Randomised controlled trial of the efficacy of HybenX in the symptomatic treatment of recurrent aphthous stomatitis.

BACKGROUND: The treatment of recurrent aphthous stomatitis (RAS) is principally directed towards reducing the pain and duration of each episode of ulceration; however, there remain few agents for which there is definitive evidence of benefit.

AIMS: The aims of the present study were to determine the efficacy of HybenX (Epien Medical Inc., Minneapolis, MN, USA), vs another device used for the treatment of RAS (Salicept; Carrington Laboratories Inc., lrving, TX, USA) to reduce the symptoms and duration of RAS and determine the safety of HybenX for this clinical application.

MATERIAL AND METHODS: Sixty-three individuals (36 male, 27 female, group median age 25 years, range 17.8-57.9 years) were entered into a prospective randomised controlled trial of HybenX vs an occlusive covering device (Salicept oral patches; Carrington Laboratories).

RESULTS: Painful symptoms over a 5-day posttreatment period were reduced by both agents although HybenX was statistically more effective at day 2 than Salicept, and there was a trend for HybenX to cause greater pain reduction than Salicept over this 5-day period. Both agents gave rise to few adverse side effects--a total of nine adverse events in eight patients were recorded. All were unlikely to be related to the treatment devices. HybenX was only applied on one occasion to the HybenX group, while individuals in the Salicept group were able to self medicate as required. The mean number of Salicept patches used per day per subject was three (s.d. 3.3) on day 1 posttreatment, 3.4 (s.d. 3.1) on day 2 and 2.7 (s.d. 1.9) on day 3. Thereafter, the number of applications fell to a mean of 0.8 on day 7.

CONCLUSION: It is concluded that HybenX safely and effectively reduces the painful symptoms of RAS.