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.

Improving access to gut-directed hypnotherapy for irritable bowel syndrome in the digital therapeutics' era: Are mobile applications a "smart" solution?

Gut-directed hypnotherapy (GDH) is a highly effective brain-gut behavioral therapy which is recommended in international guidelines for the treatment of irritable bowel syndrome (IBS). There is increasing recognition of the value of GDH as part of integrated care alongside medical and dietary approaches. This has led to recent innovations to widen access to GDH to meet the increasing demand. Recent advances include streamlined courses of individualized GDH, group therapy, and remote delivery. In this issue of Neurogastroenterology and Motility, Peters et al. retrospectively report outcomes of smartphone app-delivered GDH in a population with self-reported IBS. While adherence was low, those that completed smart phone-delivered GDH-achieved symptom benefit. This mini-review summarizes the current evidence-base for available modalities of GDH and discusses the current and future utility and development of mobile health applications in the digital therapeutics' era.

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.

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.

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.

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome.

Irritable bowel syndrome (IBS) remains one of the most common gastrointestinal disorders seen by clinicians in both primary and secondary care. Since publication of the last British Society of Gastroenterology (BSG) guideline in 2007, substantial advances have been made in understanding its complex pathophysiology, resulting in its re-classification as a disorder of gut-brain interaction, rather than a functional gastrointestinal disorder. Moreover, there has been a considerable amount of new evidence published concerning the diagnosis, investigation and management of IBS. The primary aim of this guideline, commissioned by the BSG, is to review and summarise the current evidence to inform and guide clinical practice, by providing a practical framework for evidence-based management of patients. One of the strengths of this guideline is that the recommendations for treatment are based on evidence derived from a comprehensive search of the medical literature, which was used to inform an update of a series of trial-based and network meta-analyses assessing the efficacy of dietary, pharmacological and psychological therapies in treating IBS. Specific recommendations have been made according to the Grading of Recommendations Assessment, Development and Evaluation system, summarising both the strength of the recommendations and the overall quality of evidence. Finally, this guideline identifies novel treatments that are in development, as well as highlighting areas of unmet need for future research.

Functional gastrointestinal disorders in inflammatory bowel disease: Time for a paradigm shift?

Recent advances in biological therapies have revolutionalised and redefined treatment targets in inflammatory bowel disease (IBD). There is now a stronger emphasis on achieving the more stringent therapeutic goals of mucosal and histological healing, rather than clinical remission alone. Consequently, the treatment of refractory "functional" gastrointestinal symptoms, often attributed as the aftermath of previous inflammation, has recently become more prominent in quiescent disease. With further expected advances in anti-inflammatory treatments on the horizon, the burden of such symptoms in quiescent disease, which have been relatively neglected, is set to become an even bigger problem. In this article, we highlight the current state of research and understanding in this field, including recent developments and clinical practice guidelines on the diagnosis and management of functional gastrointestinal symptoms, such as irritable bowel syndrome and functional anorectal and pelvic floor disorders, in patients with quiescent IBD. These disorders are not only highly prevalent in these patients, they are often misdiagnosed, and are difficult to treat, with very few evidence-based therapies. Moreover, they are associated with substantial impairment in quality-of-life, considerable morbidity, and psychological distress. There is therefore an urgent need for a change in emphasis towards earlier recognition, positive diagnosis, and targeted treatment for patients with ongoing functional gastrointestinal symptoms in the absence of active IBD. This article also highlights the need for further research to develop much needed evidence-based therapies.

Gut-focused hypnotherapy for Functional Gastrointestinal Disorders: Evidence-base, practical aspects, and the Manchester Protocol.

BACKGROUND: Despite their high prevalence and advances in the field of neurogastroenterology, there remain few effective treatment options for functional gastrointestinal disorders (FGIDs). It is recognized that approximately 25% of sufferers will have symptoms refractory to existing therapies, causing significant adverse effects on quality of life and increased healthcare utilization and morbidity. Gut-focused hypnotherapy, when delivered by trained therapists, has been shown to be highly effective in severe refractory FGIDs. However, hypnotherapy continues to be surrounded by much misunderstanding and skepticism. PURPOSE: The purpose of this review is to provide a contemporary overview of the principles of gut-focused hypnotherapy, its effects on gut-brain interactions, and the evidence-base for its efficacy in severe FGIDs. As supplementary material, we have included a hypnotherapy protocol, providing the reader with an insight into the practical aspects of delivery, and as a guide, an example of a script of a gut-focused hypnotherapy session.

Pharyngeal Electrical Stimulation in Dysphagia Poststroke: A Prospective, Randomized Single-Blinded Interventional Study.

Background Pharyngeal electrical stimulation (PES) appears to promote cortical plasticity and swallowing recovery poststroke. Objective We aimed to assess clinical effectiveness with longer follow-up. Methods Dysphagic patients (n = 36; median = 71 years; 61% male) recruited from 3 trial centers within 6 weeks of stroke, received active or sham PES in a single-blinded randomized design via an intraluminal pharyngeal catheter (10 minutes, for 3days). The primary outcome measure was the Dysphagia Severity Rating (DSR) scale (<4, no-mild; ≥4, moderate-severe). Secondary outcomes included unsafe swallows on the Penetration-Aspiration Scale (PAS ≥ 3), times to hospital discharge, and nasogastric tube (NGT) removal. Data were analyzed using logistic regression. Odds/hazard ratios (ORs/HRs) >1 for DSR <4, hospital discharge, and NGT removal and OR <1 for PAS ≥3, indicated favorable outcomes for active PES. Results Two weeks post-active PES, 11/18 (61%) had DSR <4: OR (95% CI) = 2.5 (0.52, 14). Effects of active versus sham for secondary outcomes included the following: PAS ≥3 at 2 weeks, OR (95% CI) = 0.61 (0.27, 1.4); times to hospital discharge, 39 days versus 52 days, HR (95% CI) = 1.2 (0.55, 2.5); NGT removal 8 versus 14 days, HR (95% CI) = 2.0 (0.51, 7.9); and DSR <4 at 3 months, OR (95% CI) = 0.97 (0.13, 7.0). PES was well tolerated, without adverse effects or associations with serious complications (chest infections/death). Conclusions Although the direction of observed differences were consistent with PES accelerating swallowing recovery over the first 2 weeks postintervention, suboptimal recruitment prevents definitive conclusions. Our study design experience and outcome data are essential to inform a definitive, multicenter randomized trial.