Saarilahti 2002.

Study characteristics
Methods	Randomised, parallel group study conducted in Finland. Clear information about withdrawals: none. Unclear if dentist involved in study. Drop outs: 0%. Duration: 10 weeks.
Participants	Adults with head and neck cancer. 40 patients eligible, enrolled between October 1999 and April 2001, and evaluated.
Interventions	2 groups, GM‐CSF mouthwash made by dissolving 150 mg of dried powder in 100 ml sterile water versus mouthwash of 4 g sucralfate with 100 ml sterile water. 4 doses x 25 ml per day after meals.
Outcomes	RTOG rating for mucositis on 0‐4 scale. Author provided data in right form for the review.
Notes	Maximum value of mucositis taken.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomisation was done using computer generated digits".
Allocation concealment (selection bias)	Low risk	Quote: "After patients provided written consent, they were assigned to a treatment group by way of a telephone call to the randomisation office". Quote: “The drug vials were marked with a study code that prevented identification of the allocation group”. Comment: central method of randomisation.
Blinding (performance bias and detection bias) Carers	Low risk	Comment: double blind study with adequate allocation concealment, drugs prepared by pharmacy.
Blinding (performance bias and detection bias) Patients	Low risk	Quote: "double blind". Comment: probably done.
Blinding (performance bias and detection bias) Outcome assessors	Low risk	Quote: "double blind". Comment: probably done.
Incomplete outcome data (attrition bias) All outcomes	Low risk	40 patients randomised. No missing outcome data.
Selective reporting (reporting bias)	Unclear risk	Data presented for mean mucositis score over time (fig 1) and mean mucosal pain scores (fig 2).
Other bias	Low risk	Study appears to be free of other sources of bias.