Sustained relief of oral aphthous ulcer pain from topical diclofenac in hyaluronan: a randomized, double-blind clinical trial.

OBJECTIVES: The purpose of this study was to test the hypothesis that topically applied 3% diclofenac in 2.5% hyaluronan reduces aphthous ulcer pain.

STUDY DESIGN: A randomized, double-blind, single dose study of 60 healthy adults with aphthous ulcers in three treatment groups--3% diclofenac in 2.5% hyaluronan, 2.5% hyaluronan, 3% viscous lidocaine--was undertaken. Visual analogue scale pain scores were obtained before and after gel application and hourly, for up to 8 hours after gel application. Statistical analysis was performed with repeated measures ANOVA with square root transformation and Bonferroni correction.

RESULTS: A 48% overall reduction in pain (p < 0.01) was observed 10 minutes after gel application; however, no significant difference was found between the three topical agents. A 35% to 52% pain reduction (p < 0.01) was reported 2 to 6 hours after the application of diclofenac in hyaluronan, whereas hyaluronan gel alone and viscous lidocaine failed to produce significant VAS reductions.

CONCLUSIONS: A dose of 3% diclofenac in 2.5% hyaluronan is an effective and novel treatment for this common, painful disorder.