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Wright-Hughes A, Ow PL, Alderson SL, Ridd MJ, Foy R, Bishop FL, Chaddock M, Fernandez C, Guthrie EA, Muir DP, Taylor CA, Farrin AJ, Everitt HA, Ford AC. Predictors of response to low-dose amitriptyline for irritable bowel syndrome and efficacy and tolerability according to subtype: post hoc analyses from the ATLANTIS trial. Gut 2025; 74:728-739. [PMID: 39863398 PMCID: PMC7617491 DOI: 10.1136/gutjnl-2024-334490] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/02/2024] [Accepted: 01/06/2025] [Indexed: 01/27/2025]
Abstract
BACKGROUND Low-dose amitriptyline, a tricyclic antidepressant (TCA), was superior to placebo for irritable bowel syndrome (IBS) in the AmitripTyline at Low-dose ANd Titrated for Irritable bowel syndrome as Second-line treatment (ATLANTIS) trial. OBJECTIVE To perform post hoc analyses of ATLANTIS for predictors of response to, and tolerability of, a TCA. DESIGN ATLANTIS randomised 463 adults with IBS to amitriptyline (232) or placebo (231). We examined the effect of baseline demographic and disease-related patient characteristics on response to amitriptyline and the effect of amitriptyline on individual symptoms and side effects by subtype. RESULTS There was a quantitative difference in amitriptyline effectiveness in those ≥50 years vs <50 on the IBS severity scoring system (IBS-SSS) (interaction p=0.048, mean difference in ≥50 years subgroup -46.5; 95% CI -74.2 to -18.8, p=0.0010), and subjective global assessment of relief (interaction p=0.068, OR in ≥50 years subgroup 2.59; 95% CI 1.47 to 4.55, p=0.0010), and those in the 70% most deprived areas of England compared with the 30% least deprived for a ≥30% improvement in abdominal pain (interaction p=0.021, OR in 70% most deprived subgroup 2.70; 95% CI 1.52 to 4.77, p=0.0007). Stronger treatment effects were seen in men, with higher Patient Health Questionnaire-12 scores, and with IBS with diarrhoea. Mean differences in individual IBS-SSS components favoured amitriptyline, and side effects were similar, across almost all IBS subtypes. CONCLUSION These exploratory analyses demonstrate there are unlikely to be deleterious effects of amitriptyline in any particular IBS subtype and could help identify patients in whom amitriptyline may be more effective. TRIAL REGISTRATION NUMBER ISRCTN48075063.
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Affiliation(s)
- Alexandra Wright-Hughes
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Pei-Loo Ow
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Sarah L Alderson
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Matthew J Ridd
- Population Health Sciences, University of Bristol, Bristol, UK
| | - Robbie Foy
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Felicity L Bishop
- Centre for Clinical and Community Applications of Health Psychology, School of Psychology, University of Southampton, Southampton, UK
| | | | - Catherine Fernandez
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Elspeth A Guthrie
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Delia P Muir
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Christopher A Taylor
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Amanda J Farrin
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, School of Medicine, University of Leeds, Leeds, UK
| | - Hazel A Everitt
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Alexander C Ford
- Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK
- Leeds Gastroenterology Institute, St James's University Hospital, Leeds, UK
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Brenner DM, Ladewski AM, Kinsinger SW. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol 2024; 22:222-234. [PMID: 37743035 DOI: 10.1016/j.cgh.2023.09.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2023] [Revised: 09/07/2023] [Accepted: 09/11/2023] [Indexed: 09/26/2023]
Abstract
BACKGROUND & AIMS Irritable bowel syndrome (IBS) is a common, debilitating disorder characterized by abdominal pain and disordered bowel habits. Current pharmacologic treatments often provide incomplete symptom relief and may be poorly tolerated. Furthermore, alleviation of gastrointestinal symptoms does not always translate into improved quality of life for IBS patients. Current treatment guidelines recommend brain-gut behavior therapy (BGBT) in conjunction with other IBS therapies, and, in randomized controlled trials, BGBT has been shown to improve symptoms, patient satisfaction, functioning, and quality of life. Access to BGBT is limited by lack of adequately trained gastrointestinal psychologists, patient time constraints, and cost. Furthermore, clinician knowledge that BGBT is specific, and different from psychotherapy approaches for common mental health disorders, may limit referrals even where available. This review provides an overview of the pathophysiology of IBS, disease burden, unmet therapeutic needs, evidence base of novel digital therapeutics for IBS, and guidance on the introduction and appropriateness of these interventions for patients. METHODS We searched the literature for available published data relating to the use of novel digital therapeutics to provide cognitive behavioral therapy and gut-directed hypnotherapy in the treatment of irritable bowel syndrome. RESULTS Clinical trial data support the development and utility of digital therapeutics designed to deliver self-guided cognitive behavioral therapy and hypnotherapy for the treatment of IBS. CONCLUSIONS BGBTs are effective, guideline-recommended treatments for IBS. Digital therapeutic devices offer accessible, cost-effective treatment options for delivery of adjunctive BGBT for the treatment of IBS. The decision to recommend digital BGBTs should be guided by careful patient assessment that includes mental health screening and risk assessment.
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Affiliation(s)
- Darren M Brenner
- Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
| | - Amy M Ladewski
- Department of Digestive Health, Digestive Health Center, Northwestern Memorial Hospital, Chicago, Illinois
| | - Sarah Wimberly Kinsinger
- Division of Gastroenterology and Nutrition, Department of Medicine, Loyola University Medical Center, Maywood, Illinois
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Song K, Fan Z, Chen Y, Fei G, Li X, Wu D. Shared decision-making improving efficacy in diarrhoea-dominant irritable bowel syndrome in Chinese outpatient setting: protocol of a prospective, randomised controlled trial. BMJ Open 2023; 13:e077605. [PMID: 38110380 DOI: 10.1136/bmjopen-2023-077605] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2023] Open
Abstract
INTRODUCTION Diarrhoea-dominant irritable bowel syndrome (IBS-D) is a disorder with multiple pathogenesis; many people with IBS-D may have psychosocial issues which can make assessment and treatment more difficult. Routine treatment procedure might not always achieve the desired outcome. Therefore, patients may not be satisfied with the conventional experience and would like to be more involved in clinical decision-making. A shared decision-making (SDM) model, that requires patient participation, has been demonstrated to have a powerful effect on the diagnosis and treatment of other diseases, which improves patients' compliance, satisfaction, thus refining the clinical outcome. However, there is no corresponding evidence in IBS-D. Herein, we hope to verify the effect of SDM through clinical studies, and we anticipate that SDM can improve the therapeutic effect in patients with IBS-D. METHODS The study is a prospective, randomised, single-centre trial. 166 IBS-D outpatients who attend Peking Union Medical College Hospital will be allocated into routine treatment group and SDM group. The primary endpoint is the severity of bowel symptoms, measured by the IBS symptom severity scale. Secondary endpoints include impact of disease and quality of life, negative psychology and the evaluation of diagnosis and treatment process. ETHICS AND DISSEMINATION Ethical approval has been obtained from the research ethics committee of Peking Union Medical College Hospital (I-23PJ470). This protocol has been approved by Chinese Clinical Trial Register (ChiCTR2300073681) in July 2023. The results of this trial will be published in an open-access way and disseminated among gastrointestinal physicians. TRIAL REGISTRATION NUMBER Chinese Clinical Trial Register (ChiCTR2300073681).
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Affiliation(s)
- Kai Song
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Zhengyang Fan
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Yang Chen
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Guijun Fei
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Xiaoqing Li
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Dong Wu
- Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
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Ford AC, Wright-Hughes A, Alderson SL, Ow PL, Ridd MJ, Foy R, Bianco G, Bishop FL, Chaddock M, Cook H, Cooper D, Fernandez C, Guthrie EA, Hartley S, Herbert A, Howdon D, Muir DP, Nath T, Newman S, Smith T, Taylor CA, Teasdale EJ, Thornton R, Farrin AJ, Everitt HA. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2023; 402:1773-1785. [PMID: 37858323 DOI: 10.1016/s0140-6736(23)01523-4] [Citation(s) in RCA: 54] [Impact Index Per Article: 27.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/03/2023] [Revised: 06/30/2023] [Accepted: 07/20/2023] [Indexed: 10/21/2023]
Abstract
BACKGROUND Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting. METHODS This randomised, double-blind, placebo-controlled trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment [ATLANTIS]) was conducted at 55 general practices in England. Eligible participants were aged 18 years or older, with Rome IV IBS of any subtype, and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥75 points) despite dietary changes and first-line therapies, a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation. Participants were randomly assigned (1:1) to low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months, with dose titration over 3 weeks (up to 30 mg once daily), according to symptoms and tolerability. Participants, their general practitioners, investigators, and the analysis team were all masked to allocation throughout the trial. The primary outcome was the IBS-SSS score at 6 months. Effectiveness analyses were according to intention-to-treat; safety analyses were on all participants who took at least one dose of the trial medication. This trial is registered with the ISRCTN Registry (ISRCTN48075063) and is closed to new participants. FINDINGS Between Oct 18, 2019, and April 11, 2022, 463 participants (mean age 48·5 years [SD 16·1], 315 [68%] female to 148 [32%] male) were randomly allocated to receive low-dose amitriptyline (232) or placebo (231). Intention-to-treat analysis of the primary outcome showed a significant difference in favour of low-dose amitriptyline in IBS-SSS score between groups at 6 months (-27·0, 95% CI -46·9 to -7·10; p=0·0079). 46 (20%) participants discontinued low-dose amitriptyline (30 [13%] due to adverse events), and 59 (26%) discontinued placebo (20 [9%] due to adverse events) before 6 months. There were five serious adverse reactions (two in the amitriptyline group and three in the placebo group), and five serious adverse events unrelated to trial medication. INTERPRETATION To our knowledge, this is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care across multiple outcomes, and was safe and well tolerated. General practitioners should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as the self-titration document developed for this trial. FUNDING National Institute for Health and Care Research Health Technology Assessment Programme (grant reference 16/162/01).
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Affiliation(s)
- Alexander C Ford
- Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK; Leeds Gastroenterology Institute, St James's University Hospital, Leeds, UK.
| | - Alexandra Wright-Hughes
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Sarah L Alderson
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Pei-Loo Ow
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Matthew J Ridd
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Robbie Foy
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Gina Bianco
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Felicity L Bishop
- Centre for Clinical and Community Applications of Health Psychology, School of Psychology, University of Southampton, Southampton, UK
| | | | - Heather Cook
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Deborah Cooper
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Catherine Fernandez
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Elspeth A Guthrie
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Suzanne Hartley
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Amy Herbert
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Daniel Howdon
- Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK
| | - Delia P Muir
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Taposhi Nath
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Sonia Newman
- Primary Care Research Centre, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Thomas Smith
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Christopher A Taylor
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Emma J Teasdale
- Centre for Clinical and Community Applications of Health Psychology, School of Psychology, University of Southampton, Southampton, UK
| | - Ruth Thornton
- Primary Care Research Centre, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Amanda J Farrin
- Clinical Trial Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
| | - Hazel A Everitt
- Primary Care Research Centre, Faculty of Medicine, University of Southampton, Southampton, UK
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Brennan J, Poon MTC, Christopher E, Fulton O, Porteous C, Brennan PM. Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a systematic review. Trials 2023; 24:370. [PMID: 37259102 PMCID: PMC10233858 DOI: 10.1186/s13063-023-07367-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2022] [Accepted: 05/09/2023] [Indexed: 06/02/2023] Open
Abstract
BACKGROUND Patient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are relevant to patients. The minimal clinically important difference (MCID) in the primary outcome influences trial design and feasibility and should be predicated on PPI. We aimed to determine current practice of reporting PPI and the MCID in phase III/IV randomised controlled trials (RCTs). METHODS Following a search of Medline, Embase, and the Cochrane Central Register of Controlled Trials, we included primary publications of phase III/IV RCTs, in English, inclusive of any medical specialty or type of intervention, that reported a health-related outcome. We excluded protocols and secondary publications of RCTs. We extracted RCT characteristics, the use of PPI, and use of the MCID. RESULTS Between 1 July 2019 and 13 January 2020, 123 phase III/IV RCTs matched our eligibility criteria. Ninety percent evaluated a medical rather than surgical intervention. Oncology accounted for 21% of all included RCTs. Only 2.4% (n = 3) and 1.6% (n = 2) RCTs described PPI and the MCID respectively. CONCLUSIONS PPI and the MCID are poorly reported, so it is uncertain how these contributed to trial design. Improvement in the reporting of these items would increase confidence that results are relevant and clinically significant to patients, contributing to improving the overall trial design. TRIAL REGISTRATION Not registered.
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Affiliation(s)
| | - Michael T. C. Poon
- Tumour Centre of Excellence, Cancer Research UK Edinburgh Centre, Brain, University of Edinburgh, Edinburgh, EH4 2XR UK
- Centre for Medical Informatics, Usher Institute, University of Edinburgh, Nine BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX UK
| | | | - Olivia Fulton
- Patient Advisory Group, Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh, EH4 2XU UK
| | - Carol Porteous
- Patient and Public Involvement, Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh, EH4 2XU UK
| | - Paul M. Brennan
- Tumour Centre of Excellence, Cancer Research UK Edinburgh Centre, Brain, University of Edinburgh, Edinburgh, EH4 2XR UK
- Translational Neurosurgery, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
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Sasseville M, LeBlanc A, Tchuente J, Boucher M, Dugas M, Gisèle M, Barony R, Chouinard MC, Beaulieu M, Beaudet N, Skidmore B, Cholette P, Aspiros C, Larouche A, Chabot G, Gagnon MP. The impact of technology systems and level of support in digital mental health interventions: a secondary meta-analysis. Syst Rev 2023; 12:78. [PMID: 37143171 PMCID: PMC10157597 DOI: 10.1186/s13643-023-02241-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2021] [Accepted: 04/20/2023] [Indexed: 05/06/2023] Open
Abstract
BACKGROUND The majority of people with a chronic disease (e.g., diabetes, hypertension, COPD) have more than one concurrent condition and are also at higher risk for developing comorbidities in mental health, including anxiety and depression. There is an urgent need for more relevant and accurate data on digital interventions in this area to prepare for an increase demand for mental health services. The aim of this study was to conduct a meta-analysis of the digital mental health interventions for people with comorbid physical and mental chronic diseases to compare the effect of technology systems and level of support. METHODS This secondary meta-analysis follows a rapid review of systematic reviews, a virtual workshop with knowledge users to identify research questions and a modified Delphi study to guide research methods: What types of digital health interventions (according to a recognized categorization) are the most effective for the management of concomitant mental health and chronic disease conditions in adults? We conducted a secondary analysis of the primary studies identified in the rapid review. Two reviewers independently screened the titles and abstracts and applied inclusion criteria: RCT design using a digital mental health intervention in a population of adults with another chronic condition, published after 2010 in French or English, and including an outcome measurement of anxiety or depression. RESULTS Seven hundred eight primary studies were extracted from the systematic reviews and 84 primary studies met the inclusion criteria Digital mental health interventions were significantly more effective than in-person care for both anxiety and depression outcomes. Online messaging was the most effective technology to improve anxiety and depression scores; however, all technology types were effective. Interventions partially supported by healthcare professionals were more effective than self-administered. CONCLUSIONS While our meta-analysis identifies digital intervention's characteristics are associated with better effectiveness, all technologies and levels of support could be used considering implementation context and population. TRIAL REGISTRATION The protocol for this review is registered in the National Collaborating Centre for Methods and Tools (NCCMT) COVID-19 Rapid Evidence Service (ID 75).
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Affiliation(s)
- Maxime Sasseville
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada.
| | - Annie LeBlanc
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
| | - Jack Tchuente
- VITAM Research Center on Sustainable Health, Quebec City, Canada
| | | | - Michèle Dugas
- VITAM Research Center on Sustainable Health, Quebec City, Canada
| | | | | | | | | | - Nicolas Beaudet
- Université de Sherbrooke, Omnimed, Sherbrooke, Quebec, Canada
| | - Becky Skidmore
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
| | - Pascale Cholette
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale, Quebec City, Canada
| | - Christine Aspiros
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
| | - Alain Larouche
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
| | - Guylaine Chabot
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
| | - Marie-Pierre Gagnon
- Université Laval-VITAM Research Center on Sustainable Health, Quebec City, Canada
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Biesiekierski JR, Manning LP, Murray HB, Vlaeyen JWS, Ljótsson B, Van Oudenhove L. Review article: exclude or expose? The paradox of conceptually opposite treatments for irritable bowel syndrome. Aliment Pharmacol Ther 2022; 56:592-605. [PMID: 35775328 PMCID: PMC11327802 DOI: 10.1111/apt.17111] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2022] [Revised: 06/15/2022] [Accepted: 06/16/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is a heterogeneous disorder of gut-brain interaction (DGBI) maintained by interacting biological, psychological, and social processes. Interestingly, there are two contrasting yet evidence-based treatment approaches for reducing IBS symptoms: exclusion diets such as those low in fermentable oligo-, di-, monosaccharides and polyols (FODMAPs) and exposure-based cognitive-behavioural therapy (CBT). Exclusion diets recommend patients avoid foods thought to be symptom-inducing, whereas exposure-based CBT encourages patients to expose themselves to foods. AIMS To address the paradox of conceptually opposite exclusion diets and exposure-based CBT for IBS. METHODS In this conceptual review, we describe the rationale, practical implementation, evidence base and strengths and weaknesses of each treatment. We conducted up-to-date literature search concerning the low FODMAP diet and CBT, and performed a secondary analysis of a previously conducted trial to illustrate a key point in our review. RESULTS The low FODMAP diet has demonstrated efficacy, but problems with adherence, nutritional compromise, and heightened gastrointestinal-specific anxiety raise caution. Exposure-based CBT has demonstrated efficacy with substantial evidence for gastrointestinal-specific anxiety as a key mechanism of action. Mediation analysis also showed that increased FODMAP intake mediated decreased symptom severity in exposure-based CBT. However, there is minimal evidence supporting which treatment "works best for whom" and how these approaches could be best integrated. CONCLUSIONS Even though exclusion diets and exposure-based CBT are conceptually opposite, they each have proven efficacy. Clinicians should familiarise themselves with both treatments. Further research is needed on predictors, mechanisms and moderators of treatment outcomes.
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Affiliation(s)
- Jessica R Biesiekierski
- Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Australia
- Department of Food, Nutrition and Dietetics, La Trobe University, Melbourne, Australia
| | - Lauren P Manning
- Department of Food, Nutrition and Dietetics, La Trobe University, Melbourne, Australia
| | - Helen Burton Murray
- Center for Neurointestinal Health, Massachusetts General Hospital, Boston, Massachusetts, USA
- Harvard Medical School, Boston, Massachusetts, USA
| | - Johan W S Vlaeyen
- Research Group Health Psychology, KU Leuven, Leuven, Belgium
- Research Group Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands
| | - Brjánn Ljótsson
- Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden
| | - Lukas Van Oudenhove
- Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism (CHROMETA), University of Leuven, Leuven, Belgium
- Leuven Brain Institute, KU Leuven, Leuven, Belgium
- Cognitive and Affective Neuroscience Lab, Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire, USA
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Song KH. Antispasmodics. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2022. [DOI: 10.7704/kjhugr.2022.0012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
Abstract
Antispasmodics are effective in reducing abdominal pain associated with visceral organs, bloating, and bowel habit changes and are commonly used as “on-demand therapy.” A relatively regular intake of antispasmodics may help patients with functional gastrointestinal disease exacerbation. Irritable bowel syndrome and functional dyspepsia are representative functional gastrointestinal diseases with abdominal pain and bloating as the main symptoms. Most of the clinical data on antispasmodics are obtained from studies on functional gastrointestinal diseases including irritable bowel syndrome. Antispasmodics can be safely used for prolonged periods without serious adverse effects; however, different antispasmodics have different anticholinergic potencies. Antispasmodics with strong anticholinergic effects should be prescribed with caution to patients with glaucoma or prostatic hypertrophy-induced dysuria and to those driving vehicles, operating machinery, or receiving other anticholinergic drugs in combination. Antispasmodics meeting US Food and Drug Administration guidelines for efficacy, those showing relatively consistent efficacy in different trials, and those with prokinetic effects are currently available. Many patients with upper gastrointestinal symptoms have overlapping functional gastrointestinal disorders and may require antispasmodic drugs. Alternatively, tricyclic antidepressant or ramosetron use can be considered in patients with irritable bowel syndrome. This review summarizes the clinical data and characteristics of antispasmodics, particularly those available in South Korea.
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D'Silva A, Marshall DA, Vallance J, Nasser Y, Rajagopalan V, MacKean G, Raman M. Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). BMJ Open 2022; 12:e059604. [PMID: 35618329 PMCID: PMC9137346 DOI: 10.1136/bmjopen-2021-059604] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022] Open
Abstract
INTRODUCTION When delivered in person, yoga has been shown to be effective in managing irritable bowel syndrome (IBS) symptoms. Research is needed to test the feasibility and effectiveness of yoga as a therapeutic option when delivered virtually. The primary aim of the mind and yoga for IBS randomised controlled trial is to determine the effects of an 8-week virtual meditation and yoga intervention on IBS symptom severity compared with an advice-only active control group. METHODS AND ANALYSIS Adults diagnosed with IBS will be randomised to receive either a Upa Yoga intervention or an advice-only control group. The intervention will consist of weekly online classes for 8 weeks delivered by a facilitator using Microsoft Office Teams and daily home practice. Feasibility will be evaluated by examining recruitment and attrition rates, adherence, participant satisfaction with the programme and safety. The primary outcome is IBS symptom severity, and key secondary outcomes include (but not limited to) quality of life, anxiety and depression symptoms, COVID-19-related stress and anxiety, and fatigue. Outcomes will be assessed at baseline, 4 weeks and 8 weeks. An embedded design experimental model substudy will be conducted post intervention using qualitative research methods to identify participants' experiences in the yoga programme. ETHICS AND DISSEMINATION This study has been approved by the Conjoint Health Research Ethics Board (REB ID 20-0084). Findings will be disseminated through peer-reviewed publication, conference presentation and social media. TRIAL REGISTRATION NUMBER NCT04302623.
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Affiliation(s)
- Adrijana D'Silva
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Deborah A Marshall
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Jeffrey Vallance
- Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada
| | - Yasmin Nasser
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Vidya Rajagopalan
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Gail MacKean
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Maitreyi Raman
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
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10
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Delivery Methods of Cognitive Behavior Therapy for Patients With Irritable Bowel Syndrome. Gastroenterol Nurs 2022; 45:149-158. [PMID: 35561102 DOI: 10.1097/sga.0000000000000671] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Accepted: 07/12/2021] [Indexed: 11/26/2022] Open
Abstract
Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal disorder and negatively impacts individuals' quality of life. Cognitive behavioral therapy appears effective for reducing symptoms in many irritable bowel syndrome patients. However, the optimal methods to deliver cognitive behavioral therapy and the effective treatment dosage for patients with IBS remain unclear. This article aims to provide an update on cognitive behavioral therapy research in IBS, particularly considering the dose of treatment, route of delivery (in-person vs. web- and telephone-based delivery), and outcome measures. A systematic literature review was conducted using databases of PubMed, CINAHL Complete, and Web of Science from 2008 through 2021. Twelve studies reporting randomized clinical trials comparing cognitive behavioral therapy delivered with in-person, telephone, and web for the management of IBS symptoms among adults with irritable bowel syndrome were found. The dose of treatment varied from 4 to 10 sessions. Six different scales measured various outcomes. No severe adverse reactions to cognitive behavioral therapy were reported. Cognitive behavioral therapy is an effective treatment for IBS symptoms regardless of the dose and the route of treatment. However, it is difficult to compare the effectiveness of these randomized clinical trials due to the various cognitive behavioral therapy protocols, combined routes of therapy delivery, and different outcome measures used.
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11
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Daniluk J, Malecka-Wojciesko E, Skrzydlo-Radomanska B, Rydzewska G. The Efficacy of Mebeverine in the Treatment of Irritable Bowel Syndrome-A Systematic Review. J Clin Med 2022; 11:jcm11041044. [PMID: 35207315 PMCID: PMC8879004 DOI: 10.3390/jcm11041044] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2022] [Revised: 02/11/2022] [Accepted: 02/15/2022] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is a common gastrointestinal tract disorder, affecting 10-20% of adults worldwide. Mebeverine is an antispasmodic agent indicated for the symptomatic treatment of abdominal pain caused by intestinal smooth muscle spasms and intestinal functional disorders in the course of IBS. The aim of this article was to perform a systematic literature review and update previous overviews of the efficacy and safety of mebeverine treatment in IBS. METHODS Major electronic medical databases, PubMed, EMBASE and Cochrane, were systematically searched from January 1965 to January 2021. RESULTS Twenty-two studies met our inclusion criteria, including 19 randomised trials, two observational retrospective studies, and one non-randomised, single-blinded study. Six studies reported a significant decrease in abdominal pain after mebeverine treatment (p-values ranging from <0.05 to <0.001). Only three studies showed no improvement after mebeverine treatment in terms of the severity of abdominal pain or discomfort. Some of the included studies also showed significant improvements in abnormal bowel habits, abdominal distension, as well as stool frequency and consistency. Adverse events were rare and associated mainly with IBS symptoms. CONCLUSIONS Mebeverine is an effective treatment option in IBS, with a good safety profile and low frequency of adverse effects.
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Affiliation(s)
- Jaroslaw Daniluk
- Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, 15-276 Bialystok, Poland
- Correspondence:
| | - Ewa Malecka-Wojciesko
- Department of Digestive Tract Diseases, Medical University of Lodz, 90-153 Lodz, Poland;
| | - Barbara Skrzydlo-Radomanska
- Department of Gastroenterology with Endoscopy Laboratory, Medical University of Lublin, 20-090 Lublin, Poland;
| | - Grazyna Rydzewska
- Clinical Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Disease Unit, CSK MSWiA, 02-507 Warsaw, Poland;
- Collegium Medicum, Jan Kochanowski University, 25-516 Kielce, Poland
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12
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White V, Linardon J, Stone JE, Holmes-Truscott E, Olive L, Mikocka-Walus A, Hendrieckx C, Evans S, Speight J. Online psychological interventions to reduce symptoms of depression, anxiety, and general distress in those with chronic health conditions: a systematic review and meta-analysis of randomized controlled trials. Psychol Med 2022; 52:548-573. [PMID: 32674747 DOI: 10.1017/s0033291720002251] [Citation(s) in RCA: 45] [Impact Index Per Article: 15.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Over the past 15 years, there has been substantial growth in web-based psychological interventions. We summarize evidence regarding the efficacy of web-based self-directed psychological interventions on depressive, anxiety and distress symptoms in people living with a chronic health condition. METHOD We searched Medline, PsycINFO, CINAHL, EMBASE databases and Cochrane Database from 1990 to 1 May 2019. English language papers of randomized controlled trials (usual care or waitlist control) of web-based psychological interventions with a primary or secondary aim to reduce anxiety, depression or distress in adults with a chronic health condition were eligible. Results were assessed using narrative synthases and random-effects meta-analyses. RESULTS In total 70 eligible studies across 17 health conditions [most commonly: cancer (k = 20), chronic pain (k = 9), arthritis (k = 6) and multiple sclerosis (k = 5), diabetes (k = 4), fibromyalgia (k = 4)] were identified. Interventions were based on CBT principles in 46 (66%) studies and 42 (60%) included a facilitator. When combining all chronic health conditions, web-based interventions were more efficacious than control conditions in reducing symptoms of depression g = 0.30 (95% CI 0.22-0.39), anxiety g = 0.19 (95% CI 0.12-0.27), and distress g = 0.36 (95% CI 0.23-0.49). CONCLUSION Evidence regarding effectiveness for specific chronic health conditions was inconsistent. While self-guided online psychological interventions may help to reduce symptoms of anxiety, depression and distress in people with chronic health conditions in general, it is unclear if these interventions are effective for specific health conditions. More high-quality evidence is needed before definite conclusions can be made.
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Affiliation(s)
- V White
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
| | - J Linardon
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
| | - J E Stone
- Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria3168, Australia
| | - E Holmes-Truscott
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria3000, Australia
| | - L Olive
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
| | - A Mikocka-Walus
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
| | - C Hendrieckx
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria3000, Australia
| | - S Evans
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
| | - J Speight
- School of Psychology, Faculty of Health, Deakin University Geelong, Victoria3220, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria3000, Australia
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13
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Layer P, Andresen V, Allescher H, Bischoff SC, Claßen M, Elsenbruch S, Freitag M, Frieling T, Gebhard M, Goebel-Stengel M, Häuser W, Holtmann G, Keller J, Kreis ME, Kruis W, Langhorst J, Jansen PL, Madisch A, Mönnikes H, Müller-Lissner S, Niesler B, Pehl C, Pohl D, Raithel M, Röhrig-Herzog G, Schemann M, Schmiedel S, Schwille-Kiuntke J, Storr M, Preiß JC, Andus T, Buderus S, Ehlert U, Engel M, Enninger A, Fischbach W, Gillessen A, Gschossmann J, Gundling F, Haag S, Helwig U, Hollerbach S, Karaus M, Katschinski M, Krammer H, Kuhlbusch-Zicklam R, Matthes H, Menge D, Miehlke S, Posovszky MC, Schaefert R, Schmidt-Choudhury A, Schwandner O, Schweinlin A, Seidl H, Stengel A, Tesarz J, van der Voort I, Voderholzer W, von Boyen G, von Schönfeld J, Wedel T. Update S3-Leitlinie Reizdarmsyndrom: Definition, Pathophysiologie, Diagnostik und Therapie. Gemeinsame Leitlinie der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen Gesellschaft für Neurogastroenterologie und Motilität (DGNM) – Juni 2021 – AWMF-Registriernummer: 021/016. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2021; 59:1323-1415. [PMID: 34891206 DOI: 10.1055/a-1591-4794] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Affiliation(s)
- P Layer
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - V Andresen
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - H Allescher
- Zentrum für Innere Medizin, Gastroent., Hepatologie u. Stoffwechsel, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Deutschland
| | - S C Bischoff
- Institut für Ernährungsmedizin, Universität Hohenheim, Stuttgart, Deutschland
| | - M Claßen
- Klinik für Kinder- und Jugendmedizin, Klinikum Links der Weser, Bremen, Deutschland
| | - S Elsenbruch
- Klinik für Neurologie, Translational Pain Research Unit, Universitätsklinikum Essen, Essen, Deutschland.,Abteilung für Medizinische Psychologie und Medizinische Soziologie, Ruhr-Universität Bochum, Bochum, Deutschland
| | - M Freitag
- Abteilung Allgemeinmedizin Department für Versorgungsforschung, Universität Oldenburg, Oldenburg, Deutschland
| | - T Frieling
- Medizinische Klinik II, Helios Klinikum Krefeld, Krefeld, Deutschland
| | - M Gebhard
- Gemeinschaftspraxis Pathologie-Hamburg, Hamburg, Deutschland
| | - M Goebel-Stengel
- Innere Medizin II, Helios Klinik Rottweil, Rottweil, und Innere Medizin VI, Psychosomat. Medizin u. Psychotherapie, Universitätsklinikum Tübingen, Tübingen, Deutschland
| | - W Häuser
- Innere Medizin I mit Schwerpunkt Gastroenterologie, Klinikum Saarbrücken, Saarbrücken, Deutschland
| | - G Holtmann
- Faculty of Medicine & Faculty of Health & Behavioural Sciences, Princess Alexandra Hospital, Brisbane, Australien
| | - J Keller
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - M E Kreis
- Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Deutschland
| | | | - J Langhorst
- Klinik für Integrative Medizin und Naturheilkunde, Sozialstiftung Bamberg, Klinikum am Bruderwald, Bamberg, Deutschland
| | - P Lynen Jansen
- Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten, Berlin, Deutschland
| | - A Madisch
- Klinik für Gastroenterologie, interventionelle Endoskopie und Diabetologie, Klinikum Siloah, Klinikum Region Hannover, Hannover, Deutschland
| | - H Mönnikes
- Klinik für Innere Medizin, Martin-Luther-Krankenhaus, Berlin, Deutschland
| | | | - B Niesler
- Abteilung Molekulare Humangenetik Institut für Humangenetik, Universitätsklinikum Heidelberg, Heidelberg, Deutschland
| | - C Pehl
- Medizinische Klinik, Krankenhaus Vilsbiburg, Vilsbiburg, Deutschland
| | - D Pohl
- Klinik für Gastroenterologie und Hepatologie, Universitätsspital Zürich, Zürich, Schweiz
| | - M Raithel
- Medizinische Klinik II m.S. Gastroenterologie und Onkologie, Waldkrankenhaus St. Marien, Erlangen, Deutschland
| | | | - M Schemann
- Lehrstuhl für Humanbiologie, TU München, Deutschland
| | - S Schmiedel
- I. Medizinische Klinik und Poliklinik Gastroenterologie, Universitätsklinikum Hamburg-Eppendorf, Deutschland
| | - J Schwille-Kiuntke
- Abteilung für Psychosomatische Medizin und Psychotherapie, Medizinische Universitätsklinik Tübingen, Tübingen, Deutschland.,Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung, Universitätsklinikum Tübingen, Tübingen, Deutschland
| | - M Storr
- Zentrum für Endoskopie, Gesundheitszentrum Starnberger See, Starnberg, Deutschland
| | - J C Preiß
- Klinik für Innere Medizin - Gastroenterologie, Diabetologie und Hepatologie, Vivantes Klinikum Neukölln, Berlin, Deutschland
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14
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Kim H, Oh Y, Chang SJ. Effects of Internet-delivered Cognitive Behavioral Therapy in Patients with Irritable Bowel Syndrome: Systematic Review and Meta-Analysis (Preprint). J Med Internet Res 2021; 24:e35260. [PMID: 35687389 PMCID: PMC9233255 DOI: 10.2196/35260] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2021] [Revised: 03/10/2022] [Accepted: 04/27/2022] [Indexed: 11/17/2022] Open
Abstract
Background Irritable bowel syndrome is a common functional gastrointestinal disorder that negatively affects all aspects of life. With the widespread use of the internet, internet-delivered cognitive behavioral therapy has been developed and applied to control symptoms and improve the quality of life of those with irritable bowel syndrome. However, few studies have systematically reviewed the effectiveness of internet-delivered cognitive behavioral therapy on irritable bowel syndrome. Objective This study aimed to systematically review studies that examined the use of internet-delivered cognitive behavioral therapy in patients with irritable bowel syndrome and to evaluate the effects of internet-delivered cognitive behavioral therapy on the improvement of symptom severity, quality of life, psychological status, and cost-effectiveness. Methods This meta-analysis involved the search of 6 databases for relevant publications. From the 1224 publications identified through database searches, 9 randomized controlled trials were finally included in the analysis. Results The internet-delivered cognitive behavioral therapies including exposure-based cognitive behavioral therapy, cognitive behavioral therapy for self-management, and cognitive behavioral therapy for stress management were provided in 5 to 13 sessions for 5 to 10 weeks. Internet-delivered cognitive behavioral therapy had medium-to-large effects on symptom severity (standardized mean difference [SMD] –0.633; 95% CI –0.861 to –0.4304), quality of life (SMD 0.582; 95% CI 0.396-0.769), and cost-effectiveness (–0.372; 95% CI –0.704 to –0.039) at postintervention. The effects on symptom severity remained over time even after the intervention, short-term follow-up (SMD –0.391; 95% CI –0.560 to –0.221), and long-term follow-up (SMD –0.357; 95% CI –0.541 to –0.172). There was no significant difference in psychological status, including anxiety and depression, in those with irritable bowel syndrome compared to the controls during the postintervention period. Conclusions This review demonstrates that internet-delivered cognitive behavioral therapy could be a cost-effective intervention for improving symptoms and the quality of life in patients with irritable bowel syndrome. However, studies are still insufficient regarding the use of internet-delivered cognitive behavioral therapy in these patients; therefore, more high-quality studies are required in the future.
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Affiliation(s)
- Hyunjung Kim
- School of Nursing, Research Institute of Nursing Science, Hallym University, Chuncheon, Republic of Korea
| | - Younjae Oh
- School of Nursing, Research Institute of Nursing Science, Hallym University, Chuncheon, Republic of Korea
| | - Sun Ju Chang
- College of Nursing, Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea
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15
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Owusu JT, Sibelli A, Moss-Morris R, van Tilburg MAL, Levy RL, Oser M. A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome. Neurogastroenterol Motil 2021; 33:e14108. [PMID: 33745228 DOI: 10.1111/nmo.14108] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2020] [Revised: 12/23/2020] [Accepted: 01/29/2021] [Indexed: 12/12/2022]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is linked with lower health-related quality of life. Cognitive behavioral therapy (CBT) designed for IBS management can improve outcomes but further research of more accessible implementations of this treatment approach for IBS is needed. This study assessed the feasibility of a web-delivered CBT program among adults with IBS to apply to a future clinical trial. METHODS Twenty-five participants were randomized to receive an unguided web-based, CBT program for IBS. The primary outcome was changes in IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS]). Secondary outcomes included IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity. KEY RESULTS Among participants randomized to receive web-based CBT, the average baseline IBS-SSS score was 296.3 (SD=100.9). IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction). GI-specific anxiety symptoms and cognitions significantly improved at 2-month follow-up, as did unhelpful IBS safety behaviors. Additionally, clinically meaningful improvement was observed in depressive and anxiety symptoms at 3-month follow-up among participants with symptoms above the clinical threshold (ie, PHQ-9 ≥ 10 and GAD-7 ≥ 10, respectively) at baseline. CONCLUSIONS & INFERENCES These preliminary findings warrant a larger trial to investigate an unguided, web-based CBT for IBS symptom management that is powered to detect between-group treatment effects.
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Affiliation(s)
| | | | | | - Miranda A L van Tilburg
- College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC, USA.,Department of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.,School of Social Work, University of Washington, Seattle, WA, USA
| | - Rona L Levy
- School of Social Work, University of Washington, Seattle, WA, USA
| | - Megan Oser
- Mahana Therapeutics, Inc, San Francisco, CA, USA
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16
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Patient Strategies for Managing the Vicious Cycle of Fatigue, Pain and Urgency in Inflammatory Bowel Disease: Impact, Planning and Support. Dig Dis Sci 2021; 66:3330-3342. [PMID: 33164146 DOI: 10.1007/s10620-020-06698-1] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/19/2020] [Accepted: 10/24/2020] [Indexed: 12/15/2022]
Abstract
BACKGROUND Inflammatory bowel disease (IBD) causes inter-related symptoms of fatigue, pain and urgency which can persist in remission. AIM To understand how people with IBD experience and self-manage these symptoms and to inform the future development of an online self-management programme. METHODS Using exploratory qualitative methods, we recruited participants from clinic and community settings. Focus groups, conducted across the UK, were audio-recorded and professionally transcribed. Transcripts were analysed over four rounds using framework analysis. Eight patients were consulted to agree the final structure of data and themes. RESULTS Seven focus groups were held; five gave useable data. Twenty-six participants (15 female; ages 21-60 years; disease duration 2-40 years) with Crohn's disease (n = 10), ulcerative colitis (n = 14) and IBD-unclassified (n = 2) attended one of these five focus groups. Three core themes emerged: The Negative Impact of Symptoms, Positively Taking Control and Seeking and Receiving Support. The persistent, often stark impact of multiple co-existing symptoms on physical and emotional wellbeing can force unwanted adjustments and limitations in working, social and intimate arenas of life. Unpredictable symptoms are challenging and impact each other in negative vicious cycles. Managing diet, pacing, accepting background levels of fatigue, pain and urgency, seeking support, exercising and attending to mental wellbeing, are all perceived as helpful in self-managing symptoms. CONCLUSION Fatigue, pain and urgency are troublesome for patients, especially in combination, suggesting that these should be addressed simultaneously by clinicians. Participants reported several strategies for self-management, providing patient-focused evidence to inform future development of a self-management intervention programme.
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17
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Rohde JA, Barker JO, Noar SM. Impact of eHealth technologies on patient outcomes: a meta-analysis of chronic gastrointestinal illness interventions. Transl Behav Med 2021; 11:1-10. [PMID: 31731292 DOI: 10.1093/tbm/ibz166] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Abstract
Gastrointestinal (GI) illness interventions are increasingly utilizing eHealth technologies, yet little is currently known about the extent of their impact on patient outcomes. The purpose of this study was to conduct a meta-analysis of the GI eHealth intervention literature. We used a comprehensive search strategy to locate studies. To be included, studies had to be a randomized controlled trial comparing an eHealth intervention condition against a no-treatment or waitlist control condition. Studies had to report data on at least one of the following patient outcomes: medication adherence, quality of life (QoL), psychological distress, illness-related knowledge, or number of patient visits to the clinic/hospital. Analyses weighted effect sizes (d) by their inverse variance and combined them using random effects meta-analytic procedures. K = 19 studies conducted in eight countries with a cumulative sample size of N = 3,193 were meta-analyzed. Findings indicated that GI eHealth interventions improved patients' QoL (d = .25, p = .008), psychological distress (d = .24, p = .017), medication adherence (d = .17, p = .014), and illness-related knowledge (d = .19, p = .002). GI eHealth interventions also significantly reduced the number of patient visits to the clinic/hospital (d = .78, p = .005). Our findings suggest that eHealth interventions hold promise in improving patient outcomes for those with GI illnesses. We suggest the next generation of GI interventions continue developing and evaluating the impact of technology using randomized controlled trial designs, and perhaps consider adapting existing efficacious interventions for burgeoning platforms, such as smartphones and tablets.
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Affiliation(s)
- Jacob A Rohde
- Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Joshua O Barker
- Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Seth M Noar
- Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.,Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
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18
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Norton C, Syred J, Kerry S, Artom M, Sweeney L, Hart A, Czuber-Dochan W, Taylor SJC, Mihaylova B, Roukas C, Aziz Q, Miller L, Pollok R, Saxena S, Stagg I, Terry H, Zenasni Z, Dibley L, Moss-Morris R. Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial. Trials 2021; 22:516. [PMID: 34344432 PMCID: PMC8329619 DOI: 10.1186/s13063-021-05466-4] [Citation(s) in RCA: 19] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2020] [Accepted: 07/16/2021] [Indexed: 12/28/2022] Open
Abstract
BACKGROUND Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support. PRIMARY RESEARCH QUESTION In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual? METHODS A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups. DISCUSSION The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients' quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals. TRIAL REGISTRATION ISRCTN71618461 . Registered on 9 September 2019.
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Affiliation(s)
| | - Jonathan Syred
- King’s College London, 57 Waterloo Road, London, SE1 8WA UK
| | - Sally Kerry
- Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
| | - Micol Artom
- NHS Digital, Skipton House, 80 London Road, London, SE1 6LH UK
| | - Louise Sweeney
- Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
| | - Ailsa Hart
- IBD Unit, St Mark’s Hospital, Watford Road, Harrow, HA13UJ UK
| | | | - Stephanie J. C. Taylor
- Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
| | - Borislava Mihaylova
- Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
- Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF UK
| | - Chris Roukas
- Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
| | - Qasim Aziz
- Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 26 Ashfield Street, London, E1 2AJ UK
| | - Laura Miller
- Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
| | - Richard Pollok
- Department of Gastroenterology, St George’s University Hospitals NHS Foundation Trust and St George’s University of London, London, SW17 0QT UK
| | - Sonia Saxena
- Department of Primary Care and Public Health Imperial College London, London, UK
| | - Imogen Stagg
- London North West University Hospitals, Watford Road, Harrow, HA1 3UJ UK
| | - Helen Terry
- Crohn’s & Colitis UK, 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE UK
| | - Zohra Zenasni
- Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
| | - Lesley Dibley
- School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, (Avery Hill Campus), London, SE9 2UG UK
| | - Rona Moss-Morris
- Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
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Brenner DM, Lacy BE. Antispasmodics for Chronic Abdominal Pain: Analysis of North American Treatment Options. Am J Gastroenterol 2021; 116:1587-1600. [PMID: 33993133 PMCID: PMC8315189 DOI: 10.14309/ajg.0000000000001266] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2021] [Accepted: 03/18/2021] [Indexed: 12/11/2022]
Abstract
Chronic abdominal pain is a common gastrointestinal (GI) symptom that characterizes many functional GI disorders/disorders of gut-brain interaction, including irritable bowel syndrome, functional dyspepsia, and centrally mediated abdominal pain syndrome. The symptoms of abdominal pain in these highly prevalent disorders are often treated with antispasmodic agents. Antispasmodic treatment includes a broad range of therapeutic classes with different mechanisms of action, including anticholinergic/antimuscarinic agents (inhibition of GI smooth muscle contraction), calcium channel inhibitors (inhibition of calcium transport into GI smooth muscle), and direct smooth muscle relaxants (inhibition of sodium and calcium transport). The aim of this review article was to examine the efficacy and safety of antispasmodics available in North America (e.g., alverine, dicyclomine, hyoscine, hyoscyamine, mebeverine, otilonium, pinaverium, and trimebutine) for the treatment of chronic abdominal pain in patients with common disorders of gut-brain interaction. For the agents examined, comparisons of studies are limited by inconsistencies in treatment dosing and duration, patient profiles, and diagnostic criteria employed. Furthermore, variability in study end points limits comparisons. Risk of selection, performance, detection, attrition, and reporting bias also differed among studies, and in many cases, risks were considered "unclear." The antispasmodics evaluated in this review, which differ in geographic availability, were found to vary dramatically in efficacy and safety. Given these caveats, each agent should be considered on an individual basis, rather than prescribed based on information across the broad class of agents.
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Affiliation(s)
- Darren M. Brenner
- Division of Gastroenterology, Department of Internal Medicine, Northwestern University-Feinberg School of Medicine, Chicago, Illinois, USA
| | - Brian E. Lacy
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
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Chen M, Qin D, Huang SL, Tang TC, Zheng H. Chinese herbal medicine versus antispasmodics in the treatment of irritable bowel syndrome: A network meta-analysis. Neurogastroenterol Motil 2021; 33:e14107. [PMID: 33660903 DOI: 10.1111/nmo.14107] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2020] [Revised: 01/06/2021] [Accepted: 02/08/2021] [Indexed: 12/20/2022]
Abstract
BACKGROUND Chinese herbal medicine (CHM) is gaining popularity in treating irritable bowel syndrome (IBS). Although its efficacy was shown in recent randomized controlled trials (RCTs), it is rarely compared with antispasmodics to confirm its effectiveness. We aimed to resolve this uncertainty through a network meta-analysis. METHODS We searched for RCTs that compared CHM or antispasmodics with placebo or one of them in the treatment of IBS. The primary outcomes were adequate relief of global IBS symptoms and abdominal pain. The data were pooled using a random-effects model. The effect size measure was pooled relative risk (RR), and treatments were ranked according to their P-scores. KEY RESULTS We included 57 RCTs (n = 8869). After completion of treatment, drotaverine, individual CHM, otilonium, cimetropium, standard CHM, and pinaverium were efficacious in adequate relief of global IBS symptoms, and drotaverine ranked the first (RR, 2.33 [95% CI, 1.31-4.14], P-score =0.91); no difference was found between these treatments. After completion of treatment, drotaverine, standard CHM, pinaverium, and individual CHM were efficacious in abdominal pain, and drotaverine ranked the first (RR, 2.71 [95% CI, 1.69-4.36], P-score =0.91); no difference was found between these treatments. Standard CHM had significantly more adverse events than placebo (RR, 1.82 [95% CI, 1.12-2.94]) and other treatments. CONCLUSIONS CHM and antispasmodics were efficacious for improvement of global IBS symptoms and abdominal pain. The adverse events of CHM were higher than antispasmodics; however, the heterogeneity of CHM formulas and the very low quality of the evidence warrants further investigation.
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Affiliation(s)
- Min Chen
- Anorectal Disease Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Di Qin
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Shi-Le Huang
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Tai-Chun Tang
- Anorectal Disease Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Hui Zheng
- Anorectal Disease Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
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21
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Pietrzak A. Antispasmodics in irritable bowel syndrome - a hoary old chestnut? Saudi J Gastroenterol 2021; 27:113-114. [PMID: 34045392 PMCID: PMC8265405 DOI: 10.4103/sjg.sjg_177_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Affiliation(s)
- Anna Pietrzak
- Department of Gastroenterology, Bielanski Hospital, Warsaw, Poland,Department of Gastroenterology, Centre of Postgraduate Medical Education, Warsaw, Poland,Address for correspondence: Dr. Anna Pietrzak, Department of Gastroenterology, Centre of Postgraduate Medical Education, Ceglowska Street 80, Warsaw, Poland. E-mail:
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22
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Bosman M, Elsenbruch S, Corsetti M, Tack J, Simrén M, Winkens B, Boumans T, Masclee A, Keszthelyi D. The placebo response rate in pharmacological trials in patients with irritable bowel syndrome: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 2021; 6:459-473. [PMID: 33765447 DOI: 10.1016/s2468-1253(21)00023-6] [Citation(s) in RCA: 42] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2020] [Revised: 01/12/2021] [Accepted: 01/14/2021] [Indexed: 12/14/2022]
Abstract
BACKGROUND Clinical trials in irritable bowel syndrome are associated with high placebo response rates. We aimed to identify the magnitude of the placebo response and the contributing factors to this occurrence. METHODS We did a systematic review and meta-analysis with a search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials between April 1, 1959, and April 30, 2020. We included all randomised controlled trials that compared an active pharmacotherapeutic agent with placebo and had a dichotomous outcome of response to therapy (in terms of global improvement or improvement in abdominal pain) in adults (aged ≥18 years) with irritable bowel syndrome. Exclusion criteria were trials reporting on treatment satisfaction as a dichotomous outcome of response to therapy or clinician-reported outcomes and a treatment duration of less than 4 weeks. Our main outcome was identification of the magnitude of the pooled placebo response rate for the following endpoints: global improvement, abdominal pain, and US Food and Drug Administration (FDA) endpoints. We extracted information from published reports and pooled proportions through meta-analysis with random effects. The study was registered with PROSPERO, CRD42020170908. FINDINGS Of the 6863 publications identified, 70 articles describing 73 randomised controlled trials were included in our analysis. The pooled placebo response rate was 27·3% (95% CI 24·3-30·9) using the global improvement endpoint, 34·4% (31·2-37·8) using the abdominal pain endpoint, and 17·9% (15·2-21·0) using the composite FDA endpoint responder definition, all with substantial heterogeneity between the trials. Studies published before 2006, and those done in Europe, with a parallel design, a run-in period of 2 weeks or less, a dose schedule of three times a day or more, or a smaller sample size of the control group were significantly associated with an increased pooled placebo response rate. INTERPRETATION More than a quarter of patients with irritable bowel syndrome had a placebo response in terms of global improvement, with multiple associated moderators. We recommend future trials apply a run-in period of at least 2 weeks and dose once or twice a day to minimise the placebo response rate. FUNDING None.
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Affiliation(s)
- Michelle Bosman
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.
| | - Sigrid Elsenbruch
- Department of Medical Psychology and Medical Sociology, Faculty of Medicine, Ruhr University Bochum, Bochum, Germany; Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - Maura Corsetti
- NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK; University of Nottingham and Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK
| | - Jan Tack
- Translational Research Center for Gastrointestinal Disorders, Catholic University of Leuven, Leuven, Belgium; Division of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium
| | - Magnus Simrén
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Functional GI and Motility Disorders, University of North Carolina, Chapel Hill, NC, USA
| | - Bjorn Winkens
- Department of Methodology and Statistics, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, Netherlands
| | - Thimo Boumans
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands
| | - Ad Masclee
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands
| | - Daniel Keszthelyi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands
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23
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Everitt H, Landau S, Little P, Bishop FL, O'Reilly G, Sibelli A, Holland R, Hughes S, Windgassen S, McCrone P, Goldsmith K, Coleman N, Logan R, Chalder T, Moss-Morris R. Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT. Health Technol Assess 2020; 23:1-154. [PMID: 31042143 DOI: 10.3310/hta23170] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Irritable bowel syndrome (IBS) affects 10-22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive-behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. DESIGN This was a three-arm randomised controlled trial. SETTING This trial took place in UK primary and secondary care. PARTICIPANTS Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. INTERVENTIONS TCBT - patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours' therapist time). WCBT - interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours' therapist time). MAIN OUTCOME MEASURES Primary outcomes - IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. RESULTS In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited - 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject's Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. CONCLUSIONS In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. FUTURE WORK Longer-term follow-up and research to translate these findings into usual clinical practice is needed. TRIAL REGISTRATION Current Controlled Trials ISRCTN44427879. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 23, No. 17. See the NIHR Journals Library website for further project information. The University of Southampton sponsored this study. Funding was received from the NIHR HTA Board and the NIHR Clinical Research Network and support was received from the NIHR Clinical Research Network.
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Affiliation(s)
- Hazel Everitt
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Sabine Landau
- Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Paul Little
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Felicity L Bishop
- Centre for Applications of Health Psychology, University of Southampton, Southampton, UK
| | - Gillian O'Reilly
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Alice Sibelli
- Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Rachel Holland
- Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Stephanie Hughes
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Sula Windgassen
- Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Paul McCrone
- Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Kim Goldsmith
- Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Nicholas Coleman
- Department of Gastroenterology, Southampton University Hospital, Southampton, UK
| | - Robert Logan
- Department of Gastroenterology, King's College Hospital, London, UK
| | - Trudie Chalder
- Academic Department of Psychological Medicine, King's College London, London, UK
| | - Rona Moss-Morris
- Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
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Palsson OS, Ballou S. Hypnosis and Cognitive Behavioral Therapies for the Management of Gastrointestinal Disorders. Curr Gastroenterol Rep 2020; 22:31. [PMID: 32495233 DOI: 10.1007/s11894-020-00769-z] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/11/2023]
Abstract
PURPOSE OF REVIEW To review the nature, current evidence of efficacy, recent developments, and future prospects for cognitive behavioral therapy (CBT) and gut-directed hypnotherapy, the two best established psychological interventions for managing gastrointestinal (GI) disorders. RECENT FINDINGS New large randomized controlled trials are showing that cost-effective therapy delivery formats (telephone-based, Internet-based, fewer therapist sessions, or group therapy) are effective for treating GI disorders. CBT and hypnotherapy can produce substantial improvement in the digestive tract symptoms, psychological well-being, and quality of life of GI patients. However, they have long been hampered by limited scalability and significant cost, and only been sufficiently tested for a few GI health problems. Through adoption of more cost-effective therapy formats and teletherapy, and by expanding the scope of efficacy testing to additional GI treatment targets, these interventions have the potential to become widely available options for improving clinical outcomes for patients with hard-to-treat GI disorders.
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Affiliation(s)
- Olafur S Palsson
- Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, P.O. Box 9126, Chapel Hill, NC, 27515, USA.
| | - Sarah Ballou
- Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
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Stuart B, Becque T, Moore M, Little P. Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials. BMC Med Res Methodol 2020; 20:83. [PMID: 32293280 PMCID: PMC7158044 DOI: 10.1186/s12874-020-00971-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2019] [Accepted: 04/07/2020] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND In randomised controlled trials, the assumption of independence of individual observations is fundamental to the design, analysis and interpretation of studies. However, in individually randomised trials in primary care, this assumption may be violated because patients are naturally clustered within primary care practices. Ignoring clustering may lead to a loss of power or, in some cases, type I error. METHODS Clustering can be quantified by intra-cluster correlation (ICC), a measure of the similarity between individuals within a cluster with respect to a particular outcome. We reviewed 17 trials undertaken by the Department of Primary Care at the University of Southampton over the last ten years. We calculated the ICC for the primary and secondary outcomes in each trial at the practice level and determined whether ignoring practice-level clustering still gave valid inferences. Where multiple studies collected the same outcome measure, the median ICC was calculated for that outcome. RESULTS The median intra-cluster correlation (ICC) for all outcomes was 0.016, with interquartile range 0.00-0.03. The median ICC for symptom severity was 0.02 (interquartile range (IQR) 0.01 to 0.07) and for reconsultation with new or worsening symptoms was 0.01 (IQR 0.00, 0.07). For HADS anxiety the ICC was 0.04 (IQR 0.02, 0.05) and for HADS depression was 0.02 (IQR 0.00, 0.05). The median ICC for EQ. 5D-3 L was 0.01 (IQR 0.01, 0.04). CONCLUSIONS There is evidence of clustering in individually randomised trials primary care. The non-zero ICC suggests that, depending on study design, clustering may not be ignorable. It is important that this is fully considered at the study design phase.
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Affiliation(s)
- Beth Stuart
- Primary Care and Population Sciences, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK.
| | - Taeko Becque
- Primary Care and Population Sciences, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK
| | - Michael Moore
- Primary Care and Population Sciences, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK
| | - Paul Little
- Primary Care and Population Sciences, Aldermoor Health Centre, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK
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Everitt HA, Landau S, O'Reilly G, Sibelli A, Hughes S, Windgassen S, Holland R, Little P, McCrone P, Bishop FL, Goldsmith K, Coleman N, Logan R, Chalder T, Moss-Morris R. Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial. Lancet Gastroenterol Hepatol 2019; 4:863-872. [PMID: 31492643 PMCID: PMC7026694 DOI: 10.1016/s2468-1253(19)30243-2] [Citation(s) in RCA: 61] [Impact Index Per Article: 10.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2019] [Revised: 07/10/2019] [Accepted: 07/18/2019] [Indexed: 12/22/2022]
Abstract
Background Irritable bowel syndrome (IBS) is common, affecting 10–20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial. Methods In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879. Findings 24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40·5 points (95% CI 15·0 to 66·0; p=0·002) lower in the telephone-CBT group and 12·9 points (−12·9 to 38·8; p=0·33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3·1 points (1·3 to 4·9; p<0·001) lower in the telephone-CBT group and 1·9 points (0·1 to 3·7; p=0·036) lower in the web-CBT group than in the TAU group. A clinically significant IBS-SSS change (≥50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment. Interpretation At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit. Funding UK National Institute for Health Research.
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Affiliation(s)
- Hazel A Everitt
- School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.
| | - Sabine Landau
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Gilly O'Reilly
- School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK
| | - Alice Sibelli
- Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Stephanie Hughes
- School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK
| | - Sula Windgassen
- Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Rachel Holland
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Paul Little
- School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK
| | - Paul McCrone
- King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Felicity L Bishop
- Centre for Applications of Health Psychology, University of Southampton, Southampton, UK
| | - Kim Goldsmith
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Nicholas Coleman
- Department of Gastroenterology, Southampton University Hospital, Southampton, UK
| | | | - Trudie Chalder
- Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Rona Moss-Morris
- Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
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Everitt HA, Landau S, O’Reilly G, Sibelli A, Hughes S, Windgassen S, Holland R, Little P, McCrone P, Bishop F, Goldsmith K, Coleman N, Logan R, Chalder T, Moss-Morris R. Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial. Gut 2019; 68:1613-1623. [PMID: 30971419 PMCID: PMC6709776 DOI: 10.1136/gutjnl-2018-317805] [Citation(s) in RCA: 51] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2018] [Revised: 01/31/2019] [Accepted: 02/22/2019] [Indexed: 12/20/2022]
Abstract
OBJECTIVE To evaluate the clinical effectiveness of two modes of cognitive-behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS. DESIGN A three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. RESULTS 558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment. CONCLUSION Both CBT interventions were superior to TAU up to 12 months of follow-up. TRIAL REGISTRATION NUMBER ISRCTN44427879.
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Affiliation(s)
- Hazel Anne Everitt
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Sabine Landau
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Gilly O’Reilly
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Alice Sibelli
- Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Stephanie Hughes
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Sula Windgassen
- Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Rachel Holland
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Paul Little
- Primary Care and Population Sciences, University of Southampton, Southampton, UK
| | - Paul McCrone
- Department of Health Services and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Felicity Bishop
- Department of Psychology, University of Southampton, Southampton, UK
| | - Kimberley Goldsmith
- Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Nicholas Coleman
- Department of Gastroenterology, University Hospital Southampton, Southampton, UK
| | - Robert Logan
- Department of Gastroenterology, King’s College Hospital, London, UK
| | - Trudie Chalder
- Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
| | - Rona Moss-Morris
- Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King’s College, London, UK
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Cong X, Perry M, Bernier KM, Young EE, Starkweather A. Effects of Self-Management Interventions in Patients With Irritable Bowel Syndrome: Systematic Review. West J Nurs Res 2018; 40:1698-1720. [PMID: 28854852 PMCID: PMC5794643 DOI: 10.1177/0193945917727705] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Irritable bowel syndrome (IBS) is a prevalent and costly condition, with expenditures exceeding US$21 billion annually. As there is no known cure for IBS, treatment is focused on symptom self-management strategies. The purpose of this systematic review was to investigate the efficacy and overall effect of self-management interventions for patients with IBS. Of the 64 publications that were identified, 20 were included in the systematic review. Self-management interventions were found in diverse formats, including web-based, self-training booklets, individual and/or group interventions with health care providers, and cognitive-behavioral therapy or exercise-based interventions. Different symptom measures were used across the studies, whereas measurement of quality of life was more standardized. Overall, there is robust evidence supporting self-management interventions for improving short-term symptom management and improving quality of life, whereas longer term outcomes are variable. Further studies are needed to use standardized symptom measures and tailor interventions for pediatric populations, and tracking longer term outcomes.
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Affiliation(s)
- Xiaomei Cong
- 1 University of Connecticut, Storrs, CT, USA
- 2 University of Connecticut, Farmington, CT, USA
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Abstract
PURPOSE OF REVIEW We reviewed research on computer-assisted cognitive-behavior therapy (CCBT) performed in medical settings with the goals of assessing the effectiveness of this newer method of treatment delivery, evaluating the need for clinician support of therapeutic computer programs, and making suggestions for future research and clinical implementation. RECENT FINDINGS The overall results of randomized, controlled trials suggest that CCBT can be an effective treatment for depression in primary care patients and health care anxiety. Also, it can be a useful component of treatment for somatic conditions including irritable bowel syndrome, diabetes, fibromyalgia, and chronic pain. The amount and type of clinician support needed for maximizing effectiveness remains unclear. CCBT offers promise for overcoming barriers to delivering effective psychotherapy in medical settings. We recommend that next steps for researchers include more definitive studies of the influence of clinician support, investigations focused on implementation in clinical practices, cost-benefit analyses, and use of technological advances.
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Hanlon I, Hewitt C, Bell K, Phillips A, Mikocka-Walus A. Systematic review with meta-analysis: online psychological interventions for mental and physical health outcomes in gastrointestinal disorders including irritable bowel syndrome and inflammatory bowel disease. Aliment Pharmacol Ther 2018; 48:244-259. [PMID: 29901820 DOI: 10.1111/apt.14840] [Citation(s) in RCA: 36] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2018] [Revised: 04/08/2018] [Accepted: 05/17/2018] [Indexed: 12/19/2022]
Abstract
BACKGROUND Online psychotherapy has been successfully used as supportive treatment in many chronic illnesses. However, there is a lack of evidence on its role in the management of gastrointestinal (GI) diseases. AIMS To examine whether online psychological interventions improve mental and physical outcomes in gastrointestinal diseases. METHODS We searched CINAHL Plus, MEDLINE, EMBASE, Health Management Information Consortium, PsycINFO, British Nursing Index, Cochrane Library, a specialised register of the IBD/FBD Cochrane Group, MEDLINE (PubMed) WHO International Clinical Trial Registry, ClinicalTrials.gov, and reference lists of all papers included in the review. The Cochrane Risk of Bias Tool was used to assess internal validity. Where possible, data were pooled using random-effects meta-analysis. RESULTS We identified 11 publications (encompassing nine studies) meeting inclusion criteria. One study had a high risk of selection bias (allocation concealment), all studies had a high risk of performance and detection bias. Eight studies were included in the meta-analyses (6 on irritable bowel syndrome [IBS] and two on inflammatory bowel disease [IBD]). Online cognitive behavioural therapy (CBT) was shown to significantly improve gastrointestinal symptom-specific anxiety (MD: -8.51, 95% CI -12.99 to -4.04, P = 0.0002) and lessen symptom-induced disability (MD: -2.78, 95% CI -5.43 to -0.12, P = 0.04) in IBS post intervention. There was no significant effect of online CBT on any other outcomes in IBS. No significant effect of online psychotherapy was demonstrated in IBD. CONCLUSION There is insufficient evidence to demonstrate the effectiveness of online CBT to manage mental and physical outcomes in gastrointestinal diseases.
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Affiliation(s)
- I Hanlon
- Department of Health Sciences, University of York, York, UK
| | - C Hewitt
- Department of Health Sciences, University of York, York, UK
| | - K Bell
- Department of Health Sciences, University of York, York, UK
| | - A Phillips
- Department of Gastroenterology, York Teaching Hospital NHS Foundation Trust, York, UK
| | - A Mikocka-Walus
- Department of Health Sciences, University of York, York, UK.,School of Psychology, Deakin University Geelong, Melbourne, Vic., Australia
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Patients' perspectives on GP interactions after cognitive behavioural therapy for refractory IBS: a qualitative study in UK primary and secondary care. Br J Gen Pract 2018; 68:e654-e662. [PMID: 30061195 PMCID: PMC6104876 DOI: 10.3399/bjgp18x698321] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2017] [Accepted: 05/16/2018] [Indexed: 02/06/2023] Open
Abstract
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.
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Helsel BC, Williams JE, Lawson K, Liang J, Markowitz J. Telemedicine and Mobile Health Technology Are Effective in the Management of Digestive Diseases: A Systematic Review. Dig Dis Sci 2018; 63:1392-1408. [PMID: 29663265 DOI: 10.1007/s10620-018-5054-z] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2017] [Accepted: 03/31/2018] [Indexed: 12/16/2022]
Abstract
BACKGROUND Mobile applications and interactive websites are an increasingly used method of telemedicine, but their use lacks evidence in digestive diseases. AIM This study aims to explore digestive disease studies that use telemedicine to effectively manage disease activity, help monitor symptoms, improve compliance to the treatment protocol, increase patient satisfaction, and enhance the patient-to-provider communication. METHODS EBSCO, PubMed, and Web of Science databases were searched using Medical Subject Headings and other keywords to identify studies that utilized telemedicine in patients with digestive disease. The PRISMA guidelines were used to identify 20 research articles that had data aligning with 4 common overlapping themes including, patient compliance (n = 13), patient satisfaction (n = 11), disease activity (n = 15), and quality of life (n = 13). The studies focused on digestive diseases including inflammatory bowel disease (n = 7), ulcerative colitis (n = 4), Crohn's Disease (n = 1), irritable bowel syndrome (n = 6), and colorectal cancer (n = 2). RESULTS From the studies included in this systematic review, patient compliance and patient satisfaction ranged between 25.7-100% and 74-100%, respectively. Disease activity, measured by symptom severity scales and physiological biomarkers, showed improvements following telemedicine interventions in several, but not all, studies. Similar to disease activity, general and disease-specific quality of life showed improvements following telemedicine interventions in as little as 12 weeks in some studies. CONCLUSION Telemedicine and mobile health technology may be effective in managing disease activity and improving quality of life in digestive diseases. Future studies should explore both gastrointestinal and gastroesophageal diseases using these types of interventions.
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Affiliation(s)
- Brian C Helsel
- Department of Public Health Sciences, Clemson University, P.O. Box 340745, Clemson, SC, 29634-0745, USA.
| | - Joel E Williams
- Department of Public Health Sciences, Clemson University, P.O. Box 340745, Clemson, SC, 29634-0745, USA
| | - Kristen Lawson
- Department of Nursing, Clemson University, Clemson, SC, USA
| | - Jessica Liang
- Department of Healthcare Leadership and Management, Medical University of South Carolina, Charleston, SC, USA
| | - Jonathan Markowitz
- Department of Pediatric Gastroenterology, Greenville Health System, Greenville, SC, USA
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The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS One 2018; 13:e0196467. [PMID: 29768436 PMCID: PMC5955495 DOI: 10.1371/journal.pone.0196467] [Citation(s) in RCA: 52] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/13/2017] [Accepted: 04/15/2018] [Indexed: 12/28/2022] Open
Abstract
Computer-based interventions target improvement of physical and emotional functioning in patients with chronic pain and functional somatic syndromes. However, it is unclear to what extent which interventions work and for whom. This systematic review and meta-analysis (registered at PROSPERO, 2016: CRD42016050839) assesses efficacy relative to passive and active control conditions, and explores patient and intervention factors. Controlled studies were identified from MEDLINE, EMBASE, PsychInfo, Web of Science, and Cochrane Library. Pooled standardized mean differences by comparison type, and somatic symptom, health-related quality of life, functional interference, catastrophizing, and depression outcomes were calculated at post-treatment and at 6 or more months follow-up. Risk of bias was assessed. Sub-group analyses were performed by patient and intervention characteristics when heterogeneous outcomes were observed. Maximally, 30 out of 46 eligible studies and 3,387 participants were included per meta-analysis. Mostly, internet-based cognitive behavioral therapies were identified. Significantly higher patient reported outcomes were found in comparisons with passive control groups (standardized mean differences ranged between -.41 and -.18), but not in comparisons with active control groups (SMD = -.26 - -.14). For some outcomes, significant heterogeneity related to patient and intervention characteristics. To conclude, there is a minority of good quality evidence for small positive average effects of computer-based (cognitive) behavior change interventions, similar to traditional modes. These effects may be sustainable. Indications were found as of which interventions work better or more consistently across outcomes for which patients. Future process analyses are recommended in the aim of better understanding individual chances of clinically relevant outcomes.
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34
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Song KH, Jung HK, Kim HJ, Koo HS, Kwon YH, Shin HD, Lim HC, Shin JE, Kim SE, Cho DH, Kim JH, Kim HJ. Clinical Practice Guidelines for Irritable Bowel Syndrome in Korea, 2017 Revised Edition. J Neurogastroenterol Motil 2018; 24:197-215. [PMID: 29605976 PMCID: PMC5885719 DOI: 10.5056/jnm17145] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2017] [Revised: 02/11/2018] [Accepted: 02/27/2018] [Indexed: 12/12/2022] Open
Abstract
In 2011, the Korean Society of Neurogastroenterology and Motility (KSNM) published clinical practice guidelines on the management of irritable bowel syndrome (IBS) based on a systematic review of the literature. The KSNM planned to update the clinical practice guidelines to support primary physicians, reduce the socioeconomic burden of IBS, and reflect advances in the pathophysiology and management of IBS. The present revised version of the guidelines is in continuity with the previous version and targets adults diagnosed with, or suspected to have, IBS. A librarian created a literature search query, and a systematic review was conducted to identify candidate guidelines. Feasible documents were verified based on predetermined inclusion and exclusion criteria. The candidate seed guidelines were fully evaluated by the Guidelines Development Committee using the Appraisal of Guidelines for Research and Evaluation II quality assessment tool. After selecting 7 seed guidelines, the committee prepared evidence summaries to generate data exaction tables. These summaries comprised the 4 main themes of this version of the guidelines: colonoscopy; a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; probiotics; and rifaximin. To adopt the core recommendations of the guidelines, the Delphi technique (ie, a panel of experts on IBS) was used. To enhance dissemination of the clinical practice guidelines, a Korean version will be made available, and a food calendar for patients with IBS is produced.
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Affiliation(s)
- Kyung Ho Song
- Department of Internal Medicine, Konyang University College of Medicine, Daejeon,
Korea
- Konyang University Myunggok Medical Research Institute Daejeon,
Korea
| | - Hye-Kyung Jung
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul,
Korea
- Correspondence: Hye-Kyung Jung, MD, PhD Department of Internal Medicine, Ewha Womans University Medical Center, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Korea, Tel: +82-2-2650-2874, Fax: +82-2-2655-2874, E-mail:
| | - Hyun Jin Kim
- Department of Internal Medicine, Gyeongsang National University, College of Medicine, Jinju,
Korea
| | - Hoon Sup Koo
- Department of Internal Medicine, Konyang University College of Medicine, Daejeon,
Korea
| | - Yong Hwan Kwon
- Department of Internal Medicine, Kyungpook National University, School of Medicine, Daegu,
Korea
| | - Hyun Duk Shin
- Department of Internal Medicine, Dankook University College of Medicine, Cheonan,
Korea
| | - Hyun Chul Lim
- Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin,
Korea
| | - Jeong Eun Shin
- Department of Internal Medicine, Dankook University College of Medicine, Cheonan,
Korea
| | - Sung Eun Kim
- Department of Internal Medicine, Kosin University College of Medicine, Busan,
Korea
| | - Dae Hyeon Cho
- Department of Internal Medicine, Sungkyunkwan University School of Medicine, Changwon,
Korea
| | - Jeong Hwan Kim
- Department of Internal Medicine, Konkuk University School of Medicine, Seoul,
Korea
| | - Hyun Jung Kim
- Department of Preventive Medicine, Korea University College of Medicine, Seoul,
Korea
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Harvey JM, Sibelli A, Chalder T, Everitt H, Moss-Morris R, Bishop FL. Desperately seeking a cure: Treatment seeking and appraisal in irritable bowel syndrome. Br J Health Psychol 2018; 23:561-579. [PMID: 29508539 PMCID: PMC6175452 DOI: 10.1111/bjhp.12304] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2017] [Revised: 02/01/2018] [Indexed: 12/13/2022]
Abstract
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.
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