The efficacy of 3% diclofenac in
2.5% hyaluronan gel base for treatment of recurrent aphthous stomatitis (RAS): A double blind study.
Iraji Fariba MD*, Ghafgasi Taghi PhD**., Eslami Samani Mazdak MD*, Tashakori Maryam MD*, Siadat Amir Hossein MD***, Enshaieh Shahla MD*, Shahmoradi Zabiholah MD*.
Egyptian Dermatology Online Journal 1 (2): 4
Purpose: To evaluate the effects of 3% Diclofenac in 2.5% hyaluronan base versus
2.5% gel base alone on the pain duration and healing time of the minor aphthous
Recurrent Aphthous stomatitis (RAS) is a chronic
condition, usually with a childhood or adolescent onset and
with a tendency to diminish in frequency and severity with
age. Most patients are otherwise healthy .RAS affects 5-25%
of the general population . It is most commonly found in
women , but there are studies that report a prevalence of
more than 50% in men , with a significantly greater
involvement among high socioeconomic groups .
Patients and methods
This study was a double – blind clinical trial and was performed in skin
diseases and leishmaniasis research center. 44 patients with minor recurrent
aphthous stomatitis were selected randomly.
The mean of age in the control group was 30.2 an in the cases group was 32.4.
There was no significant difference in age between these 2 groups of patients
Recurrent Aphthous Ulceration (RAS) is a chromic and recurrent disorder and repetitive treatment courses are often necessary. Accordingly several types of treatment have been developed.
Treatment strategies for RAS most toke into account the possible immunopathogenesis and the benefit derived from and the potential adverse effects caused by treatment.
The treatment that are used currently for treatment of RAS are largely symptomatic and include treatments such as topical corticosteroids, chlorhexidine gluconate mouth rinse, benzydamine hydrochloride spray or moth rinse, prednisolone, levamisole, pentoxifylline, disodium cromoglycate, colchicine and thalidomide[14-18].
In this study, we evaluated the efficacy of topical diclofenac in hyaluronan gel base for treatment of RAS. Our results showed that this treatment was effective in reducing pain duration of the lesions.
On the other hand, the healing period was less in the diclofenac treated group than placebo group although this difference was not significant.
We can conclude from our results that diclofenac gel is not effective in healing of the aphthous lesions although it is effective in reducing pain duration of the lesions. These effects may be related to anti inflammatory and pain reliving effects of the diclofenac in hyaluronan base.
In the literature review, only one study suggested the use of diclofenac in 2.5% hyaluronan gel for treatment of the RAS . In this study, 60 healty adults were allocated in 3 groups and were treated with 3% diclofenac in 2.5% hyaluronan, 2.5% hyaluronan and 3% viscous lidocaine. Their results showed a 35% to 52% pain reduction (P<0.01) in 6 hours after the application of diclofenac in hyaluronan, where as hyaluronan gel alone and viscous lidocaine failed to produce pain reductions. They concluded that 3% diclofenac in 2.5% hyaluronan was an effective treatment for this common, painful disorder although they didn't evaluate the effect of this drug on the whole pain duration or healing time of the lesions.
With respect to results of our study and Saxes MA et al studies, we can conduce that 3% diclofenac in hyaluronan gel group is an effective therapy for treatment of the RAS.
References1. Crispian Scully, Meir Gorsky, Francina Lozada-Nur. Aphthous Ulceration Dermatologic Therapy. Volume 15 Issue 3 Page 185, September 2002.
2. Miller MF, Ship II. A retrospective study of the prevalence and incidence of recurrent aphthous ulcers in a professional population, 1958 1971. Oral Surg Oral Med Oral Pathol 1977: 43: 532 537.
3. Bagan JV, Sanchis JM, Milian MA, Penarrocha M, Silvestre FJ. Recurrent aphthous stomatitis. A study of the clinical characteristics of lesions in 93 cases. Oral Pathol Med 1991: 20: 395 397.
4. Crivelli MR, Aguas S, Adler I, Quarracino C, Bazergue P. Influence of socio-economic status on oral mucosa lesion prevalence in schoolchildren. Community Dent Oral Epidemiol 1988; 16: 58-60.
5. Rogers RS III. Recurrent aphthous stomatitis: clinical characteristics and associated systemic disorders. Semin Cutan Med Surg 1997: 16: 278 283.
6. Meiller TF, Kutcher MJ, Overholser CD, Niehaus C. Effect of an antimicrobial mouthrinse on recurrent aphthous ulceration. Oral Surg Oral Med Oral Pathol 1991: 72: 425-429.
7. Porter SR, Hegarty A. Kaliakostov F et al. Recurrent Aphthous Stomatitis. Clinical Dermatol 2000;18(5):569-578.
8. Ogura M, Yamamoto T, Morita M, Watanabe T. A case control study on food intake of patients with recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001; 91 (1): 45-49.
9. Storck C. Aphthae of the oral cavity: differential diagnostic considerations concerning a case report. Schweiz Med Wochenschr Suppl 2000; 125: 127.
10. Riggio MP, Lennon A, Wray D. Detection of Helicobacter pylori DNA in recurrent aphthous stomatitis tissue by PCR. J Oral Pathol Med 2000; 29 (10): 507-513.
11. Boulinguez S, Cornee-Leplat I, Bouyssou-Gauthier ML, et al. Analysis of the literature about drug-induced aphthous ulcers. Ann Dermatol Venereol 2000; 127 (2): 155-158.
12. Barnadas MA, Remacha A, Condomines J, de Moragas JM. Hematologic deficiencies in patients with recurrent oral aphthae. Med Clin (Barc) 1997; 109 (3): 85-87.
13. Saxen MA, Ambrosius WT, Rehemtula al-KF et al. Sustained relief of oral aphthous ulcer pain from topical diclofenac in hyaluronan: a randomized, double-blind clinical trial.Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Oct;84(4):356-61.
14. Barrons RW. Treatment strategies for recurrent oral aphthous ulcers. Am J Health Syst Pharm 2001; 58 (1): 41-50.
15. Popovsky JL, Camisa C. New and emerging therapies for diseases of the oral cavity. Dermatol Clin 2000; 18: 113-125.
16. Lacosta Nicolas JL, Martinez Iniguez JC. Treatment of recurrent aphthous stomatitis. A bibliographic review. Rev Clin Esp 1998; (4): 234-236.
17. Woo SB, Sonis ST. Recurrent aphthous ulcers: a review of diagnosis and treatment. J Am Dent Assoc 1996; 127 (8): 1202-1213.
18. Hunter L, Addy M. Chlorhexidine glucunate mouthwash in the management of minor aphthous ulceration. A double-blind placebo controlled cross-over trial. Br Debt J 1987; 162: 106-10.
© 2004 Egyptian Dermatology Online Journal