Hejna 2001

Methods	Location: Vienna, Austria. Number of centres: One. Funding source: Not stated. Recruitment period: March 1998 to June 1999.
Participants	Inclusion: Patients with WHO grade 1 to 3 oral mucositis following 5 FU based chemotherapy. Patients were > 19 years of age, could read & understand German, had WHO Performance Status < 3. Exclusion: History of adverse reactions to G‐CSF, or GM‐CSF, or iodine, severe concomitant diseases including hyperthyroidism, dermatitis herpetiformis or need for systemic G‐CSF or GM‐CSF for neutropenia. 31 recruited and randomised and completed.
Interventions	Gr A (n = 15) GM‐CSF (Malgramostim) mouthwash three times daily (400 ug molgramostim dissolved in 250 ml water. Patients were instructed to wash mouths with 25 ml and keep in mouth for 3 min, then rinse and repeat 10 times within 30 mins). Gr B (n = 16) Antiseptic mouthwash (Povidone iodine) 4 ml povidone‐iodine in 125 ml water was used 6 times daily. This was kept in mouth for 3 mins. Patients received 4 daily tablets of amphotericin B, 10 mg (AA regimen). All patients with oral mucositis exceeding grade 2 were offered topical lidocaine 6 times daily.
Outcomes	Mean duration of therapy until complete remission.
Notes	No power calculation reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: "Randomisation performed without stratification according to a balanced block randomisation procedure carried out by a third investigator".
Allocation concealment?	Unclear risk	No details given.
Blinding of participants/carers?	High risk	Quote " Physicians were not blinded but the patients were as to the efficacy of any of the chosen regimes". Comment: Different mouthwashes for different frequencies plus only one group received amphotericin B tablets.
Blinding of outcome assessors?	High risk	Quote " Physicians were not blinded but the patients were as to the efficacy of any of the chosen regimes".
Incomplete outcome data addressed?	Unclear risk	All patients completed. 2/16 (12%) patients in control group did not provide final OM score.
Free of selective reporting?	Unclear risk	Unclear.
Free of other bias?	High risk	Significant differences between groups at baseline for the following prognostic factors age group, WHO performance status, smoking status, oral hygiene. May have influenced results. 4 patients in control arm did not receive treatment but ITT analysis conducted.