Summary of findings 2. Edaravone plus corticosteroids compared to corticosteroids for the treatment of brain radionecrosis after radiotherapy or radiosurgery.
| Edaravone plus corticosteroids compared to corticosteroids for the treatment of brain radionecrosis after radiotherapy or radiosurgery | ||||
| Patient or population: people previously treated with radiosurgery or fractionated radiotherapy to the brain or head and neck region with a diagnosis of brain radionecrosis based on clinical and radiological criteria Setting: hospital Intervention: edaravone + corticosteroids Comparison: corticosteroids | ||||
| Outcomes | Summary | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) |
| Reduction in oedema (T2 hyperintensity) | At 3 months after completing study treatment, greater reduction in brain oedema (5.08 ± 10.32 cm2) was noted in the edaravone + corticosteroid group (edaravone 30 mg orally twice daily for 14 days plus conventional methylprednisolone 500 mg IV x 3 days followed by tapering prednisone orally) than in the corticosteroid alone group (2.05 ± 6.71 cm2) although the result approached borderline significance (P = 0.04) | MD = 3.03, 95% CI 0.14 to 5.92 | 137 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
| Reduction in post‐gadolinium enhancement | At 3 months after completing study treatment, there was no evidence of any important difference in the reduction in post‐gadolinium enhancement between arms (1.67 ± 4.69 cm2; control group, 1.20 ± 2.71 cm2) | MD = 0.47, 95% CI ‐0.80 to 1.74 | 137 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
| Improvement in LENT/SOMA | At 3 months after completing study treatment, participants who received the combination treatment were noted to have significantly greater clinical improvement than corticosteroids alone measured using the Late Effects Normal Tissue Task Force‐Subjective, Objective, Management, Analytic (LENT‐SOMA) scale and defining improvement as a reduction in the LENT‐SOMA scale of > 1. | OR = 2.51, 95% CI 1.26 to 5.01 | 137 (1 RCT) | ⊕⊝⊝⊝ LOW 1 2 3 |
| Change in neurocognitive function | Not reported | |||
| Severe adverse events | No differences in treatment toxicities were observed between arms and no severe adverse events were reported. | Not reported | 137 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
| Quality of life | None of the included studies reported quality of life outcomes or adequately reported details about corticosteroid requirements | |||
| Corticosteroid requirements | ||||
| *The risk in the intervention group (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; OR: Odds ratio; | ||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||
1 Open‐label trial
2 At overall high risk of bias and/or imprecision in estimate
3 Inadequate blinding giving high risk of detection bias