RESUMO
BACKGROUND: Post-stroke fatigue (PSF) affects 50% of stroke survivors. Current guidance on management of this condition is limited. AIMS: This systematic review and meta-analysis aimed to identify and analyze all randomized clinical trials (RCTs) of non-pharmacological interventions for the treatment of PSF. SUMMARY OF REVIEW: Six electronic databases were searched from inception to January 2023 for English-language RCTs investigating the efficacy of non-pharmacological interventions versus passive controls in patients with PSF. The primary outcome was fatigue severity at the end of the intervention. The Cochrane risk-of-bias (ROB)2 tool was used to assess evidence quality. A total of 7990 records were retrieved, 333 studies were scrutinized, and 13 completed RCTs (484 participants) were included. Interventions included psychological therapies, physical therapies, and brain stimulation. Nine studies provided sufficient data for meta-analysis, of which seven also had follow-up data. Fatigue severity was lower in the intervention groups at the end of the intervention compared with control (participants = 310, standardized mean difference (SMD) = -0.57, 95% confidence intervals (CIs) (-0.87 to -0.28)) and at follow-up (participants = 112, SMD = -0.36, 95% CIs (-0.83 to 0.10)). Certainty in the effect estimate was downgraded to low for a serious ROB and imprecision. Subgroup analysis revealed significant benefits with physical therapy and brain stimulation but not psychological therapies, though sample sizes were low. CONCLUSION: Non-pharmacological interventions improved fatigue but the quality of evidence was low. Further RCTs are needed for PSF management.
RESUMO
BACKGROUND: Post-stroke fatigue (PSF) affects around 50% of stroke survivors. Previous systematic reviews of randomized controlled trials found insufficient evidence to guide practice, but most excluded Chinese studies. Furthermore, their searches are now out-of-date. AIMS: To systematically review and perform a meta-analysis of randomized placebo-controlled trials of pharmacological interventions for treating PSF. METHODS: We screened Airitri, CNKI, VIP, CINAHL, ClinicalTrials.gov, CENTRAL, Cochrane Stroke Group Trial Register, EMBASE, EU Clinical Trial Register, ISRCTN, MEDLINE, PsycINFO, Wanfang, and WHO ICTRP up to 11 November 2022. Our primary outcome was fatigue severity. We conducted subgroup analysis by drug type and sensitivity analysis after excluding the trials at high risk of bias. Secondary outcomes included mood and quality of life. RESULTS: We screened 33,297 citations and identified 10 published completed trials, 6 unpublished completed trials, and 6 ongoing trials. Pharmacological treatments were associated with lower fatigue severity at the end of treatment (10 published completed trials, 600 participants, pooled standardized mean difference (SMD) = -0.80, 95% confidence interval (CI): -1.29 to -0.31; I2 = 86%, p < 0.00001), but not at follow-up (265 participants, pooled SMD = -0.14, 95% CI: -0.38 to 0.10; I2 = 0, p = 0.51). However, these trials were small and had considerable risk of bias. Beneficial effects were seen in trials with low risk of bias on randomization, missing outcome data, and reporting bias. There were insufficient data on secondary outcomes for meta-analysis, but six trials reported improved quality of life. CONCLUSION: There is insufficient evidence to support a particular pharmacological treatment for PSF, thus current clinical guidelines do not require amendment.
