Irritable Bowel Syndrome Severity Research Articles

Involvement of peripheral alpha2A adrenoceptor in the acceleration of gastrointestinal transit and abdominal visceral pain induced by intermittent deprivation of REM sleep

Many studies have associated sleep alterations with the severity of irritable bowel syndrome (IBS) symptoms, but the direct pathophysiological relationship has not been clarified. In addition, alterations in noradrenergic signaling have been implicated in the pathophysiology of IBS, and alpha2-adrenoceptors are potential treatment targets. We have previously shown that acceleration of gastrointestinal transit (GIT) elicited by intermittent rapid eye movement (REM) sleep deprivation stress may fulfill the profile of a model of IBS. Moreover, we showed hypernoradrenergic function in the brain of sleep-deprived mice. On the other hand, acetic acid-induced writhes indicate visceral pain features of IBS model animals. In this study, using mice, we investigated whether intermittent REM sleep deprivation stress causes changes in acetic acid-induced writhing and whether the number of writhes and GIT are improved by administration of the hydrophilic clonidine analogue, ST-91. Mice were deprived of REM sleep intermittently using the small-platform method (20h/day) for 3days. The intermittent REM sleep deprivation stress elicited acceleration of GIT and the increased number of writhes was significantly improved by ST-91 treatment. The ID50 values of ST-91 on the GIT in cage-control mice and intermittent REM sleep-deprived mice were 0.24 and 0.70mg/kg, respectively. In addition, the ID50 values of ST-91 on the writhes in cage-control mice and intermittent REM sleep-deprived mice were 0.52 and 0.73mg/kg, respectively. Further, the expression of alpha2A-adrenoceptor was decreased in the distal ileum of intermittent REM sleep-deprived mice compared to that in cage-control mice. Moreover, the effects of ST-91 on GIT and writhes in cage-control and intermittent REM sleep-deprived mice were decreased by the administration of BRL44408 (6mg/kg, i.p.), a selective alpha2A–adrenoceptor antagonist, and not by the administration of imiloxan (3mg/kg, i.p.), or JP-1302 (3mg/kg, i.p.), selective alpha2B-and alpha2C–adrenoceptor antagonists, respectively. These results suggest that the increase in GIT and writhes induced by intermittent REM sleep deprivation stress may serve as a model of diarrhea and visceral pain symptoms in IBS. Further, the onset of these symptoms may be related to the hypofunction of peripheral alpha2A–adrenoceptor.

Implicit Identification with Illness in Patients with Irritable Bowel Syndrome (IBS)

Identification with pain has been linked to symptom severity in chronic pain conditions. However, the role of identification with illness in patients with Irritable Bowel Syndrome (IBS) is unknown. We investigated whether participants with IBS show identification with illness and if the degree of illness identification is related to IBS symptom severity and additional physical and psychological variables. In this cross-sectional study, 42 participants with IBS and 41 healthy participants completed an Implicit Association Test (IAT) to measure their level of identification with illness and health. Data on illness duration, explicit illness associations, IBS severity, depression, anxiety, stress and additional symptoms were obtained. IBS participants scored significantly lower on identification with health than healthy participants. The level of health identification was negatively correlated with ‘Nonspecific Somatic Symptoms’. Reduced health identification may be a maintaining factor of IBS that could be targeted with psychological treatments to reduce symptoms. Further, it may be possible to use the IAT to monitor the course of recovery.

Increased Postprandial Colonic Motility and Autonomic Nervous System Activity in Patients With Irritable Bowel Syndrome: A Prospective Study.

Background/AimsThe prevalence and severity of irritable bowel syndrome (IBS) declines with age, but the cause of this is unknown. This study tested 2 hypotheses: (1) autonomic nervous system responses to eating and bowel distention, measured by heart rate variability (HRV), differs by age in IBS patients and (2) HRV is correlated with colonic motility and IBS symptoms.MethodsOne hundred and fifty-six Rome III positive IBS patients and 31 healthy controls underwent colonic manometry with bag distention in the descending colon, followed by ingestion of an 810-kcal meal. HRV, evaluated by low frequency (%LF; 0.04–0.15 Hz) component, high frequency (%HF; 0.15–0.40 Hz) component, and the LF/HF ratio, was measured during colonic distention and after the meal. Motility index and subjective symptom scores were simultaneously quantified.ResultsBoth colonic distention and eating decreased %HF and increased the LF/HF ratio, and both indices of autonomic nervous system correlated with age. In IBS patients, %HF negatively correlated with the postprandial motility index after adjusting for age. The %HF and LF/HF ratios also correlated with psychological symptoms but not bowel symptoms in IBS patients.ConclusionDecreased vagal activity is associated with increase in age and greater postprandial colonic motility in patients with IBS, which may contribute to postprandial symptoms.

Prevalence and Associated Factors of Insomnia in College Students with Irritable Bowel Syndrome

Purpose: The purpose of this study was to identify factors associated with insomnia in college students with Irritable Bowel Syndrome (IBS). Methods: College students with IBS (n=259) were recruited in 4 universities in Daegu city and Ulsan city, South Korea. Participants completed questionnaires measuring the following variables: insomnia (Insomnia Severity Index [ISI]), dysfunctional beliefs and attitudes about sleep (Dysfunctional Beliefs and Attitudes about Sleep Scale-16 [DBAS-16]), pre-sleep arousal (Pre-Sleep Arousal Scale [PSAS]), gastrointestinal symptoms during sleep (Gastrointestinal Symptoms during Sleep), sleep hygiene (Sleep Hygiene Practices Scale [SHPS]), psychological distress (Brief Symptom Inventory-18 [BSI-18]), and IBS symptom severity(IBS Severity Scoring System [IBS-SSS]). Results: In our participants, 53.3%(n=138) reported having insomnia (ISI score ≥10). Compared to the non-insomnia group (n=121), the insomnia group reported significantly higher scores in DBAS-16, PSAS, gastrointestinal symptoms during sleep, IBS-SSS, SHPS, and BSI-18 (p＜.001 for all). Multiple logistic regression analysis revealed that gastrointestinal symptoms during sleep (Odds Ratio [OR]=2.77, 95% Confidence Interval [CI]: 1.29~5.96), dysfunctional beliefs and attitudes about sleep (OR=1.04, 95% CI: 1.03~1.06), cognitive arousal before sleep (OR=1.10, 95% CI: 1.05~1.17), and somatization (OR=1.12, 95% CI: 1.02~1.23) were associated with insomnia in this sample. Conclusion: Our findings indicate that insomnia is a serious problem for college students with IBS and that gastrointestinal symptoms during sleep and sleep related dysfunctional cognitions should be managed to improve insomnia of them.

Correlates of Body Mass Index in Moderate to Severe Irritable Bowel Syndrome Patients

SII es un trastorno gastrointestinal común y potencialmente incapacitante, susceptible a las influencias psicológicas fuertes, especialmente entre los pacientes más graves. Se sabe poco sobre el papel de los factores del estilo de vida (p.ej. obesidad) que influyen en la trayectoria de otras enfermedades crónicas. Este estudio ha examinado la correlación entre la obesidad y los diferentes aspectos de la experiencia de enfermedad en los pacientes más graves con el SII. Nuestra hipótesis fue que el SII se podría correlacionar positivamente con peores resultados de salud, incluyendo síntomas más graves del SII, molestias extraintestinales y angustia emocional. Durante el pretratamiento, en una prueba de comportamiento basada en NIH, 448 pacientes con el SII diagnosticados mediante los criterios de Roma (MEDAD = 41, MIMC = 26, F = 8%) fueron sometidos a una batería de prueba que incluía una variedad de variables clínicas (gravedad del SII, miedo de síntomas gastrointestinales, IMC etc.) y sociodemográficas (p. ej. edad etc.) El IMC fue positiva y significativamente correlacionado con la somatización (molestias somáticas inexplicadas), pero no con la gravedad de los síntomas del SII o angustia emocional. Una serie de múltiples análisis regresivos moderados demostró que la relación entre el IMC y la somatización fue moderada por la interacción entre el IMC, la edad y el miedo de los síntomas gastrointestinales. Los pacientes mayores con el IMC más alto mostraron niveles de somatización más altos, y los pacientes que tenían más miedo de los síntomas gastrointestinales tenían más posibilidad de sufrir la somatización si tenían también el IMC alto. Estos datos subrayan la relación entre los factores de estilo de vida y los síntomas extraintestinales entre los pacientes más graves con el SII, tanto como el impacto que tienen factores sociodemográficos (edad) y psicosociales (miedo de los síntomas gastrointestinales) en su relación.

Prevalence of severe irritable bowel syndrome among Italian adults. A meta-analysis.

To provide a summary estimate of the prevalence of irritable bowel syndrome (IBS) and IBS with severe symptomatology, stratified by gender and subtype, among Italian adults. We searched MedLine and Scopus databases to identify surveys on IBS prevalence among Italian samples, and/or severe IBS prevalence among Caucasian populations, up to June 2017. Random-effect proportion meta-analyses were used to obtain summary estimates of IBS prevalence. Raw numbers of adults with IBS or severe IBS were computed multiplying pooled prevalence estimates by the current Italian adult population. For both IBS and severe IBS, several estimates were provided according to different scenarios, using the pooled estimates from meta-analyses, their highest and lowest 95% confidence intervals (CI), and the lowest prevalence among all individual studies. The pooled prevalence of IBS among Italian adults, resulting from a meta-analysis of 5 studies including 40,654 subjects, was 7.7% (95% CI: 6.0%-9.7%). The lowest published estimate was 5.4%. The overall number of Italian adults with IBS may thus range between a minimum of 2,736,700 (1,797,800 females; 65.7%) and 4,915,800. From a meta-analysis of 17 studies including 16,873 subjects, the pooled proportion of severe IBS was 23.5% (95% CI: 18.7%-28.7%), with a lowest published estimate of 8.4%. The overall number of Italian adults with severe IBS may thus range between 229,900 (86,600 with constipation-predominant subtype; 70,600 diarrhea-predominant; 72,600 mixed/alternating) and 1,410,800. In a standard, still conservative scenario, based upon the lowest 95% CIs from meta-analyses, the Italians with severe IBS would be 511,800. Using an extremely conservative, lowest plausible estimate, no less than 230,000 Italian adults are suffering from severe IBS, requiring appropriate treatment and recognition by healthcare providers. A standardized instrument to measure IBS severity is urgently required to support diagnostic and therapeutic processes, and improve the precision of epidemiological estimates.

Design and validation of a German version of the GSRS-IBS - an analysis of its psychometric quality and factorial structure

BackgroundCurrently, a suitable questionnaire in German language is not available to monitor the progression and evaluate the severity of irritable bowel syndrome (IBS). Therefore, this study aimed to translate the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) into German and to evaluate its psychometric qualities and factorial structure.MethodsThis study is based on a total sample of 372 participants [62.6% female, mean age = 41 years (SD = 17 years)]. 17.5% of the participants had a diagnosis of IBS, 19.9% were receiving treatment for chronic inflammatory bowel disease, 12.1% of the participants were recruited from a psychosomatic clinic, and 50.5% belonged to a control group. All participants completed the German version of GSRS-IBS (called Reizdarm-Fragebogen, RDF), as well as the Gießen Subjective Complaints List (GBB-24) and the Hospital Anxiety and Depression Scale - German version (HADS-D).ResultsThe internal consistency of the RDF total scale was at least satisfactory in all subsamples (Cronbach’s Alpha between .77 and .92), and for all subscales (Cronbach’s Alpha between .79 and .91). The item difficulties (between .25 and .73) and the item-total correlations (between .48 and .83) were equally satisfactory. Principal axis analysis revealed a four-factorial structure of the RDF items, which mainly resembled the structure of the English original. Convergent validity was established based on substantial and significant correlations with the stomach-complaint scale of the GBB-24 (r = .71; p < .01) and the anxiety (r = .42; p < .01) and depression scales (r = .43; p < .01) of the HADS-D.ConclusionThe German version of the GSRS-IBS RDF proves to be an effective, reliable, and valid questionnaire for the assessment of symptom severity in IBS, which can be used in clinical practice as well as in clinical studies.

Positive and negative affect mediate the bidirectional relationship between emotional processing and symptom severity and impact in irritable bowel syndrome

IntroductionIndividuals with IBS report higher levels of psychological distress compared to healthy controls. Distress has been associated with emotional processing difficulties but studies have not explored how the relationship between distress and emotional processing affects IBS. There is little research on the role of positive affect (PA) in IBS. Aims(a) If difficulties in self-reported emotional processing are associated with affect and IBS measures (i.e., symptom severity, interference in life roles) (b1) If affect mediates the relationship between emotional processing and IBS measures (b2) Alternative model: if affect mediates the relationship between IBS and emotional processing (c) If PA moderates the relationship between distress and IBS. MethodsParticipants with a confirmed diagnosis of IBS (n=558) completed a questionnaire including measures of emotional processing (i.e., unhelpful beliefs about negative emotions, impoverished emotional experience), distress, PA, and IBS symptoms/interference. Mediation and moderation analyses were conducted with Maximum Likelihood Estimation. ResultsDistress and PA mediated or partly mediated the relationship between unhelpful beliefs about negative emotions/impoverished emotional experience and both IBS measures. The alternative models were also valid, suggesting a two-way relationship between emotional processing and IBS through affect. PA did not moderate the relationship between distress and IBS. ConclusionFuture interventions in IBS may benefit from not only targeting the management of physical symptoms and their daily impact but also aspects related to the experience of both negative and positive affect, and the acceptance and expression of negative emotions. Longitudinal studies are needed to confirm causal relationships within the explored models.

Does the low FODMAP diet improve symptoms of radiation-induced enteropathy? A pilot study

Rationale: Patients with radiation-induced enteropathy (RE) after cancer treatment show similar symptoms as patients with irritable bowel syndrome (IBS). The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD) is a widespread management strategy for IBS. We aimed to investigate if there may be a positive effect of LFD on symptoms and health-related quality of life (HRQOL) in patients with RE.Methods: In an open non-controlled pilot study, 11 patients (all female) with RE-related IBS symptoms were recruited largely based on own initiative. All followed LFD for four weeks. IBS Severity Scoring System (IBS-SSS) and IBS Symptom Questionnaire (IBS-SQ) were used to assess symptoms. Short Form Nepean Dyspepsia Index (SF-NDI) and 12-item Short Form Health Survey (SF-12) evaluated HRQOL. A three day food record was used to estimate baseline intake of FODMAPs and to reveal dietary changes.Results: FODMAP intake was successfully reduced, although LFD was found a burdensome intervention. IBS symptoms improved significantly based on mean total score of IBS-SSS and IBS-SQ, which changed from 310.2 ± 60.7 to 171.4 ± 107.2 (p = .001) and 27.4 ± 4.1 to 15.7 ± 10.1 (p = .002). HRQOL improved based on SF-NDI total score (30.5 ± 9.4 to 18.3 ± 8.2, p = .001) and based on mental (p = .047) and physical (p = .134) score of SF-12. Main additional dietary changes were reduced intake of energy, carbohydrates, and fiber.Conclusion: Our findings from this small-scaled pilot study indicate that the LFD may alleviate symptoms and improve HRQOL in patients with RE. Further controlled studies with larger sample size should be conducted to verify our results and hopefully enable implementation of LFD as a future part of the management strategy for RE.

Symptom Severity Following Rifaximin and the Probiotic VSL#3 in Patients with Chronic Pelvic Pain Syndrome (Due to Inflammatory Prostatitis) Plus Irritable Bowel Syndrome.

This study investigated the effects of long-term treatment with rifaximin and the probiotic VSL#3 on uro-genital and gastrointestinal symptoms in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) plus diarrhoea-predominant irritable bowel syndrome (D-IBS) compared with patients with D-IBS alone. Eighty-five patients with CP/CPPS (45 with subtype IIIa and 40 with IIIb) plus D-IBS according to the Rome III criteria and an aged-matched control-group of patients with D-IBS alone (n = 75) received rifaximin and VSL#3. The primary endpoints were the response rates of IBS and CP/CPPS symptoms, assessed respectively through Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) and The National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), and performed at the start of therapy (V0) and three months after (V3). In IIIa prostatitis patients, the total NIH-CPSI scores significantly (p < 0.05) decreased from a baseline mean value of 21.2 to 14.5 at V3 , as did all subscales, and in the IIIb the total NIH-CPSI score also significantly decreased (from 17.4 to 15.1). Patients with IBS alone showed no significant differences in NIH-CPSI score. At V3, significantly greater improvement in the IBS-SSS and responder rate were found in IIIa patients. Our results were explained through a better individual response at V3 in IIIa prostatitis of urinary and gastrointestinal symptoms, while mean leukocyte counts on expressed prostate secretion (EPS) after prostate massage significantly lowered only in IIIa cases.

Patient with Severe Constipation-Predominant Irritable Bowel Syndrome Successfully Treated With Encapsulated Lyophilized Full Spectrum Microbiota: A Case Study

Patient with Severe Constipation-Predominant Irritable Bowel Syndrome Successfully Treated With Encapsulated Lyophilized Full Spectrum Microbiota: A Case Study

Correlates of Body Mass Index in Moderate to Severe Irritable Bowel Syndrome Patients

Correlates of Body Mass Index in Moderate to Severe Irritable Bowel Syndrome Patients

Symptomatic characteristics and factors related to severity of irritable bowel syndrome

Objective To analyze symptomatic characteristics and the factors related to severity of irritable bowel syndrome (IBS). Methods Total 516 IBS patients met Rome Ⅲ criteria were enrolled in the study from June 2009 to February 2016.A questionnaire survey was conducted in face-to-face manner, including intestinal and extra-intestinal symptoms, sleeping and psychological status.Severity of IBS was determined by symptom scores. Results Among 516 patients, there were 135 cases with mild symptoms (26.2%), 267 with moderate symptoms (51.7%) and 114 with severe symptoms (22.1%). Periumbilical pain/discomfort associated with defecation was a common symptom location (34.6%, 178/516), however, 53.3% (275/516) patients also reported having abdominal pain/discomfort during non-defecation period.In IBS patients, 51.2% (264/516) were coexisted with gastroesophageal reflux disease (GERD), 59.1% (305/516) with functional dyspepsia (FD), and 46.9% (242/516) with depression.The prevalence of ordinary abdominal pain/discomfort[57.0%(217/381) vs. 43.0%(58/135), χ2=7.841], sensation of incomplete defecation[74.5%(284/381)vs. 61.5%(83/135), χ2=8.277] and coexisted GERD[54.1%(206/381) vs. 43.0%(58/135), χ2=4.920], FD[64.0%(244/381)vs. 45.2%(61/135), χ2=14.664], headache[50.7%(193/381)vs. 38.5%(52/135), χ2=5.889] and depression[52.2%(199/381)vs. 31.9%(43/135), χ2=16.623] in patients with moderate to severe symptoms were significantly higher than that in patients with mild symptoms(all P<0.05). The predictors to moderate-severe IBS symptoms were coexisted FD (OR=1.798, 95%CI: 1.162-2.783, P=0.010) and depression (OR=1.696, 95%CI: 1.043-2.759, P=0.014). Conclusion The symptoms of IBS patients are various, and patients coexisted with FD and depression are more likely to have more severe symptoms. Key words: Irritable bowel syndrome; Severity of illness index; Comorbidity

Factors Associated with Severity of Irritable Bowel Syndrome Symptoms in Patients with Endometriosis.

This study sought to examine factors associated with severity of irritable bowel syndrome (IBS) by using the Birmingham IBS symptom scale in patients presenting with endometriosis to a tertiary referral centre. A prospective research cohort of patients presenting to a tertiary referral centre for endometriosis was evaluated for the presence and severity of IBS between December 2013 and April 2015. Patients with endometriosis had a diagnosis of IBS by using the Rome III criteria and were evaluated for severity of IBS symptoms by using the Birmingham IBS symptom scale. Multifactorial variables, including stage of endometriosis at the time of previous surgery, clinical examination findings, mood disorder questionnaire scores, and lifestyle factors, were evaluated using the t test and Spearman rank correlation test. A total of 194 of 373 (52%) women with confirmed endometriosis had a diagnosis of IBS. Factors associated with severity of IBS symptoms in patients with endometriosis included lower-stage endometriosis (P = 0.004), presence of mood disorders (P <0.001), tenderness on physical examination (P ≤ 0.001), a history of sexual assault (P ≤ 0.02), and presence of sleep disturbance (P ≤ 0.01). Evaluation of the subscales of the Birmingham IBS symptom scale revealed a strong association between the previously identified factors and the pain subscale. Using the Birmingham IBS symptom scale, our study revealed more severe IBS symptoms in patients with lower-stage endometriosis and identified other variables highly associated with severity of IBS. Continued research is required to characterize further the clinical importance of IBS symptoms in patients with endometriosis-associated pelvic pain.

The role of high expectations of self and social desirability in emotional processing in individuals with irritable bowel syndrome: A qualitative study.

Although high levels of distress are associated with the onset and severity of Irritable bowel syndrome (IBS), it is unclear how this relates to emotional processing, particularly in relation to maintenance of symptoms and treatment outcome. This qualitative study embedded within a randomized controlled trial aimed to explore how individuals with refractory IBS experience, express, and manage their emotions after either therapist-delivered cognitive behavioural therapy (TCBT) or Web-based CBT (WBCBT) compared to treatment as usual (TAU). Cross-sectional qualitative study. Fifty-two semi-structured interviews were conducted at post-treatment with 17 TCBT, 17 WBCBT, and 18 TAU participants. The transcripts were analysed using inductive thematic analysis with grounded theory elements. NVivo 11 was used to compare themes across groups. Across all groups, high expectations of self was a recurring reason for how participants experienced and expressed their emotions. Three themes with subthemes captured how high expectations related to specific aspects of emotional processing: perceived causes of emotions, strategies for coping with emotions (bottling up, avoiding emotions, and active coping strategies), and the perceived interplay between emotions and IBS symptoms. Patients recognized that their IBS symptoms both triggered and were triggered by negative emotions. However, there was a tendency to bottle up or avoid negative emotions for reasons of social desirability regardless of whether patients had CBT for IBS or not. Future psychological interventions in IBS may benefit from addressing negative beliefs about expressing emotions, promoting assertive emotional expression, and encouraging the experience of positive emotions. Statement of contribution What is already known on this subject? High levels of distress are consistently associated with both the onset and maintenance of IBS symptoms. Little is known about how this relates to the concept of emotional processing. Preliminary findings suggest a positive correlation between poor emotional processing and IBS. However, further studies need to confirm its role in relation to aetiology, maintenance of symptoms, and response to treatment. What does this study add? High expectations of self and social desirability seem to be important aspects shaping the way individuals with IBS experience, express, and manage their emotions. Emotional avoidance and bottling up were reported as key strategies to cope with negative emotions. The study revealed that bottling up is not perceived as an all-or-nothing strategy but can be applied selectively depending on the context. Psychological interventions in IBS may benefit from addressing not only illness-related causes of negative emotions but also personal and social triggers of distress.

Mixture model analysis identifies irritable bowel syndrome subgroups characterised by specific profiles of gastrointestinal, extraintestinal somatic and psychological symptoms.

Current subgrouping of Irritable Bowel Syndrome (IBS) is exclusively based on stool consistency without considering other relevant gastrointestinal (GI), extraintestinal somatic or psychological features. To identify subgroups based on a comprehensive set of IBS-related parameters. Mixture model analysis was used, with the following input variables: 13 single-item scores from the IBS-specific Gastrointestinal Symptom Rating Scale, average stool consistency and frequency from a 7-day Bristol Stool Form diary, 12 single-item extraintestinal symptom scores from the Patient Health Questionnaire-12, and anxiety and depression subscale scores from the Hospital Anxiety and Depression scale. The resulting latent subgroups were compared regarding symptom profiles using analysis of variance followed by pair-wise comparisons. One hundred and seventy-two IBS patients (Rome III; 69% female; mean age 33.7 [range 18-60] years) were included. The optimal subgrouping showed six latent groups, characterised by: (I) constipation with low comorbidities, (II) constipation with high comorbidities, (III) diarrhoea with low comorbidities, (IV) diarrhoea and pain with high comorbidities, (V) mixed GI symptoms with high comorbidities, (VI) a mix of symptoms with overall mild severity. The subgroups showed differences in the distribution of Rome III-subtypes, IBS severity, presence of anxiety and depression, and gender, but not regarding age, IBS duration or reported post-infectious onset of IBS. This model-based subgrouping of IBS partly supports the distinction of subgroups based on bowel habits, but additionally distinguishes subgroups with or without co-morbid extraintestinal somatic and psychological symptoms. The resulting groups show specific profiles of symptom combinations.

Diarrhea-predominant irritable bowel syndrome: creation of an electronic version of a patient-reported outcome instrument by conversion from a pen-and-paper version and evaluation of their equivalence

BackgroundSubjects with diarrhea-predominant irritable bowel syndrome (IBS-D) experience abdominal cramping, bloating, pressure, and pain. Due to an absence of clinical biomarkers for IBS-D severity, evaluation of clinical therapy benefits depends on valid and reliable symptom assessments. A patient-reported outcome (PRO) instrument has been developed, comprising of two questionnaires – the IBS-D Daily Symptom Diary and IBS-D Symptom Event Log – suitable for clinical trials and real-world settings. This program aimed to support instrument conversion from pen-and-paper to electronic format.Materials and methodsDigital technology (Android/iOS) and a traditional mode of administration study in the target population were used to migrate or convert the validated PRO IBS-D pen-and-paper measure to an electronic format. Equivalence interviews, conducted in three waves, each had three parts: 1) conceptual equivalence testing between formats, 2) electronic-version report-history cognitive debriefing, and 3) electronic version usability evaluation. After each inter-view wave, preliminary analyses were conducted and modifications made to the electronic version, before the next wave. Final revisions were based on a full analysis of equivalence interviews. The final analysis evaluated subjects’ ability to read, understand, and provide meaningful responses to the instruments across both formats. Responses were classified according to conceptual equivalence between formats and mobile-format usability assessed with a questionnaire and open-ended probes.ResultsEquivalence interviews (n=25) demonstrated conceptual equivalence between formats. Mobile-application cognitive debriefing showed some subjects experienced difficulty with font/screen visibility and understanding or reading some report-history charts and summary screens. To address difficulties, minor revisions/modifications were made and landscape orientation and zoom-in/zoom-out features incorporated.ConclusionThis study indicates that the two administration modes are conceptually equivalent. Since both formats are conceptually equivalent, both are psychometrically reliable, as established in the pen-and-paper version. Subjects found both mobile applications (Android/iOS) offered many advantages over the paper version, such as real-time assessment of their experience.

Diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols, and quality of life in patients with irritable bowel syndrome in Colombia

A growing body of evidence has pointed out the effectiveness of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) in patients with irritable bowel syndrome. However, there are no local studies to estimate the effects of this strategy on the symptoms and the health-related quality of life in these patients in Colombia or Latin America. To determine the effect of a diet low in FODMAP on the quality of life and the severity of symptoms in patients with irritable bowel syndrome in Colombia. We collected clinical and demographic information of all patients at the time of inclusion. Immediately afterwards, a trained interviewer applied the IBS-QoL survey to estimate the quality of life of patients. Then, we evaluated the intensity of the symptoms using an analogue visual scale, before and after the diet low in FODMAP. We included 50 subjects in the final analysis. We observed an increase in all the IBS-QoL scales (average increase in overall summary: 14.7 points, 95% CI: 9.4 to 20.1; p<0.001) and a significant reduction in all symptoms (-19.8 mm; 95% CI: 23.4 mm 16.2 mm; p<0.001). Sex, age, body mass index, socioeconomic status and the health care provider were not associated with the improvement in the health-related quality of life. A low diet in FODMAP reduced symptoms and improved quality of life in Colombian patients with irritable bowel syndrome. Controlled studies taking into account other factors linked to the severity of irritable bowel syndrome are required.

High risk of lower urinary tract symptoms in patients with irritable bowel syndrome.

The aim of the present study was to investigate the prevalence of urinary tract infection (UTI) and the risk of lower urinary tract symptoms (LUTS) in women with irritable bowel syndrome (IBS) (including each subtype: constipation, diarrhea, and mixed) compared to women in the general population. Between January 2014 and December 2015, consecutive adult female patients diagnosed with IBS at the outpatient clinic of the University of Salerno and healthy women with regular bowel habits were enrolled in the study. At baseline, we checked for UTI with a dipstick test and questioned patients about the presence of LUTS in the previous 24h. We enrolled 141 IBS patients and 91 healthy controls in the study. There was no difference in the prevalence of UTI between IBS patients and healthy controls (4.9 vs 3.3%, p=0.5). When we excluded patients with UTI, we found a 2.79 higher risk of increased urinary frequency [odds ratio (OR) 2.79, 95% confidence interval (CI) 1.37-5.68], a 2.68 higher risk of urinary urgency (OR 2.68, 95% CI 1.04-6.91), and more than three times the risk of having dysuria (OR 3.25, 95% CI 1.06-9.97) in IBS women compared to healthy controls. The risk of having at least one urinary symptom was independent of IBS subtype and IBS severity. Our study shows that IBS women have a similar risk of UTI compared to healthy women even if they complain more of LUTS, independently of IBS subtype and severity.

Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea

BackgroundPrevious studies have indicated that ramosetron, a 5-hydroxytryptamine-3 receptor antagonist, achieves global improvement in irritable bowel syndrome (IBS) symptoms in male patients with IBS with diarrhea (IBS-D). However, in addition to global assessment it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms”. We performed a randomized, placebo-controlled, phase IV pilot study to explore and examine efficacy variables that allow such evaluation of ramosetron in male patients with IBS-D.MethodsWe performed a prospective study of 115 male outpatients with IBS-D (according to the Rome III criteria), from June 2009 to December 2009 at 25 centers in Japan. After a one-week baseline period, subjects received either 5 μg of ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks. To evaluate “clinically meaningful improvements focusing on the severity of major IBS symptoms,” the Japanese version of the IBS severity index (IBSSI-J) was used.ResultsChange in IBSSI-J overall score from baseline was −133.5 ± 110.72 in the ramosetron 5 μg group and −108.2 ± 94.44 in the placebo group (P = 0.228) at the last evaluation point. Differences in responder rates for at least a 50% reduction from baseline in IBSSI-J between the ramosetron 5 μg group and the placebo group were over 10%, except Month 1. The monthly responder rate for global assessment of relief of overall IBS symptoms in the ramosetron 5 μg group showed a statistically significant improvement compared to placebo at the second month (44.4% vs 18.4%, P = 0.012). The proportion of patients who had a ≥ 50% reduction in IBSSI-J overall score was 24/37 (64.9%) in the responder group on global assessment and 18/54 (33.3%) in the non-responder group at Week 12.ConclusionsFurther examination will be needed before IBSSI-J can be used in clinical trials of agents for IBS-D. However, this study revealed that response on global assessment was correlated with improvement in the IBSSI-J, suggesting that global assessment reflects improvement of the symptom severity of patients with IBS-D. (Clinicaltrials.gov ID: NCT00918411 Registered 9 June 2009).