Treatment Strategies for Recurrent Oral Aphthous Ulcers

Am J Health Syst Pharm. 2001;58(1)

Conclusion

The primary goals of therapy for RAU are relief of pain, reduction of ulcer duration, and restoration of normal oral function. Secondary goals include reductions in the frequency and severity of recurrences and maintenance of remission. Topical medications can achieve the primary goals but have not been shown to alter recurrence or remission rates. Systemic medications can be tried if topical therapy is ineffective. Levamisole has shown variable efficacy in reducing ulcer frequency and duration in patients with minor RAU. Oral corticosteroids should be reserved for severe cases of major RAU. Because of its toxicity, thalidomide should be used only as an alternative to oral corticosteroids.

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Acknowledgments

The contributions of Camtu Ho, PharmD, are acknowledged.

References

Table 1. Summary of Double-Blind, Placebo-Controlled Trials of Topical Antibiotics, Antiseptics, and Corticosteroids for Treatment of Aphthous Ulcers ^[a]
Reference	No. Patients	Dosage Regimen	Duration of Ulcers (Days)	Frequency of New Ulcers ^[b]	No. Ulcers	Subjective Improvement (Score or % ^[c])
Antiseptics
17	20	1% chlorhexidine gel t.i.d. after meals x 35 days	Mean: T = 4.8, PC = 7.7 (p < 0.05)	NA	T = 104, PC = 140 d (NS ^[e])	Score: T = 0.93, PC =1.21 (p < 0.05)
18	40	0.1% hexetidine mouth rinse 15 mL for 1 min t.i.d. after meals x 6 wk	NA (p > 0.05 ^[f])	NA	NA (p > 0.05 ^[f])	NA (p > 0.05 ^[f])
19	41	0.2% chlorhexidine mouthwash 10 mL for 1 min t.i.d. x 6 wk	Mean: T = 5.02, PC =5.78 (p > 0.05)	NA	Mean: T = 7.54, PC = 8.32 ^[g]	NA (NS ^[f])
16	96	Listerine mouth rinse (unspecified volume) for 30 sec b.i.d. x 6 mo	NA (NS ^[f])	NA	NA (NS ^[f])	NA (NS ^[f])
Antibiotics
20	7	0.5% chlortetracycline 50 mL held in mouth 1 min q.i.d.	NA (p < 0.01 ^[h])	NA	NA	T = 58%, PC = 62% (NS ^[e])
21	49	2.5% chlortetracycline 10 mL held in mouth 1 min q.i.d.	NA (p < 0.01 ^[h])	NA	NA	NA (p < 0.01 ^[h])
22	25	5% tetracycline 1 tsp held in mouth 1 min q.i.d.	Mean: T = 5.46, PC =8.21 (p < 0.05)	T = 1.07, PC = 0.20 i (NS ^[e])	NA	Score: T = 1.11, PC =1.78 (p < 0.05)
Corticosteroids
23	57	0.025% betametha-sone benzoate gel 1 drop over lesion t.i.d. and h.s.	T < 6, PC > 6 (p < 0.05)	NA	NA	T = 88%, PC = 60% (p < 0.05)
24	15	Beclomethasone dipropionate spray 2 puffs (800 µg) directly to ulcer q.i.d.	NA (p < 0.001 ^[h])	NA	NA	NA (p < 0.05 ^[h])
a	T = active treatment, PC = placebo, NA = not available, NS = no significant changes. All p values apply to comparisons between active treatment and placebo unless otherwise indicated.
b	Mean number of new ulcers, compared with baseline.
c	Mean score on a scale from 0 to 3 (0 = no pain, 1= mild pain, 2 = moderate pain, 3 = severe pain) or percentage of patients with symptomatic relif.
d	Cumulative number of ulcers in all patients.
e	Details of statistical analysis not reported.
f	Reported as no significant difference between treatment and placebo groups in change in duration, number, or severity of ulcers.
g	Daily number of ulcers per patient. Statistical analysis not reported.
h	Reported as a significant difference between treatment and placebo groups in days with ulcers or ulcer pain.
i	Mean number of new ulcers per week, compared with baseline.

a	T = active treatment, PC = placebo, NA = not available, NS = no significant changes. All p values apply to comparisons between active treatment and placebo unless otherwise indicated.
b	Mean number of new ulcers, compared with baseline.
c	Mean score on a scale from 0 to 3 (0 = no pain, 1= mild pain, 2 = moderate pain, 3 = severe pain) or percentage of patients with symptomatic relif.
d	Cumulative number of ulcers in all patients.
e	Details of statistical analysis not reported.
f	Reported as no significant difference between treatment and placebo groups in change in duration, number, or severity of ulcers.
g	Daily number of ulcers per patient. Statistical analysis not reported.
h	Reported as a significant difference between treatment and placebo groups in days with ulcers or ulcer pain.
i	Mean number of new ulcers per week, compared with baseline.

Table 2. Summary of Double-Blind, Placebo-Controlled Trials of Levamisole and Thalidomide for Treatment of Aphthous Ulcers ^[a]
Reference	No. Patients	Dosage Regimen	Complete Response(%)^[b]	Partial Response (%)^[c]	Ulcer Duration (Days)	Subjective Improvement
Levamisole
33	71	150 mg/day x 3 days every 2 wk for 4 mo	Levamisole = 19, PC = 10 (p < 0.05)	NA^[e]	NA^[e]	Levamisole = 65, PC = 33 (p < 0.05)
	20	Above regimen x 2 mo, then 50 mg t.i.d. x 3 days every 2 wk if ulcers present	Levamisole = 10, PC = 0 (p < 0.05)	NA^[e]	NA^[e]	Levamisole > PC (p < 0.001)
35	20	150 mg/day x 3 days every 2 wk	NA	NA	Mean: levamisole = 8.43, PC = 7.40 (p > 0.05)	Levamisole = 90, PC = 30 ^[f]
37	18	50 mg t.i.d. x 3 days every 2 wk if ulcers present	Levamisole = 30, PC = 0 ^[f]	NA	Median: levamisole = 4, PC = 8 (p < 0.05)	Levamisole = 66, PC = 11 ^[f]
34	48	150 mg/day x 3 days every week at first sign of ulcers	NA	NA	Median: levamisole = 7, PC = 6 ^[f]	Levamisole = 65, PC = 28 (p < 0.05)
36	33	150 mg/day x 3 days every week at first sign of ulcers	NA	NA	Mean: levamisole = 8.0, PC = 5.9 ^[f]	Levamisole = 55, PC = 38 (p > 0.10)
38	47	150 mg/day x 2 days every week at first sign of ulcers	Levamisole = 13, PC = NA ^[e]	Levamisole = 51, PC = NA ^[e]	NA	NA ^[g]
39	33	150 mg/day x 1 or 2 days/wk	NA	NA^[e]	Median: levamisole = 0, PC = 8.5 (p < 0.05)	NA ^[e]
Thalidomide
40	57	200 mg h.s. x 4 wk	Thalidomide = 55, PC = 7 (p < 0.05)	Thalidomide = 34, PC = 18 (p < 0.05)	NA	Thalidomide > PC (p < 0.03)
41	96	100 or 300 mg q.d. x 24 wk	Thalidomide 100 mg = 6, thalidomide 300 mg = 16, PC = 0 (p < 0.05 ^[h])	NA	NA	NA
42	73	100 mg h.s. x 8 wk	Thalidomide = 48, PC = 9 (p < 0.05)	NA	NA	NA
a	PC = placebo, NA = not available, NS = not significant. All p values apply to comparisons between active treatment and placebo.
b	No ulcer episodes within one month of therapy.
c	A reduction of 50% in the number of ulcer episodes or the total ulcer surface area.
d	In the levamisole trials, the percentage of patients reporting moderately or markedly reduced pain. In the reference 40 trial (thalidomide), a score of 1 or 2 (on a scale from 1 to 15) on 14 of 15 quality-of-life measures.
e	Number or duration of ulcer episodes, size of ulcers, or pain score reported as significantly improved with levamisole compared with placebo.
f	Statistical analysis not reported.
g	Reported as no significant difference.
h	Thalidomide 100 mg versus placebo and thalidomide 300 mg versus placebo.

a	PC = placebo, NA = not available, NS = not significant. All p values apply to comparisons between active treatment and placebo.
b	No ulcer episodes within one month of therapy.
c	A reduction of 50% in the number of ulcer episodes or the total ulcer surface area.
d	In the levamisole trials, the percentage of patients reporting moderately or markedly reduced pain. In the reference 40 trial (thalidomide), a score of 1 or 2 (on a scale from 1 to 15) on 14 of 15 quality-of-life measures.
e	Number or duration of ulcer episodes, size of ulcers, or pain score reported as significantly improved with levamisole compared with placebo.
f	Statistical analysis not reported.
g	Reported as no significant difference.
h	Thalidomide 100 mg versus placebo and thalidomide 300 mg versus placebo.

Table 3. Cost of Medications Used To Treat Recurrent Aphthous Ulcers
Agent	Formulation	Dosage	Cost/Week ($) ^[a]
5% amlexanox paste (Aphthasol, Block)	5-g tube	1 dab q.i.d.b	10.50
Tetracycline Powder, USP (Medisca)	25-g powder	250 mg q.i.d.	4.76
0.012% chlorhexidine gluconate (generic)	480 mL	10 mL t.i.d.	2.68
Beclomethasone dipropionate (generic)	17-g inhaler	2 puffs q.i.d.^[b]	31.15
Levamisole hydrochloride (Ergamisol, Janssen)	50-mg tablet	50 mg t.i.d. x 3 days	55.04
Thalidomide (Thalomid, Celgene)	50-mg tablet	200 mg q h.s.	210.00
a	Based on average wholesale price.^[49]
b	Administered directly to ulcers.

a	Based on average wholesale price.^[49]
b	Administered directly to ulcers.

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