4 research outputs found
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 nonâpharmacological treatments for fatigue in IBD is not yet established through systematic review of studies. Objectives: To assess the efficacy and safety of pharmacological and nonâpharmacological 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 topâup 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 nonâpharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or diseaseâspecific fatigue measure, a subscale of a larger quality of life scale or as a singleâitem 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 nonâpharmacological 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 solutionâfocused therapy). Electroacupuncture: Fatigue was measured with Functional Assessment of Chronic Illness Therapy â Fatigue (FACITâF) (scores range from 0 to 52). The FACITâF 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; lowâcertainty evidence). Results at week 16 could not be calculated. FACITâF 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; lowâcertainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; lowâcertainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solutionâfocused therapy: Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel DiseaseâFatigue (IBDâF) section I: MD â2.16, 95% CI â6.13 to 1.81; IBDâF section II: MD â21.62, 95% CI â45.02 to 1.78; 1 RCT, 18 participants, very lowâcertainty evidence). The efficacy of solutionâfocused 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, FACITâF scores were higher (better) in the physical activity advice plus omega 3 group (FACITâF MD 6.40, 95% CI â1.80 to 14.60, very lowâcertainty evidence) and the physical activity advice plus placebo group (FACITâF MD 9.00, 95% CI 1.64 to 16.36, very lowâcertainty 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 moderatelyâtoâseverely active Crohn's disease, but the evidence is very uncertain (FACITâF MD 4.30, 95% CI 1.75 to 6.85; very lowâcertainty 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; moderateâcertainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderateâcertainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SFâ36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD â9.31, 95% CI â17.15 to â1.47; 118 participants; lowâcertainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; lowâcertainty 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 highâquality 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
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