Review article: do stimulant laxatives damage the gut? A critical analysis of current knowledge.

Stimulant laxatives are well established as first- or second-line treatments for constipation and although they have a reliable therapeutic effect, alleged safety concerns still exist, particularly with long-term use. The potential harmful effects on the gastrointestinal system (including carcinogenicity) of the long-term use of diphenylmethane [bisacodyl, sodium picosulfate (SPS)] and senna stimulant laxatives were assessed in a comprehensive review of the publications identified in literature searches performed in PubMed and Embase up to and including June 2023. We identified and reviewed 43 publications of interest. While stimulant laxatives at supratherapeutic doses have been shown to cause structural alterations to surface absorptive cells in animals and humans, these effects are reversible and not considered clinically relevant. No formal long-term studies have demonstrated morphological changes in enteric neural elements or intestinal smooth muscle with bisacodyl or SPS in humans. Furthermore, there is no convincing evidence that stimulant laxatives are associated with the development of colon cancer, and in fact, chronic constipation itself has been reported to potentially increase the risk of colon cancer, therefore, the use of stimulant laxatives might reduce this risk. Many studies suggesting a possible harmful effect from laxatives were limited by their failure to consider confounding factors such as concomitant neurological disease, metabolic disorders, and age. These findings highlight the lack of evidence for the harmful effects of laxatives on the colon, and thus, the benefits of treatment with stimulant laxatives, even in the long-term, should be reconsidered for the management of patients with constipation.

Do stimulant laxatives damage the gut? Stimulant laxatives are widely used treatments for constipation that work by causing the muscles in the gut to contract and so move stool more effectively. Examples of these treatments include senna, bisacodyl and sodium picosulfate. Treatments such as these are typically available without a doctor's prescription and have a long history of helping people relieve their constipation. However, some concerns have been expressed about the safety of these treatments, particularly when they are used for a long time. We did a critical review of published studies of the safety of stimulant laxatives to try to find out whether there is any strong evidence for harm being caused by these treatments. We found 43 papers with information on the gut safety of stimulant laxatives. These studies looked at whether the treatments are associated with changes to gut structure or function and at whether there might be a link between these treatments and bowel cancer. Unfortunately, many of the studies were of poor quality. For instance, they did not look for things, in addition to the laxatives, that could have affected the results, such as the age of the patients, other medications they were taking or whether they had other health conditions that might have affected the bowel. Also, the populations in which the studies were done differed a lot, so they were hard to compare with one another. However, we did not find any strong evidence suggesting that stimulant laxatives damage the gut or cause cancer. We therefore concluded that the harms associated with stimulant laxatives are likely to have been overstated, and that patients should not be denied the benefits of stimulant laxatives for constipation, especially as they have been on the market for a very long time with no serious problems emerging.

Clinical trial: predictive factors for response to gut-directed hypnotherapy for refractory irritable bowel syndrome, a post hoc analysis.

BACKGROUND: Gut-directed hypnotherapy is effective for patients with irritable bowel syndrome (IBS). Despite its considerable evidence base, gut-directed hypnotherapy is not widely available and remains a limited resource. This emphasises the need to select patients who are most likely to benefit. AIM: To determine whether baseline patient characteristics were predictive of response to gut-directed hypnotherapy in patients with IBS METHODS: We conducted a secondary analysis of outcomes of 448 patients with refractory Rome III IBS who participated in a randomised study confirming non-inferiority of 6 compared to 12 sessions of gut-directed hypnotherapy. We compared baseline patient characteristics, including age, sex, IBS subtype, quality of life and IBS-Symptom Severity Scale (IBS-SSS), non-colonic symptom score and Hospital Anxiety and Depression (HAD) score between responders and non-responders. We defined response as ≥50-point decrease in IBS-SSS or ≥30% reduction in pain severity scores. RESULTS: Overall, 76.3% achieved ≥50-point decrease in IBS-SSS. Responders had a higher baseline non-colonic symptom score (p = 0.005). Those who achieved ≥30% improvement in abdominal pain scores (59.8%) had higher baseline IBS-SSS (p = 0.03), and lower baseline HAD-depression score (p = 0.012). Fifty-four patients (12%) dropped out of gut-directed hypnotherapy. Compared to completers, dropouts had higher baseline HAD-anxiety score (p = 0.034). CONCLUSIONS: These data suggest that patients with a higher burden of gastrointestinal and extraintestinal symptoms are most likely to benefit from gut-specific behavioural intervention for refractory IBS. Clinical assessment of gastrointestinal, somatic and psychological symptom profiles may play a role in selecting patients for gut-directed hypnotherapy.

Face-to-face interviews versus Internet surveys: Comparison of two data collection methods in the Rome foundation global epidemiology study: Implications for population-based research.

BACKGROUND AND AIMS: The Rome Foundation Global Epidemiology Study (RFGES) assessed the prevalence, burden, and associated factors of Disorders of Gut-Brain Interaction (DGBI) in 33 countries around the world. Achieving worldwide sampling necessitated use of two different surveying methods: In-person household interviews (9 countries) and Internet surveys (26 countries). Two countries, China and Turkey, were surveyed with both methods. This paper examines the differences in the survey results with the two methods, as well as likely reasons for those differences. METHODS: The two RFGES survey methods are described in detail, and differences in DGBI findings summarized for household versus Internet surveys globally, and in more detail for China and Turkey. Logistic regression analysis was used to elucidate factors contributing to these differences. RESULTS: Overall, DGBI were only half as prevalent when assessed with household vs Internet surveys. Similar patterns of methodology-related DGBI differences were seen within both China and Turkey, but prevalence differences between the survey methods were dramatically larger in Turkey. No clear reasons for outcome differences by survey method were identified, although greater relative reduction in bowel and anorectal versus upper gastrointestinal disorders when household versus Internet surveying was used suggests an inhibiting influence of social sensitivity. CONCLUSIONS: The findings strongly indicate that besides affecting data quality, manpower needs and data collection time and costs, the choice of survey method is a substantial determinant of symptom reporting and DGBI prevalence outcomes. This has important implications for future DGBI research and epidemiological research more broadly.

The national prevalence of disorders of gut brain interaction in the United Kingdom in comparison to their worldwide prevalence: Results from the Rome foundation global epidemiology study.

BACKGROUND: There are minimal epidemiological data comparing the burden of disorders of gut brain interaction (DGBI) in the UK with other countries. We compared the prevalence of DGBI in the UK with other countries that participated in the Rome Foundation Global Epidemiology Study (RFGES) online. METHODS: Participants from 26 countries completed the RFGES survey online including the Rome IV diagnostic questionnaire and an in-depth supplemental questionnaire with questions about dietary habits. UK sociodemographic and prevalence data were compared with the other 25 countries pooled together. KEY RESULTS: The proportion of participants with at least one DGBI was lower in UK participants compared with in the other 25 countries (37.6% 95% CI 35.5%-39.7% vs. 41.2%; 95% CI 40.8%-41.6%, p = 0.001). The UK prevalence of 14 of 22 Rome IV DGBI, including irritable bowel syndrome (4.3%) and functional dyspepsia (6.8%), was similar to the other countries. Fecal incontinence, opioid-induced constipation, chronic nausea and vomiting, and cannabinoid hyperemesis (p < 0.05) were more prevalent in the UK. Cyclic vomiting, functional constipation, unspecified functional bowel disorder, and proctalgia fugax (p < 0.05) were more prevalent in the other 25 countries. Diet in the UK population consisted of higher consumption of meat and milk (p < 0.001), and lower consumption of rice, fruit, eggs, tofu, pasta, vegetables/legumes, and fish (p < 0.001). CONCLUSIONS AND INFERENCES: The prevalence and burden of DGBI is consistently high in the UK and in the rest of the world. Opioid prescribing, cultural, dietary, and lifestyle factors may contribute to differences in the prevalence of some DGBI between the UK and other countries.

Current Practices, Experiences, and Views in Clinical Hypnosis: Findings of an International Survey.

An online survey of 691 clinicians who use hypnosis was conducted in 31 countries to gain a broad real-world picture of current practices, views, and experiences in clinical hypnosis. Among 36 common clinical uses, stress reduction, wellbeing and self-esteem-enhancement, surgery preparations, anxiety interventions, mindfulness facilitation, and labor and childbirth applications were the most frequently rated as highly effective (each by ≥70% of raters) in the clinicians' own experience. Adverse hypnosis-associated effects had been encountered by 55% of clinicians but were generally short-lived and very rarely judged as serious. The most common hypnosis approaches used were Ericksonian (71%), hypnotic relaxation therapy (55%), and traditional hypnosis (50%). Almost all respondents reported regularly using other therapeutic modalities alongside hypnosis. Among a range of client variables potentially affecting therapy, most clinicians rated hypnotist-client rapport (88%) and client motivation (75%) as very or extremely important factors for successful hypnotherapy. The majority of respondents had conducted hypnosis treatment via teletherapy, and 54% of those estimated it to be as effective as in-person treatment.

A comparative study of disorders of gut-brain interaction in Western Europe and Asia based on the Rome foundation global epidemiology study.

OBJECTIVE: Many studies have been published on disorders of the gut-brain interaction (DGBI) in Asia and Western Europe, but no previous study has directly assessed the difference between the two regions. The aim was to compare the prevalence of DGBI in Asia and Western Europe. METHODS: We used data collected in a population-based Internet survey, the Rome Foundation Global Epidemiology Study, from countries in Western Europe (Belgium, France, Germany, Netherlands, Italy, Spain, Sweden, and the United Kingdom) and Asia (China, Japan, South Korea, and Singapore). We assessed DGBI diagnoses (Rome IV Adult Diagnostic Questionnaire), anxiety/depression (Patient Health Questionnaire-4, PHQ-4), non-GI somatic symptoms (PHQ-12), and access to and personal costs of doctor visits. RESULTS: The study included 9487 subjects in Asia and 16,314 in Western Europe. Overall, 38.0% had at least one DGBI; younger age, female sex, and higher scores on PHQ4 and PHQ12 were all associated with DGBI. The prevalence of having at least one DGBI was higher in Western Europe than in Asia (39.1% vs 36.1%, OR 1.14 [95% CI 1.08-1.20]). This difference was also observed for DGBI by anatomical regions, most prominently esophageal DGBI (OR 1.67 [1.48-1.88]). After adjustment, the difference in DGBI prevalence diminished and psychological (PHQ-4) and non-GI somatic symptoms (PHQ-12) had the greatest effect on the odds ratio estimates. CONCLUSION: The prevalence of DGBI is generally higher in Western Europe compared to Asia. A considerable portion of the observed difference in prevalence rates seems to be explained by more severe psychological and non-GI somatic symptoms in Western Europe.

Randomised, placebo-controlled trial and meta-analysis show benefit of ondansetron for irritable bowel syndrome with diarrhoea: The TRITON trial.

BACKGROUND: Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D). AIM: To conduct a 12-week parallel group, randomised, double-blind, placebo-controlled trial of ondansetron 4 mg o.d. (titrated up to 8 mg t.d.s.) in 400 IBS-D patients. PRIMARY ENDPOINT: % responders using the Food and Drug Administration (FDA) composite endpoint. Secondary and mechanistic endpoints included stool consistency (Bristol Stool Form Scale) and whole gut transit time (WGTT). After literature review, results were pooled with other placebo-controlled trials in a meta-analysis to estimate relative risks (RR), 95% confidence intervals (CIs) and number needed to treat (NNT). RESULTS: Eighty patients were randomised. On intention-to-treat analysis, 15/37 (40.5%; 95% CI 24.7%-56.4%) met the primary endpoint on ondansetron versus 12/43 (27.9%; 95% CI 14.5%-41.3%) on placebo (p = 0.19). Ondansetron improved stool consistency compared with placebo (adjusted mean difference - 0.7; 95% CI -1.0 to-0.3, p < 0.001). Ondansetron increased WGTT between baseline and week 12 (mean (SD) difference 3.8 (9.1) hours, versus placebo -2.2 (10.3) hours, p = 0.01). Meta-analysis of 327 patients from this, and two similar trials, demonstrated ondansetron was superior to placebo for the FDA composite endpoint (RR of symptoms not responding = 0.86; 95% CI 0.75-0.98, NNT = 9) and stool response (RR = 0.65; 95% CI 0.52-0.82, NNT = 5), but not abdominal pain response (RR = 0.95; 95% CI 0.74-1.20). CONCLUSIONS: Although small numbers meant the primary endpoint was not met in this trial, when pooled with other similar trials meta-analysis suggests ondansetron improves stool consistency and reduces days with loose stool and urgency. Trial registration - http://www.isrctn.com/ISRCTN17508514.

Patient satisfaction after remotely delivered gut-directed hypnotherapy for irritable bowel syndrome during the COVID-19 era: implications for future practice.

OBJECTIVE: Gut-directed hypnotherapy (GDH) is an evidence-based treatment for irritable bowel syndrome (IBS). Adoption of remote GDH has been accelerated by the COVID-19 pandemic. We aimed to evaluate patient experience and satisfaction following remote GDH. DESIGN: On completing 12 sessions of remote GDH via Skype using the Manchester protocol, patients with refractory IBS completed a feedback form on their experience. The proportion reporting positive outcomes (≥30% improvement in global IBS symptoms or abdominal pain, satisfaction, recommendation to family/friends) were compared by patient factors (age, gender, proximity, preferences). RESULTS: Of 52 patients completing the feedback form, 27 (52%) indicated that they would have opted for remote over face-to-face GDH, regardless of the pandemic situation. On a five-point scale (5=easy), patients rated the platform easy-to-use (mean 4.5±0.8) without impairment of communication (mean rating 4.6±0.8). Following remote GDH, 30/52 (58%) reported ≥30% global IBS symptom improvement, and 24/52 (46%) reported ≥30% pain reduction. 90% would recommend remote GDH to others. Only 39% felt they would have benefitted more from face to face. Those who would have chosen remote GDH regardless of the pandemic were more likely to be satisfied (p=0.01). Age, gender and proximity did not influence outcomes, satisfaction and likelihood of recommending remote GDH to others. Difficulties during remote sessions were infrequent in both those that were satisfied, and those that would have preferred face to face. CONCLUSION: These data support the need to continue developing remote GDH in the post-COVID era but suggest that there is still a role for face-to-face GDH, with patient choice being an important factor.

Recognizing and Defining Occasional Constipation: Expert Consensus Recommendations.

Constipation is a common problem, affects 15% of the population, and is often self-diagnosed and self-managed. Over the past 3 decades, there have been significant advances in our understanding and management of chronic constipation, with the emerging recognition that occasional constipation (OC) is another subtype that falls outside current classifications. The purpose of this review was to describe the process of developing and proposing a new definition for OC based on expert consensus and taking into consideration the multifactorial nature of the problem such as alterations in bowel habit that include stool frequency and difficulty with stool passage, perception of the sufferer, duration of symptoms, and potential responsiveness to treatment. Leading gastroenterologists from 5 countries met virtually on multiple occasions through an online digital platform to discuss the problem of OC and recommended a practical, user-friendly definition: "OC can be defined as intermittent or occasional symptomatic alteration(s) in bowel habit. This includes a bothersome reduction in the frequency of bowel movements and/or difficulty with passage of stools but without alarming features. Bowel symptoms may last for a few days or a few weeks, and episodes may require modification of lifestyle, dietary habits and/or use of over-the-counter laxatives or bulking agents to restore a satisfactory bowel habit." Prospective studies are required to validate this definition and determine OC prevalence in the community. This review highlights current knowledge gaps and could provide impetus for future research to facilitate an improved understanding of OC and development of evidence-based management guidelines.

Experience and clinical efficacy of gut-directed hypnotherapy in an Asian population with refractory irritable bowel syndrome.

Background and Aim: Recent studies have highlighted the high worldwide prevalence of irritable bowel syndrome (IBS) and disparities in its management between ethnic groups. For instance, gut-directed hypnotherapy (GDH), one of the most effective evidence-based treatments for IBS, is not recommended in Asian countries partly due to lack of population-specific outcome data. In this context, we evaluated the outcomes of GDH in an Asian population. Methods: Consecutive British Asian patients with refractory IBS who received 12-sessions of GDH using the Manchester protocol were included. Patients were treated by a team including a therapist able to speak several Asian languages. All patients prospectively completed the following questionnaires before and after GDH: IBS symptom severity score (IBS-SSS), hospital anxiety and depression scale (HADS), non-colonic symptom score, and the quality-of-life (QOL) score. The primary outcome measure was response to GDH defined by ≥50-point reduction in IBS-SSS. Pre- and post-treatment data were compared statistically. Results: Forty-four Asian patients with IBS (age 49 ± 13 years; 29 [66%] female; baseline IBS-SSS: 332.8 ± 94.6) completed GDH. Overall, 37 of 44 (84%) achieved a ≥50-point reduction in IBS-SSS and 25 of 44 (57%) achieved ≥30% reduction in abdominal pain scores. Following GDH, there were also significant mean improvements in IBS-SSS (-132.1, P < 0.0001), non-colonic symptom score (P < 0.0001), QOL score (P < 0.0001), HADS-anxiety (P < 0.0001), and HADS-depression (P < 0.0001), compared with baseline. Conclusion: Regardless of the ethnicity of the therapist, GDH was highly effective with similar response rates to outcomes in other IBS populations, supporting the development of GDH in Asian countries.

Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D).

OBJECTIVE: Irritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D. DESIGN: After a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period. RESULTS: 440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect -0.32 (-0.62 to -0.02)) and urgency (treatment effect -0.59 (-0.85 to -0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel. CONCLUSION: Enterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options. TRIAL REGISTRATION NUMBER: ISRCTN17149988.

The symptom burden of Irritable Bowel Syndrome in tertiary care during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic caused unprecedented disruption to healthcare services worldwide with well-documented detrimental effects on mental health. Patients with refractory disorders of gut-brain interaction such as Irritable Bowel Syndrome (IBS) seen in tertiary care tend to exhibit higher levels of psychological comorbidity, but the impact of the pandemic on IBS symptom severity in tertiary care is unknown. METHODS: As part of routine clinical care, consecutive tertiary referrals with refractory IBS patients prospectively completed a series of baseline questionnaires including IBS symptom severity score (IBS-SSS), non-colonic symptom score, Hospital Anxiety and Depression (HAD), and Illness impact scores. The symptom severity questionnaire data were compared for consecutive patients seen in tertiary care 12 months before and after the onset of COVID-19 pandemic restrictions. KEY RESULTS: Of 190 consecutive tertiary referrals with IBS, those seen during the pandemic had greater IBS severity (IBS-SSS: 352 vs. 318, p = 0.03), more severe extra-intestinal symptoms (non-colonic score: 269 vs. 225, p = 0.03), sleep difficulties (p = 0.03), helplessness and loss of control (p = 0.02), but similar HAD-Anxiety (p = 0.96) and HAD-Depression (p = 0.84) scores. During the pandemic, unmarried patients (p = 0.03), and keyworkers (p = 0.0038) had greater IBS severity. CONCLUSIONS AND INFERENCES: This study has shown for the first time that patients seen in tertiary care with refractory IBS during the COVID-19 pandemic had a significantly higher symptom burden emphasizing the importance of gut-brain axis in IBS. Furthermore, lack of support and perceived loss of control appear to be contributory factors.

Guidelines for the Assessment of Efficacy of Clinical Hypnosis Applications.

Research on the efficacy of hypnosis applications continues to grow, but there remain major gaps between the science and clinical practice. One challenge has been a lack of consensus on which applications of hypnosis are efficacious based on research evidence. In 2018, 6 major hypnosis organizations collaborated to form the Task Force for Establishing Efficacy Standards for Clinical Hypnosis. This paper describes a Guideline for the Assessment of Efficacy of Clinical Hypnosis Applications developed by the Task Force, which makes 10 specific recommendations. The guideline is intended to be a tool for those who want to assess the quality of existing evidence on the efficacy of clinical hypnosis for any particular indication. The paper also discusses methodological issues in the interpretation and implementation of these guidelines. Future papers will report on the other products of the Hypnosis Efficacy Task Force, such as best practice recommendations for outcomes research in hypnosis and an international survey of researchers and clinicians on current practice and attitudes about hypnosis.

A double-blind randomised placebo-controlled trial investigating the effects of lesogaberan on the objective cough frequency and capsaicin-evoked coughs in patients with refractory chronic cough.

Objective: Baclofen is a centrally acting γ-aminobutyric acid type B (GABAB) receptor agonist which reduces gastro-oesophageal reflux and suppresses the cough reflex; however, central nervous system side-effects limit its use. Lesogaberan is a novel peripherally acting GABAB agonist, but its effects on refractory chronic cough are unknown. Design: We performed a single-centre, placebo-controlled, double-blind randomised crossover study in patients with chronic cough, refractory to the treatment of underlying conditions. Patients were randomised to treatment with lesogaberan 120 mg modified release twice daily or matched placebo for 2 weeks and then crossed over to the alternative therapy after a 2-week washout. The primary end-point was 24-h cough frequency measured with an acoustic monitoring system. In addition, cough responses to capsaicin were measured, and gastro-oesophageal reflux assessed by 24-h pH/impedance at screening. Results: 22 patients were randomised to receive lesogaberan/placebo or placebo/lesogaberan (female (73%); mean±sd age 63.7±7.2 years; median (interquartile range) cough duration 10.5 (5.8-17.0) years; mean (95% CI) 45 (29-67) reflux events in 24 h; two patients had abnormal oesophageal acid exposure times). Although lesogaberan reduced cough counts by 26% over placebo, this did not reach statistical significance (p=0.12). However, lesogaberan did significantly improve cough responses to capsaicin (p=0.04) and the number of cough bouts (p=0.04) compared with placebo. Lesogaberan was well tolerated in this study. Conclusions: Lesogaberan improved cough hypersensitivity and the number of bouts of coughing, but not coughs per hour. This implies a possible role for peripheral GABAB receptors in refractory chronic cough.

Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions.

INTRODUCTION: Numerous studies have shown that hypnotherapy (HT) is effective in irritable bowel syndrome (IBS) using traditional symptom severity end points. However, there is now interest in capturing the patient's perception of their illness and treatment because what patients expect from their treatment may differ from that of their healthcare provider. OBJECTIVE: To record patient perceptions and expectations of hypnotherapy as well as their symptom response. METHODS: 150 consecutive IBS patients (116 females, 34 males, aged 16-81 years) receiving hypnotherapy completed questionnaires recording IBS symptom severity, quality of life, noncolonic symptoms, anxiety and depression levels before and after treatment. Their expectations and perceptions of HT were also recorded, including a free text reflection. RESULTS: 121 patients (81%) responded to treatment consistent with our previous experience. Symptom severity scores, noncolonic symptoms, quality of life, anxiety and depression significantly all improved after HT (p < 0.001). Expectancy of an improvement with hypnotherapy was greater in those who did not respond to treatment (63%) than those who did (57%, p < 0.001). Scepticism and apprehension were common before treatment and replaced with enthusiasm afterwards. Free text responses after treatment were overwhelmingly positive. Patients also reported a variety of other benefits and even 20 of 29 symptom nonresponders (70%) still considered treatment worthwhile. CONCLUSION: Although initially perceived negatively, hypnotherapy improved symptoms and resulted in a wide range of additional benefits. Expectation did not necessarily influence outcome. Recording IBS symptoms alone does not fully capture the patient's experience of treatment and needs to be considered in future research.

The Intestinal Gas Questionnaire (IGQ): Psychometric validation of a new instrument for measuring gas-related symptoms and their impact on daily life among general population and irritable bowel syndrome.

BACKGROUND: Gas-related symptoms (GRS) are common in the general population (GPop) and among patients with disorders of gut-brain interactions but there is no patient-reported outcome evaluating these symptoms and their impact on daily life. We have previously developed a 43-item intestinal gas questionnaire (IGQ). The aim of the present study is to perform a psychometric validation of this instrument. METHODS: Participants (119 from the GPop and 186 irritable bowel syndrome (IBS) patients) were recruited from 3 countries (UK, Spain, France). IBS patients fulfilled ROME IV criteria with an IBS severity score between 150 and 300. Participants completed the IGQ, the functional Digestive Disorders Quality of Life (FDDQL), and the EQ-5D. A subgroup (n = 90) repeated the IGQ completion after 7 days on paper or electronically. RESULTS: From the original IGQ questionnaire, 26 items were deleted because of poor performance. Confirmatory factorial analysis on the remaining 17 items (7 symptom and 10 impact items) yielded a 6-factor structure accounting for 67% of the variance for bloating (6 items), flatulence (3), belching (2), bad breath (2), stomach rumbling (2), and difficult gas evacuation (2). Global score (0-100) was worse among IBS vs GPop (40 ± 15 vs 33 ± 17; p = 0.0016). At the second visit, the intraclass correlation coefficient of IGQ scores was between 0.71 and 0.86 (n = 67) for test-retest reliability and 0.61-0.87 (n = 64) for equivalence between electronic and paper versions of IGQ. CONCLUSION: The IGQ available in paper and electronic versions in 3 languages is a robust instrument for capturing and measuring GRS and their impact on daily life.

Greater Overlap of Rome IV Disorders of Gut-Brain Interactions Leads to Increased Disease Severity and Poorer Quality of Life.

BACKGROUND AND AIMS: Conditions such as irritable bowel syndrome (IBS), functional dyspepsia, and functional constipation are among the prevalent gastrointestinal (GI) disorders classified as disorders of gut-brain interaction (DGBI), which can adversely affect the lives of sufferers. This study aimed to assess the degree and consequences of overlapping DGBI in a large population-based global scale. METHODS: Internet survey data from 54,127 adults (49.1% women) in 26 countries were analyzed by 4 GI anatomic regions (esophageal, gastroduodenal, bowel, and anorectal). The number of DGBI-affected GI regions was assessed, including associations with sex, age, disease severity, quality of life, psychosocial variables, and health care utilization. RESULTS: A total of 40.3% of surveyed individuals met Rome IV criteria for a DGBI. The percentages with 1-4 DGBI-affected GI regions were 68.3%, 22.3%, 7.1%, and 2.3%, respectively. The IBS symptom severity score increased significantly from 1 (207.6) to 4 (291.6) regions, as did non-GI symptom reporting (somatization), anxiety and depression, concerns and embarrassment about bowel function, doctor visits, medications, and abdominal surgeries (all P < .0001). Quality of life decreased with increasing number of DGBI regions (P < .0001). In a logistic mixed model, non-GI symptoms (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.08-1.10), being very vs not concerned (OR, 2.55; 95% CI, 2.27-2.90), being very vs not embarrassed about bowel function (OR, 1.20; 95% CI, 1.08-1.33), and mean number of doctor visits (OR, 1.23; 95% CI, 1.115-1.32) were most strongly associated with number of DGBI regions. CONCLUSIONS: DGBI in multiple anatomic GI regions is associated with increased psychological comorbidity, health care utilization, and IBS severity. Physician awareness of overlap could improve quality of care, prevent unnecessary interventions, and yield more positive health outcomes.

Gut-focused hypnotherapy for children and adolescents with irritable bowel syndrome.

OBJECTIVE: Severe irritable bowel syndrome (IBS) in school children and adolescents often leads to stigmatisation, social withdrawal, disrupted education and psychological distress. While there are few effective treatment options for IBS in this age group, gut-focused hypnotherapy (GFH) has shown promise in several trials. Unfortunately, GFH is not widely available, and clinical data outside of trials are scarce. Here, we evaluated outcomes from GFH in patients with IBS, aged ≤18 years, from a tertiary referral centre. DESIGN/METHOD: Consecutive patients aged ≤18 years with severe IBS received 12 sessions of GFH, at weekly intervals, using the Manchester Protocol. Clinical outcomes data, including IBS Symptom Severity Score (IBS-SSS), Hospital Anxiety and Depression Scale (HADS), Non-colonic Symptom Score and Quality-of-Life (QoL) score, were collected prospectively, and compared pre-GFH and post-GFH. Clinical response was defined as ≥50 point reduction in IBS-SSS. RESULTS: 32 young patients fulfilling Rome III diagnostic criteria for IBS (median age 16 (range 8-18) years, n=23/32 (72%) female individuals) completed GFH. At baseline, the mean duration of IBS was 5.9±0.9 years, and the mean IBS-SSS was 313±14. After GFH, 28/32 (88%) responded, with a mean overall reduction in IBS-SSS -159±16 (p<0.0001), and 24/32 (75%) achieved ≥30% reduction in abdominal pain scores. GFH also improved: non-colonic symptoms (p<0.0001), HADS-anxiety (p<0.0001), HADS-depression (p=0.0002) and QoL Scores (p<0.0001). CONCLUSION: GFH is highly effective in children and adolescents with IBS. Early intervention with GFH in childhood IBS may reduce the subsequent burden of this problem in adults.

Genome-wide analysis of 53,400 people with irritable bowel syndrome highlights shared genetic pathways with mood and anxiety disorders.

Irritable bowel syndrome (IBS) results from disordered brain-gut interactions. Identifying susceptibility genes could highlight the underlying pathophysiological mechanisms. We designed a digestive health questionnaire for UK Biobank and combined identified cases with IBS with independent cohorts. We conducted a genome-wide association study with 53,400 cases and 433,201 controls and replicated significant associations in a 23andMe panel (205,252 cases and 1,384,055 controls). Our study identified and confirmed six genetic susceptibility loci for IBS. Implicated genes included NCAM1, CADM2, PHF2/FAM120A, DOCK9, CKAP2/TPTE2P3 and BAG6. The first four are associated with mood and anxiety disorders, expressed in the nervous system, or both. Mirroring this, we also found strong genome-wide correlation between the risk of IBS and anxiety, neuroticism and depression (rg > 0.5). Additional analyses suggested this arises due to shared pathogenic pathways rather than, for example, anxiety causing abdominal symptoms. Implicated mechanisms require further exploration to help understand the altered brain-gut interactions underlying IBS.