Barber 2007

Methods	Location: United Kingdom. Number of centres: Two. Funding source: Not stated. Recruitment period: September 2004 to April 2005.
Participants	Adults aged 18 years and over, with at least Grade 1 OM and when they felt they were no longer receiving adequate pain control via simple analgesic, receiving daily doses of radiotherapy to the head and neck. 20 eligible, 20 randomised.
Interventions	GpA (10) Gelclair, 4x in the 24 hour study (30 min to 1 hour before eating/drinking and before bedtime, swished around mouth and spat out). GpB (10) Standard care 10 ml 4x in 24 hour study (30 min to 1 hour before eating/drinking sucralfate and Mucaine swished around mouth and swallowed) (30 min to 1 hour before eating/drinking).
Outcomes	Assessed at baseline, 1 hour, 3 hours and 24 hours post treatment. VAS scores for pain (not used as only 24 hour assessment), Pain on speaking, Mucositis score NCI Common Toxicity Criteria (0‐4 scale). Secondary outcome ‐ extent to which ability to swallow is influenced by pain (odynophagia).
Notes	Outcomes assessed by nurse specialists blinded to group allocation. No power calculation reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Quote: "computer generated random allocation sequence for the 2 centres was prepared by Exeter clinical research radiographer".
Allocation concealment?	Low risk	Quote: "radiographer accessed the randomisation list by telephone to determine the patients group allocation".
Blinding of participants/carers?	High risk	Comment: Not possible to blind patients and carers because one product 'swish and spit' and the other 'swish and swallow'.
Blinding of outcome assessors?	Low risk	Quote: "single blind trial with the administering nurse specialist being unaware as to what medication had been issued".
Incomplete outcome data addressed?	Low risk	Quote: "one patient despite their eagerness to participate fell asleep during the course of the trial and did not take their Sucralfate and Mucaine before the 24‐h assessment" "The missing 24‐h scores were substituted with 3‐h assessment scores". Comment: Unlikely to influence results.
Free of selective reporting?	High risk	Comment: Despite intention to report mucositis it was not reported apart from at baseline.
Free of other bias?	Unclear risk	Small pilot study which lacks power. At baseline there are differences between the groups that may have influenced the results. Intervention group had more severe OM (6/10 vs 3/10), and included all patients with enteral feeding and support. 3/10 in control group and 1/10 of intervention group had concomitant chemotherapy during trial. Funding unclear.