Randomised controlled trialindependent cross-checkabstract checked★ key study I-CHM-113 standard review
Protecting children's hearing during cisplatin treatment
Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss.
Overview
Brock PR et al.. N Engl J Med 2018 · PMID 29924955 · DOI 10.1056/NEJMoa1801109
Hearing loss fell from 63% to 33% with sodium thiosulfate, and survival stayed above 90%.
Does the study support the specific claim? Yes · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Prevent cisplatin hearing loss
- How was the study done?
Randomised trial
- How many people, animals or samples were studied?
109 children with liver cancer
- What was actually found?
Half as much hearing loss
- How large was the observed effect?
RR 0.52; NNT about 3
- What do the results mean in everyday life?
Hearing damage is common but can be reduced, while the cure rate stays high
- What are the study's limitations?
Small, children only
- What does it say about Elawady's specific claim?
Supports the harm claim and shows mitigation
- Do the results apply to Germany and Europe?
High
- What can explicitly not be concluded from this study?
Does not show cisplatin should be avoided
Scientific in-depth review
1. Full reference
- Authors
- Brock PR et al.
- Journal
- N Engl J Med
- Year
- 2018
- Identifier
- PMID 29924955 DOI 10.1056/NEJMoa1801109
- Verification
- verified – PubMed efetch 2026-10-26 (PublicationType and CommentsCorrections checked); Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Cancer Research UK and others.
2. Research question
Does sodium thiosulfate after cisplatin reduce hearing loss without compromising survival in children with hepatoblastoma?
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre randomised phase III trial (SIOPEL 6)
- Population
Children 1 month to 18 years with standard-risk hepatoblastoma
- Country
International (SIOPEL)
- Period
Median follow-up 52 months
- Sample size
109 randomised; 101 assessed for hearing
- Inclusion and exclusion criteria
Standard-risk hepatoblastoma
4. Methods and endpoints
- Exposure / intervention
Cisplatin plus sodium thiosulfate 6 h after cisplatin
- Comparator
Cisplatin alone
- Endpoints
Absolute hearing threshold (Brock grade); 3-year event-free and overall survival
- Statistical methods
Relative risk; Kaplan-Meier
5. Actual results
- Results
Hearing loss grade >=1: 18/55 (33%) with sodium thiosulfate vs 29/46 (63%) with cisplatin alone; RR 0.52 (0.33-0.81), P=0.002. 3-year EFS 82% vs 79%; 3-year OS 98% vs 92%.
- Absolute risks
Absolute reduction in hearing loss 30 percentage points (NNT about 3)
- Authors' conclusion
Sodium thiosulfate reduced cisplatin-induced hearing loss without jeopardising overall or event-free survival.
6. Strengths
- Randomised
- Objective audiometry
- Survival outcomes
7. Weaknesses
- Small; open-label
- Paediatric hepatoblastoma only
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Randomised with objective primary outcome.
9. Assessment of the statistical interpretation
RR and CI reproduced exactly from counts: 0.52 (0.33-0.81); ARR 30.3%, NNT 3.3 (stats/C-CHM-05.py).
10. Relevance to the specific claim
Confirms cisplatin hearing loss is common (63% of children) and called irreversible by the authors, and shows it can be reduced; also shows cisplatin-based treatment cures most of these children (3-year OS 92-98%).
11. Independent contrary findings
None.
12. Transferability to Germany and Europe
Applicable; sodium thiosulfate is approved in Europe for this use.
13. Overall methodological judgement
High-quality confirmation and a prevention option.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Use in adults.
15. Linked fact checks
- Cisplatin chemotherapy causes permanent, dose-dependent hearing loss and tinnitus. – Studies supporting the claim