PMID- 32297974 OWN - NLM STAT- MEDLINE DCOM- 20200831 LR - 20240103 IS - 1469-493X (Electronic) IS - 1361-6137 (Linking) VI - 4 IP - 4 DP - 2020 Apr 16 TI - Interventions for fatigue in inflammatory bowel disease. PG - CD012005 LID - 10.1002/14651858.CD012005.pub2 [doi] LID - CD012005 AB - BACKGROUND: Inflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies. OBJECTIVES: To assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator. SEARCH METHODS: A systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies. SELECTION CRITERIA: Randomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used. MAIN RESULTS: We included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy). Electroacupuncture Fatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solution-focused therapy Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants). Physical activity advice One 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Pharmacological interventions Compared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence) AUTHORS' CONCLUSIONS: The effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome. CI - Copyright (c) 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. FAU - Farrell, Dawn AU - Farrell D AD - Institute of Technology Tralee, Department of Nursing and Healthcare Sciences, Tralee, County Kerry, Ireland. FAU - Artom, Micol AU - Artom M AD - King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA. FAU - Czuber-Dochan, Wladyslawa AU - Czuber-Dochan W AD - King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA. FAU - Jelsness-Jorgensen, Lars P AU - Jelsness-Jorgensen LP AD - Ostfold University College, Health Sciences, Hogskolen i Ostfold, Postboks 700, Halden, Norway, NO-1757. FAU - Norton, Christine AU - Norton C AD - King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA. FAU - Savage, Eileen AU - Savage E AD - University College Cork, School of Nursing and Midwifery, Brookfield Health Sciences Complex, Cork, Ireland. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20200416 PL - England TA - Cochrane Database Syst Rev JT - The Cochrane database of systematic reviews JID - 100909747 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Fatty Acids, Omega-3) RN - 0 (Ferric Compounds) RN - 0 (Hematinics) RN - 0 (Pyrones) RN - FYS6T7F842 (Adalimumab) RN - MA10QYF1Z0 (ferric maltol) SB - IM UOF - doi: 10.1002/14651858.CD012005 MH - Adalimumab/administration & dosage/adverse effects MH - Anti-Inflammatory Agents/administration & dosage/adverse effects MH - Cognitive Behavioral Therapy MH - Electroacupuncture MH - Exercise MH - Fatigue/etiology/*therapy MH - Fatty Acids, Omega-3/administration & dosage/adverse effects MH - Ferric Compounds/adverse effects MH - Hematinics/adverse effects MH - Humans MH - Inflammatory Bowel Diseases/*complications MH - Psychotherapy, Brief MH - Pyrones/adverse effects MH - Quality of Life MH - Randomized Controlled Trials as Topic PMC - PMC7161727 COIS- Dawn Farrell: This paper presents independent research funded by the Health Research Board of Ireland under the Cochrane Fellowship programme (Reference Number CFT-2014-887). Infrastructure support was provided from the host institution, University College Cork, to conduct this review. Micol Artom: This paper presents independent research funded by the UK National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-0216-20001). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. Wladyslawa Czuber-Dochan: Serves as a member of Scientific Committee for Crohn's and Colitis UK, and Nurse-European Crohn's and Colitis Organisation. She has also received speaker fees from Pfizer. This paper presents independent research funded by the UK National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-0216-20001). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. Lars-Petter Jelsness-Jorgensen has received unrestricted research grants from Ferring Pharmaceuticals and Tillots Pharma. and has also acted as consultant and speaker for Abbvie. All of these activities are outside the submitted work. Christine Norton: Tillotts, Takeda, AbbVie, Ferring (lecture fees) (outside submitted work). This paper presents independent research funded by the UK National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-0216-20001). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. Eileen Savage: None known. EDAT- 2020/04/17 06:00 MHDA- 2020/09/01 06:00 PMCR- 2021/04/16 CRDT- 2020/04/17 06:00 PHST- 2020/04/17 06:00 [entrez] PHST- 2020/04/17 06:00 [pubmed] PHST- 2020/09/01 06:00 [medline] PHST- 2021/04/16 00:00 [pmc-release] AID - CD012005.pub2 [pii] AID - 10.1002/14651858.CD012005.pub2 [doi] PST - epublish SO - Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012005. doi: 10.1002/14651858.CD012005.pub2.