Irritable bowel syndrome (IBS) is a common, functional gastrointestinal disorder. Because IBS often develops and worsens with stress, it requires treatment from both physical and mental perspectives. Recent years have seen increasing reports of its impact on the daily performance and productivity of workers with IBS, leading to sick leaves and lower quality of life. Therefore, this narrative review aimed to summarize the work and psychosocial characteristics of individuals with IBS.

Workers with IBS report greater occupational stressors and work productivity impairments, including presenteeism or absenteeism, in addition to suffering from psychological distress, low quality of life, and medical and economic problems, similar to those with IBS in the general population. Anxiety about abdominal symptoms, as well as the severity of IBS, is related to the degree of interference with one's work. Regarding the association between characteristics of work and IBS, shift work and job demands/discretion have been associated with IBS. Studies on specific occupations have revealed associations between IBS and various occupational stressors in healthcare workers, firefighters, and military personnel. Telecommuting, which has become increasingly popular during the coronavirus disease pandemic, has not found to improve IBS. Moreover, the effectiveness of medication, diet, and a comprehensive self-management program, including cognitive behavioral therapy, in improving the productivity of workers with IBS have been examined.

As mentioned above, the IBS of workers is related not only to their problematic physical and mental health but also to work-related problems; workers with IBS exhibit severe occupational stress factors and work productivity impairment. Further research is required to develop efficient and appropriate interventions for workers.

Prokinetics are a class of pharmacological drugs designed to improve gastrointestinal (GI) motility, either regionally or across the whole gut. Each drug has its merits and drawbacks, and based on current evidence as high-quality studies are limited, we have no clear recommendation on one class or other. However, there remains a large unmet need for both regionally selective and/or globally acting prokinetic drugs that work primarily intraluminally and are safe and without systemic side effects.

Here, we describe the strengths and weaknesses of six classes of prokinetic drugs, including their pharmacokinetic properties, efficacy, safety and tolerability and potential indications.

As a common disorder of the gastrointestinal tract, irritable bowel syndrome (IBS) can have negative effects on patients and society, with irritable bowel syndrome with constipation(IBS-C) accounting for a large proportion of these effects. The main clinical manifestations of IBS-C are constipation, abdominal pain, and abdominal distension, which seriously impact the quality of life of patients. The mechanisms of IBS are complex, and the gut-brain axis has been an emerging and recognized theoretical system in recent years. Based on the theory of the gut-brain axis and the theory of Chinese medicine, we designed this study to evaluate the efficacy of one-finger meditation massage in treating IBS-C.

This is a randomized controlled trial. Eligible patients with irritable bowel syndrome (IBS-C) wererandomized 1:1 to a test group (massage plus probiotics) and a control group (probiotics). Patients in the test group weretreated once every 10 days for three consecutive courses of treatment (i.e., three months) and weregiven Bifidobacterium trifolium capsules 630 mg/dose three times daily 30 min after meals every day during the treatment period, with follow-up observations at the end of the third and sixth months of the treatment period. The control group weregiven Bifidobacterium trifolium capsules 630 mg/dose, 3 times a day for 3 months, with follow-up observations at the end of the third and sixth months of the treatment period. The primary outcome indicators are the concentrations of 5-HT and substance P and the IBS Severity Scale (IBS-SSS) assessment. Secondary outcomes are the Bristol Rating Scale (BRSA) score, the IBS Quality of Life Questionnaire (IBS-QOL scale) score, and the assessment of the effectiveness of the evidence. The results wereassessed at the pretreatment, posttreatment, and follow-up stages. Any side effects weresubject to assessment.

The aim of this trial is to provide a new method of treatment based on pharmacological treatment that is easy to use, easy to promote and has proven efficacy and to establish the efficacy and safety of treating IBS-C through this trial.

Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022. https://www.chictr.org.cn/bin/project/edit?pid=183461.

Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common gastrointestinal disorders imposing considerable impact on the quality of life and well-being of affected individuals. A paucity of evidence-based treatment options exist for CIC and IBS-C sufferers. Tegaserod, a 5-HT₄ agonist, has a substantial body of preclinical and clinical study evidence to support its beneficial role in modulating sensorimotor function of the luminal gastrointestinal tract. Tegaserod was first approved for use by the U.S. Food and Drug Administration for the management of IBS-C and CIC in 2002 and 2004, respectively. Tegaserod enjoyed a successful uptake in the management of these disorders during its first several years of availability in the United States, but was later withdrawn from the market in 2007 over concerns related to adverse cardiovascular events. Since then, additional safety data has been generated, and following a resubmission and review by the Food and Drug Administration, in April 2019, tegaserod was once again approved for use in IBS-C under a more restricted labeling, confining use to women under 65 years of age without heart disease or additional cardiovascular risk factors. This review summarizes the regulatory journey of tegaserod and details the existing pharmacokinetic, physiologic, clinical, and safety data of tegaserod generated over the last 2 decades. The discussion also examines the future of tegaserod in the treatment of these constipation disorders, as well as its potential role in other related disorders of brain-gut interaction.

Individuals with irritable bowel syndrome (IBS) are more likely to miss work (absenteeism), have reduced work effectiveness (presenteeism) and experience activity impairment. This study compared the effect of a comprehensive self-management (CSM) intervention program (incorporating cognitive behavioral therapy, diet education and relaxation) versus usual care on work- and activity-impairments in adults with IBS. This secondary data analysis used daily diaries and Work Productivity and Activity Impairment in Irritable Bowel Syndrome (WPAI-IBS) questionnaire data collected at baseline, 3, 6 and 12 months post-randomization from 160 adults with IBS. Mixed-effects modeling was used to compare the effect of CSM versus usual care on work- and activity-related outcomes. The effect of CSM was shown to be superior to usual care in improving WPAI-IBS and diary-measured presenteeism, overall work productivity loss and activity impairment with sustained effects up to 12 months post-randomization (all p < 0.05). Moreover, the CSM intervention was found to be particularly beneficial for IBS patients with greater baseline work and activity impairments (all p < 0.05). The CSM intervention may bring benefits to individuals and society through improving symptoms and reducing presenteeism associated with IBS.

Constipation is a frequent complaint of patients with functional bowel disorders. The present study aimed to evaluate the relationship between the perceived constipation severity with demographics, clinical, physiological, and psychological parameters in constipated patients.

Four hundred seven constipated patients were included and had clinical, physiological, and psychological evaluation. The self-reported severity of constipation was analyzed using stepwise linear regression in the total population and within each clinical group.

The patients were mainly of female gender (81%) and were 47.4 ± 16.5 years old. They complained of IBS (65%), and 62% had defecation disorders. The depression scale was abnormal in 200 patients (49%). The relationships of the constipation severity varied according to the Rome IV phenotype. In all phenotypes, it was positively associated with bloating severity, and negatively with Bristol stool form. In IBS patients, perceived constipation severity was also associated with abdominal pain severity.

Our data support the hypothesis that perceived constipation severity is associated with clinical and physiological factors but not demographics and psychological factors. Besides, the relationships of perceived constipation severity with these factors vary according to clinical phenotypes.

Fecal incontinence (FI), the involuntary passage of stool, is common and can markedly impair the quality of life. Among patients who fail initial options (pads or protective devices, bowel modifying agents, and pelvic floor exercises), the options are pelvic floor biofeedback (BIO), perianal injection with bulking agents (INJ), and sacral nerve electrical stimulation (SNS), which have not been subjected to head-to-head comparisons. This study will compare the safety and efficacy of BIO and INJ for managing FI. The impact of these approaches on quality-of-life and psychological distress, cost effectiveness, and predictors of response to therapy will also be evaluated. Six centers in the United States will enroll approximately 285 patients with moderate to severe FI. Patients who have 4 or more FI episodes over 2 weeks proceed to a 4-week trial of enhanced medical management (EMM) (ie, education, bowel management, and pelvic floor exercises). Thereafter, 194 non-responders as defined by a less than 75% reduction in the frequency of FI will be randomized to BIO or INJ. Three months later, the efficacy, safety, and cost of therapy will be assessed; non-responders will be invited to choose to add the other treatment or SNS for the remainder of the study. Early EMM responders will be re-evaluated 3 months later and non-responders randomized to BIO or INJ. Standardized, and where appropriate validated approaches will be used for study procedures, which will be performed by trained personnel. Prospectively collected data on care costs and resource utilization will be used for cost effectiveness analyses.

Patients with irritable bowel syndrome (IBS) are more likely to be both absent from and impaired at work compared to non-IBS patients. We investigated the impact of IBS on work productivity and activity impairment and the relationship to disease specific and general health measures.

In total, 525 patients with IBS completed questionnaires assessing work productivity and activity impairment, IBS symptom severity, IBS-related quality of life and GI-specific anxiety. In addition, 155 of the patients completed questionnaires assessing severity of somatic symptoms, depression, anxiety and fatigue. Uni- and bivariate analyses were performed, as well as linear regression to determine factors independently associated with the work productivity and activity impairment measures.

Of employed patients, 24.3% reported absenteeism and 86.8% reported presenteeism because of their IBS. With increasing severity of IBS symptoms and GI-specific anxiety, higher degrees of work impairment were seen. Work productivity impairment in IBS was also associated with low quality of life. GI-specific anxiety was independently associated with absenteeism (R² = 0.23; p < 0.05), IBS-symptom severity and general fatigue with presenteeism (R² = 0.40; p < 0.05), IBS-symptom severity, general fatigue and GI-specific anxiety with overall work loss (R² = 0.50; p < 0.05), and IBS symptom severity and somatic symptoms with activity impairment (R² = 0.38; p < 0.05).

Work impairment is a substantial problem in patients with IBS. A combination of IBS and somatic symptom severity, fatigue and psychological factors influence patients' ability to be present, active and productive at work. Based on this, a multidimensional treatment approach for patients with IBS seems logical.

The International Continence Society defines nocturia as the need to void one or more times during the night, with each of the voids preceded and followed by sleep. The chronic sleep disturbance and sleep deprivation experienced by patients with nocturia affects quality of life, compromising both mental and physical well-being. This paper aims to characterise the burden of nocturia by comparing published data from patients with nocturia with data from patients with any of 12 other common chronic conditions, specifically focusing on its impact on work productivity and activity impairment, as measured by the instrument of the same name (WPAI).

A systematic literature review of multiple data sources identified evaluable studies for inclusion in the analysis. Study eligibility criteria included use of the WPAI instrument in patients with one of a predefined list of chronic conditions. We assessed the quality of each included study using the Newcastle-Ottawa scale and extracted basic study information, work and activity impairment data. To assess how work and activity impairment from nocturia compares with impairment from other common chronic diseases, we conducted two data syntheses (pooled and unpooled).

The number of evaluable studies and the range of overall work productivity impairment reported, respectively, were as follows: nocturia (3; 14-39 %), overactive bladder (5; 11-41 %), irritable bowel syndrome/constipation (14; 21-51 %), gastroesophageal reflux disease (GERD) (13; 6-42 %), asthma/allergies (11; 6-40 %), chronic obstructive pulmonary disease (COPD) (7; 19-42 %), sleep problems (3; 12-37 %), arthritis (13; 21-69 %), pain (9; 29-64 %), depression (4; 15-43 %) and gout (2; 20-37 %).

The overall work productivity impairment as a result of nocturia is substantial and was found to be similar to impairment observed as a result of several other more frequently researched common chronic diseases. Greater awareness of the burden of nocturia, a highly bothersome and prevalent condition, will help policy makers and healthcare decision makers provide appropriate management of nocturia.

Irritable bowel syndrome (IBS) is a highly prevalent medical condition that adversely affects patient quality of life and constitutes a significant economic burden on healthcare resources. A large proportion of patients suffer from the constipation subtype of IBS (IBS-C), most commonly afflicting older individuals and those with a lower socioeconomic status. Conventional pharmacologic and nonpharmacologic treatment options have limited efficacies and/or significant adverse events, which lead to increased long-term health care expenditures. Failure to effectively treat IBS-C patients over the past decades has largely been due to a poor understanding of disease pathophysiology, lack of a global view of the patient, and an inappropriate selection of patients and treatment endpoints in clinical trials. In recent years, however, more effective and safer drugs have been developed for the treatment of IBS-C. The advancement in the area of pharmacologic treatment is based on new knowledge of the pathophysiologic basis of IBS-C and the development of drugs with increased selectivity within pharmacologic classes with recognized efficacies. This narrative review covers the spectrum of available drugs and their mechanisms of action, as well as the efficacy and safety profiles of each as determined in relevant clinical trials that have investigated treatment options for IBS-C and chronic constipation. A brief summary of laxative-based treatment options is presented, followed by up-to-date assessments for three classes of drugs: prokinetics, prosecretory agents, and bile acid modulators.

We sought to evaluate the association between constipation severity, productivity losses and healthcare utilization in a national sample of Italian patients with chronic non-organic constipation (CC).

We enrolled 878 outpatients with CC. Clinical and demographic data were collected by physicians during clinical examinations. Patients completed a self-administered questionnaire (Patient Assessment of Constipation-Symptoms, PAC-SYM; Work Productivity and Activity Impairment; healthcare utilization, and Symptoms Checklist 90 Revised - Somatization Scale, SCL-90 R).

Mean PAC-SYM score was 1.62 ± 0.69. Mean weekly sick time due to constipation was 2.7 ± 8.6 h and productivity losses due to presenteeism was 19.7% ± 22.3%. Adjusted productivity losses in patients with severe CC (PAC-SYM score 2.3-4.0) compared to patients with mild symptoms (PAC-SYM score 0.0-1.0) was Italian Purchase Power Parity US$ 6160. Constipation severity (PAC-SYM quintiles) was associated with higher healthcare utilization (RRPAC-SYM 4/01.84; p-value for linear trend <0.01). After adjustment for somatization scores, the association of constipation severity with productivity losses and healthcare utilization rates was attenuated yet statistically significant.

We observed a graded increase in productivity losses and healthcare utilization with increasing constipation severity. Further studies should evaluate whether significant savings might be achieved with regimens aimed at reducing the constipation severity.

To conduct a systematic literature review to assess burden of disease and unmet medical needs in patients with irritable bowel syndrome (IBS) with constipation (IBS-C), with a focus on five European countries (France, Germany, Italy, Spain, UK).

MEDLINE, EMBASE, and grey literature searches were carried out using terms for IBS and constipation, to identify studies reporting epidemiological, clinical, humanistic, or economic outcomes for IBS-C, published between 2000 and 2010.

Searches identified 885 unique abstracts and 33 supplementary articles, of which 100 publications and six grey literature sources met the inclusion criteria. Among patients with IBS, the prevalence estimates of IBS-C ranged from 1 to 44%. Co-morbid conditions, such as personality traits, psychological distress, and stress, were common. Patients with IBS-C had lower health-related quality-of-life (HRQoL) compared with the general population, and clinical trials suggested that effectively treating IBS-C improves HRQoL. The European societal cost of IBS-C is largely unknown, as no IBS-C-specific European cost-of-illness studies were identified. Two cost analyses demonstrated the substantial societal impact of IBS-C, including reduced productivity at work and work absenteeism. Guidelines offered similar recommendations for the diagnosis and management of IBS; however, recommendations specifically for IBS-C varied by country. Current IBS-C treatment options have limited efficacy and the risk:benefit profile of early 5-HT(4) agonists restricts clinical use.

This systematic review indicates a clear need for European-focused IBS-C burden-of-disease and cost-of-illness studies to address identified evidence gaps. There is a need for new therapies for IBS-C that are effective, well tolerated, and have a positive impact on HRQoL.

The aim of this article is to review the pathophysiology and clinical role of serotonin receptor modulators used in the treatment of irritable bowel syndrome. Serotonin is an important monoamine neurotransmitter that plays a key role in the initiation of peristaltic and secretory refl exes, and in modulation of visceral sensations. Several serotonin receptor subtypes have been characterized, of which 5HT3, 5HT4, and 5HT1b are the most important for GI function. 5HT4 agonists (eg, tegaserod) potentiate peristalsis initiated by 5HT1 receptor stimulation. 5HT4 agonists are therefore useful in constipation predominant form of IBS and in chronic constipation. 5HT3 antagonists (Alosetron and Cilansetron) prevent the activation of 5HT3 receptors on extrinsic afferent neurons and can decrease the visceral pain associated with IBS. These agents also retard small intestinal and colonic transit, and are therefore useful in diarrhea-predominant IBS. Tegaserod has been demonstrated in several randomized, placebo controlled trials to relieve global IBS symptoms as well as individual symptoms of abdominal discomfort, number of bowel movements and stool consistency. Several randomized, controlled trials have shown that alosetron relieves pain, improves bowel function, and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. However, ischemic colitis and severe complications of constipation have been major concerns leading to voluntary withdrawal of Alosetron from the market followed by remarketing with a comprehensive risk management program.

Autogenic training (AT) is a useful and comprehensive relaxation technique. However, no studies have investigated the effects of AT on irritable bowel syndrome (IBS). In this study we tested the hypothesis that AT improves symptoms of IBS. Twenty-one patients with IBS were randomly assigned to AT (n = 11, 5 male, 6 female) or control therapy (n = 10, 5 male, 5 female). AT patients were trained intensively, while the control therapy consisted of discussions about patients' meal habits and life styles. All patients answered a question related to adequate relief (AR) of IBS symptoms and four questionnaires: Self-induced IBS Questionnaire (SIBSQ), Self-reported Depression Scale (SDS), State-Trait Anxiety Inventory (STAI), and Medical Outcome Short Form 36 Health Survey (SF-36). The proportion of AR in the last AT session in the AT group (9/11, 81.8%) was significantly higher than that in the controls (3/10, 30.0%, Chi-square test, p = 0.048). Two subscales of the SF-36, i.e., social functioning and bodily pain, were significantly improved in the AT group (p < 0.05) as compared to the control group. Role emotional (p = 0.051) and general health (p = 0.068) showed a tendency for improvement in the AT group. AT may be useful in the treatment of IBS by enhancing self-control.

The effect of certolizumab pegol on employment status and work productivity has not been previously assessed.

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.

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) (> or = 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.

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.

Induction and maintenance therapy with certolizumab pegol significantly improved the work productivity of patients with active CD compared with those in the placebo group.

Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).

A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT(4) receptor agonist, prucalopride, in patients with chronic constipation [<or=2 spontaneous complete bowel movements (SCBMs)/week].

Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with >or=3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability.

Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (>or=3 SCBMs/week) or an increase of >or=1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events.

Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.

Employers are becoming concerned with the costs of presenteeism in addition to the healthcare and absenteeism costs that have traditionally been explored. But what is the true impact of health conditions in terms of on-the-job productivity? This article examines the literature to assess the magnitude of presenteeism costs relative to total costs of a variety of health conditions. Searches of MEDLINE, CINAHL and PubMed were conducted in July 2008, with no starting date limitation, using 'presenteeism' or 'work limitations' as keywords. Publications on a variety of health conditions were located and included if they assessed the total healthcare and productivity cost of one or more health conditions. Literature on presenteeism has investigated its link with a large number of health conditions ranging from allergies to irritable bowel syndrome. The cost of presenteeism relative to the total cost varies by condition. In some cases (such as allergies or migraine headaches), the cost of presenteeism is much larger than the direct healthcare cost, while in other cases (such as hypertension or cancer), healthcare is the larger component. Many more studies have examined the impact of pharmaceutical treatment on certain medical conditions and the resulting improvement in on-the-job productivity. Based on the research reviewed here, health conditions are associated with on-the-job productivity losses and presenteeism is a major component of the total employer cost of those conditions, although the exact dollar amount cannot be determined at this time. Interventions, including the appropriate use of pharmaceutical agents, may be helpful in improving the productivity of employees with certain conditions.

IBS is a complex disorder that encompasses a wide profile of symptoms. The symptoms of chronic constipation frequently resemble those of constipation-predominant IBS. Current drug treatments for irritable bowel syndrome (IBS) are of limited value. Many target specific symptoms only. Tegaserod, a 5HT(4) partial agonist, represents a novel mechanism of action in the treatment of IBS and chronic constipation.

The objective of this review was to evaluate the efficacy and tolerability of tegaserod for the treatment of IBS and chronic constipation in adults and adolescents aged 12 years and above.

MEDLINE 1966-December 2006 and EMBASE 1980 to December 2006 were searched. The text and key words used included "tegaserod", "HTF 919", "irritable bowel", "constipation" and "colonic diseases, functional". The Cochrane Central Register of Controlled Trials, and the Inflammatory Bowel Disease Review Group Specialized Trials Register were also searched. Searches stopped on 15th December 2006. Relevant articles were retrieved, and their reference lists were also reviewed.

Randomised or quasi-randomised controlled trials comparing tegaserod with placebo, no treatment or any other intervention (pharmacological or non-pharmacological) in subjects aged 12 years and above with a diagnosis of IBS or chronic constipation, focusing on clinical endpoints were considered for review.

Study inclusion and exclusion, data extraction and quality assessment was undertaken by two authors independently. Meta-analysis was performed where study populations, designs, outcomes, and statistical reporting allowed combination of data in a valid way, using the summary statistics relative risk for dichotomous data and weighted mean difference for continuous data, both with 95% CI. Thirteen short-term placebo-controlled studies fulfilled the inclusion criteria. These were predominantly conducted in women. Ten studies evaluated the efficacy of tegaserod on global gastrointestinal (GI) symptoms in patients with constipation-predominant IBS (C-IBS). One small study evaluated safety in patients with diarrhoea-predominant IBS. Two studies evaluated the effectiveness of tegaserod for the treatment of chronic constipation.

In patients with C-IBS, the relative risk (RR) of being a responder in terms of global relief of GI symptoms during the last 4 weeks of treatment was significantly higher with both tegaserod 12 mg and 4 mg doses compared with placebo. Although the pooled results indicate statistically significant benefit with tegaserod, the a priori minimal clinically important differences set in two of three studies were not reached. The responder rate for this endpoint was also higher when considered for the first 4 weeks of treatment (tegaserod 12 mg only). Tegaserod did not significantly improve the patients' individual symptoms of abdominal pain and discomfort although bowel habit showed a statistically significant improvement with tegaserod 4 mg and there was a non-significant trend in this outcome in favour of tegaserod 12 mg. In patients with chronic constipation, the RR of being a responder in terms of complete spontaneous bowel movements per week with tegaserod 12 mg was 1.54 (95% CI 1.35 to 1.75), WMD for this endpoint compared with placebo 0.6 (95% CI 0.42 to 0.78). Differences between tegaserod and placebo in increases in frequency of bowel movements were small (less than one per week). The proportion of patients with either diagnosis who experienced diarrhea was significantly higher in the tegaserod 12 mg group compared with placebo (RR 2.80, 95% CI 2.13 to 3.68), with a number needed to harm (NNH) of 20. Effects of tegaserod on GI symptoms such as bloating, stool consistency, and straining were not consistent across the studies.

Tegaserod appears to improve the overall symptomatology of IBS, and the frequency of bowel movements in those with chronic constipation. The clinical importance of these modest improvements is not clear. There are currently few data on its effect on quality of life. In addition, more information is needed about its efficacy in men. It would also be of interest to know whether treatment with tegaserod leads either directly, or indirectly, to changes in visceral sensitivity or psychopathology, which are also considered important in the pathophysiology of these conditions.

There are frequent advances in knowledge about the clinical presentation, pathophysiology, and treatment of irritable bowel syndrome. It is important for clinicians to be aware of available therapies and the supporting evidence for those therapies to increase patient satisfaction. This is best achieved with a collaborative and long-term clinician-patient relationship and mutual commitment to modify therapy and try new modalities until the greatest relief of symptoms and improvement in health-related quality of life is achieved. This article reviews symptoms, comorbidities, gender differences, and measure of severity in irritable bowel syndrome and current and evidence-based approaches to evaluation and treatment, and the new symptom-based Rome III diagnostic criteria are reviewed and explained.

Many employers focus on their large and easily measured cost of health care, yet until recently they have ignored the impact of health on productivity. Studies of some chronic conditions and some health risk factors suggest that costs of lost productivity exceed costs of medical care. This review will examine the literature to explore the link between employee health and on-the-job productivity, also known as presenteeism.

Searches of Medline, CINAHL and PubMed were conducted in October 2006, with no starting date limitation with "presenteeism" or "work limitations" as keywords. A total of 113 studies were found using this method. Each study was evaluated based on the strength of the study design, statistical analyses, outcome measurement, and controlling of confounding variables.

Literature on presenteeism has investigated its link with a large number of health risks and health conditions ranging from exercise and weight to allergies and irritable bowel syndrome. As expected, the research on some topic areas is stronger than others.

Based on the research reviewed here, it can be said with confidence that health conditions such as allergies and arthritis are associated with presenteeism. Moreover, health risks traditionally measured by a health risk appraisal (HRA), especially physical activity and body weight, also show an association with presenteeism. The next step for researchers is to tease out the impact of individual health risks or combinations of risks and health conditions on this important outcome measure.

Tegaserod is effective, safe, and well-tolerated in the treatment of patients with irritable bowel syndrome (IBS) with constipation. The aim of this study was to assess, from a payer perspective, the cost-effectiveness of tegaserod in the treatment of IBS patients, based on the TEgaserod in NORdic region (TENOR) trial data.

Female and male patients (Rome II criteria) were randomized to receive tegaserod 6 mg b.i.d. or placebo for 12 weeks. Patients (247 tegaserod; 238 placebo) completed the EuroQol EQ-5D questionnaire at baseline, Week 4, and Week 12. A 12-week economic study was undertaken to assess the incremental cost-effectiveness ratio (ICER) of tegaserod in terms of cost per quality-adjusted life-year (QALY) gained. Cost-effectiveness acceptability curves were calculated to estimate the probability of tegaserod being cost-effective at different benchmark values of cost per QALY gained.

By assuming a daily drug cost to payers of Euro 2, Euro 3, and Euro 4, the ICER of tegaserod ranges between Euro 19,000 and Euro 38,000 per QALY gained, with the percentage of the bootstrap estimates below the willingness to pay level of Euro 50,000 per QALY gained ranging between 90% and 69%.

This study established directly from a randomized controlled clinical trial that tegaserod is cost-effective in the treatment of non-D-IBS patients.

Irritable bowel syndrome with constipation (IBS-C) as the predominant bowel symptom is a prevalent disorder, characterized by recurring abdominal pain/discomfort, bloating, and constipation, and imposes a significant socio-economic burden. Traditional treatments generally address just one of the multiple IBS symptoms. The efficacy and safety profile of tegaserod, a serotonin 5-HT(4) receptor agonist, has been demonstrated in several randomized, placebo-controlled, and open-label trials. This review discusses the major clinical trials of tegaserod, which have involved 8948 IBS patients. Overall, data reveal that tegaserod is an effective treatment for IBS-C, providing statistically significant relief of overall and multiple individual IBS-C symptoms (abdominal pain/discomfort, bloating, and constipation) in both placebo-controlled and "real-life" open-label settings. Repeat treatments with tegaserod were also shown to be effective, which is noteworthy given the chronic and episodic nature of IBS. Moreover, tegaserod was associated with improvements in patients' quality of life and work productivity. Data also indicate that tegaserod is well tolerated over the short-term (4 weeks), long-term (12 months), and repeated treatments. Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient. Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

Abdominal pain/discomfort, bloating, and constipation are gastrointestinal dysmotility and sensory symptoms associated with irritable bowel syndrome (IBS). No studies have followed patients with IBS symptoms for 1 year under conditions of routine clinical practice to assess prospectively the impact of treatments on health outcomes.

The objective of this ongoing, naturalistic study is to assess the long-term impact of IBS treatments on quality of life (QOL), work productivity, and resource utilization. This report describes the baseline characteristics and patterns of care of the patients enrolled in this study.

Patients with physician-diagnosed IBS symptoms were enrolled from 147 physician sites across Canada between May 4, 2004, and March 31, 2005. Clinical data were collected at baseline and at the end of the 12-month follow-up (patients were followed for 1 year between May 4, 2005, and March 31, 2006). Patient-reported outcomes were collected at baseline and at months 1, 2, 6, 9, and 12. Health-related QOL, health status, and work productivity were assessed with the IBS-QOL, a 5-item EuroQol descriptive system, and Work Productivity and Activity Impairment questionnaires, respectively. A resource utilization questionnaire elicited information on physician; visits, treatments, and procedures. Baseline data are reported here.

Data were obtained from 1555 patients; 85.1% (1320/1552) were women. Patients had a mean (SD) age of 45.8 (15.0) years and mean (SD) duration of IBS symptoms of 11.4 (11.5) years. Self-reported bowel patterns were predominantly constipation (41.0%, 587/1433) and constipation alternating with diarrhea (39.4%, 564/1433); 60.3% (938/1555) of subjects used > or =3 IBS treatments in the previous 4 weeks. Approximately 50% of all patients reported distress "quite a bit or "extremely" for abdominal pain, gas, bloating, and constipation. The mean overall IBS-QOL score (0-100 scale, with 0 indicating poor QOL) was 66.3; food avoidance (51.8) and health worry (59.3) were the most serious concerns. Patients reported 5.6% work absenteeism, 31.4% presenteeism, and 34.6% overall work productivity loss, equivalent to 13.8 hours lost productivity per 40-hour workweek.

The baseline data from this ongoing, prospective, naturalistic study are consistent with previous findings that suggested significant use of health care resources with concomitant low QOL and decreased work productivity in patients with IBS symptoms.

Gastro-oesophageal reflux disease has wide-ranging effects on patients' lives.

To review systematically the effects of gastro-oesophageal reflux disease on work productivity.

Studies of gastro-oesophageal reflux disease and work productivity were identified in a systematic literature search and their results were valued in US dollars using the human capital method. Work productivity loss was defined as absence from work (absenteeism) plus reduced effectiveness while working (presenteeism).

Eight eligible studies were included. Reported work productivity loss among individuals with gastro-oesophageal reflux disease ranged from 6% to 42% and was primarily because of presenteeism (6-40%) rather than absenteeism (<1% to 7%). Reported losses were greatest in patients experiencing sleep disturbance because of gastro-oesophageal reflux disease, and lowest in individuals from the general population taking appropriate prescription medication. Work productivity impairment correlated with symptom severity and responded to acid-suppressive therapy. Assuming a 40-h working week and average wages in the US, the weekly mean productivity loss per employee with gastro-oesophageal reflux disease can be estimated between 2.4 (62 dollars) and 16.6 h (430 dollars), depending on the population studied.

Gastro-oesophageal reflux disease has a substantial impact on employee productivity, primarily by impairing productivity while working. Further studies are needed to confirm that this impact can be decreased by acid-suppressive therapy.

A growing body of evidence implicates abnormal serotonergic regulation of gastrointestinal function in the pathogenesis of the irritable bowel syndrome (IBS). Drugs targeting this system are therefore attractive concepts. The partial 5-HT4 receptor agonist tegaserod might be predicted to have positive therapeutic effects on a constipated and uncomfortable gut. However, IBS runs a chronic, benign course and carries no associated mortality, so it is imperative that the safety profile of new pharmacological agents made available to physicians is exemplary. The authors review the evidence for 5-HT in the aetiology of IBS and its symptoms, and the data available concerning the partial 5-HT4 receptor agonist tegaserod, in terms of rationale, efficacy and safety.

Tegaserod, a novel serotonin receptor agonist, has gained acceptance and widespread use for the treatment of women with irritable bowel syndrome and constipation. Development of this therapy evolved from the emerging role of serotonin in gastrointestinal motor, secretory and sensory functions. The efficacy and safety of tegaserod has been well established in women suffering from irritable bowel syndrome with constipation. Large, randomized, double-blind, placebo-controlled trials involving more than 3500 predominantly female patients with irritable bowel syndrome and constipation have demonstrated the superiority of tegaserod over placebo in improving global and individual symptoms. The most common side effects of tegaserod in clinical trials were diarrhea and headache. Recent data suggest that retreatment with tegaserod after a drug holiday is efficacious, opening the door to the possibility of intermittent therapy for patients with irritable bowel syndrome and constipation. Areas in need of further investigation include the role of tegaserod in the treatment of pain and bloating in irritable bowel syndrome, whether tegaserod has a role in male patients, the long-term efficacy of tegaserod, whether tolerance develops in a subset of patients with extended therapy and whether tegaserod is beneficial for the treatment of other functional gastrointestinal disorders.