Abstract
BackgroundThis is the protocol for a systematic review (and meta-analysis) of an intervention. The primary objective of this systematic review will be to assess the benefits and harms of pharmacological therapies (pharmacotherapies) for the management of fatigue in adults with CLD of any etiology. The effects of pharmacological therapies on fatigue in CLD will be compared against those of placebo, no intervention, or non-pharmacological interventions. Specifically, this review will examine whether pharmacological therapies improve CLD-associated fatigue, and if they do, what key elements are associated with their effectiveness. The results of this systematic review will assist clinicians, policy-makers, researchers, and people with CLD in decision-making on how best to manage fatigue and its associated symptoms.MethodsMEDLINE, SCOPUS, EMBASE, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, CENTRAL (The Cochrane Library), ClinicalTrials.gov, reference lists of articles and conference proceedings will be searched for relevant studies. No language or date restrictions will be applied. Eligible studies will include adults with CLD of any etiology. Included studies will be randomized controlled trials. From included studies, data on participant characteristics, study design, setting, research ethics compliance, and intervention outcomes will be extracted. Risk of bias in included studies will be assessed using the Cochrane Risk of Bias Tool. A random-effects meta-analysis will be conducted. If substantial or considerable levels of heterogeneity are detected, analysis will be limited to a narrative synthesis.DiscussionThis systematic review will examine the effectiveness of pharmacological therapies on fatigue reduction in people with CLD. Such therapies may be more effective than non-pharmacological interventions in treating fatigue symptoms in CLD. Evidence derived from the findings of this study will guide future practice, policy, and research.Systematic review registrationPROSPERO, CRD42017076957
Highlights
This is the protocol for a systematic review of an intervention
This review will examine whether pharmacological therapies improve chronic liver disease (CLD)-associated fatigue, and if they do, what key elements are associated with their effectiveness
Few high quality studies exist that have evaluated the use of pharmacotherapies in the treatment of fatigue in people with CLD
Summary
The primary objective of this systematic review will be to assess the benefits and harms of pharmacological therapies (pharmacotherapies) for the management of fatigue in adults with CLD of any etiology. The effects of pharmacological therapies on fatigue in CLD will be compared against those of placebo, no intervention, or non-pharmacological interventions. Diseases which comprise CLD include compensated cirrhosis of any etiology, chronic hepatitis, alcoholic liver disease (ALD), non-alcoholic steatohepatitis (NASH), cholestatic liver disease, and metabolic liver disease. In the USA, non-alcoholic fatty liver disease (NAFLD), a form of NASH, and defined as abnormal accumulation (> 5%) of hepatic triglyceride in the absence of excess alcohol consumption, is the most common form of CLD [4]. This review will include studies in which CLD was detected
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