Interventions for fatigue in inflammatory bowel disease (Protocol)

This is the protocol for a review and there is no abstract. The objectives are as follows: The aim of this review is to assess the efficacy and safety of interventions for fatigue in IBD

Interventions for fatigue in inflammatory bowel disease

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

Patient decision-making about emergency and planned stoma surgery for IBD: a qualitative exploration of patient and clinician perspectives

Background: Many IBD patients worry about stoma forming surgery (SFS), sometimes enduring poor bowel-related quality of life to avoid it. Anticipation of SFS and whether expectations match experience is under-reported. This qualitative study explored influences on patients’ SFS decision-making, and compared pre-operative concerns with post-operative outcomes. Methods: We purposively recruited participants with IBD from UK hospital outpatient and community sources, and IBD clinicians from public hospitals. Four focus groups and 29 semi-structured patient participant interviews, and 18 clinician interviews were audio recorded, transcribed, and analysed thematically. Participants had a current temporary, recently-reversed, or permanent stoma, or were stoma naïve. Results: Four themes emerged: Pre-operative concerns and expectations, Patient decision-making, Surgery and recovery, and Long-term outcomes. Participants and clinicians agreed about most pre-operative concerns, that outcomes were often better than expected, and support from others with a stoma is beneficial. Patient decision-making involves multiple factors, including disease status. Some clinicians avoid discussing SFS, and the phrase ‘last resort’ can bias patient perceptions; others recommend early discussion, increasing dialogue when medical management becomes ineffective. The post-operative period is particularly challenging for patients. Stoma acceptance is influenced by personal perceptions and pre- and post-operative clinical and social support. Conclusion: Patients need balanced information on all treatment options, including surgery, from an early stage. Early multi-disciplinary team dialogue about SFS, and contact with others living well with a stoma, could enable informed decision-making. Life with a stoma is often better than anticipated, improving quality of life and control. Ongoing specialist nursing support aids recovery and adjustment

Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element:Study protocol for a randomised controlled trial

SPIRIT Checklist. (DOC 104 kb

Targets for interventions for faecal incontinence in inflammatory bowel disease:a systematic review

Objective: Prevalence of faecal incontinence is greater in patients with inflammatory bowel disease than in the general population. It is a major concern for patients with inflammatory bowel disease, even when disease is in remission. It is underreported and negatively affects quality of life. We explored the evidence on the associations of faecal incontinence in inflammatory bowel disease and the effectiveness of interventions. Material and methods: Databases searched in October 2017: Web of Science, MEDLINE, EMBASE, CINAHL, PsycINFO, British Nursing Index and Scopus. Manual search of reference lists was also conducted. Four researchers independently screened references and extracted data. Results: Eighteen studies were included in the review (14 on associations, four on interventions). The presence of faecal incontinence was reported as 12.7–76% among 5924 participants, varying in definitions adopted and populations studied. Factors associated with faecal incontinence included disease activity, loose stool, female gender, childbirth, previous surgery, anal sphincter weakness or fatigability, anxiety and depression. The cross-sectional design of studies means causation cannot be inferred. Interventions included surgery (sphincter repair and sacral nerve stimulation) and tibial nerve stimulation which each improved faecal incontinence. However, the four intervention studies were small (34 participants in total) and uncontrolled. Conclusion: There is a high prevalence of faecal incontinence in inflammatory bowel disease associated with various sociodemographic, clinical and psychosocial factors which could be targeted in future interventions. Future intervention studies with control groups, targeting likely underlying causes such as disease activity, loose stool, psychological factors and anal sphincter function, are needed.</p