Effect of tegaserod on work and daily activity in irritable bowel syndrome with constipation

BACKGROUND: Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation. AIM: To assess tegaserod's effect on work productivity and daily activity. METHODS: Women, 18-65 years old and meeting Rome II criteria for irritable bowel syndrome with constipation, were randomized to a double-blind, placebo-controlled, multicentre study of tegaserod 6 mg b.d. or placebo. Productivity loss and daily activity impairment because of irritable bowel syndrome were measured with the Work Productivity and Activity Impairment questionnaire for irritable bowel syndrome, modified to exclude diarrhoea as a symptom. Assessments were made at baseline, weeks 2 and 4. RESULTS: A total of 2660 women were randomized and, of these, 1675 [tegaserod (n = 1363), placebo (n = 312)] were employed and completed Work Productivity and Activity Impairment for irritable bowel syndrome questionnaires. Compared with placebo, tegaserod significantly reduced work and daily activity impairment at weeks 2 and 4. Tegaserod reduced absenteeism by 2.6% (P = 0.004), presenteeism by 5.4% (P < 0.0001), overall work productivity loss by 6.3% (P < 0.0001), and activity impairment by 5.8% (P < 0.0001) at week 4 (vs. baseline). Assuming a 40-h workweek, tegaserod reduced work productivity loss by 2.5 h/week. CONCLUSIONS: Tegaserod significantly reduced work productivity loss and daily activity impairment at 2 weeks, and this benefit was maintained at 4 weeks.     

A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective

Health impairment often leads to work impairment in the form of both absenteeism and presenteeism (i.e. reduced productivity while at work). Several self-report productivity instruments have been designed over the past few years to measure the impact of illness on productivity at work and/or in non-work activities. In a review of the literature we identified six generic subjective instruments - the Endicott Work Productivity Scale, Health and Labor Questionnaire, Health and Work Questionnaire, Health and Work Performance Questionnaire, Work Limitations Questionnaire (WLQ) and the Work Productivity and Activity Impairment Questionnaire (WPAI) - that could theoretically be used in any working population. These instruments were usually validated against other subjective measures (such as health-related QOL). Each productivity instrument has benefits in certain research settings, but the psychometric properties of the WPAI have been assessed most extensively. It was the most frequently used instrument and has also been modified to measure productivity reductions associated with specific diseases (e.g. allergic rhinitis, gastro-oesophageal reflux disease, chronic hand dermatitis). The WLQ has also been tested extensively to measure the general health impact and impact of specific conditions. Two migraine-specific subjective instruments were also identified: the Migraine Disability Assessment questionnaire and the Migraine Work and Productivity Loss Questionnaire, of which the latter was found to have better psychometric properties. Productivity outcomes are useful in that they characterise the impact of an illness in the workplace and show the effect of treatment on productivity. Evidence of psychometric properties and generalisability of different instruments was found to a varying degree. Thus, further research is needed to assess the accuracy and usefulness of individual instruments in certain research settings. Health-related productivity has been increasingly recognised as an important component of the burden of illness associated with a given disease; without it, one cannot reliably assess this burden.     

Systematic review: the economic impact of irritable bowel syndrome

BACKGROUND: Although little mortality is associated with irritable bowel syndrome, curative therapy does not exist and thus the economic impact of this disorder may be considerable. METHODS: A systematic review of the literature was performed. Studies were included if their focus was irritable bowel syndrome, and direct and/or productivity (indirect) costs were reported. Two investigators abstracted the data independently. RESULTS: One hundred and seventy-four studies were retrieved by the search; 11 fulfilled all criteria for entry into the review. The mean direct costs of irritable bowel syndrome management were reported to be UK pound sterling90, Canadian$259 and US$619 per patient annually, with total annual direct costs related to irritable bowel syndrome of pound sterling45.6 million (UK) and $1.35 billion (USA). Direct resource consumption of all health care for irritable bowel syndrome patients ranged from US$742 to US$3166. Productivity costs ranged from US$335 to US$748, with total annual costs of $205 million estimated in the USA. Annual expenditure for all health care, in addition to expenditure limited to gastrointestinal disorders, was significantly higher in irritable bowel syndrome patients than in control populations. CONCLUSIONS: Despite the lack of significant mortality, irritable bowel syndrome is associated with high direct and productivity costs. Irritable bowel syndrome patients consume more gastrointestinal-related and more total health care resources than non-irritable bowel syndrome controls, and sustain significantly greater productivity losses.     

Stability of irritable bowel syndrome using a Rome II-based classification

BACKGROUND: As there is no biological marker for irritable bowel syndrome, a diagnosis is made using symptom-based criteria. AIM: To evaluate the stability of self-reported symptoms consistent with Rome II-based irritable bowel syndrome classification. METHODS: Irritable bowel syndrome subjects identified in a 2001 population-based study by modified Rome II criteria were re-contacted 2 years later. Data were collected via a web-based questionnaire. RESULTS: Of the 697 subjects, 30% remained in the same irritable bowel syndrome subtype in both surveys, 18.4% changed irritable bowel syndrome subtype and 52% no longer met the irritable bowel syndrome criteria at follow-up. Subjects continuing to meet the irritable bowel syndrome criteria were more likely to have been initially classified in the alternating irritable bowel syndrome subtype and had more psychological impairment and lower irritable bowel syndrome-related quality of life than subjects not fulfilling the irritable bowel syndrome criteria at follow-up. Lack of pain caused more subjects to fall out of the irritable bowel syndrome criteria than the absence of non-painful bowel symptoms. However, the majority of subjects that did not fulfill the pain component of the irritable bowel syndrome criteria continued to report abdominal pain of at least moderate severity. CONCLUSION: In a US population-based follow-up study using modified Rome II criteria, we found irritable bowel syndrome is episodic in nature and current classification is limited in capturing fluctuation of disease over time.     

Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate‐to‐severe Crohn’s disease in the PRECiSE 2 study

Aliment Pharmacol Ther 31 , 1276–1285

Summary

Background The effect of certolizumab pegol on employment status and work productivity has not been previously assessed. Aim To assess the impact of treatment with certolizumab pegol, the only PEGylated, Fab′ TNF antagonist, on work productivity in patients with active Crohn’s disease (CD) from the PRECiSE 2 study. Methods Patients (n = 668) with active disease [CD activity index (CDAI) score of 220–450] were treated with open‐label subcutaneous certolizumab pegol 400 mg (week 0, 2, 4). Responders (n = 425) (≥100‐point decrease in CDAI from baseline) were randomized to receive certolizumab pegol 400 mg or placebo every 4 weeks until week 24, with final evaluation at week 26. Patients completed the Work Productivity and Activity Impairment for CD questionnaire (WPAI:CD) and the Inflammatory Bowel Disease Questionnaire (IBDQ) at weeks 0, 6, 16 and 26 and at the withdrawal visit. Results Work productivity improved following induction with certolizumab pegol. Between week 6 and 26, certolizumab pegol‐treated patients experienced significant improvement in work productivity compared with placebo recipients (11% and 10% overall improvement in work and activity impairment, respectively). During the maintenance phase, impairments in productivity and activities due to CD were significantly less in the certolizumab pegol group than in the placebo group. Conclusion Induction and maintenance therapy with certolizumab pegol significantly improved the work productivity of patients with active CD compared with those in the placebo group.     

Current patterns of irritable bowel syndrome in Taiwan: the Rome II questionnaire on a Chinese population

BACKGROUND: Irritable bowel syndrome is a common condition seen in Western countries. In Asia, however, it is less known and even less studied. AIM: To determine the prevalence and social impact of irritable bowel syndrome as well as the health-seeking behaviour of irritable bowel syndrome patients in Taiwan METHODS: Using the modified Rome II questionnaire, a survey was carried out in a population receiving physical check-up (n = 2865). RESULTS: The prevalence of irritable bowel syndrome in Taiwan was 22.1% and 17.5% (kappa = 0.73) according to the Rome II and I criteria, respectively. No gender difference was found between subjects with and without irritable bowel syndrome symptoms. Irritable bowel syndrome subjects were likely to undertake an excessive number of physician-visits (P < 0.01). Such subjects were often absent from work/school, with more days of absenteeism than irritable bowel syndrome-free subjects (P < 0.01). They also suffered obvious sleep disturbance (P < 0.01). Nearly half of the irritable bowel syndrome subjects were 'consulters', and they were more likely to have frequent physician-visits, suffer from work/school absenteeism, and endure sleep disturbance and bowel symptoms than irritable bowel syndrome nonconsulters (P < 0.05). CONCLUSIONS: Irritable bowel syndrome is common in a Chinese population of Taiwan. Similar to irritable bowel syndrome in the West, it also involves significant social and medical burdens. However, in the irritable bowel syndrome subjects of Taiwan there is no gender difference, and more irritable bowel syndrome subjects will seek physician consultations, which may be due to Taiwan's easily accessible and affordable heath care facilities.     

Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab

Aliment Pharmacol Ther 2011; 33: 541–550

Summary

Background Crohn’s disease (CD) is associated with impaired health‐related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti‐TNF agent infliximab (WELCOME study). Aim To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study. Methods Patients with loss of response to infliximab received open‐label certolizumab pegol induction and were randomised to receive double‐blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively. Results Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups. Conclusions Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).     

Overlap of gastro-oesophageal reflux disease and irritable bowel syndrome: prevalence and risk factors in the general population

BACKGROUND: Gastro-oesophageal reflux disease (GERD) and irritable bowel syndrome may occur more often than expected by chance, but little community data exists and risk factors are unknown. AIM: To determine prevalence and risk factors for overlap of GERD and irritable bowel disease. METHODS: Population-based, cross-sectional survey was conducted by mailing a valid symptom questionnaire to eligible residents of Olmsted County, MN, aged 30-95 years. Irritable bowel syndrome were defined by Rome III; GERD was defined by weekly or more frequent heartburn and/or acid regurgitation. RESULTS: 2298 questionnaires returned (women 52%, 55% response). Irritable bowel syndrome and GERD occurred together more commonly than expected by chance; the prevalence of irritable bowel syndrome-GERD overlap, GERD alone and irritable bowel syndrome alone were 3%, 15% and 5% in men, and 4%, 14% and 10% in women, respectively. Predictors of irritable bowel syndrome-GERD overlap vs. irritable bowel syndrome alone, and separately, GERD alone, were insomnia (OR 1.3, 95% CI: 1.06-1.70; OR 1.5, 95% CI: 1.13-1.90, respectively) and frequent abdominal pain (OR 3.9, 2.2-6.7; OR 1.8, 1.02-3.2, respectively). An additional predictor of irritable bowel syndrome-GERD overlap vs. GERD alone was higher somatization (OR 1.7, 1.1-2.4) and for irritable bowel syndrome-GERD overlap vs. irritable bowel syndrome alone was a higher body mass index (OR 1.0, 1.003-1.07). CONCLUSIONS: Irritable bowel syndrome and GERD overlap is common in the population and does not occur by chance.     

Relationship between symptom load of gastro-oesophageal reflux disease and health-related quality of life, work productivity, resource utilization and concomitant diseases: survey of a US cohort

Background Analysis of the burden of gastro‐oesophageal reflux disease (GERD) in relation to the severity and frequency of symptoms is essential to identify individuals and groups in whom targeted management is justified. Aim To describe the relationship between symptoms of GERD and self‐reported health‐related quality of life (HRQL), work productivity, healthcare utilization and concomitant diseases. Methods US respondents to the Internet‐based 2004 National Health and Wellness Survey who had self‐reported GERD (n = 10 028, mean age: 52 years, 58% female) were age‐ and gender‐matched to a control group without GERD (n = 10 028). Respondents with GERD were classified according to symptom severity and frequency. HRQL and productivity were assessed using the Short‐Form 8 survey (SF‐8) and Work Productivity and Activity Impairment questionnaire, respectively. Results Symptom frequency increased with increasing symptom severity. Compared with controls, respondents with GERD had more concomitant diseases [mean difference (MD): 1.6], lower SF‐8 physical and mental health scores (MD: 4.1 units and 3.1 units, respectively), increased absenteeism (MD: 0.9 h/week), reduced percent productivity at work (MD: 7.5%) and increased healthcare utilization. All tested variables deteriorated with increasing symptom severity and/or frequency. Conclusions Increasing severity and frequency of GERD symptoms is associated with more concomitant diseases, lower HRQL, lower work productivity and increased healthcare utilization, suggesting that patients with moderate or severe GERD should receive targeted management with the most effective treatment strategies.     

Clinical trial: short- and long-term benefit of relaxation training for irritable bowel syndrome

BACKGROUND: Psychotherapy is effective in treating irritable bowel syndrome, but the effect of relaxation training, a brief psychological group intervention, is not known. AIM: To determine the efficacy of relaxation training in a large cohort of irritable bowel syndrome patients. METHODS: Ninety-eight irritable bowel syndrome patients were included in this randomized controlled trial. Forty-six patients received standard medical care (CON) and 52 received four 90-min sessions of relaxation training in small groups in addition to standard medical care. Irritable bowel syndrome symptom severity, medical consumption and quality of life were assessed at baseline in patients and in 38 healthy controls and evaluated in patients at 3, 6 and 12 months after intervention. RESULTS: Irritable bowel syndrome symptom severity was significantly reduced in the relaxation training group compared to CON at 3, 6 and 12 months after treatment (time-by-treatment interaction, P = 0.002). The number needed to treat for long-term improvement was 5. Quality of life had improved (general health, P = 0.017; health change, P = 0.05). Frequency of doctor visits was reduced (P = 0.039). CONCLUSIONS: Relaxation training is a brief group intervention that significantly improves symptom severity, general health perception and medical consumption in irritable bowel syndrome patients immediately after, as well as 6 and 12 months after intervention.     

Health-related quality of life among persons with irritable bowel syndrome: a systematic review

AIM: To perform a systematic review of the literature with three objectives: (1) to compare the health related quality of life (HRQoL) of patients with irritable bowel syndrome with that of healthy controls; (2) to compare the HRQoL of irritable bowel syndrome patients to those with other diseases; and (3) to examine therapy-associated changes in HRQoL of irritable bowel syndrome patients. METHODS: Searches of all English and non-English articles from 1980 to 2001 were performed in Medline and Embase, and two investigators performed independent data abstraction. RESULTS: Seventeen articles met our selection criteria. 13 studies addressed objective no. 1; 11 showed a significant reduction in HRQoL among irritable bowel syndrome patients. Of these, only one study was considered of high quality. Four studies addressed objective no. 2, none of which was considered to be high quality in addressing this objective. Four trials (three of high quality) addressed objective no. 3. One showed that symptomatic improvement with Leupron compared to placebo was accompanied an improvement only in the comparative health domain of the HRQoL. The second study reported significant positive changes in HRQoL after 12 weeks of cognitive behavioural therapy. The third report of two placebo-controlled studies indicated significant improvement with alosetron on most domains of Irritable Bowel Syndrome Quality of Life Questionnaire. CONCLUSIONS: (i) There is reasonable evidence for a decrease in HRQoL in patients with moderate to severe irritable bowel syndrome; however, the data are conflicting regarding the impact of irritable bowel syndrome on HRQoL in population-based studies of nonconsulters. (ii) HRQoL in irritable bowel syndrome patients is impaired to a degree comparable to other chronic disorders such as GERD and depression. (iii) A therapeutic response in irritable bowel syndrome-related pain has a corresponding improvement in HRQoL. (iv) Limitations of the literature include focusing on moderate-severe irritable bowel syndrome in referral centres, and lack of appropriate controls     

Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact

BACKGROUND: The impact of irritable bowel syndrome, a gastrointestinal motility disorder, is underestimated and poorly quantified, as clinicians may see only a minority of sufferers. AIM: To determine the prevalence, symptom patterns and impact of irritable bowel syndrome in the US. METHODS: This two-phase community survey used quota sampling and random-digit telephone dialing (screening interview) to identify individuals with medically diagnosed irritable bowel syndrome or individuals not formally diagnosed, but fulfilling irritable bowel syndrome diagnostic criteria (Manning, Rome I or II). Information on irritable bowel syndrome symptoms, general health status, lifestyle and impact of symptoms on individuals' lives was collected using in-depth follow-up interviews. Data were also collected for healthy controls identified in the screening interviews. RESULTS: The total prevalence of irritable bowel syndrome in 5009 screening interviews was 14.1% (medically diagnosed: 3.3%; undiagnosed, but meeting irritable bowel syndrome criteria: 10.8%). Abdominal pain/discomfort was the most common symptom prompting consultation. Most sufferers (74% medically diagnosed; 63% undiagnosed) reported alternating constipation and diarrhoea. Previously diagnosed gastrointestinal disorders occurred more often in sufferers than non-sufferers. Irritable bowel syndrome sufferers had more days off work (6.4 vs. 3.0) and days in bed, and reduced activities to a greater extent than non-sufferers. CONCLUSIONS: Most (76.6%) irritable bowel syndrome sufferers in the US are undiagnosed. Irritable bowel syndrome has a substantial impact on sufferers' well-being and health, with considerable socioeconomic consequences.     

A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome

BACKGROUND: Irritable bowel syndrome is a common gastrointestinal disorder characterized by abdominal pain and discomfort and altered bowel habit. Antagonism at the 5-HT3 receptor may be of benefit in the treatment of irritable bowel syndrome. AIMS: To evaluate the effect of 12 weeks of treatment with alosetron, a 5-HT3 receptor antagonist at doses of 0.1 mg b.d., 0.5 mg b.d. and 2 mg b.d. in irritable bowel syndrome patients. METHODS: A double-blind, placebo-controlled, parallel-group study with a 2-week screening and a 12-week treatment period was conducted. A total of 462 patients (335 female) recorded details of the severity of their abdominal pain, and bowel function daily on a diary card throughout the study. At monthly clinic visits patients recorded the severity of their abdominal pain/discomfort and diarrhoea on a visual analogue scale. RESULTS: In the total population and in the female subpopulation (but not in males) alosetron 2 mg b.d. significantly increased the proportion of pain-free days and decreased the visual analogue scale score for diarrhoea compared with placebo. Alosetron at doses of 0.5 mg b.d. and 2 mg b.d. led to a significant hardening of stool, and a reduction in stool frequency in the total population. CONCLUSION: Alosetron at a dose of 2 mg b.d. is an effective treatment for female patients with irritable bowel syndrome.     

Anxiety but not depression determines health care-seeking behaviour in Chinese patients with dyspepsia and irritable bowel syndrome: a population-based study

AIMS: To study the prevalence of dyspepsia and irritable bowel syndrome and the effects of co-existing anxiety and depression on health care utilization by a population survey in Chinese. METHODS: Ethnic Chinese households were invited to participate in a telephone survey using a validated bowel symptom questionnaire and the hospital anxiety and depression scale. Gastrointestinal symptoms were classified as dyspepsia and irritable bowel syndrome according to the Rome I criteria and gastro-oesophageal reflux disease by the presence of weekly heartburn or acid regurgitation. The anxiety and depression scores were compared between patients who sought medical attention and those who did not, using multiple logistic regression analysis. RESULTS: One thousand, six hundred and forty-nine subjects completed the interview (response rate, 62%). The population prevalences of dyspepsia, irritable bowel syndrome and gastro-oesophageal reflux disease were 18.4%, 4.1% and 4.8%, respectively. Dyspepsia and irritable bowel syndrome were associated with anxiety, depression, medical consultation, sick leave and adverse effects on social life. The degree of anxiety was an independent factor associated with health care-seeking behaviour in both dyspeptics (P = 0.003) and irritable bowel syndrome patients (P = 0.036). CONCLUSIONS: Irritable bowel syndrome and dyspepsia are associated with anxiety, depression, significant social morbidity, health care utilization and days off work. Anxiety is an independent factor in determining health care utilization in patients with dyspepsia and irritable bowel syndrome.     

Impact of solifenacin on resource utilization,work productivity and health utility in overactive bladder patients switching from tolterodine ER

ABSTRACT

Objective: Assess changes in resource utilization, work and activity impairment, and health utility among OAB patients continuing to have urgency symptoms with tolterodine ER 4?mg and willing to try solifenacin 5/10?mg.

Research design and methods: This was an open-label, non-comparative, flexible-dosing, multicenter, 12-week study assessing the efficacy and safety of solifenacin 5/10?mg/day. Patients receiving tolterodine ER 4?mg/day for ≥4 weeks but continuing to experience residual urgency symptoms (≥3 urgency episodes/24?h) were enrolled into the study. After a 14-day washout, patients began treatment with solifenacin 5?mg/day with dosing adjustments allowed at Weeks 4 and 8.

Main outcome measures: Outcomes were assessed using the Work Productivity and Activity Impairment Questionnaire?–?Specific Health Problem (WPAI-SHP), Health Utilities Index (HUI), and a resource utilization questionnaire administered at Pre-Washout and Week 12.

Results: Patients (n?=?440) reported significantly fewer physician office visits (p?<?0.0001), UTIs (p?<?0.0001), and pads/diapers (p?=?0.0009) during the study period while receiving solifenacin 5/10?mg/day, compared with the Pre-Washout period when receiving tolterodine ER 4?mg/day. After 12 weeks of treatment with solifenacin 5/10?mg/day, patients reported a reduction in work time missed (p?=?0.0017), less impairment while working (p?<?0.0001), less overall work impairment (p?<?0.0001) and a reduction in activity impairment (p?<?0.0001) compared to Pre-Washout. There was no significant difference in health utility scores. Treatment-emergent adverse events were mostly anticholinergic in nature, and were mild to moderate in severity.

Conclusion: Overall, solifenacin 5/10?mg/day improved work productivity, activity participation, and reduced medical care use in OAB patients who continued to have urgency symptoms with tolterodine ER 4?mg/day and wished to switch to solifenacin 5/10?mg. This was an open-label, non-comparative study; therefore, further research is needed to confirm these results.     

Gender difference on the symptoms, health-seeking behaviour, social impact and sleep quality in irritable bowel syndrome: a Rome II-based survey in an apparent healthy adult Chinese population in Taiwan

BACKGROUND: Little is known about the gender effect on irritable bowel syndrome in Asia. AIM: To assess the gender difference in Chinese subjects with irritable bowel syndrome meeting Rome II criteria. METHODS: Irritable bowel syndrome was identified from an apparently healthy adult population receiving a routine health maintenance program (n = 2018). RESULTS: Female gender is not a factor associated with irritable bowel syndrome or irritable bowel syndrome-related health care-seeking behaviour. Female irritable bowel syndrome subjects, irrespective of consulting behaviour for irritable bowel syndrome, are likely to have < 3 bowel movements/week, hard/lumpy stools and abdominal fullness/bloating (P < 0.05). Female irritable bowel syndrome subjects are prone to be absent from school/work with more days of absenteeism, irrespective of consultation status (P < 0.05). Only female irritable bowel syndrome consulters have more absenteeism for their irritable bowel syndrome-related symptoms, reporting more sleep disturbances than their male counterparts (P < 0.001). CONCLUSIONS: In an apparent healthy adult population in Taiwan, gender difference is present in Rome II defined Chinese subjects with irritable bowel syndrome as regards bowel symptoms, social impact and sleep quality. Female predominance was not found in irritable bowel syndrome subjects and irritable bowel syndrome-related health care-seeking behaviour in the current population. Both irritable bowel syndrome non-consulters and consulters have similar gender difference profiles in presenting symptoms, suggesting that bowel symptoms per se may not be the only factor leading to health care-seeking behaviour. The gender differences in sleep problems were observed solely in irritable bowel syndrome consulter.     

A cross-cultural perspective on irritable bowel syndrome

Irritable bowel syndrome is a functional gastrointestinal illness, defined by symptoms. Irritable bowel syndrome has been described as a biopsychosocial condition, in which colonic dysfunction is affected by psychological and social factors. As a result of this unusual constellation, irritable bowel syndrome may be subject to cultural variables that differ in different parts of the globe. In this article, we describe some of the ways in which irritable bowel syndrome may be experienced differently, depending on local belief systems, psychological pressures, acceptance or resistance to a mind-body paradigm, and breakdown in support or relationship structure. Examples are given in which irritable bowel syndrome investigators from countries around the world describe various aspects of the syndrome that may affect the illness experience of their patients. We describe our own research studies that have demonstrated possible adverse effects on disease severity from relationship conflict, attribution of symptoms to physical rather than emotional cause, and the belief that irritable bowel syndrome is enduring and mysterious. Also described is our finding that symptom patterns may differ significantly between different geographic locations. Finally, we discuss the importance of "cultural competence" on the part of healthcare professionals in regard to caring for patients of diverse cultural backgrounds.     

Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study

Aliment Pharmacol Ther 2011; 34: 714–723

Summary

Background Patients with dyspepsia often experience troublesome symptoms. Aim To assess the burden of uninvestigated dyspepsia (symptoms, health‐related quality of life [HRQL] and work productivity) before and after 8 weeks’ esomeprazole treatment. Methods Patients (n = 1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤2 endoscopies within 10 years) underwent a 1‐week esomeprazole acid‐suppression test before randomisation to 7 weeks’ esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1‐week off‐treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid‐suppression test. Results The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub‐population of acid‐suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. Conclusions Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1‐week acid‐suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.