Exercise therapy of patients with irritable bowel syndrome: A systematic review of randomized controlled trials.

BACKGROUND: As drug use has limitations in the treatment of irritable bowel syndrome (IBS), increasing attention is being paid to nondrug therapies and complementary treatments, especially exercise. It is known that bowel movements are more frequent and colon transit is more rapid in physically active individuals than in sedentary individuals. However, the effects of exercise on IBS are unclear. PURPOSE: We conducted a systematic review to assess the effects of exercise on IBS. METHODS: We searched PubMed, Web of Science, EMBASE, Cochrane Library, and two Chinese databases (Wanfang Database and Chinese Biomedical Literature [CBM]) for eligible studies. We extracted and pooled relevant information regarding the effects of exercise in patients with IBS. The primary outcomes were gastrointestinal symptoms, quality of life, depression, and anxiety. KEY RESULTS: A total of 683 patients with IBS from 14 randomized controlled trials met our inclusion criteria. The exercise interventions in this review were yoga, walking/aerobic physical activity, Tai Ji, mountaineering, and Baduanjin qigong activity. The results of this review suggested exercise had significant benefits for patients with IBS, but studies were limited by the strong risk of bias. CONCLUSIONS AND INFERENCES: Our findings suggest that exercise is potentially a feasible and effective treatment for IBS patients. However, because of methodologic issues, no firm conclusions could be drawn about the true effects of this intervention. Researchers should design a rigorous study to assess the effects of exercise on IBS.

Experiences of the effects of physical activity in persons with irritable bowel syndrome (IBS): a qualitative content analysis.

OBJECTIVE: Increased physical activity has been tested among patients with irritable bowel syndrome (IBS) in a randomized trial which demonstrated improvement in gastrointestinal (GI) symptoms. The patients' experiences of the effects of physical activity on IBS symptoms are unknown. This knowledge is necessary to enable suitable support from health care professionals. The aim of this study was therefore to explore patients' experiences of the effects of physical activity. MATERIALS AND METHODS: Deep interviews were conducted with 15 patients (10 women and 5 men) aged 31-78 years. Their IBS had lasted for 10-57 years. The transcribed interviews were analyzed through a qualitative content analysis. RESULTS: The analysis of the material revealed three themes; GI symptoms, extra-intestinal symptoms, and quality of life (QOL). In relation to GI symptoms, the patients discussed how physical activity affected these symptoms and how they used physical activity to normalize and control their GI symptoms. Extra-intestinal symptoms were also affected by physical activity, and the patients described how they experienced a general bodily wellbeing as well as improved mood and energy in relation to physical activity. In terms of QOL, the patients discussed their perspectives on physical activity as giving them achievements, being pleasurable, and being strengthening of the self. CONCLUSIONS: Our results emphasize the importance of taking into account the patient's experiences of the effects of physical activity when coaching patients with IBS to be physically active. Using a person-centred approach incorporating, the patient's own experiences and resources is the key to successfully promoting physical activity in the clinic.

Patients' perspectives on GP interactions after cognitive behavioural therapy for refractory IBS: a qualitative study in UK primary and secondary care.

BACKGROUND: Previous studies have identified issues with the doctor-patient relationship in irritable bowel syndrome (IBS) that negatively impact symptom management. Despite this, little research has explored interactions between GPs and patients with refractory IBS. National guidelines suggest cognitive behavioural therapy (CBT) as a treatment option for refractory symptoms. AIM: To explore perceptions of interactions with GPs in individuals with refractory IBS after receiving CBT for IBS or treatment as usual (TAU). DESIGN AND SETTING: This qualitative study was embedded within a trial assessing CBT in refractory IBS. Fifty-two participants took part in semi-structured interviews post-treatment in UK primary and secondary care. METHOD: Inductive and/or data-driven thematic analysis was conducted to identify themes in the interview data. RESULTS: Two key themes were identified: perceived paucity of GPs' IBS knowledge and lack of empathy from GPs, but with acknowledgement that this has improved in recent years. These perceptions were described through three main stages of care: reaching a 'last-resort diagnosis'; searching for the right treatment through a trial-and-error process, which lacked patient involvement; and unsatisfactory long-term management. Only CBT participants reported a shared responsibility with their doctors concerning symptom management and an intention to reduce health-seeking behaviour. CONCLUSION: In this refractory IBS group, specific doctor-patient communication issues were identified. Increased explanation of the process of reaching a positive diagnosis, more involvement of patients in treatment options (including a realistic appraisal of potential benefit), and further validation of symptoms could help. This study supports a role for CBT-based IBS self-management programmes to help address these areas and a suggestion that earlier access to these programmes may be beneficial.

[Combined rehabilitation in the patients presenting with dorsopathies of the lumbar spine and concomitant irritable bowel syndrome based at a therapeutic clinic].

BACKGROUND: Comorbidity constitutes a serious challenge for rehabilitative medicine. The comorbidity of the dorsopathy of the lumbar spine and irritable bowel syndrome mutually complicates the clinical course of both conditions, significantly reduces the patients' quality of life. and increases the costs of diagnostic procedures and restoration of the working capacity. The approaches to the non-pharmacological management of the patients presenting with these diseases remain to be developed. AIMS: The objective of the present study was to evaluate the effectiveness of the proposed combined non-medicinal rehabilitation modality which included a course of therapy with the application of modulated sinusoidal currents, total wrappings with the use of a Rapan saline solution, and sedative inhalations additionally introduced into the basic medicinal therapy of the patients presenting with dorsopathy of the lumbar spine combined with irritable bowel syndrome in the stationary phase. MATERIALS AND METHODS: A total of 59 patients at the age from 20 to 65 years suffering from dorsopathy of the lumbar spine and concomitant irritable bowel syndrome were examined and treated. All the patients were randomized into two groups, the main (n=21) and control (n=38) one, matched for the sex and age. The patients in the control group received the conventional medical treatment in accordance with the adopted medical and economic standards during 2 weeks. The patients of the main group received, in addition to the basal medicinal therapy, the proposed combined rehabilitative physiotherapeutic treatment that included a course of therapy with modulated sinusoidal currents, total wrapping with the use of a Rapan saline solution, and sedative inhalations of the of peony root extract. The effectiveness of these rehabilitation modalities was monitored before and after the course of therapy based on the estimation of bowel function dynamics, the severity of pain syndrome, and the patient's quality of life in terms of the health status with the use of the SF-36 questionnaire. RESULTS: The therapeutic and rehabilitative procedures resulted in a well apparent improvement of the genera condition in the patients of the main group associated with a greater degree of reduction of the incidence of specific clinical symptoms, more rapid relief of the pain syndrome, and a more pronounced improvement of the quality of life indices in comparison with the same variables in the patients comprising the control group. After the course of the treatment and rehabilitation, the incidence of spinal pain in the patients of the main group was significantly reduced by 87% (p=0.001) compared with those of the control group (32%; p=0.005). The frequency of abdominal pain decreased in the main group by 47% (p=0.021) versus the control group (by 27%; p=0.007). The quality of life indices increased 1.2 times in the main group but remained unaltered in the control group. DISCUSSION: The patients of the main group exhibited a more pronounced than in the control group positive dynamics of health conditions characterized by a well apparent reduction in the incidence of the major clinical symptoms of the disease, faster alleviation of the pain syndrome, and the marked improvement of the quality of life indices. CONCLUSIONS: The results of the study with the inclusion of therapy with modulated sinusoidal currents together with total wrapping using the Rapan saline solution and sedative inhalations into the program of the combined treatment of the patients presenting with dorsopathy of the lumbar spine and concomitant irritable bowel syndrome provide a basis for recommending this physiotherapeutic modality for personalized rehabilitation of this group of patients under conditions of a therapeutic clinic.

Irritable bowel syndrome-specific health-related quality of life instrument: development and psychometric evaluation.

BACKGROUND: Health-related quality of life (HRQOL) is an important outcome indicator for chronic disease, and particularly in the absence of biological markers for illness, such as with irritable bowel syndrome (IBS). The aims of this study were to develop and evaluate a new IBS-specific HRQOL instrument (IBS-HR-QOL). METHODS: This methodological study comprised three steps: conceptualization of the IBS-HR-QOL, item extraction and establishment of content validity, and psychometric evaluation of the instrument with 267 IBS patients recruited from four university hospitals. RESULTS: The content validity of the developed IBS-HR-QOL was assessed by 11 experts. Exploratory and confirmatory factor analyses yielded four factors. The criterion and convergent validities of the IBS-HR-QOL were demonstrated using the Short Form-36 and the Hospital Anxiety and Depression Scale, respectively. Known-groups validity was demonstrated using a symptom-severity scale. The internal consistency reliability and test-retest reliability were satisfactory, with a Cronbach's alpha and intraclass correlation coefficient of 0.93 and 0.88, respectively. CONCLUSIONS: The IBS-HR-QOL comprises a total of 16 items. The IBS-HR-QOL demonstrated good psychometric properties. This instrument is easily comprehensible and short, rendering it feasible for use in clinical practice and research.

Abdominothoracic mechanisms of functional abdominal distension and correction by biofeedback.

BACKGROUND & AIMS: In patients with functional gut disorders, abdominal distension has been associated with descent of the diaphragm and protrusion of the anterior abdominal wall. We investigated mechanisms of abdominal distension in these patients. METHODS: We performed a prospective study of 45 patients (42 women, 24-71 years old) with functional intestinal disorders (27 with irritable bowel syndrome with constipation, 15 with functional bloating, and 3 with irritable bowel syndrome with alternating bowel habits) and discrete episodes of visible abdominal distension. Subjects were assessed by abdominothoracic computed tomography (n = 39) and electromyography (EMG) of the abdominothoracic wall (n = 32) during basal conditions (without abdominal distension) and during episodes of severe abdominal distension. Fifteen patients received a median of 2 sessions (range, 1-3 sessions) of EMG-guided, respiratory-targeted biofeedback treatment; 11 received 1 control session before treatment. RESULTS: Episodes of abdominal distension were associated with diaphragm contraction (19% ± 3% increase in EMG score and 12 ± 2 mm descent; P < .001 vs basal values) and intercostal contraction (14% ± 3% increase in EMG scores and 6 ± 1 mm increase in thoracic antero-posterior diameter; P < .001 vs basal values). They were also associated with increases in lung volume (501 ± 93 mL; P < .001 vs basal value) and anterior abdominal wall protrusion (32 ± 3 mm increase in girth; P < .001 vs basal). Biofeedback treatment, but not control sessions, reduced the activity of the intercostal muscles (by 19% ± 2%) and the diaphragm (by 18% ± 4%), activated the internal oblique muscles (by 52% ± 13%), and reduced girth (by 25 ± 3 mm) (P ≤ .009 vs pretreatment for all). CONCLUSIONS: In patients with functional gut disorders, abdominal distension is a behavioral response that involves activity of the abdominothoracic wall. This distension can be reduced with EMG-guided, respiratory-targeted biofeedback therapy.

How patients with long-term experience of living with irritable bowel syndrome manage illness in daily life: a qualitative study.

OBJECTIVES: Irritable bowel syndrome (IBS) is a chronic, disabling and functional gastrointestinal disorder. Effective treatments are lacking. Self-care and coping with symptoms are considered important but little is known about what patients with IBS actually do to manage their illness. The aim of this study was to explore how patients with long-term experience of living with IBS perceive their situation and manage illness in daily life. PATIENTS AND METHODS: The study adopted a qualitative approach - an interpretative phenomenological analysis. Twenty patients with IBS (16 women) with a mean age of 46 (27-74) years were interviewed. The mean IBS duration was 24 (7-65) years. RESULTS: Two themes emerged from the analysis: Healed but not cured and Take control of daily life. Healed but not cured is about mastering IBS. Even though the patients feel there has been an improvement, their abdomen is constantly present. The patients live with intermittent interaction between well-being and illness and construct explanations for the cause of the IBS symptoms. Taking control of daily life is about the activities the patients perform to master IBS symptoms: self-centredness, disciplined self-care, control over daily routines and finding social support. CONCLUSION: These results suggest that the negative impact of IBS on daily life can be reduced. Over time, the patients had found effective strategies for symptom improvement, although this is a long-term learning process. The healthcare system could be more effective in supporting patients to find solutions to problems caused by IBS that are consistent with person-centred care and could be adopted as part of different supportive/educational interventions.

Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial.

OBJECTIVE: In light of the low efficiency of available drugs in treating irritable bowel syndrome (IBS), there has been a growing interest in its alternative therapies. The aim of this study was to evaluate the effectiveness of visceral osteopathy for IBS. METHODS: In total, 31 consecutive refractory IBS patients were prospectively included in a randomized, crossover placebo-controlled study. Qualitative evaluation of depression and four symptoms including constipation, diarrhea, abdominal distension and abdominal pain before and after each phase of the study were conducted using visual analog scales, measures of rectal sensitivity and colonic transit time. One year after the study, the assessment of symptoms was performed again in all patients. RESULTS: Visceral osteopathy was associated with a significant amelioration of self-reported diarrhea, abdominal distension and abdominal pain, while constipation did not change significantly after this therapy. It was also associated with decreased rectal sensitivity, presenting as an increase in threshold volume, constant sensation volume and maximum tolerable volume (P < 0.001). However, no significant evolution of rectal sensitivity was observed when patients underwent placebo manipulations. Modifications of depression and total or segmental colonic transit time were not observed. One year after the end of this trial, symptom scores of diarrhea, abdominal distension and abdominal pain were significantly lower than those at enrollment (P < 0.05). CONCLUSION: This study suggests that visceral osteopathy improves short-term and long-term abdominal distension and pain, and also decreases rectal sensitivity in IBS patients.

[Interest of the prosthetic occlusal rehabilitation in improving irritable bowel syndrome at the University Hospital of Cocody (Abidjan)]. / Intérêt de la réhabilitation occluso-prothétique dans l'amélioration des colopathies fonctionnelles au CHU de Cocody (Abidjan).

The functional colopathies are frequent in digestive pathology and are particularly badly felt by African patients. The authors, after the determination of the masticatory efficiency score (classification of Verkindere) of 100 subjects affected by colopathies and diagnosed in the service of gastroenterology of Cocody University Hospital (Abidjan), attempt to determine the importance of the masticatory deficiency in functional colopathies. Among the toothless subjects with functional colopathies, the restoration of the masticatory efficiency by functional prosthetic rehabilitation constitutes an essential therapeutic act in the reduction of the symptoms of the functional colopathies and the improvement of the comfort of the patients. Patients' global care raises the interest of collaboration between odontologists and gastroenterologists for an efficient treatment.

Sex differences in the symptoms and psychological factors that influence quality of life in patients with irritable bowel syndrome.

OBJECTIVE: To investigate the relationship between gender and symptomatology, psychological factors, and quality of life (QOL) in irritable bowel syndrome (IBS). METHODS: The diagnosis of IBS was made on the basis of the Rome III Criteria. A physician obtained demographic and symptom data, Zung Self-Rated Anxiety and Depression Scale scores (SAS/SDS), and IBS-specific quality-of-life ratings (IBS-QOL). RESULTS: Of the 4015 patients approached, 452 patients were diagnosed with IBS. Age ranged from 14 to 79 years (44.05 ± 14.89 years) and the male to female ratio was 1 : 1.3. The gender composition between the four IBS subtypes differed significantly (P<0.01). Male and female patients differed in their rating of abdominal pain/discomfort in terms of severity and time (P<0.01). Groups did not differ with regard to attack frequency. Female patients more frequently reported headache, dizziness, backache, muscular soreness, inappetence, insomnia, and fatigue (P<0.01). In comparison with men, anxiety and depression scores were significantly higher in women (P<0.01). Severity, duration, and frequency of abdominal pain/discomfort did not correlate with IBS-QOL scores. Insomnia/fatigue was negatively correlated with IBS-QOL scores (P<0.01). SAS and SDS scores were negatively correlated with IBS-QOL (total score and each subscale; P<0.01). CONCLUSION: There are significant gender differences in the symptoms, psychological rating, and QOL scores in IBS. Somatic symptoms, anxiety, and depression all contribute to the negative impact of IBS. Our findings suggest that gender differences should be recognized in IBS treatment.

Lower gastrointestinal symptoms and quality of life in patients with systemic sclerosis: a population-based study.

OBJECTIVE: To investigate the frequency and nature of bowel symptoms in a population-based cohort of patients with systemic sclerosis (SSc), compared with healthy controls, and to relate these symptoms to health-related quality of life (HR-QOL). METHOD: Seventy-nine SSc patients and 158 matched controls answered a validated questionnaire on gastrointestinal (GI) symptoms and Medical Outcomes Study Short Form Health Survey (SF-36). Modified Miller Score, a composite score measuring faecal incontinence, was computed. RESULTS: Abnormal stool consistency, bloating, a feeling of incomplete evacuation, faecal incontinence and rectal bleeding were more frequently reported by SSc patients than controls. The ability for anorectal discrimination, and deferring defecation was diminished in SSc patients. Bowel function affected general well being in 30% of patients and social life in 20%. Patients had lower SF-36 scores, that is, worse HR-QOL than controls. Modified Miller Score did not correlate to the SF-36 scores in patients, but other lower GI symptoms, especially abdominal pain and bloating, were associated with diminished HR-QOL. CONCLUSION: Lower GI symptoms, including faecal incontinence, are more common in patients with SSc than in healthy controls and are of consequence to the individual patient's life. The lower prevalence of anorectal discrimination in the SSc patients suggests a neuronal defect in these patients. Increased awareness of these symptoms might stimulate a search for new diagnostic and therapeutic strategies.

[Efficiency of autogenous training in medical rehabilitation of patients with irritable colon syndrome with constipation dominance].

It was established that use of autogenous training makes possible to increase efficiency of the therapy, leading to considerable more evident improvement of somatic and psychotic state, decrease of pain syndrome. Predictors of efficiency of autogenous training were marked out. Indications for use the method in medical rehabilitation of patients with irritable colon syndrome with constipation dominance were elaborated.

Reduced brainstem inhibition during anticipated pelvic visceral pain correlates with enhanced brain response to the visceral stimulus in women with irritable bowel syndrome.

Cognitive factors such as fear of pain and symptom-related anxiety play an important role in chronic pain states. The current study sought to characterize abnormalities in preparatory brain response before aversive pelvic visceral distention in irritable bowel syndrome (IBS) patients and their possible relationship to the consequences of distention. The brain functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) response to anticipated and delivered mild and moderate rectal distention was recorded from 14 female IBS patients and 12 healthy controls. During cued anticipation of distention, activity decreased in the insula, supragenual anterior cingulate cortex (sACC), amygdala, and dorsal brainstem (DBS) of controls. IBS patients showed less anticipatory inactivation. Group differences were significant in the right posterior insula and bilateral DBS. Self-rated measures of negative affect during scanning were higher in patients than controls (p < 0.001), and the anticipatory BOLD decreases in DBS were inversely correlated with these ratings. During subsequent distention, both groups showed activity increases in insula, dorsal ACC, and DBS and decreases in the infragenual ACC. The increases were more extensive in patients, producing significant group differences in dorsal ACC and DBS. The amplitude of the anticipatory decrease in the pontine portion of DBS was associated with greater activation during distention in right orbitofrontal cortex and bilateral sACC. Both regions have been associated previously with corticolimbic inhibition and cognitive coping. Deficits in preparatory inhibition of DBS, including the locus ceruleus complex and parabrachial nuclei, may interfere with descending corticolimbic inhibition and contribute to enhanced brain responsiveness and perceptual sensitivity to visceral stimuli in IBS.

The standard gamble showed better construct validity than the time trade-off.

BACKGROUND AND OBJECTIVE: There is little evidence for the relative cross-sectional validity of the standard gamble (SG) and time trade-off (TTO). We compared these preference-based instruments in patients with Irritable Bowel Syndrome (IBS). METHODS: Patients rated their own health on the SG and TTO and completed the disease-specific IBS questionnaire, the Brief Pain Inventory, the SF-36, the Sickness Impact Profile, and a global rating of disease severity. RESULTS: Mean scores of the 96 enrolled patients (mean age 39.5 years, 84.4% women) were 0.84 (standard deviation 0.16) for the SG and 0.76 (0.22) for the TTO. The correlation of the SG with the TTO was 0.36. For the SG, correlation coefficients with the IBS questionnaire domain scores ranged from 0.36 to 0.47, whereas those of the TTO were substantially lower (0.15-0.42). The SG also had higher correlations than the TTO with generic questionnaires (0.18-0.34 versus 0.13-0.26), Brief Pain Inventory (0.27 versus 0.11), global rating of disease severity (0.22 versus 0.10) as well as with SF-36-derived patient preferences (0.31-0.43 versus 0.27-0.31). CONCLUSIONS: The higher correlations of the SG with validation measures indicate that the SG better reflects health-related quality of life and patient preferences compared to the TTO.

Internet-based assessment of bowel symptoms and quality of life.

OBJECTIVES: We wished to determine the value of an open-access internet questionnaire for assessment of upper and lower gastrointestinal symptoms and health-related quality of life. METHODS: Between January 2002 and June 2005, a symptom scale for upper gastrointestinal and lower gastrointestinal symptoms was placed on a genuine website (www.gesundheits-umfrage.de) and linked to the website of the German irritable bowel syndrome patient group (www.Reizdarmselbsthilfe.de). Patients were asked to report gastrointestinal symptoms that had occurred during the last month. Patients who finished this symptoms questionnaire and acknowledged more than two of a total of eight upper gastrointestinal symptoms and/or more than two of 16 lower gastrointestinal symptoms were immediately offered the assessment of their health-related quality of life by a validated general quality of life scale--the patient general well-being inventory--a 22-item scale with six subscales (anxiety, depression, general well-being, self-control, health, and vitality) and a global scale. Total patient general well-being inventory scores and subscale values were correlated to upper gastrointestinal and lower gastrointestinal symptom scores including the Rome I definition of the irritable bowel syndrome, and to social variables. RESULTS: Five thousand two hundred and fifty-six individuals completed symptom assessment. Out of these, 4431 had three or more upper gastrointestinal symptoms, the mean number of upper gastrointestinal symptoms reported was 3.2+/-2.0; 4456 had three or more lower gastrointestinal symptoms (mean: 10.3+/-3.3), and 3187 met the Rome I criteria for irritable bowel syndrome. A total of 3316 individuals completed the patient general well-being inventory assessment (1156 men, 2160 women, mean age: 37.7+/-12.3 years). Upper gastrointestinal, lower gastrointestinal, and total symptom score were higher in women than in men (P < 0.001), and significantly correlated to the global quality of life assessment. Family status affected the symptom scores (higher in singles) and quality of life scores (lower in people living in partnership for health, but higher for vitality and depression). Age correlated negatively with upper gastrointestinal, lower gastrointestinal, and with total symptom scores as well as with some patient general well-being inventory scores. CONCLUSION: Symptom and quality of life assessment using an open internet questionnaire is feasible and generates data which are, in large, comparable to those from other sources of assessment, despite the fact that the population addressed is, on average, moderately younger than previously studied cohorts.

Impact of upper digestive symptoms in patients with irritable bowel syndrome.

BACKGROUND: Functional digestive disorders constitute a sizable proportion of gastroenterology and primary healthcare consultations, and have a negative impact on health-related quality of life. Dyspepsia and heartburn are often associated with irritable bowel syndrome (IBS); however, the incidence of these symptoms and their effect on IBS patients have not been evaluated. AIM: To investigate the clinical, psychological and health-related quality of life impact of upper digestive symptoms on IBS patients. METHODS: A prospective, observational, multicentered study was conducted in Spain: 517 IBS patients (Rome II criteria), grouped according to predominant symptoms of constipation (IBS-C), diarrhea (IBS-D) or alternating bowel habit (IBS-A) and 84 controls without IBS were recruited. Upper digestive symptoms were recorded in a 30-day diary. Health-related quality of life was evaluated by Irritable Bowel Syndrome Quality of Life and Euro-Quality of Life Five-Dimension Questionnaires; psychological well-being was evaluated by the Psychological General Well-Being Index. RESULTS: IBS patients had greater frequencies of upper digestive symptoms (72.3 vs. 6.0%), dyspepsia (21.1 vs. 4.8%) and heartburn (40.0 vs. 13.1%) (all P < 0.05) than controls. Prevalence of upper digestive symptoms was lower in patients with IBS-D than in those with IBS-C or IBS-A (P < 0.05). Health-related quality of life and psychological status were significantly worse in IBS patients with upper digestive symptoms than in those without. CONCLUSIONS: Upper digestive symptoms, frequently present in IBS patients, impair health-related quality of life and psychological status. This effect is greater in patients with IBS-C and IBS-A than in those with IBS-D. These data emphasize the importance of evaluating the presence of upper digestive symptoms in IBS patients.

Performance of the EQ-5D in patients with irritable bowel syndrome.

OBJECTIVE: The EQ-5D is a standardized, nondisease-specific instrument for evaluating patients' preference-based valuations of health-related quality of life (HRQoL). This study's purpose was to determine the psychometric properties of EQ-5D in patients with irritable bowel syndrome (IBS). METHODS: Data from four European IBS studies were assessed: UK (n = 161 and n = 297), Spain (n = 503), and Germany (n = 100). The EQ-5D is a five-item health state descriptive system used to develop health states (EQ-5D(INDEX)) and a visual analog scale (VAS) (0-100 from worst to best imaginable health state, EQ-5D(VAS)). Measures used with the EQ-5D included the SF-36, Irritable Bowel Syndrome--Quality of Life (IBS-QOL), and both subjective and clinical global assessments of IBS. Convergent validity was assessed using SF-36 and IBS-QOL data, discriminant validity using global ratings of IBS severity, and responsiveness by subjective and physician assessment of condition. RESULTS: Moderate-to-high associations (r >or= 0.33) were seen between the EQ-5D(VAS) and the SF-36 and IBS-QOL subscales. Mean response scores to EQ-5D(INDEX) dimensions and the EQ-5D(VAS) score were significantly better for control patients than for patients with IBS (all P < 0.01). The EQ-5D(VAS) was able to discriminate between levels of pain severity (quartiles, P < 0.001; mild/moderate/severe, P < 0.05) and general health severity (mild/moderate/severe, P < 0.001). The EQ-5D(VAS) and the EQ-5D(INDEX) were responsive in patients using both a self-perceived (Subject's Global Assessment) and physician-rated (Clinic Global Assessment) improvement. CONCLUSIONS: The EQ-5D performs well in comparison to general and disease-specific outcomes. It is a valid and responsive measure that can be used to generate preference-based valuations of HRQoL in patients with IBS and useful for comparisons in clinical and cost-effectiveness studies.

Validation of electronic data capture of the Irritable Bowel Syndrome--Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol.

OBJECTIVES: To assess the comparability, reliability, and subject acceptability of electronic data capture (EDC) versions of Irritable Bowel Syndrome-Quality of Life (IBS-QOL), EuroQoL (EQ-5D) and Work Productivity and Activity Impairment (WPAI:IBS) instruments. METHODS: Comparability of EDC and paper questionnaires was evaluated in 72 subjects with IBS who completed a baseline EDC or paper questionnaire, a crossover questionnaire 24 hours later, and a retest of the crossover version at 1 week. The EDC version was presented on a hand-held device. Comparability was assessed using paired t-test statistics, intraclass correlation coefficients (ICC) and tests for internal consistency (Cronbach's alpha). RESULTS: No significant differences were found between scores obtained by paper questionnaire and EDC at the baseline and crossover assessments. ICCs between baseline and crossover assessments ranged from 0.83 to 0.96 for the IBS-QOL scores, 0.82 to 0.96 for the WPAI:IBS scores, and 0.77 to 0.82 for the EQ-5D. Internal consistency was comparable for the two data collection methods for the IBS-QOL overall score (0.96) and subscales and the EQ-5D Index (0.70 vs. 0.74). Retest statistics (ICC) were generally comparable between the EDC and paper versions for all scores. Ease of use was comparable for the two modes of administration, but more patients preferred EDC (47.2%) than the paper questionnaire (23.6%). CONCLUSIONS: EDC versions of the IBS-QOL, EQ-5D, and WPAI:IBS are comparable to paper questionnaires in internal consistency and test-retest reliability, and have greater patient acceptability.

A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation.

BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. PATIENTS: Women (> or = 18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. RESULTS: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.