Methods | Location: USA. Number of centres: One. Funding source: Not stated. Recruitment period: Not stated. |
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Participants | Inclusion: Adult cancer patients who had undergone chemotherapy with no prior treatment for oral mucositis, no oral yeast infection or oral herpes infection. All had oral mucositis grades 2 to 4 (WHO criteria). "24 were initially evaluated but 6 were subsequently excluded". Unclear when randomisation took place. |
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Interventions | Gr A (n = 9) Vitamin E oil 400 mg/ml 1 ml applied topically to lesions twice daily for 5 days. Gr B (n = 9) Placebo (coconut and soyabean oil) 1 ml applied topically to lesions twice daily for 5 days. |
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Outcomes | Clinical evaluation of eradication of lesions over 5 day study period using WHO criteria (0 to 4 scale). | |
Notes | No power calculation reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Quote: "Randomised double‐blind placebo controlled study. Patients were randomly assigned to receive in a double blind manner vitamin E or placebo". |
Allocation concealment? | Unclear risk | No details given. |
Blinding of participants/carers? | Low risk | Double blind. |
Blinding of outcome assessors? | Low risk | Ddouble blind. |
Incomplete outcome data addressed? | Unclear risk | Unclear information on withdrawals which were either before or after randomisation. 0% or 25% lost to follow‐up. |
Free of selective reporting? | Low risk | Planned outcome described and reported. |
Free of other bias? | Low risk | Yes. |