ABSTRACT
Objectives:
Compare 5% amlexanox, 0.1% triamcinolone acetonide, and 0.03% tacrolimus in the management of oral lichen planus (OLP).
Materials and Methods:
A received 0.03% tacrolimus, group B received 0.1% triamcinolone acetonide and group C received topical 5% amlexanox. All patients were evaluated for pain on visual analog scale (VAS) and erosive area on day 1, 7, and 15.
Results:
There was decrease in visual analogue score (VAS) for pain in all tested group after 15 days. There was significant decrease in erosive area in left and right buccal mucosa in all groups after 15 days for inter and intra group comparison.
Conclusion:
All the drugs used were effective in management of patients with OLP and thus it can be advised to consider these agents as alternatives.
KEYWORDS: Erosive, oral lichen planus, visual analog scale
INTRODUCTION
Oral lichen planus (OLP) is a mucocutaneus potentially malignant disorder affecting 4th and 5th decades of life.[1] The prevalence is high in females as compared to males. Though the etiology of OLP is unknown, it is considered to be cell-mediated immune response to basal keratinocyte. Various common forms of OLP are reticular, atrophic, plaque, papular, bullous, ulcerative, erosive, etc.[2]
The symptoms of OLP vary from person to person that ranges from stomatitis, ulceration, vesiculation, burning sensation to spicy, as well as hot food beverages. The common site of occurrence of LP is thigh, flexor surfaces of arm, forearms, and buttocks. In mouth, any part of the oral cavity gets involved.[3] The favorable site is buccal mucosa, lips, tongue, soft palate, and gingiva. Bilateral appearance is hallmark of disease. Whitish keratotic radiating striations known as Wickham straie are commonly seen and diagnostic factors especially in reticular form.[4]
Corticosteroids in both local and systemic formulation are mainstay of treatment. Triamcinolone acetonide 0.01% in topical form found to cure disease. The choice of treatment is based on disease stage and symptoms in patients.[5] Amlexanox is an anti-allergic, anti-inflammatory drug usually recommended in 0.5% oral paste form. The main mechanism of action is on decreasing histamine liberation from mast cells, neutrophils, and basophils. Topical immunosuppressive tacrolimus can be used in OLP patients not responding to corticosteroids.[6] In this research work, we compared topical 5% amlexanox, 0.1% triamcinolone acetonide, and 0.03% tacrolimus in the management of oral lichen planus (OLP).
MATERIALS AND METHODS
The study was done on 100 patients, in department of oral medicine after attaining institutional ethics committee approval and informed consent from all the participants and after considering the inclusion and exclusion criteria.
A case history recording followed by thorough oral examination was carried in all patients. Randomization of patients was done in 3 groups and each group comprised of forty (40) patients. Group A received 0.03% tacrolimus, group B received 0.1% triamcinolone acetonide, and group C received topical 5% amlexanox. All patients were advised to apply drugs in their respective groups for 1 month. All patients were clinical evaluated for size of erosive area and pain on visual analog scale (VAS). Erosive area (cm2) was measured as maximum diameter (cm) × maximum width (cm). Both pain and erosive area was recorded on day 1, 7, and 15. The results were compiled and subjected for statistical analysis using Mann–Whitney U test. P value less than 0.05 were set significant.
RESULTS
VAS in group A was 7.5, in group B was 8.1 and in group C was 7.3 on day 1, 5.2, 6.4 and 4.2 on day 7 and 0.6, 0.5 and 0.2 on day 15 in group A, B, and C, respectively. The difference was significant (P < 0.05) [Table 1].
Table 1.
Comparison of VAS in all groups
| Day | Group A | Group B | Group C | P |
|---|---|---|---|---|
| 1 | 7.5 | 8.1 | 7.3 | 0.05 |
| 7 | 5.2 | 6.4 | 4.2 | 0.03 |
| 15 | 0.6 | 0.5 | 0.2 | 0.04 |
| P | 0.02 | 0.02 | 0.01 |
There was decrease in visual analogue score (VAS) for pain in all tested group after 15 days [Table 1]. There was significant decrease in erosive area in left and right buccal mucosa in all groups after 15 days for inter and intra group comparison [Tables 2 and 3].
Table 2.
Comparison of erosive area in right buccal mucosa in all groups
| Day | Group A | Group B | Group C | P |
|---|---|---|---|---|
| 1 | 1.42 | 1.45 | 1.32 | 0.91 |
| 7 | 0.32 | 0.51 | 0.69 | 0.05 |
| 15 | 0.011 | 0.002 | 0.021 | 0.01 |
| P | 0.01 | 0.01 | 0.02 |
Table 3.
Comparison of erosive area in left buccal mucosa in all groups
| Day | Group A | Group B | Group C | P |
|---|---|---|---|---|
| 1 | 1.46 | 1.43 | 1.32 | 0.84 |
| 7 | 0.34 | 0.43 | 0.47 | 0.05 |
| 15 | 0.024 | 0.018 | 0.007 | 0.01 |
| P | 0.09 | 0.02 | 0.04 |
DISCUSSION
Oral lichen planus is commonly encountered in females with stress as a risk factor. Burning sensation is quite common in erosive and atrophic form.[7] The most common type of OLP is reticular one. Most of the patients are put on topical and systemic steroids even if their side effects are more. Both relapse and remission occur.[8] A wide range of steroids have found to have significant results. Amlexanox is an anti-inflammatory drug that can be used in topicalform.[9] It prevents the de-gradation of mast cells, and therefore, prevent the liberation of histamine, TNF-α, and leukotrienes that can increase the permeability of vessels, and hence, lead to swelling of the involved tissues and resulting in inflammation by affecting the functions of other leukocytes in the involved area.[10] In this research work, we compared topical 5% amlexanox, 0.1% triamcinolone acetonide, and 0.03% tacrolimus in the management of Oral lichen planus (OLP).
Seth et al. in their study of comparison of amlexanox, tacrolimus and triamcinolone acetonide observed that all groups had significant reductions in VAS scores and erosive areas after 15 days of treatment.[11] Fu et al. compared topical amlexanox and topical dexamethasone and observed that both drugs showed a significant reduction in erosive area and VAS scores in their patients after 7 days of treatment.[12]
A study by Laeijendecker et al. assessing efficacy of topical tacrolimus 0.1% ointment observed that patients responded well to this drug with better therapeutic response.[5] Hettiarachchi et al. compared efficacy of clobetasol and tacrolimus in treatment of 86 cases diagnosed with OLP. Authors revealed that tacrolimus 0.1% may be used as an alternative to tacrolimus and show promising results.[13]
The shortcoming of this study is that we recruited limited number of patients and only 3 drugs were selected for comparison.
CONCLUSION
All the drugs used were effective in management of patients with OLP and thus it can be advised to consider these agents as alternatives.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
REFERENCES
- 1.El Shennawy M. Efficacy of topical use of amlexanox and fluocinolone acetonide gels in the treatment of oral lichen planus. Egypt Dent J. 2001;47:367–74. [Google Scholar]
- 2.Khandwala A, Van Inwegen RG, Charney MR, Alfano MC. 5% Amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers:II. Pharmacokinetics and demonstration of clinical safety. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997;83:231–8. doi: 10.1016/s1079-2104(97)90010-x. [DOI] [PubMed] [Google Scholar]
- 3.Bhat S, Sujatha D. A clinical evaluation of 5% amlexanox oral paste in the treatment of minor recurrent aphthous ulcers and comparison with the placebo paste:A randomized, vehicle controlled, parallel, single center clinical trial. Indian J Dent Res. 2013;24:593–8. doi: 10.4103/0970-9290.123382. [DOI] [PubMed] [Google Scholar]
- 4.Katti G, Darshan DD. Amlexanox in the treatment of recurrent minor aphthous ulcers. Int J Dent Clin. 2011;3:23–6. [Google Scholar]
- 5.Laeijendecker R, Tank B, Dekker SK, Neumann HAM. A comparison of treatment of oral lichen planus with topical tacrolimus and triamcinolone acetonide ointment. Acta Derm Venereol. 2006;86:227–9. doi: 10.2340/00015555-0070. [DOI] [PubMed] [Google Scholar]
- 6.Qazi JA. Treatment of oral lichen planus with topical tacrolimus and triamcinolone acetonide ointment-A comparative study. Pak Oral Dental J. 2010;30:19–21. [Google Scholar]
- 7.Rozycki TW, Rogers RS, 3rd, Pittelkow MR, McEvoy MT, el-Azhary RA, Bruce AJ, et al. Topical tacrolimus in the treatment of symptomatic oral lichen planus:A series of 13 patients. J Am Acad Dermatol. 2002;46:27–34. doi: 10.1067/mjd.2002.119648. [DOI] [PubMed] [Google Scholar]
- 8.Kiyani A, Sohail K, Saeed MHB. Efficacy of 0.1% tacrolimus in longterm management of erosive lichen planus. J Dermatolog Treat. 2019;8:1–5. doi: 10.1080/09546634.2019.1654072. [DOI] [PubMed] [Google Scholar]
- 9.Kiyani A, Sohail K, Saeed MHB. Efficacy of 0.1% tacrolimus in long-term management of erosive lichen planus. J Dermatolog Treat. 2021;32:367–71. doi: 10.1080/09546634.2019.1654072. [DOI] [PubMed] [Google Scholar]
- 10.Tsushima F, Sakurai J, Uesugi A, Oikawa Y, Ohsako T, Mochizuki Y, et al. Malignant transformation of oral lichen planus:A retrospective study of 565 Japanese patients. BMC Oral Health. 2021;21:298. doi: 10.1186/s12903-021-01652-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Seth V, Patil RG, Moger G, Singh U, Sharma A, Saxena S. Comparative evaluation of the efficacy of topical amlexanox 5%, triamcinolone acetonide 0.1%, and tacrolimus 0.03% in the treatment of oral erosive lichen planus –A double-blinded randomized clinical trial. J Indian Acad Oral Med Radiol. 2022;34:136–40. [Google Scholar]
- 12.Fu J, Zhu X, Dan H, Zhou Y, Liu C, Wang F, et al. Amlexanox is as effective as dexamethasone in the topical treatment of erosive oral lichen planus:A short-term pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012;113:638–43. doi: 10.1016/j.oooo.2011.10.013. [DOI] [PubMed] [Google Scholar]
- 13.Hettiarachchi PVKS, Hettiarachchi RM, Jayasinghe RD, Sitheeque M. Comparison of topical tacrolimus and clobetasol in the management of symptomatic oral lichen planus:A double-blinded, randomized clinical trial in Sri Lanka. J Investig Clin Dent. 2017;8:1–5. doi: 10.1111/jicd.12237. [DOI] [PubMed] [Google Scholar]