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Meta-Analysis
. 2023 Oct;18(9):1071-1083.
doi: 10.1177/17474930231196648. Epub 2023 Sep 7.

Systematic review: Pharmacological interventions for the treatment of post-stroke fatigue

Shuk Han Chu  1 , Xu Zhao  2 , Ahmad Komber  1 , Joshua Cheyne  3 , Simiao Wu  4 , Eileen Cowey  5 , Mansur Kutlubaev  6 , Gillian Mead  1
Affiliations
Meta-Analysis

Systematic review: Pharmacological interventions for the treatment of post-stroke fatigue

Shuk Han Chu et al. Int J Stroke. 2023 Oct.

Abstract

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 Furthermore, their searches are now out-of-date.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Results: We screened 33,297 citations and identified 10 published completed trials, 6 unpublished completed trials, and 6 ongoing trials.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.

Keywords: RCT; Stroke rehabilitation; clinical trial; fatigue; pharmacological intervention; stroke care.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.K. was supported by the Bashkir State Medical University Strategic Academic Leadership Program (PRIORITY-2030). S.W., member of DSMB of Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial (LATE-MT), received grants from National Natural Science Foundation of China (82171285) and Science and Technology Department of Sichuan Province (2021YJ0433I). S.H.C., X.Z., A.K., J.C., E.C., and G.M. have no conflicts of interest.

Figures

Figure 1.
Figure 1.
PRISMA flow diagram showing the selection of trials.
Figure 2.
Figure 2.
Risk of bias summary: review authors’ judgments on each risk of bias domain for each included study.
Figure 3.
Figure 3.
Risk of bias graph: each risk of bias domain presented as percentages across all included studies.
Figure 4.
Figure 4.
Treatment effects on fatigue at the end of the treatment.
Figure 5.
Figure 5.
Treatment effects on fatigue of the included trials at follow-up.
Figure 6.
Figure 6.
Funnel plot of the meta-analysis of published trials.
See this image and copyright information in PMC

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