were performed to increase prediction. The final model was significant (Chi2 = 2.2; p=0.82; RMSEA < .05) predicting 36% of variance in IBS severity. Catastrophizing (Standardized coefficient (β)=0.33; p <.001) and Somatization (β=0.20; p <.001) were the only two psychological variables directly associated with IBS severity. Anxiety had an indirect effect on IBS symptoms through catastrophizing (β=0.80; p <.001); as well as somatization (β=0.37; p <.001). Anxiety, in turn, was predicted by neuroticism (β=0.66; p<.001) and stressful life events (β=0.31; p<.001).
While cause-and-effect cannot be determined from these cross-sectional data, the outcomes suggest that the most fruitful approach to curb negative effects of psychological factors on IBS is to reduce catastrophizing and somatization.
PMCID: PMC3673027  PMID: 23731745
Irritable Bowel Syndrome; Psychological distress; Somatization; Catastrophizing; Life Events; Neuroticism
5.  Psychological Treatments in Functional Gastrointestinal Disorders: A Primer for the Gastroenterologist 
The functional gastrointestinal disorders (FGIDs) often show inadequate response to usual medical care. Psychological treatments can help improve FGID patient outcomes, and such treatment should be considered for patients who have moderate or severe symptoms after 3 to 6 months of medical care, and those whose symptoms are clearly exacerbated by stress or emotional symptoms. Effective psychological treatments, based on multiple randomized controlled trials, include cognitive behavioral therapy (CBT) and hypnosis for irritable bowel syndrome and pediatric functional abdominal pain; CBT for functional chest pain; and biofeedback for dyssynergic constipation in adults. Successful referral by the gastroenterologist for psychological treatment is facilitated by educating the patient about the rationale for such treatment, reassurance about the diagnosis and continuation of medical care, firm doctor-patient therapeutic alliance, and identification of, and communication with, an appropriate psychological services provider.
PMCID: PMC3591464  PMID: 23103907
6.  Obstetric Sphincter Injury Interacts with Diarrhea and Urgency to Increase the Risk of Fecal Incontinence in Women with IBS 
To confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with IBS (irritable bowel syndrome), and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI.
The study is a supplement to a diary study of bowel symptoms in 164 female patients with IBS. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement (BM) for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire which included the Fecal Incontinence Severity Index (FISI).
Out of 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least one episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean FISI score was 13.9±9.7. Upon multivariable analysis, FI was significantly associated with parity (p=0.007), operative vaginal delivery (p=0.049), obstetrical sphincter lacerations (p=0.007), fecal urgency (p=0.005), diarrhea (p=0.008), and hysterectomy (p=0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (p=0.002) and diarrhea (p=0.004) were significant risk factors for FI.
Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.
PMCID: PMC3920582  PMID: 23321658
fecal incontinence; obstetric anal sphincter injury; diarrhea; urgency
7.  Therapeutic mechanisms of a mindfulness-based treatment for IBS: Effects on visceral sensitivity, catastrophizing, and affective processing of pain sensations 
Journal of behavioral medicine  2011;35(6):591-602.
Irritable bowel syndrome (IBS) is a prevalent functional disorder characterized by abdominal pain and hypervigilance to gastrointestinal sensations. We hypothesized that mindfulness training (MT), which promotes nonreactive awareness of emotional and sensory experience, may target underlying mechanisms of IBS including affective pain processing and catastrophic appraisals of gastrointestinal sensations. Seventy five female IBS patients were randomly assigned to participate in either 8 weeks of MT or a social support group. A theoretically grounded, multivariate path model tested therapeutic mediators of the effect of MT on IBS severity and quality of life. Results suggest that MT exerts significant therapeutic effects on IBS symptoms by promoting nonreactivity to gut-focused anxiety and catastrophic appraisals of the significance of abdominal sensations coupled with a refocusing of attention onto interoceptive data with less emotional interference. Hence, MT appears to target and ameliorate the underlying pathogenic mechanisms of IBS.
PMCID: PMC3883954  PMID: 22161025
Mindfulness; irritable bowel syndrome; pain; therapeutic mechanisms; path analysis; interoception
8.  Small Intestinal Bacterial Overgrowth in Irritable Bowel Syndrome: Association with Colon Motility, Bowel Symptoms, and Psychological Distress 
Small intestinal bacterial overgrowth (SIBO) has been implicated in the pathogenesis of irritable bowel syndrome (IBS), although with significant controversy.
To determine the prevalence of SIBO in IBS and its association with colonic motility, bowel symptoms and psychological distress.
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.
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).
SIBO is unlikely to contribute significantly in the pathogenesis of IBS. Methane production is associated with constipation.
PMCID: PMC3856223  PMID: 18482250
Small intestinal bacterial overgrowth; Irritable bowel syndrome; Breath test; Methane; Constipation; Visceral hypersensitivity; Psychological
9.  IBS Patients Show Frequent Fluctuations between Loose/Watery and Hard/Lumpy Stools: Implications for Treatment 
The American journal of gastroenterology  2011;107(2):10.1038/ajg.2011.358.
To determine how variable stool consistency is in patients with irritable bowel (IBS) and assess the relationship between stool consistency and gastrointestinal symptoms.
Individuals with a physician diagnosis of IBS were recruited by advertisement. Enrollment questionnaires included the Rome III Diagnostic Questionnaire and IBS Symptom Severity Scale. Then 185 patients meeting Rome criteria for IBS rated the consistency (using the Bristol Stool Scale) of each bowel movement (BM) for 90 days and whether the BM was accompanied by pain, urgency, or soiling. Each night they transferred BM ratings from a paper diary to an internet form and also reported the average daily intensity of abdominal pain, bloating, bowel habit dissatisfaction, and life interference of bowel symptoms. Only the longest sequence of consecutive days of diary data was used in analysis (average of 73 days).
Patients were 89% female with average age 36.6 years. 78% had both loose/watery and hard/lumpy stools; the average was 3 fluctuations between these extremes per month. The proportion of loose/watery stools correlated r=.78 between the first and second months and the proportion of hard/lumpy stools correlated r=.85 between months. Loose/watery stools were associated with more BM-related pain, urgency, and soiling than hard/lumpy or normal stools; however, IBS-C patients had significantly more BM-unrelated abdominal pain, bloating, dissatisfaction with bowel habits, and life interference than IBS-D. Questionnaires overestimated the frequency of abnormal stool consistency and gastrointestinal symptoms compared to diaries.
Stool consistency varies greatly within individuals. However, stool patterns are stable within an individual from month to month. The paradoxical findings of greater symptom severity after individual loose/watery BMs vs. greater overall symptom severity in IBS-C implies different physiological mechanisms for symptoms in constipation compared to diarrhea. Daily symptom monitoring is more sensitive and reliable than a questionnaire.
PMCID: PMC3855407  PMID: 22068664
10.  Development and Validation of New Disease-Specific Measures of Somatization and Comorbidity in IBS 
Journal of psychosomatic research  2012;73(5):10.1016/j.jpsychores.2012.08.007.
To create and validate empirically derived questionnaires that measure non-gastrointestinal symptoms and disorders that co-exist with irritable bowel syndrome (IBS).
A systematic review of the world literature identified all non-GI symptoms and diagnoses known to have excess frequency in IBS patients. This data was used to create the Recent Physical Symptoms Questionnaire (RPSQ), which measures somatization (the psychological tendency to report multiple physical symptoms), and the Comorbid Medical Conditions Questionnaire (CMCQ). The psychometric properties of these questionnaires were assessed in two studies: 109 IBS patients in Study I; 286 IBS patients and 67 healthy controls in Study II.
In Study I, the RPSQ and CMCQ showed high test-retest reliability (r=.88 and .95) and good internal consistency (Cronbach alphas: .86 and .70, respectively). In Study II, principal components analysis demonstrated that the RPSQ is a homogeneous somatization scale, but the CMCQ could be divided into 4 subscales: one for psychiatric disorders and 3 for different types of somatic disorders. Concurrent validity was shown by strong correlations of both the RPSQ and the CMCQ with the Cornell Medical Index (CMI) and the Brief Symptom Inventory-18 (BSI-18) somatization scales. Discriminant validity was modest: the BSI-18 anxiety and depression scales were less strongly correlated with the RPSQ than the BSI-18 somatization scale. The RPSQ and CMCQ scores of IBS patients were significantly higher than the scores of healthy controls (P<.001).
The RPSQ and CMCQ are highly reliable and valid measures of somatization and medical comorbidities in IBS.
PMCID: PMC3855416  PMID: 23062808
Irritable Bowel Syndrome; Comorbidity; Somatization; Validity
11.  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.
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.
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.
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.
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.
PMCID: PMC3855425  PMID: 18684175
irritable bowel syndrome; visceral hypersensitivity; colonic motility; symptom severity; subtypes of bowel habit
American journal of obstetrics and gynecology  2010;202(5):10.1016/j.ajog.2010.01.018.
To estimate the frequency of self-reported fecal incontinence (FI), identify what proportion of these patients have a diagnosis of FI in their medical record, and compare healthcare costs and utilization in patients with different severities of FI to those without FI.
Study Design
Patients in a healthcare maintenance organization were eligible and 1707 completed a survey. Patients with self-reported FI were assessed for a diagnosis of FI in their medical record for the last five years. Healthcare costs and utilization were obtained from claims data.
Fecal incontinence was reported by 36.2% of primary care patients, but only 2.7% of patients with FI had a medical diagnosis. FI adversely affected quality of life and severe FI was associated with 55% higher healthcare costs (including 77% higher gastrointestinal-related healthcare costs) compared to continent patients.
Increased screening of FI is needed.
PMCID: PMC3855440  PMID: 20223447
Fecal incontinence; screening; healthcare costs; healthcare utilization
13.  Neuromodulation for fecal incontinence: An effective surgical intervention 
Fecal incontinence is a disabling symptom with medical and social implications, including fear, embarrassment, isolation and even depression. Most patients live in seclusion and have to plan their life around the symptom, with secondary impairment of their quality of life. Conservative management and biofeedback therapy are reported to benefit a good percentage of those affected. However, surgery must be considered in the non-responder population. Recently, sacral nerve electrostimulation, lately named neuromodulation, has been reported to benefit patients with fecal incontinence in randomized controlled trials more than placebo stimulation and conservative management, by some unknown mechanism. Neuromodulation is a minimally invasive procedure with a low rate of adverse events and apparently favorable cost-efficacy profile. This review is intended to expand knowledge about this effective intervention among the non-surgically skilled community who deals with this disabled group of patients.
PMCID: PMC3819539  PMID: 24222947
Fecal incontinence; Neuromodulation; Sacral nerve stimulation; Biofeedback; Anal sphincter
14.  Association of Low Dietary Intake of Fiber and Liquids with Constipation: Evidence from the National Health and Nutrition Examination Survey (NHANES) 
Epidemiological studies support an association of self-defined constipation with fiber and physical activity, but not liquid intake. The aims of this study were to assess the prevalence and associations of dietary fiber and liquid intake to constipation.
Analyses were based on data from 10,914 adults (≥20 years) from the 2005-2008 cycles of the National Health and Nutrition Examination Surveys (NHANES). Constipation was defined as hard or lumpy stools (Bristol Stool Scale types 1 or 2) as the “usual or most common stool type.” Dietary fiber and liquid intake from total moisture content were obtained from dietary recall. Co-variables included: age, race, education, poverty income ratio, body mass index, self-reported general health status, chronic illnesses, and physical activity. Prevalence estimates and prevalence odds ratios (POR) were analyzed in adjusted multivariable models using appropriate sampling weights.
Overall, 9,373 (85.9%) adults (4,787 women and 4,586 men) had complete stool consistency and dietary data. Constipation rates were 10.2% (95% CI: 9.6,10.9) for women and 4.0 (95% CI: 3.2,5.0) for men (p<.001). After multivariable adjustment, low liquid consumption remained a predictor of constipation among women (POR: 1.3, 95% CI: 1.0,1.6) and men (POR: 2.4, 95% CI: 1.5,3.9); however, dietary fiber was not a predictor. Among women, African-American race/ethnicity (POR: 1.4, 95% CI: 1.0,1.9), being obese (POR: 0.7, 95% CI: 0.5,0.9), and having a higher education level (POR: 0.8, 95% CI: 0.7,0.9) were significantly associated with constipation.
The findings support clinical recommendations to treat constipation with increased liquid, but not fiber or exercise.
PMCID: PMC3786707  PMID: 23567352
constipation; functional bowel disorders; epidemiology
15.  Inability of the Rome III Criteria to Distinguish Functional Constipation from Constipation Subtype Irritable Bowel Syndrome 
Introduction and Aims
The Rome III classification system treats functional constipation (FC) and irritable bowel syndrome with constipation (IBS-C) as distinct disorders, but this distinction appears artificial, and the same drugs are used to treat both. This study’s hypothesis is that FC and IBS-C defined by Rome III are not distinct entities.
1,100 adults with a primary care visit for constipation and 1,700 age and gender matched controls from a health maintenance organization completed surveys 12 months apart; 66.2% returned the first questionnaire. Rome III criteria identified 231 with FC and 201 with IBS-C. The second survey was completed by 195 of the FC and 141 of the IBS-C cohorts. Both surveys assessed the severity of constipation and IBS, quality of life (QOL), and psychological distress.
(1) Overlap: If the Rome III requirement that patients meeting criteria for IBS cannot be diagnosed FC is suspended, 89.5% of IBS-C cases meet criteria for FC and 43.8% of FC patients fulfill criteria for IBS-C. (2) No qualitative differences between FC and IBS-C: 44.8% of FC patients report abdominal pain, and paradoxically IBS-C patients have more constipation symptoms than FC. (3) Switching between diagnoses: by 12 months, 1/3 of FC transition to IBS-C and 1/3 of IBS-C change to FC.
Patients identified by Rome III criteria for FC and IBS-C are not distinct groups. Revisions to the Rome III criteria, possibly including incorporation of physiological tests of transit and pelvic floor function, are needed.
PMCID: PMC3786710  PMID: 20502449
Constipation; Irritable bowel; Diagnostic criteria; Symptom-based diagnosis
16.  Likelihood of Nursing Home Referral for Fecally Incontinent Elderly Patients is Influenced by Physician Views on Nursing Home Care and Outpatient Management of Fecal Incontinence 
(1) Characterize physicians’ management practices for fecal incontinence (FI) among elderly patients, (2) describe physician perceptions of the quality of care for FI provided in nursing homes (NH), and (3) identify physician views and attributes associated with referral of elderly patients with FI to a NH.
United States.
Physician members of the American Geriatrics Society.
Questionnaire pertaining to physician views on (1) their own FI management practices, (2) management of FI in NHs, and (3) referral of an elderly patient with FI to a NH.
Of the respondents (N=606), 54.1% reported screening for FI and 59.3% thought FI could be managed conservatively on an outpatient basis. Only 32.9% believed NHs provide good care for FI, and 27.1% believed NH care conditions exacerbate FI. Responding to a hypothetical vignette, 10.6% would probably or definitely refer an older adult patient with only FI to a NH, and 17.2% were uncertain about whether or not to refer. Logistic regression analysis identified physician characteristics associated with decreased likelihood of NH referral as the belief that FI can be managed conservatively, the belief that NHs provide poor care for FI, longer practice experience, and practicing in an academic medical center.
Most geriatricians believe FI can be managed conservatively and that NH provide poor care for FI. These beliefs plus longer years of practice and practice in an academic setting decrease the likelihood of referral to NH for patients with FI.
PMCID: PMC3129470  PMID: 21450249
Fecal incontinence; nursing home admissions; physician perspectives
17.  The Potential Role of a Self-Management Intervention for Ulcerative Colitis: A Brief Report From the Ulcerative Colitis Hypnotherapy Trial 
Inflammatory bowel diseases (IBD) are chronic inflammatory illnesses marked by unpredictable disease flares, which occur spontaneously and/or in response to external triggers, especially personal health behaviors. Behavioral triggers of flare may be responsive to disease self-management programs. We report on interim findings of a randomized controlled trial of gut-directed hypnotherapy (HYP, n = 19) versus active attention control (CON, n = 17) for quiescent ulcerative colitis (UC). To date, 43 participants have enrolled; after 5 discontinuations (1 in HYP) and 2 exclusions due to excessive missing data, 36 were included in this preliminary analysis. Aim 1 was to determine the feasibility and acceptability of HYP in UC. This was achieved, demonstrated by a reasonable recruitment rate at our outpatient tertiary care clinic (20%), high retention rate (88% total), and our representative IBD sample, which is reflected by an equal distribution of gender, an age range between 21 and 69, recruitment of ethnic minorities (~20%), and disease duration ranging from 1.5 to 35 years. Aim 2 was to estimate effect sizes on key clinical outcomes for use in future trials. Effect sizes (group × time at 20 weeks) were small to medium for IBD self-efficacy (.34), Inflammatory Bowel Disease Questionnaire (IBDQ) total score (.41), IBDQ bowel (.50), and systemic health (.48). Between-group effects were observed for the IBDQ bowel health subscale (HYP > CON; p = .05) at 20 weeks and the Short Form 12 Health Survey Version 2 (SF-12v2) physical component (HYP > CON; p < .05) at posttreatment and 20 weeks. This study supports future clinical trials testing gut-directed HYP as a relapse prevention tool for IBD.
PMCID: PMC3574577  PMID: 21362636
inflammatory bowel disease; ulcerative colitis; self-efficacy; hypnotherapy; self-management
18.  Lubiprostone does not Influence Visceral Pain Thresholds in Patients with Irritable Bowel Syndrome 
In clinical trials, lubiprostone reduced the severity of abdominal pain.
The primary aim was to determine whether lubiprostone raises the threshold for abdominal pain induced by intraluminal balloon distention. A secondary aim was to determine whether changes in pain sensitivity influence clinical pain independently of changes in transit time.
Sixty-two patients with irritable bowel syndrome with constipation (IBS-C) participated in an 8-week crossover study. All subjects completed a 14-day baseline ending with a barostat test of pain and urge sensory thresholds. Half, randomly selected, then received 48 ug/day of lubiprostone for 14 days ending with a pain sensitivity test and a Sitzmark test of transit time. This was followed by a 14-day washout and then a crossover to 14 days of placebo with tests of pain sensitivity and transit time. The other half of the subjects received placebo before lubiprostone. All kept symptom diaries.
Stools were significantly softer when taking lubiprostone compared to placebo (Bristol Stool scores 4.20 vs. 3.44, p<0.001). However, thresholds for pain (17.36 vs. 17.83 mmHg, lubiprostone vs. placebo) and urgency to defecate (14.14 vs. 14.53 mmHg) were not affected by lubiprostone. Transit time was not significantly different between lubiprostone and placebo (51.27 vs. 51.81 hours), and neither pain sensitivity nor transit time was a significant predictor of clinical pain.
Lubiprostone has no effect on visceral sensory thresholds. The reductions in clinical pain that occur while taking lubiprostone appear to be secondary to changes in stool consistency.
PMCID: PMC3184461  PMID: 21914041
19.  Survey of Geriatricians on the Impact of Fecal Incontinence on Nursing Home Referral 
Determine the impact of fecal incontinence (FI) in health care providers’ decisions to refer patients for nursing home (NH) placement.
Survey of members of the American Geriatrics Society (AGS).
The survey presented a clinical scenario of a 70-year-old woman ready for discharge from a hospital and asked their likelihood of making a NH referral if the patient had (a) no incontinence, (b) urinary incontinence (UI) alone, or (c) FI. Subsequent questions modified the clinical situation to include other conditions that might affect the decision to refer. A second survey of respondents to Survey 1 addressed possible moderators of the decision to refer (e.g., family caregiver presence, diarrhea or constipation, other physical or psychiatric limitations). Significance of differences in the relative risk (RR) for NH referral was tested by Chi square.
716 members (24.7% response rate) completed the first survey and 686 of 716 (96%) completed the second. The likelihood of NH referral was increased by FI (RR=4.71, p<0.001) more than UI (RR=1.90, p<0.001). Mobility restrictions, cognitive decline, and multiple chronic illnesses increased the likelihood of NH referral more than FI alone (p<0.001 for each), but in all scenarios, adding FI further increased the likelihood of referral (p<0.001). Having family caregivers willing to help with toileting attenuated the likelihood of referral.
FI increases the probability that geriatricians will refer to a NH. More aggressive outpatient treatment of FI could possibly delay or prevent NH referral, improve quality of life, and reduce healthcare costs.
PMCID: PMC2924928  PMID: 20487073
Fecal Incontinence; Nursing Home referral; Hospital discharge; Physician survey; Caregiver; Urinary incontinence
20.  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.
The aim was to determine whether lower visceral pain thresholds in irritable bowel syndrome (IBS) primarily reflect physiological or psychological factors.
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).
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.
Increased colonic sensitivity in IBS is strongly influenced by a psychological tendency to report pain and urge rather than increased neurosensory sensitivity.
PMCID: PMC1954968  PMID: 17483191
hypersensitivity; hypervigilance; perceptual response bias; irritable bowel syndrome
21.  Parental Worries and Beliefs about Abdominal Pain 
Solicitous parental responses to stomach aches may perpetuate chronic abdominal pain in children. Discussing these issues in clinical practice is difficult as parents feel misunderstood and blamed for their child’s pain. Focusing on parental worries and beliefs that motivate solicitous responses may be better accepted.
Our aim was to determine parental fears, worries and beliefs about their child’s chronic abdominal pain that influence parental responses to child’s pain.
In two studies, a large online sample and a smaller community sample consisting of parents with children who suffer from abdominal pain, we developed and evaluated a self-report questionnaire to assess parental Worries and Beliefs about Abdominal Pain (WAP).
Principal component analysis identified four subscales: (1) Pain-is-Real; (2) Desire for Care; (3) Worry about Coping; and (4) Exacerbating Factors. The WAP is easily understood and possesses adequate initial reliability (Cronbach alphas of .7–.9) and shows good initial validity (i.e., families who consulted a physician for their child’s pain scored higher on the WAP than families who did not consult a physician and the WAP correlates with parental reactions to the child’s pain).
Discussing parents’ fears and worries about their children’s chronic abdominal pain may facilitate discussions of social learning of gastrointestinal illness behavior.
PMCID: PMC2654586  PMID: 19274787
22.  Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial 
Irritable bowel syndrome (IBS), a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS.
The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format) or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale [1].
214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies.
Trial Registration
Clinical Identifier: NCT00680693
PMCID: PMC2729728  PMID: 19638214
23.  Hypnosis and upper digestive function and disease 
Hypnosis is a therapeutic technique that primarily involves attentive receptive concentration. Even though a small number of health professionals are trained in hypnosis and lingering myths and misconceptions associated with this method have hampered its widespread use to treat medical conditions, hypnotherapy has gained relevance as an effective treatment for irritable bowel syndrome not responsive to standard care. More recently, a few studies have addressed the potential influence of hypnosis on upper digestive function and disease. This paper reviews the efficacy of hypnosis in the modulation of upper digestive motor and secretory function. The present evidence of the effectiveness of hypnotherapy as a treatment for functional and organic diseases of the upper bowel is also summarized, coupled with a discussion of potential mechanisms of its therapeutic action.
PMCID: PMC2768043  PMID: 19009639
Hypnosis; Hypnotherapy; Gastric emptying; Small bowel transit; Functional dyspepsia; Functional esophageal disorders; Functional bowel disorders
24.  Complementary and alternative medicine use and cost in functional bowel disorders: A six month prospective study in a large HMO 
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.
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.
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.
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.
PMCID: PMC2499988  PMID: 18652682
25.  Translation and validation of a Japanese version of the irritable bowel syndrome-quality of life measure (IBS-QOL-J) 
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.
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.
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.
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.
PMCID: PMC1832201  PMID: 17371576

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