Comparison of digitally-delivered gut-directed hypnotherapy program to an active control for irritable bowel syndrome.

OBJECTIVES: Gut-directed hypnotherapy (GDH) treats irritable bowel syndrome (IBS) but its accessibility is limited. This problem may be overcome by digital delivery. This study aimed to perform a randomised control trial comparing the efficacy of a digitally-delivered program with and without GDH in IBS. METHODS: Adults with IBS were randomized to a 42-session daily digital program with the GDH Program (Nerva) or without (Active Control). Questionnaires were completed to assess gastrointestinal symptoms via IBS-SSS, quality of life (IBS-QOL) and psychological symptoms (DASS-21) at regular intervals during the program and 6 months following conclusion on the intervention. The primary endpoint was the proportion of participants with ≥50-point decrease in IBS-SSS between the interventions at the end of the program. RESULTS: Of 240/244 randomized participants, 121 received GDH Program - median age 38 (range 20-65) years, 90% female, IBS-SSS 321 (IQR 273-367) - and 119 Active Control - 36 (21-65), 91% female, IBS-SSS 303 (255-360). At program completion, 81% met the primary endpoint with GDH Program versus 63% Active Control (p=0.002). IBS-SSS was median 208 (IQR 154-265) with GDH and 244 (190-308) with Control (p=0.004), 30% reduction in pain was reported by 71% compared with 35% (p<0.001), and IBS-QOL improved by 14 (6-25) compared with 7 (1-15), respectively (p<0.001). Psychological status improved similarly in both groups. CONCLUSIONS: A digitally-delivered GDH Program provided to patients with IBS was superior to the active control, with greater improvement in both gastrointestinal symptoms and quality of life and provides an equitable alternative to face-to-face behavioural strategies.

Smartphone app-delivered gut-directed hypnotherapy improves symptoms of self-reported irritable bowel syndrome: A retrospective evaluation.

BACKGROUND: Gut-directed hypnotherapy (GDH) has high rates of durable efficacy for treating irritable bowel syndrome (IBS) but its widespread use is limited due to high costs and poor access. A smartphone app delivering GDH was developed to fill gaps in accessibility but has not been assessed in IBS patients. The current retrospective evaluation aims to assess the efficacy of app-delivered GDH in managing IBS symptoms and to investigate associating factors that predict response. METHODS: Irritable bowel syndrome patients who downloaded the app between June 2019 and April 2020 were retrospectively evaluated. The first seven sessions were free. Daily GDH, psycho-education, and breathing exercises were included. Overall and individual gastrointestinal symptoms were assessed at baseline and completion using a 100-mm visual analogue scale. Clinical data were extracted. KEY RESULTS: 2843 patients with self-reported IBS commenced the free sessions, 1428 (50%) purchased the app and 253 (9%) completed all 42 sessions. Outcome data were available for 190 users who completed all 42 sessions. 64% of patients who completed the GDH and provided outcome data responded (defined as >30% reduction in abdominal pain). Abdominal pain reduced from 60mm (50-73mm) at baseline to 26mm (13-50mm) on study completion (p<0.001 Wilcoxon). Similar results were seen for overall and individual symptoms. On multivariable analysis, symptom response was positively associated with being ≥ 40 years (estimated OR 0.398, p=0.025) and negatively associated with trying probiotics (0.323, p=0.042). CONCLUSIONS & INFERENCES: Adherence to app-delivered gut-directed hypnotherapy was low but users who completed the program saw notable improvements in their IBS symptoms. Patients ≥40 years, with symptoms for ≥5 years, may respond better. A controlled trial comparing face-to-face to app-delivered GDH is indicated.

No effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates.

BACKGROUND & AIMS: Patients with non-celiac gluten sensitivity (NCGS) do not have celiac disease but their symptoms improve when they are placed on gluten-free diets. We investigated the specific effects of gluten after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates (fermentable, oligo-, di-, monosaccharides, and polyols [FODMAPs]) in subjects believed to have NCGS. METHODS: We performed a double-blind cross-over trial of 37 subjects (aged 24-61 y, 6 men) with NCGS and irritable bowel syndrome (based on Rome III criteria), but not celiac disease. Participants were randomly assigned to groups given a 2-week diet of reduced FODMAPs, and were then placed on high-gluten (16 g gluten/d), low-gluten (2 g gluten/d and 14 g whey protein/d), or control (16 g whey protein/d) diets for 1 week, followed by a washout period of at least 2 weeks. We assessed serum and fecal markers of intestinal inflammation/injury and immune activation, and indices of fatigue. Twenty-two participants then crossed over to groups given gluten (16 g/d), whey (16 g/d), or control (no additional protein) diets for 3 days. Symptoms were evaluated by visual analogue scales. RESULTS: In all participants, gastrointestinal symptoms consistently and significantly improved during reduced FODMAP intake, but significantly worsened to a similar degree when their diets included gluten or whey protein. Gluten-specific effects were observed in only 8% of participants. There were no diet-specific changes in any biomarker. During the 3-day rechallenge, participants' symptoms increased by similar levels among groups. Gluten-specific gastrointestinal effects were not reproduced. An order effect was observed. CONCLUSIONS: In a placebo-controlled, cross-over rechallenge study, we found no evidence of specific or dose-dependent effects of gluten in patients with NCGS placed diets low in FODMAPs.