Schubert 1987

Methods	Location: USA. Number of centres: Multicentre. Funding source: Inter America Pharmaceuticals. Recruitment period: Not stated.
Participants	Inclusion: Adults with moderate oral mucositis pain after chemotherapy of chemoradiotherapy with clinically obvious mucosal changes consistent with oral mucositis. Exclusion: Patients taking systemic analgesics or anti‐inflammatory drugs or those using topical anaesthetics. 44 randomised, 44 completed.
Interventions	Gr A (n = 25): Benzydamine 0.15% in mouthwash base. Swish and hold 15 ml of solution for 1 min every 2 hours. Minimum of 5 doses per day. Gr B (n = 19): Placebo. Swish and hold 15 ml of solution for 1 min every 2 hours. Minimum of 5 doses per day. Study length min 9 hours, max 10 days.
Outcomes	Patients assessment of pain relief at day 1. We dichotomised this as poor versus fair to excellent and used this as an outcome for whether mucositis had improved or not.
Notes	Sample size calculation reported (post hoc): to have a 90% chance of detecting a significant difference between placebo and benzydamine solutions (assuming placebo 45% effective and benzydamine 65%) would require 105 subjects per arm, if difference in effectiveness between the groups is increased to 25% (45% and 70%) then would need 75 subjects per group. Study planned to accrue 214 subjects.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: 'A multicentre double blind controlled trial was undertaken".
Allocation concealment?	Unclear risk	No information given.
Blinding of participants/carers?	Low risk	Double blind.
Blinding of outcome assessors?	Low risk	Double blind.
Incomplete outcome data addressed?	Low risk	All randomised patients included in outcome assessment.
Free of selective reporting?	High risk	Preliminary results reported, for pain at day 1 and duration of treatment.
Free of other bias?	Unclear risk	Unclear.