JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES

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1 JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES Sinha Abhishek, Srivastava Sunita, Mishra Anuj, Agarwal Nitin & Sinha M Pooja. Aloevera vs topical steroid in treatment of erosive lichen planus. Journal of pharmaceutical and biomedical sciences (J Pharm Biomed Sci.) 2013 September; 34(34): The online version of this article, along with updated information and services, is located on the World Wide Web at: Journal of Pharmaceutical and Biomedical Sciences (J Pharm Biomed Sci.), Member journal. Committee of Publication ethics (COPE) and Journal donation project (JDP).

2 Original article Aloevera vs topical steroid in treatment of erosive lichen planus Sinha Abhishek 1 *,Srivastava Sunita 2, Mishra Anuj 3, Agarwal Nitin 4 & Pooja M. Sinha 5 Affiliation:- 1 Reader, 2 Senior Lecturer, 3 Post graduate student, 4 Professor & Head, Department of Oral Medicine and Radiology, 5 Senior lecturer, Department of public health dentistry, Sardar Patel Post Graduate Institute of Dental & Medical Sciences, Raebareily Road, Lucknow, Uttar Pradesh, India. Author s contributions:- All the authors contributed equally to this paper. *Correspondence to:- Dr.Abhishek Sinha, MDS, Reader, Dept of Oral Medicine and Radiology, Sardar Patel Post Graduate Institute of Dental & Medical Sciences, Raebareily Road, Lucknow, Uttar Pradesh, India Work attributed by: Department of Oral Medicine and Radiology, Sardar Patel Post Graduate Institute of Dental & Medical Sciences, Raebareily Road, Lucknow, Uttar Pradesh, India. Abstract: Background: Oral Lichen planus is a chronic inflammatory disorder that can be painful especially in erosive forms that commonly affects skin and oral mucosa. In this area different treatments have been used in symptomatic oral lichen planus (OLP), with variable results. Aim: To compare the efficacy of aloevera and topical steroids in symptomatic treatment of Erosions and burning sensation in Erosive Lichen Planus. Methods: A total of 10 patients with Oral Lichen Planus were randomly selected for the study and divided into two groups (A and B). The group A received aloe vera gel and group B topical steroids. The patients were under regular follow up every 2 weeks for 3 months. Clinical evaluation and pain reduction was evaluated by VAS method in group A and B. Data were evaluated statistically by using Wilcoxon signed rank test. Results: In group A, 4 patients had complete remission and 1 patient showed good response to treatment where as in group B, 2 patients had complete remission, 2 patient showed good response and 1 patient showed no response to treatment (p<0.001), it was determined that Aloevera was stastistically significant (p<0.05) as compared to Topical Steroid at the end of treatment. Conclusion: The topical application of Aloe vera improves the total quality of life score in patients with oral lichen planus. However, according to result of this study, the use of aloevera gel instead of steroid in treating erosive lichen planus is better and more appropriate choice. Key words: Aloevera gel; Burning sensation; Oral lichen planus; Triamcinolone acetonide. Article citation:- Aloevera vs topical steroid in treatment of erosive lichen planus. Journal of pharmaceutical and biomedical sciences (J Pharm Biomed Sci.) 2013 September; 34(34): Available at INTRODUCTION Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disorder characterized by outbreaks or flares 1. The prevalence rate may differ among races and geographic areas 2. Although the etiology is unknown, the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused by cytotoxic CD8 + lymphocytes 3. OLP are clinically classified as reticular, atrophic, popular, erosive, and bullous 4-6. Reticular, papular, and plaque lesions seldom present with any symptoms. They are usually asymptomatic and found upon routine oral examination. However, atrophic, erosive, and bullous lesions cause complaints of pain or burning sensations 7. Current treatment modalities for oral lichen planus are 1657

3 aimed at alleviating the pain and burning sensation and eliminating the lesions. A wide range of therapeutic agents, including topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus, photochemotherapy and surgery, have been used for treatment of oral lichen planus 8,3. No treatment modalities provide complete resolution of the lesion; therefore, the management strategy focuses on the use of drugs that counter tissue inflammation and their underlying immunologic mechanisms 9. Many plants are used in medicine for treating various diseases, and aloevera is one among them. It is a complex plant containing biologically active substances with properties that enhance the immune system to combat many oral diseases 10. Aloe vera is a cactus like plant that belongs to the liliaceae family. It contains 75 potentially active constituents, including vitamins, enzymes, minerals, sugars, lignins, saponins, salicylic acids, and amino acids 11,10. Several topical and systemic treatments are available for oral lichen planus patients, but therapeutic responses may differ 12, 13. Previous studies have proven that aloe vera is effective in the treatment of oral lichen planus. Therefore, the present study is designed to evaluate the efficacy of topical aloe vera gel in the treatment of oral lichen planus compared with triamcinolone acetamide. METHOD AND MATERIALS The present study was designed with the main objective of determining the effectiveness of aloevera gel in the treatment of oral lichen planus when compared with triamcinolone acetamide. Methodology The study sample comprised 10 patients, which were randomly divided into two groups of 5 patients each. subjects received aloe vera gel and subjects received triamcinolone acetamide 0.01%. The participant s demographic data were obtained and entered in a predesigned proforma. patients were asked to take 30ml for 5 days and 50 ml for next 10 days of aloevera juice, empty stomach twice daily. Similarly group B patients were asked to apply topical steroids i.e. Triamcinalone acetamide 0.1% thrice daily, for 15 days. If any allergic manifestations were seen after first applying the prescribed medicament, patients were asked to stop medication and immediately report to the hospital. Patients were recalled for periodic review and treatment response in both groups was recorded at a 15 days interval for 3 consecutive weeks. Clinically, the location of the lesions was recorded: 0, no lesion; 1, mild white striae; 2, white striae with no erosive area; 3, white striae with erosive area less than 1cm 2 ; 4, white striae with an erosive area more than 1cm 2 ; and 5, white striae with an erosive area more than 1cm 2 or an ulcerative lesion (Table 1). Any burning sensation was scored by VAS (Figure 2). Patients were asked to score their intensity of burning sensation at each visit. Scores ranged from 0 (no pain) to 10 (extreme pain). Table 1. Clinical score to measure size of the lesion according to Hegarty 2002; Campisi 2004; Conrotto 2006; Choonhakarn 2008; Carbone 2009 Score Size of lesion 0 No lesion 1 Mild white striae 2 White striae with no erosive area 3 White striae with erosive area less than 1cm 2 4 White striae with erosive area more than 1cm 2 5 White striae with an erosive area more than 1cm 2 or an ulcerative lesion Treatment response was graded as complete when the scores were either 0 or 1, good when scores decreased by more than 50% from baseline, poor when scores decreased by less than 50% from baseline, and as no response when the lesions were unchanged. RESULTS The data were analysed using SPSS 14 (IBM). The Wilcoxon matched pairs test by ranks was used for group comparison. Statistical significance was set at P<0.05. The total patients included 10 patients among whom comparison of clinical scores in both the groups, an insignificant differences was observed with respect to clinical scores at 5% level of significance. This means that clinical scores of both the groups were similar at the initial visit. A significant difference was observed between both the groups with clinical scores at 1 st, 2 nd, 3 rd follow up at a 5% of significance. This means that the clinical scores among both the groups were different and the clinical scores were less in group A as compared to group B. In this we can see that group A had much more positive impact on clinical signs as compared to group B. So, according to both statistical analysis we can see that group A is much more effective in improvement of erosions i.e. clinical signs (Figure 1). 1658

4 Mean±SD Mean±SD ISSN NO A significant difference observed in different follow up except between the 1 st and 2 nd follow up with respect to burning sensation in both the groups (Table 2). This shows that as time interval increases, the VAS score of burning sensation decreases with respect to the initial visit. The statistical analysis we can see that the mean & standard deviation value was higher for burning sensation before treatment but after that values got decreased indicating that patient got relief & burning sensation was reduced. During third follow up it was seen that, the mean value signify that group A was significant as compared to group B (Figure 2). A statistically significant difference was observed (P<0.05). Aloe vera Topical Aloe vera Topical Before treatment First follow up Second follow up Third follow up Figure 1. The statistical significance impact of treatment on erosions was evaluated using Wilcoxon signed rank test 0-2 Before treatment First follow up Second follow up Third follow up Figure 2. Bar chart showing means VAS scores and statistical significance difference in the mean ranks obtained for the paired comparisons of burning sensation Table 2. Comparison of and with respect to burning sensation scored by VAS score at different time intervals Group Mean ± SD Z value P value Initial visit 2 wk 4 wk 6 wk 9.20 ± ± * ± ± ± ± * ± * ± *p<0.05 (Significant as compared to before treatment values) Wilcoxon signed rank test At the end of treatment the clinical signs and burning score in total patients were observed in both the groups. In group A, 4 patients presented with score 0 (complete remission of symptomatology) and 1 patient showed scores 1 (relief by 50% from baseline). In group B, 2 patients presented with score 0 (complete remission of symptomatology), 2 patient showed scores 1 (relief by 50% from baseline) and 1 patient with score 3 (no relief) at the end of treatment. Neither group experienced adverse effects during application of the product at any of the evaluated timepoints, but the reoccurrence of the symptoms were seen in some of the group B patients. 1659

5 Figure 3. Photographs of patients (Aloe vera treated) Pre Operative Photographs Post Operative Photographs Figure 4. Photographs of patients (Topical steroid treated) Pre Operative Photographs Post Operative Photographs 1660

6 DISCUSSION Lichen planus is a chronic inflammatory disease that can be painful especially in erosive forms that commonly affects skin and oral mucosa. 10 patients (both males and females) were included in the study. Most of the patient presented with erosive variants of oral lichen planus. The most common site for oral lichen planus was buccal mucosa extending to retro molar area. In the present study, aloevera gel was more effective in improving clinical score as compared with triamcinolone acetonide. The finding was similar to that of Hayes 13, who reported a case of successful treatment of lichen planus with aloe vera. Choonhakarn et al. 14 reported that aloevera was effective in the treatment of oral lichen planus compared with triamcinolone acetonide and Salazar- Sanchez et al. 3 concluded that topical application of aloevera improves quality in patients with oral lichen planus. This is because aloevera can inhibit the inflammatory process by its interfering action on the archidonic acid pathway via cyclo-oxygenase. Recent data suggest that aloevera also has anti-inflammatory effects by the reduction of leukocyte adhesion and TNF-alpha level 3,14. Burning sensation scores compared at different time intervals, an insignificant (P>0.05) was observed between both the groups. Both the medicaments have potent anti-inflammatory actions. The burning sensation of the lesions was compared in both groups with respect to burning sensation score at the initial lesion and on the 1 st, 2 nd and 3 rd week follow up. A statistically significant difference was observed (P< 0.05) in both groups until the 3 rd follow up but the statistically significant difference continued in the group A until the end of therapy. This shows that as time interval increased, burning sensation score decreased continuously in patients who received group A treatment. At the end of 3 rd follow up improvement is seen in the clinical sign and burning sensation. This might be due to faster healing of lesion due to presence of active growth factor like substance in aloe vera, which enhances fibroblastic activity resulting in tissue repair 15. CONCLUSION Aloevera was seen to be efficacious as a safe, cheap and reliable drug in management of Erosive Lichen Planus. It also offers a noninvasive option that yield significant improvements in symptoms as well as objective signs of condition. To clear the effect of aloevera gel in cases of OLP further researches need to be carried out with larger sample size and increased follow up period to understand the role of aloevera in reducing the reoccurrence of OLP. REFERENCES 1.Amerikanou CP, Markopoulos AK, Belazi M, Karamitsos D,Papanayotou P. Prevalence of oral lichen in diabetes mellitus according to the type of diabetes. Oral Dis 1998;4: Vas dis ML, Parks ET. Prevalence of oral lichen planus in patients with diabetes mellitus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1995;79: Salazar-Sánchez N, López-Jornet P, Camacho- Alonso F, Sanchez-Siles M. Efficacy of topical aloe vera in patients with oral lichen planus: A randomized double-blind study. J Oral Pathol Med 2010;39: Burket S. Oral Medicine, ed 11. Hamilton: BC Decker, McCarthy PL, Shklar G. Diseases of the Oral Mucosa, ed 2. Philadelphia: Febiger Philadelphia, 1980: Huber MA. Oral lichen planus. Quintessence Int 2004; 35: Dusek JJ, Frick WG. Lichen planus: Oral manifestations and suggested treatments. J Oral Maxillofac Surg 1982;40: Reddy Lavanya Reddy, Tatapudi Ramesh, Lingam Amara Swapna: Randomized trial of aloe vera vs triamcinolone acetonide ointment in the treatment of oral lichen planus. Quintessence international 2012;43:9:

7 9.Lodi G, Scully C, Carrozzo M, Griffiths M, Sugerman PB, Thongprasom K. Current controversies in oral lichen planus: Report of an international consensus meeting. Part 2.Clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2005;100: Baby Joseph, S.Justin Raj. Pharmacognostic And Phytochemical Properties Of Aloe Vera Linn An Overview: 2010;4;2: Niveditha Baiju, Srilakshmi. Aloe Vera - A Soothing Therapy in Modern Dentistry. Trivandrum dental journal 2010;1: Sampath Kumar KP, Bhowmik D, Chiranjib L, Biswajit M. Aloe vera: A potential herb and its medicinal importance. J Chem Pharm Res 2010;2: Hayes SM. Lichen planus Report of successful treatment with aloe vera. Gen Dent 1999;47: Choonhakarn C, Busaracome P, Sripanidkulchai B, Sarakarn P. The efficacy of aloe vera gel in the treatment of oral lichen planus: A randomized controlled trial. Br J Dermatol 2008;158: Davis RH, Joseph JD, Donato D, Hartman GM, Haas RC. Inflammatory and Wound Healing Action of Aloe Vera. Hightstown: Mettler Instrument, 1994: Conflict of interest: - Authors has not declared any conflict of interest. Source of funding: - None Copyright 2013 Sinha Abhishek,Srivastava Sunita, Mishra Anuj, Agarwal Nitin. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 1662