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| PMC full text: | Published online 2016 Jul 14. doi: 10.1002/14651858.CD008890.pub4
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Summary of findings for the main comparison
Intracystic bleomycin compared to other types of intracystic treatment for cystic craniopharyngiomas in children
| Intracystic bleomycin compared to intracystic radiotherapy with 32P for cystic craniopharyngiomas in children | ||||||
| Patient or population: cystic craniopharyngiomas in children from birth to 18 years old Setting: inpatients from 3 hospitals in China Intervention: intracystic bleomycin Comparison: intracystic radiotherapy with 32P | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with intracystic 32P | Risk with intracystic bleomycin | |||||
| Survival | NA | NA | ‐ | ‐ | ‐ | There was no information on overall survival and event‐free survival reported in this trial |
| Change in cyst size | Mean reduction in cyst size was 65.5% | Mean reduction in cyst size was 50.7% | MD ‐15% (‐69% to 39%) | 7 (1 RCT) | ![[plus sign in circle]](/http/europepmc.org/corehtml/pmc/pmcents/x2295.gif) ![[hyphen in circle]](/http/europepmc.org/corehtml/pmc/pmcents/x229D.gif) VERY LOW 1 | MD was 15% reduction in cyst size; the 95% CI mean a 69% reduction to a 39% increase in cyst size |
| Neurological status | See comment | See comment | Not estimable | Not estimable | VERY LOW 1 | 1 patient in the bleomycin group had left paralysis, while none of the patients in the 32P group had severe sequelae. There was no significant difference between the 2 groups (Fisher's exact P value = 0.429). |
| Total number of adverse effects | 500 per 1000 | 875 per 1000 (340 to 1000) | RR 1.75 (0.68 to 4.53) | 7 (1 RCT) | VERY LOW 1 | Adverse effects including fever, 3rd nerve paralysis, headache and vomiting were included in this outcome measure |
| Fever | 250 per 1000 | 730 per 1000 (183 to 1000) | RR 2.92 (0.73 to 11.70) | 7 (1 RCT) | VERY LOW 1 | ‐ |
| 3rd nerve paralysis | See comment | See comment | Not estimable | 7 (1 RCT) | VERY LOW 1 | 1 patient in the 32P group had 3rd nerve paralysis, while none of the patients in the bleomycin group suffered from this. There was no significant difference between the 2 groups (Fisher's exact P value = 1.00). |
| Headache and vomiting | See comment | See comment | Not estimable | 7 (1 RCT) | VERY LOW 1 | All 3 patients in the bleomycin group had headache and vomiting, while none of the patients in the 32P group did. There was a significant difference in favour of the 32P group (Fisher's exact P value = 0.029). |
| *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; MD: mean difference; NA: not available; 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 | ||||||
1We downgraded a total of 3 levels due to study limitations (the trial had a high risk of performance bias, detection bias and baseline imbalance bias, and an unclear risk of selection bias, attrition bias, reporting bias and early stopping bias), small sample size (the current review includes only one trial with small sample size (n = 7)), and wide confidence intervals including 'no effect', 'appreciable harm' and 'appreciable benefit'.