Baharvand 2010

Methods	Location: Iran. Number of centres: Multicentre. Funding source: Unclear. Recruitment period: December 2006 to May 2007.
Participants	Inclusion: Adults undergoing chemotherapy who developed oral mucositis Gr 2 or worse, with no other systemic disease, life expectancy at least 6 months. Exclusion: Other concomitant disease, heavy smoker, severe psychological disorder. 14 randomised, 12 completed.
Interventions	GpA (6) Phenytoin, 0.5% (50:50 mixture sodium phenytoin and phenytoin powder), 10 ml given 4 times daily, swished around mouth and spat out. GpB (6) Placebo 10 ml 4 times daily, swished around mouth and spat out.
Outcomes	Assessed at baseline, 1 week and 2 weeks after start of treatment. VAS scores for pain, Mucositis score NCI Common Toxicity Criteria (0 to 4 scale), duration of mucositis (not used as data presented in a format not suitable for pooling).
Notes	No power calculation reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	'Patients were assigned to case and control groups randomly and separately at each department. Sampling method was performed on a multi‐central, non‐probable (easy to access) basis.'
Allocation concealment?	Unclear risk	Not mentioned.
Blinding of participants/carers?	Low risk	Patients and nurses blinded to treatment group.
Blinding of outcome assessors?	Unclear risk	Ppatients self assessed pain and QoL, unclear who conducted the mucositis assessments.
Incomplete outcome data addressed?	Unclear risk	2/14 randomised were subsequently excluded because they were 'uncooperative' ‐ no details given. It is not stated which group these were from, but if both exclusions were from the same group, this would represent 25% drop out from that group and a significant risk of bias.
Free of selective reporting?	Low risk	Reported mucositis scores, duration of mucositis, pain and quality of life.
Free of other bias?	Low risk