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Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial.
Hunt, M, Miguez, S, Dukas, B, Onwude, O, White, S
JMIR mHealth and uHealth. 2021;9(5):e26152
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Cognitive behavioural therapy (CBT) is a proven treatment method to tackle many psychiatric issues. Irritable bowel syndrome (IBS) is considered a chronic gastrointestinal disorder with psychiatric comorbidity. However, patients find it difficult to access CBT for IBS management. As per previous research findings, web-based and telephone-based CBT, self-help CBT books and CBT treatment manuals offer promising therapeutic effects in improving IBS. Therefore, this crossover randomised controlled trial aimed to look at the efficacy of Zemedy, a mobile digital therapeutic application that provides a comprehensive CBT programme to IBS patients. This study found that Zemedy is an effective modality that increases access to effective CBT treatment for IBS patients. Results showed significant improvement in gastrointestinal symptoms, irritable bowel syndrome quality of life, gastrointestinal cognition, visceral sensitivity, fear of food, depression, and improved health-related quality of life in 62 IBS patients enrolled in the immediate treatment group. Further robust studies are required to determine the efficacy of digital applications in IBS patients with significantly higher psychiatric comorbidity. Healthcare practitioners can use the results of the study to understand the importance of digital applications and make them part of intervention strategies.
Abstract
BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.
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Systematic review: probiotics in the management of lower gastrointestinal symptoms - an updated evidence-based international consensus.
Hungin, APS, Mitchell, CR, Whorwell, P, Mulligan, C, Cole, O, Agréus, L, Fracasso, P, Lionis, C, Mendive, J, Philippart de Foy, JM, et al
Alimentary pharmacology & therapeutics. 2018;47(8):1054-1070
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The role of the gut microbiota in health and disease is far reaching and there is a growing body of evidence on the therapeutic potential of probiotics in gastrointestinal (GI) disease. Patients with GI disease present with a variety of symptoms and current evidence suggests probiotics may play a role in ameliorating these adverse symptoms. The purpose of this review is to update the previous systematic review and incorporate new findings on the role of probiotics in adult patients presenting with a variety of GI symptoms. Based on the updated evidence, this study confirms the finding that specific probiotics are beneficial for certain lower GI problems. According to this review, the author deems this study useful for clinicians when recommending probiotics to patients.
Abstract
BACKGROUND In 2013, a systematic review and Delphi consensus reported that specific probiotics can benefit adult patients with irritable bowel syndrome (IBS) and other gastrointestinal (GI) problems. AIM: To update the consensus with new evidence. METHODS A systematic review identified randomised, placebo-controlled trials published between January 2012 and June 2017. Evidence was graded, previously developed statements were reassessed by an 8-expert panel, and agreement was reached via Delphi consensus. RESULTS A total of 70 studies were included (IBS, 34; diarrhoea associated with antibiotics, 13; diarrhoea associated with Helicobacter pylori eradication therapy, 7; other conditions, 16). Of 15 studies that examined global IBS symptoms as a primary endpoint, 8 reported significant benefits of probiotics vs placebo. Consensus statements with 100% agreement and "high" evidence level indicated that specific probiotics help reduce overall symptom burden and abdominal pain in some patients with IBS and duration/intensity of diarrhoea in patients prescribed antibiotics or H. pylori eradication therapy, and have favourable safety. Statements with 70%-100% agreement and "moderate" evidence indicated that, in some patients with IBS, specific probiotics help reduce bloating/distension and improve bowel movement frequency/consistency. CONCLUSIONS This updated review indicates that specific probiotics are beneficial in certain lower GI problems, although many of the new publications did not report benefits of probiotics, possibly due to inclusion of new, less efficacious preparations. Specific probiotics can relieve lower GI symptoms in IBS, prevent diarrhoea associated with antibiotics and H. pylori eradication therapy, and show favourable safety. This study will help clinicians recommend/prescribe probiotics for specific symptoms.