Summary of findings for the main comparison. Modafinil compared with placebo for fatigue in people with a primary brain tumour.
| Modafinil compared with placebo for fatigue in people with a primary brain tumour | ||||||
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Patient or population: people with a primary brain tumour Settings: hospital, outpatient Intervention: modafinil Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Modafinil | |||||
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Fatigue ‐ concentration problems Sub‐scale from Checklist Individual Strength Scale from: 0 to 35 (follow‐up: 6 weeks) |
The mean concentration problem score ranged across control groups from 15.91 to 23.91 points | The mean concentration problem score in the intervention groups was 1.06 lower (‐3.18 to 1.06 lower) |
‐ | 37 (1) | ⊕⊕⊝⊝ low | Higher scores indicate a high level of concentration problems |
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Fatigue ‐ reduced motivation Sub‐scale from Checklist Individual Strength Scale from: 0 to 28 (follow‐up: 6 weeks) |
The mean reduced motivation score ranged across control groups from 10.22 to 19.48 points | The mean reduced motivation score in the intervention groups was 0.48 lower (‐2.93 to 1.97 lower) |
‐ | 37 (1) | ⊕⊕⊝⊝ low | Higher scores indicate lower motivation |
|
Fatigue ‐ reduced activity Sub‐scale from Checklist Individual Strength Scale from: 0 to 21 (follow‐up: 6 weeks) |
The mean reduced activity score ranged across control groups from 3.84 to 21.34 points | The mean reduced activity score in the intervention groups was 1.01 lower (‐5.64 to 3.62 lower) |
‐ | 37 (1) | ⊕⊕⊝⊝ low | Higher scores indicate lower activity |
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Fatigue ‐ fatigue severity Sub‐scale from Checklist Individual Strength Scale from: 0 to 56 |
The mean fatigue severity score ranged across control groups from 34.06 to 36.22 points | The mean fatigue severity score in the intervention groups was 0.22 lower (‐0.79 to 0.35 lower) |
‐ | 37 (1) | ⊕⊕⊝⊝ low | High scores indicate a high level of fatigue |
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Adverse events (follow‐up: 6 weeks) |
Low‐risk population | RR 2.79, 95% CI 0.59 to 13.16 | 37 (1) | ⊕⊕⊝⊝ low | ‐ | |
| ‐ | 30 per 100 (1 to 180) | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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 quality: We are very uncertain about the estimate. | ||||||