Yesterday we looked at a study that looked at multivitamins for the treatment of recurrent aphthous stomatitis (RAS). Today we have another study whose aim was to explore the efficacy and safety of dexamethasone ointment in the treatment of RAS.

 What did they do

This was a multi-centre trail conducted across 5 centres in China. Patients were randomised to receive either dexamethasone ( n=120) or a placebo ( n=120) ointment. Patients were instructed to apply the given agent to the identified ulcer 3 times a day (after meals) for 5 days.   Patient were included if they were not pregnant, aged between 18-60 years, had a history of recurrent aphthous ulceration longer than 6 months and expectation that the ulcers normally take more than 5 days to resolve without treatment; and they presented with of 1-3 aphthous ulcers (duration, <48 hours) with a diameter <10 mm.

The patients kept a log diary and were monitored for potential biochemical abnormalities. The primary objectives were to evaluate the size of ulcers and pain level before and after the drug management (at days 1 and 6±2 days after entering the study). Pain was assessed using a visual analogue scale no pain ( 0) to unbearable pain (10)

 What did they find

• Nine patients were discontinued (5 because of loss to follow-up; one because of the development of a systemic rash; 3 because of combination with other drugs).
• There was significant difference in the reduction of ulcer size between the treatment group and the control group and in the reduction of pain level between the groups with better healing in the treatment group.

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• No severe adverse reactions were observed.
• No serum dexamethasone was detected before or after the use of the agents (< 0.502 ng/mL).

They concluded

The current study revealed that dexamethasone ointment was safe and efficient in reducing ulcer size, alleviating ulcer pain, and hastening ulcer healing in patients with recurrent aphthous ulceration. In addition, the patients had a good overall assessment of the agents.

Liu C, Zhou Z, Liu G, Wang Q, Chen J, Wang L, Zhou Y, Dong G, Xu X, Wang Y,Guo Y, Lin M, Wu L, Du G, Wei C, Zeng X, Wang X, Wu J, Li B, Zhou G, Zhou H. Efficacy and safety of dexamethasone ointment on recurrent aphthous ulceration. Am J Med. 2012 Mar;125(3):292-301. PubMed PMID: 22340928.

Comment

This is short term study, and it not clear if outcome assessors were blind to intervention. There were also some potential variations between the centres in relation to pain assessment a point noted by the authors.