Alice Sibelli

Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website

BackgroundMany patients with IBS suffer on-going symptoms. The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines. Cognitive Behavioural Therapy (CBT) can be helpful, but availability is poor in the NHS. We developed a web-based CBT self-management programme (Regul8) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial.MethodsPatients, 16 to 60xa0years, with IBS symptoms fulfilling Rome III criteria were recruited via GP practices and randomised to over-encapsulated mebeverine, methylcellulose or placebo for 6xa0weeks and to 1 of 3 website conditions: Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website.Results135 patients recruited from 26 GP practices. Mean IBS SSS score 241.9 (sd 87.7), IBS-QOL 64 (sd 20) at baseline. 91% follow-up at 12xa0weeks. Mean IBS SSS decreased by 35 points from baseline to 12xa0weeks. There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12xa0weeks, or in medication groups at 6xa0weeks, or IBS-QOL in website groups at 6xa0weeks. However, IBS SSS at 6xa0weeks was lower in the No website group than the website groups (IBS SSS no website =162.8 (95% CI 137.4-188.3), website 197.0 (172.4 - 221.7), Website + telephone support 208.0 (183.1-233.0) pu2009=u20090.037).Enablement and Subjects Global Assessment of relief (SGA) were significantly improved in the Regul8 groups compared to the non-website group at 12xa0weeks (Enablement =u20090 in 56.8% of No website group, 18.4% website, 10.5% Website + support, pu2009=u20090.001) (SGA; 32.4% responders in No website group, 45.7% website group, 63.2% website + support group, pu2009=u20090.035).ConclusionsThis exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial. Primary outcomes (IBS SS and IBS QOL) did not reach significance at 6 or 12xa0weeks, apart from IBS SSS being lower in the no-website group at 6xa0weeks - this disappeared by 12xa0weeks. Improved Enablement suggests patients with access to the Regul8 website felt better able to cope with their symptoms than the non-website group. Improved SGA score in the Regul8 groups may indicate some overall improvement not captured on other measures.Trial registrationClinicalTrials.gov Identifier (NCT number): NCT00934973.

Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial).

BackgroundIBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.Methods/DesignThe aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups.Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.DiscussionThis pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will enable economic analysis to be undertaken.Trial RegistrationClinicalTrials.gov Identifier (NCT number): NCT00934973.

A systematic review with meta-analysis of the role of anxiety and depression in irritable bowel syndrome onset.

BACKGROUNDnIt is well established that people with irritable bowel syndrome (IBS) have higher levels of anxiety and depression compared with controls. However, the role of these as risk factors is less clearly established. The aims of this systematic review were to investigate: (1) whether anxiety and/or depression predict IBS onset; (2) the size of the relative risk (RR) of anxiety versus depression in IBS onset. Subgroup analyses explored if methodological factors affected the overall findings.nnnMETHODnProspective cohort or case-control studies were included if they: (1) focused on the development of IBS in population-based or gastroenteritis cohorts; (2) explored the effects of anxiety and/or depression at baseline as predictors of IBS onset at a future point. In all, 11 studies were included of which eight recruited participants with a gastrointestinal infection. Meta-analyses were conducted.nnnRESULTSnThe risk of developing IBS was double for anxiety cases at baseline compared with those who were not [RR 2.38, 95% confidence interval (CI) 1.58-3.60]. Similar results were found for depression (RR 2.06, 95% CI 1.44-2.96). Anxiety and depression seemed to play a stronger role in IBS onset in individuals with a gastrointestinal infection although this could be attributed to other differences in methodology, such as use of diagnostic interviews rather than self-report.nnnCONCLUSIONSnThe findings suggest that self-reported anxiety and depression provide a twofold risk for IBS onset. There is less support for the role of anxiety or depressive disorder diagnosed using clinical interview. These findings may have implications for the development of interventions focused on IBS prevention and treatment.

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

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

Positive and negative affect mediate the bidirectional relationship between emotional processing and symptom severity and impact in Irritable Bowel Syndrome

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

The journey between brain and gut: A systematic review of psychological mechanisms of treatment effect in irritable bowel syndrome

PURPOSEnIrritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder characterized by abdominal pain and altered bowel habits. It is estimated to affect 10-22% of the UK population. The use of psychological interventions in IBS is increasingly empirically supported, but little is known about the mechanism of psychological treatment approaches. The present systematic review aimed to investigate the mechanisms of psychological treatment approaches applied to IBS.nnnMETHODSnThe systematic review included studies conducting mediation analysis in the context of psychological interventions for IBS, focusing on the outcomes of symptom severity and/or quality of life (QoL).nnnRESULTSnNine studies in total were included in the review. Eight of the studies assessed mediation in the context of cognitive behavioural-based interventions, and one study assessed mediation in a mindfulness-based stress reduction intervention. Results indicate that change in illness-specific cognitions is a key process by which psychological treatments may have an effect on the outcomes of symptom severity and QoL. Furthermore, results suggest that whilst GI-specific anxiety may also be a key mechanism of treatment effect, it would appear that general or state anxiety is not. Although less commonly included in mediation analysis, illness-specific behaviours may also have a mediating role.nnnCONCLUSIONSnA mediational model amalgamating the results of studies is proposed to illustrate the findings of the review. The model depicts the process by which psychotherapy changes illness-specific cognitions, behaviours, and anxiety to achieve reduction in symptom severity. Statement of contribution What is already known on this subject? Cognitive behavioural therapy (CBT) is the predominant psychological treatment for irritable bowel syndrome (IBS), although there is some research supporting other treatments such as mindfulness and hypnotherapy. Mediation analysis in the context of psychological treatments for IBS has just begun to explore possible mechanisms of treatment effect especially within CBT studies. Some studies include anxiety in a basic mediation analysis, whilst others include cognitions with inconsistent results for each. What does this study add? Reviews mediators included in mediation analysis and the methods used for mediation analysis Proposes a mediation model informed by the results of the review for future studies to investigate Provides clinical implications for the targeting of cognitions and behaviours rather than general anxiety.

Desperately seeking a cure: Treatment seeking and appraisal in irritable bowel syndrome

Objectives Irritable bowel syndrome (IBS) is common and adversely affects patients quality of life. Multiple potential treatment options exist for patients (and clinicians) to choose from, with limited evidence to inform treatment selection. The aim was to explore how patients with IBS go about seeking and appraising different treatment modalities, with a view to elucidating the psychological processes involved and identifying opportunities to improve clinical practice. Design Qualitative study nested within a randomized controlled trial of therapist‐delivered and web‐based cognitive behavioural therapy versus treatment‐as‐usual for IBS. Methods A total of 52 people participated in semi‐structured interviews about their prior experiences of treatments for IBS. Transcripts were analysed using inductive thematic analysis. Results Key themes (desperation for a cure, disappointment at lack of cure, appraising the effects of diverse treatments, and hope for positive effects) clustered around an overarching theme of being trapped within a vicious cycle of hope and despair on treatment seeking. A desperation and willingness drove interviewees to try any treatment modality available that might potentially offer relief. Coming to accept there is no cure for IBS helped interviewees escape the vicious cycle. Treatments were appraised for their effects on symptoms and quality of life while also considering, but rarely prioritizing, other aspects including convenience of the regimen itself, whether it addressed the perceived root causes of IBS, perceived side‐effects, and cost. Conclusion Treatment seeking in IBS can be challenging for patients. Supportive discussions with health care professionals about illness perceptions, treatment beliefs, and goals could improve patients experiences. Statement of contribution What is already known on this subject? Irritable bowel syndrome (IBS) is a highly prevalent chronic relapsing functional gastrointestinal disorder. Studies show few treatment modalities provide complete symptom relief. IBS is associated with emotional and physical distress, and negatively impacts personal, social, and professional aspects of quality of life. What does this study add? Patients appraise IBS treatments for impact on quality of life and treatment characteristics. Developing acceptance and coping strategies helps escape treatment‐seeking vicious cycles of hope and despair. Clinicians could better support patients by discussing their illness perceptions, treatment goals, and values.

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

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

Cognitive and Behavioral Differences Between Subtypes in Refractory Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a functional gastrointestinal syndrome consisting of different bowel pattern subtypes: diarrhea predominant (IBS-D), constipation predominant (IBS-C), and alternating (IBS-A). This paper aimed to identify whether (a) psychological factors implicated in the cognitive behavioral model of IBS were differentially associated with bowel pattern subtypes, (b) whether there were differences in symptom severity and work and social adjustment across the IBS-subtypes. Analysis was conducted on baseline data of 557 individuals with refractory IBS recruited into the Assessing Cognitive Therapy in Irritable Bowel (ACTIB) randomized controlled trial. Correlations assessed the associations between psychological factors, stool patterns, symptom severity, and work and social adjustment. Hierarchical regressions identified whether cognitive and behavioral factors were significantly associated with frequency of loose/watery stools, hard/lumpy stools and symptom severity while controlling for affective (anxiety and depression) and demographic factors (age, gender, symptom duration). One-way ANOVAs were conducted to assess differences across Rome III classified subtypes (IBS-A, D and C) in cognitive, behavioral, affective, symptom severity, and adjustment measures. Psychological factors were significantly associated with symptom severity and work and social adjustment. Increased avoidance behavior and unhelpful gastrointestinal (GI) cognitions were significantly associated with higher frequency of loose/watery stools. Increased control behaviors were associated with higher frequency of hard/lumpy stools. Cognitive and behavioral differences were significant across the Rome III classified IBS subtypes. There were no differences in anxiety, depression, overall symptom severity, or work and social adjustment. The results are discussed in terms of their utility in tailoring cognitive behavioral treatments to IBS subtypes.