Summary of findings 2. Laigle‐Donadey 2019: dexamfetamine sulfate compared with placebo for fatigue in primary brain tumour.
| Dexamfetamine sulfate compared with placebo for fatigue in primary brain tumour | |||||
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Patient or population: people with a primary brain tumour Settings: hospital, outpatient Intervention: dexamfetamine sulfate Comparison: placebo | |||||
| Outcomes | Median change from baseline (IQR) | Between‐group comparison | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments |
| Placebo | dexamfetamine sulfate | ||||
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Fatigue MFI‐20 scale (follow‐up: 3 months) |
The median difference in fatigue score between baseline and 3‐month follow‐up in the control group was 14 points (IQR 4.5 to 24.25) | The median difference in fatigue score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 4 points lower (IQR 4 to 13) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate a higher level of fatigue. |
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Fatigue ('asthenia') Norris Scale |
The median difference in fatigue score between baseline and 3‐month follow‐up in the control group was 4.25 points (IQR –0.06 to 12.16) | The median difference in fatigue score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 2.31 points lower (IQR –10.88 to 13.96) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate a higher level of fatigue. |
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Cognition Trail Making Test A |
The median difference in score between baseline and 3‐month follow‐up in the control group was 6.5 points (IQR –0.75 to 17.5) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 7.5 points lower (IQR –4 to 10) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate poorer cognition. |
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Cognition Trail Making Test B |
The median difference in score between baseline and 3‐month follow‐up in the control group was –2 points (IQR –16 to 21.75) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 18 points higher (IQR –37 to 39) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate poorer cognitive performance. |
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Cognition Semantic Fluency |
The median difference in score between baseline and 3‐month follow‐up in the control group was 1 points (IQR –1 to 3) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 1 point lower (IQR –5 to 3) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better cognitive performance. |
| Cognition Lexical Fluency | The median difference in score between baseline and 3‐month follow‐up in the control group was 1 point (IQR –0.75 to 2.75) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 2 points lower (IQR –4 to 4) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better cognitive performance. |
| Cognition Episodic memory (Grober and Buschke test) | The median difference in score between baseline and 3‐month follow‐up in the control group was –0.5 points (IQR –4.25 to 2.5) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 0.5 points higher (IQR –4.5 to 4) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better cognitive performance. |
| Cognition Mattis Scale | The median difference in score between baseline and 3‐month follow‐up in the control group was –2 (IQR –7 to 1) | The median difference in fatigue score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 1point higher (IQR –4 to 0) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better cognitive performance. |
| Affectivity Norris Scale | The median difference in score between baseline and 3‐month follow‐up in the control group was 8.25 (IQR 2.34 to 18.09) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 5.87 points lower (IQR –10.78 to 10) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate higher affectivity. |
| Apathy Marin Scale | The median difference in score between baseline and 3‐month follow‐up in the control group was 0.5 (IQR –6 to 2.75) | The median difference in score between baseline and 3‐month follow‐up in the dexamfetamine sulfate group was 1.5 points higher (IQR –2 to 11) | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicated higher apathy. |
| Depression HADS | — | — | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate more severe depression symptoms. |
| Quality of life EORTC QLQ‐C30 | — | — | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better quality of life. |
| Quality of life EORTC QLQ‐BN 20 | — | — | 41 (1) | ⊕⊝⊝⊝ Very lowa | Higher scores indicate better quality of life. |
| EORTC QLQ‐BN 20: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Brain Neoplasm; EORTC QLQ‐C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire‐C30; HADS: Hospital Anxiety and Depression Scale; IQR: interquartile range; MFI‐20: 20‐item Multidimensional Fatigue Inventory. | |||||
| GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | |||||
aDowngraded three levels; there was very low‐certainty evidence due to low accrual, such that recruitment did not meet the estimated power requirement to detect a true effect.