Abstract
Background:
Post-stroke fatigue (PSF) affects around 50% of stroke survivors. Previous systematic reviews of randomised 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 Furthermore, their searches are now out-of-date.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 randomised 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, 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We screened 33,297 citations and identified 10 published completed trials, 6 unpublished completed trials, and 6 ongoing trials.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 SMD -0.80, 95% 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 biasThere were insufficient data on secondary outcomes for meta-analysis, but six trials reported improved quality of life.
Conclusions:
There is insufficient evidence to support a particular pharmacological treatment for PSF, thus current clinical guidelines do not require amendment.
Post-stroke fatigue (PSF) affects around 50% of stroke survivors. Previous systematic reviews of randomised 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 Furthermore, their searches are now out-of-date.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 randomised 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, 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 SMD -0.80, 95% 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 biasThere were insufficient data on secondary outcomes for meta-analysis, but six trials reported improved quality of life.
Conclusions:
There is insufficient evidence to support a particular pharmacological treatment for PSF, thus current clinical guidelines do not require amendment.
| Original language | English |
|---|---|
| Number of pages | 18 |
| Journal | International Journal of Stroke |
| Early online date | 7 Sept 2023 |
| DOIs | |
| Publication status | E-pub ahead of print - 7 Sept 2023 |
Keywords / Materials (for Non-textual outputs)
- Stroke Rehabilitation
- fatigue
- clinical trial
- stroke care
- RCT
- pharmacological intervention