(NICE). Clinical Practice Guideline: Irritable Bowel Syndrome in Adults
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Clinical practice guideline Irritable bowel syndrome in adults: Diagnosis and management of irritable bowel syndrome in primary care National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence February 2008 Irritable bowel syndrome: full guideline Page 1 of 554 National Collaborating Centre for Nursing and Supportive Care This guideline was developed by the National Collaborating Centre for Nursing and Supportive Care (NCCNSC) on behalf of the National Institute for Health and Clinical Excellence (NICE). The guideline was commissioned and funded by NICE and developed in accordance with NICE processes and methodologies. Based at the Royal College of Nursing, the NCCNSC is a partnership of organisations brought together for the purposes of supporting the development of NICE clinical practice guidelines. The partnership is comprised of representatives from the following organisations: • Centre for Evidence-Based Medicine, University of York • Clinical Effectiveness Forum for Allied Health Professions • Healthcare Libraries, University of Oxford • Health Economics Research Centre, University of Oxford • Royal College of Nursing • UK Cochrane Centre. Disclaimer As with any clinical practice guideline, the recommendations contained in this guideline may not be appropriate in all circumstances. A limitation of a guideline is that it simplifies clinical decision- making (Shiffman 1997). Decisions to adopt any particular recommendations must be made by practitioners in the context of: • Available resources • Local services, policies and protocols • The circumstances and wishes of the patient • Available personnel and devices • Clinical experience of the practitioner • Knowledge of more recent research findings Irritable bowel syndrome: full guideline Page 2 of 554 Contents Page National collaborating centre for nursing and supportive care 2 Disclaimer 2 Guideline development group membership and acknowledgements 5 Terminology 8 Abbreviations 8 Glossary 10 1 EXECUTIVE SUMMARY 27 2 PRINCIPLES OF PRACTICE 32 2.1 Person-centred care 32 2.2 A collaborative interdisciplinary approach to care 32 2.3 Organisational issues 32 2.4 Background 33 2.5 Clinical need for the guideline 33 2.6 Management issues 35 3 SUMMARY OF GUIDELINE RECOMMENDATIONS 36 4 AIMS OF THE GUIDELINE 41 4.1 Who the guideline is for 41 4.2 Groups covered by the guideline 41 4.3 Groups not covered by the guideline 41 4.4 Healthcare setting 41 4.5 Diagnosis and management interventions covered by the guideline 42 4.6 Interventions not covered by the guideline 42 4.7 Guideline development group 42 5 METHODS USED TO DEVELOP THE GUIDELINE 44 5.1 Summary of development process 44 5.2 Clinical effectiveness review methods 45 5.3 Cost effectiveness review methods 59 5.4 Submission of evidence 73 5.5 Formulating recommendations 73 6 DIAGNOSIS 76 7 DIET AND LIFESTYLE 128 7.1 General dietary and lifestyle advice 135 7.2 Physical activity 136 7.3 Fibre 145 7.4 Probiotics and prebiotics 168 7.5 Aloe vera 191 7.6 Exclusion diets 199 8 PHARMACOLOGICAL INTERVENTIONS 212 8.1 Laxatives 214 Irritable bowel syndrome: full guideline Page 3 of 554 8.2 Antimotility agents 260 8.3 Antispasmodics 291 8.4 Antidepressants 314 8.5 Adverse effects: pharmacological interventions 349 8.5.1 Adverse effects: antispasmodics, antimotility agents and laxatives 349 8.5.2 Adverse effects: tricyclics and selective serotonin re-uptake inhibitors 369 9 PSYCHOLOGICAL INTERVENTIONS 374 9.1 Relaxation 377 9.2 Biofeedback 381 9.3 Evidence to recommendation: relaxation and biofeedback 388 9.4 Psychotherapy 388 9.5 Cognitive behavioural therapy (CBT) 407 9.6 Hypnotherapy 441 9.7 Indirect comparison of psychological interventions 458 9.8 Evidence to recommendation: psychotherapy, CBT and hypnotherapy 463 10 COMPLEMENTARY AND ALTERNATIVE THERAPIES 465 10.1 Reflexology 467 10.2 Acupuncture 471 10.3 Herbal medicines 481 11 PSYCHOSOCIAL INTERVENTION: PATIENT INFORMATION AND SUPPORT GROUPS 507 11.1 Support groups and self help 509 11.2 Patient information 515 11.3 Evidence to recommendation: psychosocial and patient information 520 12 RECOMMENDATIONS FOR RESEARCH 521 13 IMPLEMENTATION OF THE GUIDELINE 524 14 RELATED NICE GUIDANCE 525 15 UPDATE OF THE GUIDELINE 525 16 REFERENCES 526 APPENDIX A Registered stakeholders APPENDIX B Search strategies and searched databases APPENDIX C Tables of included studies APPENDIX D Quality assessment of studies APPENDIX E Tables of excluded studies APPENDIX F Grading the evidence APPENDIX G Literature review of prognostic resource use and quality of life data APPENDIX H PSA parameters APPENDIX I Bristol Stool Form Scale APPENDIX J General Practice Physical Activity Questionnaire APPENDIX K Declarations of interests Irritable bowel syndrome: full guideline Page 4 of 554 Guideline development group membership and acknowledgements Mr Jonathan Blanchard-Smith Patient/carer representative IBS Network Dr Ian Bullock Director NCCNSC Dr Jamie Dalrymple Medical Practitioner, Drayton & St Faith's Medical Practice, Norwich Primary Care Society for Gastroenterology Ms Sarah Davis Senior Health Economist NCCNSC Ms Jackie Eastwood Specialist Pharmacist in Gastroenterology, St. Mark’s Hospital, Harrow Royal Pharmaceutical Society of Great Britain Dr Charles Foster Senior Researcher, University of Oxford British Heart Foundation, Health Promotion Research Group Dr Jenny Gordon Research and Development Fellow NCCNSC Mrs Jenny Gough Nurse Consultant, Camden Primary Care Trust, London Royal College of Nursing Prof Elspeth Guthrie Professor of Psychological Medicine & Medical Psychotherapy, Manchester Royal Infirmary Royal College of Psychiatrists Dr Miranda Lomer Consultant Dietitian in Gastroenterology, King’s College London Irritable bowel syndrome: full guideline Page 5 of 554 British Dietetic Association Ms Marion Saunders Patient/carer representative Ms Theresa Shaw (Chair) Chief Executive Foundation of Nursing Studies Dr Richard Stevens General Practitioner, East Oxford Health Centre Royal College of General Practitioners Dr Maggie Westby Senior Research and Development Fellow NCCNSC Prof Peter Whorwell Professor of Medicine and Gastroenterology, Wythenshawe Hospital, Manchester British Society of Gastroenterology Dr Mary Wilson Nurse Specialist, Westwood Hospital, North Humberside Royal College of Nursing Staff at the NCCNSC who contributed to this guideline Dr Anayo Akunne Health Economist Ms Nahara Martinez-Gonzales Systematic Reviewer Mr Paul Miller Information Specialist Ms Emma Nawrocki Administrator Irritable bowel syndrome: full guideline Page 6 of 554 Mr Edward Weir Centre Manager The NCCNSC would like to thank the following people for their assistance with developing the guideline Dr Yoon Loke Dr Giok Ong Dr Jacoby Patterson Dr Joanne Lord The NCCNSC also acknowledges the expert opinions of the following people Kevin Whelan Nutritional Sciences Division, King’s College London Professor E Quigley Yvonne McKenzie, Liane Reeves, Annabel Drake, Anna Brian, Carolyn Johnstone, Adele Nichol, Kristina Zaremba Gastroenterology Specialist Group of the British Dietetic Association Scottish Nutrition & Diet Resources Initiative (SNDRI) Irritable bowel syndrome: full guideline Page 7 of 554 Terminology Where the term ‘carer’ is used, this refers to unpaid carers as opposed to paid careworkers. Abbreviations ARR: Absolute Relative Risk BNF: British National Formulary CAM: Complementary and Alternative Medicine CBT: Cognitive Behavioural Therapy CEAC: Cost-effectiveness acceptability curve CI: Confidence interval CRP: C-reactive protein - is used mainly as a marker of inflammation ESR: Erythrocyte Sedimentation Rate - is a non-specific measure of inflammation that is commonly used as a medical screening test. EMA: Anti-endomysium antibodies, inflammatory markers used in the diagnosis of Coeliac disease FBC: Full blood count FOB: Faecal occult blood GDG: Guideline development group GI: Gastrointestinal GP: General practitioner GRADE: Guidelines Recommendations Assessment Development Evaluation HRQoL: Health-related quality of life Irritable bowel syndrome: full guideline Page 8 of 554 IBD: Inflammatory Bowel Disease, A general term for any disease characterized by inflammation of the bowel. Examples include colitis and Crohn's disease. Symptoms include abdominal pain, diarrhea, fever, loss of appetite and weight loss. IBS: Irritable Bowel Syndrome IBS-A: Irritable Bowel Disease with alternating symptoms of diarrhoea and constipation IBS-C: Irritable Bowel Disease with constipation as primary bowel dysfunction IBS-D: Irritable Bowel Disease with diarrhoea as the primary bowel dysfunction ICER: Incremental cost-effectiveness ratio LY: Life-year NHS: National Health Service NICE: National Institute for Health and Clinical Excellence NNT: Number needed to treat OR: Odds ratio PCT: Primary Care Trust PEG: polyethylene glycol (macrogol) PSA: Probabilistic sensitivity analysis PSS: Personal Social Services QALY: Quality-adjusted life-year RCT: Randomised controlled trial RR: Relative risk SSRI: selective serotonin re-uptake inhibitors Irritable bowel syndrome: full guideline Page 9 of 554 TGTT: Total gut transit time. TTG: Anti-transglutaminase antibodies, inflammatory markers used in the diagnosis of Coeliac disease Organisations DoH Department of Health NCCNSC National Collaborating Centre for Nursing and Supportive Care NICE National Institute for Health and Clinical Excellence RCN Royal College of Nursing General glossary Absolute risk