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Comparison of Aloe Vera Mouthwash With Triamcinolone Acetonide 0.1% on Oral Lichen Planus: A Randomized Arash Mansourian, DDS, MS, Fatemeh Momen-Heravi, DDS, Mahnaz Saheb-Jamee, DDS, MS, Mahsa Esfehani, DDS, MS, Omid Khalilzadeh, MD, MPH and Jalil Momen-Beitollahi, DDS, MS merous side effects. The most commonly documented adverse Introduction: Corticosteroids are the mainstay for treatment of oral effects of treatment of OLP, including corticosteroid therapy, lichen planus (OLP) and have their own side effects. The aim of this are local irritation, tingling, burning sensation, steroid-related study was to compare the therapeutic effects of aloe vera (AV) fungal infection, taste alterations and nausea.7–9 mouthwash with triamcinolone acetonide 0.1% (TA) on OLP.
Aloe vera (AV; named Aloe barbadensis in Latin), a Methods: A total of 46 patients with OLP were enrolled in this study.
plant of dry and warm weather, contains polysaccharides, The patients were randomly divided into 2 groups. Each group was anthraquinone, lectin, superoxide dismutase (an antioxidant treated with received AV mouthwash or TA. The treatment period for enzyme), glycoprotein, amino acids, vitamin C and E and both groups was 4 weeks. The basement data were recorded for each minerals.10,11 Several studies revealed anti-inflammatory, anal- patient. Patients were evaluated on days 8, 16 and after completing the gesic, liver protection, antiproliferative, anticarcinogenic and course of treatment (visit 1–3). The last follow-up was 2 months after antiaging properties of AV.12–15 It seems that these effects are the start of treatment (visit 4). Visual analogue scale was used for a result of antioxidant properties, cyclooxygenase-2 suppres- evaluating pain and burning sensation and Thongprasom index for sion and immunomodulatory mechanisms.15,16 Some data sug- clinical improvement and healing. In addition, lesion sizes were mea- gest that AV can suppress tumor growth and improve the sured and recorded at each visit using a grid. Results: Baseline survival of patients. It can also be used in the treatment of characteristics, including pain and burning sensation score, size and asthma, ischemic heart disease, diabetes and skin diseases.16–19 clinical characteristics of the lesions according to Thongprasom index, According to the good therapeutic effects of AV on were not different between the 2 treatment groups. Both AV and TA many different diseases and its antioxidant and anticancer significantly reduced visual analogue scale score, Thongprasom score effects, in this study, we decided to evaluate the therapeutic and size of the lesions after treatment (P Ͻ 0.001) and after 2 months effects of AV mouthwash in comparison with triamcinolone of discontinuation of the treatment (P Ͻ 0.001). In the AV group, acetonide 0.1% (TA) on OLP lesions. Because AV does not 74% of patients and in the TA group 78% of patients showed some possess the immunosuppressive and other side effects of com- degrees of healing in the last follow-up. Conclusions: AV mouthwash mon treatments for OLP, and according to the newly explained is an effective substitute for TA in the treatment of OLP.
etiology considering oxidative stress in OLP pathogenesis,3,18 Key Indexing Terms: Aloe vera; Oral lichen planus; Triamcinolone
replacement of AV in the treatment of OLP lesions can be a acetonide. [Am J Med Sci 2011;342(6):447–451.]
significant advance in the management of this chronic prema-lignant disease of oral cavity.
Lichen planus is a chronic immune-mediated mucocutaneous disease, which can affect the oral mucosa in 50% of cases.
The exact etiology is still unknown, but it is reported that MATERIALS AND METHODS
immune system disturbances may play a significant role in its Patients
pathogenesis.1,2 In addition, the role of free radicals by pro-ducing oxidative stress has been discussed in the etiology of This study was a randomized double-blinded clinical disease.3,4 The common remedies for the disease include sys- trial. Patients with OLP were randomly selected from the temic corticosteroids, immunosuppressives, retinoids, photo- department of Oral Medicine, Tehran University of Medical therapy and topical steroids. Corticosteroids are considered as Sciences. Both clinical and histopathologic criteria were used the first-line treatment of oral lichen planus (OLP).2,5 This kind for the diagnosis based on World Health Organization diagnos- of treatment is symptomatic and will not completely cure the disease. Therefore, shortly after discontinuation of the therapy, Patients with erosive or atrophic OLP confirmed by there is recurrence of lesions, and the patient should use clinical and histopathologic criteria were included in this study.
medicines for a long time.6 In addition, drugs such as cyclo- Patients with any systemic diseases, including: heart disease, sporine and tacrolimus are immunosuppressive and have nu- renal disease, hypertension, neurologic disorders, etc., wereexcluded. Patients using any medication for treatment of OLPor any immunosuppressive medication during the 4 weeks From the Oral Medicine Department (AM, MS-J, JM-B), School of Dental preceding the study were excluded. Patients with lichenoid Medicine, Tehran University of Medical Sciences; Craniomaxillofacial lesions, those whose lesions were in direct contact with amal- Research Center (FM-H), Shariati Hospital, Tehran University of Med- gam restorations, those who had allergy to other dental mate- ical Sciences; Dental Research Center (ME), School of Dentistry, TehranUniversity of Medical Sciences; and School of Medicine (OK), Tehran rials and those who had dysplastic lesions were also excluded.
University of Medical Sciences, Tehran, Iran. Between September 2009 and June 2010, a total of 57 Submitted January 6, 2011; accepted in revised form February 23, 2011. randomly selected subjects were evaluated for inclusion to the Correspondence: Fatemeh Momen-Heravi, DDS, Craniomaxillofacial study. On the basis of the criteria, 46 subjects were enrolled in Research Center, Shariati Hospital, Tehran University of Medical Sciences,Enghelab Avenue, Tehran, Iran (E-mail: f_m_heravi@yahoo.com). this study. This study was approved by the ethics committee of The American Journal of the Medical Sciences • Volume 342, Number 6, December 2011 Tehran University of Medical Sciences. The whole process wasexplained for patients to decide whether they are willing to take TABLE 1. Baseline characteristics of the study participants part in the study, and informed consent was obtained. All steps Triamcinolone
of the study were planned and conformed to the principles Aloe vera
acetonide
outlined in the Declaration of Helsinki21 and ethical codes 0.1% (n ؍ 23)
provided by ethics committee of Tehran University of Medical Study Design and Intervention
After determining eligibility and obtaining consent, to guarantee blinding, a random number was generated for each participant using the SPSS software (version 16.0; SPSS, Chi- cago, IL), and patients were referred to the pharmacist to pick up their assigned medication according to their number. The patients were randomly divided to an AV mouthwash group(n ϭ 23) and a TA group (n ϭ 23). Both medications had identical sealed package. The patients in the AV group were asked to rinse the mouth with 2 tablespoons of AV mouthwash (Barij Essence Company, Tehran, Iran) for 2 minutes, 4 times The patients in the TA group were instructed to apply a thin layer of triamcinolone acetonide 0.1% paste (Adcortyl, Bristol-Myers Squibb, Anagni, Italy) on the oral lesions, 4 times daily. The patients were asked not to eat, drink or smoke for 20 minutes after each application and continue treatment for1 month. The patients were asked to report immediately if there Variables are expressed as mean Ϯ standard error of mean, unless was any side effect at any time of the study until 6 months after treatment. Patients were also assessed for any possible side effects by researchers at each appointment. All of the patientswere truly monitored and were compliant to the drugs.
History of any systemic diseases, demographic informa- tion and clinical data related to lesions were recorded for each using paired sample t test for comparison of variables with patient in a separate questionnaire.
normal distribution or nonparametric Wilcoxon’s rank test for The basement data were recorded for each patient. The variables deviated from normal distribution. The baseline char- treatment period for both groups was 4 weeks. Patients were acteristics and the changes occurred in the characteristics of the evaluated on days 8, 16 and after completing the course of 2 groups after treatment were compared using ␹2 analysis for treatment (visit 1–3). The last follow-up was 2 months after the categorical variables, Student’s sample t test for normally start of treatment (visit 4). All the measurements and evalua- distributed continuous variables and Mann-Whitney U test tions were performed by 1 clinician who was blind to the type for continuous variables, which were deviated from normal distribution. A P value Ͻ0.05 was considered statisticallysignificant.
Measurements
Size of the lesions were measured and recorded for each patient using a grid. Intensity of pain was also recorded for each patient using visual analogue scale. For this purpose, a 10-cm Baseline characteristics of the study participants are ruler was used, and each patient correlated his/her degree of presented in Table 1. The patients were between 33 and 75 pain to a number on this scale. Zero score was considered for years old. There were no significant differences between groups a patient without any pain, whereas a score of 10 was given to with respect to age, sex, duration of lesions and type or site of the highest level of perceived pain. Clinical characteristics of OLP. The most prevalent site for OLP lesions was buccal the lesions were scored using Thongprasom criteria. According mucosa followed by tongue and gingival area. All patients in to Thongprasom et al,22 clinical presentation of OLP can be both groups had involvement of buccal area. Baseline pain and scored from 0 to 5 according to the following findings: 0, no burning sensation score was not different between the 2 treat- lesion; 1, mild white lesions without erythematous areas; 2, ment groups. Furthermore, there was no significant difference white striae with atrophic lesions Ͻ1 cm; 3, white striae with between the 2 groups in baseline size and clinical characteris- atrophic lesions Ͼ1 cm; 4, white lesions with ulcerative areas tics of the lesions according to Thongprasom score (Table 1).
Ͻ1 cm; and 5, white lesions with ulcerative areas Ͼ1 cm.
Both AV and TA 0.1% significantly reduced pain and burning sensation score, Thongprasom score and size of the Statistical Analysis
lesions after treatment (P Ͻ 0.001) and after 2 months of Data were analyzed using SPSS software (version 16.0; discontinuation of the treatment (P Ͻ 0.001; Figure 1). In the SPSS). The required sample size for this study using ␣ ϭ 0.05 AV group, 74% of patients and in the TA group 78% of patients and power ϭ 0.80 was calculated to be 23 patients in each showed some degrees of healing in the last follow-up step.
group. The null hypothesis was assumed that the level of Characteristics of the study participants during treatment and healing of OLP would be similar between the AV and TA follow-up visits are presented in Table 2. The changes occurred groups. Quantitative variables are expressed as mean Ϯ stan- in size of lesions and Thongprasom score, and pain and burning dard error of mean. To evaluate the efficacy of each individual sensation score were not statistically different between the 2 treatment on OLP, before-and-after analysis was performed Volume 342, Number 6, December 2011 Aloe Vera Versus Triamcinolone Acetonide in Oral Lichen Planus FIGURE 1. Treatment with both aloe vera and triamcinolone acetonide 0.1% significantly (P Ͻ 0.001) reduced pain and burningsensation score (A) and Thongprasom score (B) after the treatment period (third visit) and after 2 months of discontinuation of thetreatment (fourth visit). Handles represent standard error of mean.
DISCUSSION
that AV can be an effective treatment of OLP lesions. Both AV The main aim of the current therapies for OLP is to and TA significantly reduced pain and burning sensation score reduce pain and eliminate the lesions. Although it is accepted and the size of lesions after treatment and after 2 months of that there is no definitive cure for OLP, the basic treatment in discontinuation of the treatment. In addition, both AV and TA mild to moderate cases is corticosteroid therapy. Treatment is treatment groups showed the same degree of healing after primarily aimed at reducing the severity and duration of le- sions.2–6 Because there is no definite cure for the disease, the Recent researches have shown that an increase in intra- therapy that has its efficacy at the least side effects is most cellular adhesion molecules and secreting cytokines, such as favorable. The results of this study, for the first time, showed interleukin (IL)-10, tumor necrosis factor alpha, IL2 and IL4,by activated lymphocytes and keratinocytes can contribute tothe pathogenesis of OLP.3,23 In addition, an imbalance between TABLE 2. Characteristics of the study participant during the level of free radicals and reactive oxygen species probably has a significant influence on initiation and progression of oralinflammatory lesions. It has been shown that oxidative stress is Triamcinolone
far greater in patients with OLP than in healthy subjects.3,24–26 Aloe vera
acetonide
AV exhibits some anti-inflammatory effects by inhibiting cy- 0.1% (n ؍ 23)
clooxygenase and reducing leukocyte adhesion molecules and tumor necrosis factor alpha level.27 Stimulatory effects of AV can increase antibody production and accelerate wound healing by increasing growth factors. Furthermore, it has antioxidant properties and eliminates production of free radicals.11–13,28 Therefore, our results, which show the good efficacy of AV in the treatment of OLP, are of considerable pathophysiologic The efficacy of TA in the treatment of OLP is reported in previous studies.29 In a study conducted by Thongprasom et al,30 the effect of 0.1% solution of fluocinolone acetonide was evaluated on OLP lesions. Approximately 73% of patients using this topical treatment showed complete improvement after treatment. In another study by Thongprasom et al,31 the effect of topical cyclosporine was compared with TA 0.1% in OLP lesions. The study was conducted on 13 patients, and the results showed that 50% of patients treated with TA had complete improvement and 50% showed partial healing. In patients receiving cyclosporine, 33.5% showed partial im- provement and 66.75% did not show any response to the treatment. Gonza´lez-García et al32 evaluated the effects of TA The changes occurred in each of the characteristics from baseline to 0.3% and 0.5% on OLP erosive lesions. Of the total of 35 either the 1st, 2nd, 3rd, or 4th visits were not significantly different patients enrolled in their study and similarly in both groups, between aloe vera or triamcinolone acetonide 0.1% groups.
80% had complete improvement at the end of sixth month, 2011 Lippincott Williams & Wilkins whereas 17% showed partial improvement. In our study, tacrolimus and pimecrolimus in the treatment of oral lichen planus: an 78% of patients treated with TA showed clinical improve- update. J Oral Pathol Med 2009;280:201–5.
ment, which is more or less similar to the results reported in 10. Pakfetrat A, Mansourian A, Momen-Heravi F, et al. Comparison of
colchicine versus prednisolone in recurrent aphthous stomatitis: a dou- In a study conducted by Salazar-Sa´nchez et al, AV ble-blind randomized clinical trial. Clin Invest Med 2010;33:E189 –95.
solution consisting of 70% aloe juice was used. Of 32 cases in 11. Xing JM, Li FF. Purification of aloe polysaccharides by using aqueous
the AV group, complete pain remission was achieved in 31.2% two-phase extraction with desalination. Nat Prod Res 2009;23: of the cases after 6 weeks and in 61% after 12 weeks. In the placebo group, these percentages were 17.2% and 41.6%, 12. Rajasekaran S, Sivagnanam K, Subramanian S. Mineral contents of
respectively. The results of their study revealed that the topical aloe vera leaf gel and their role on streptozotocin-induced diabetic rats.
application of AV, 3 times a day, improves the pain, the oral Biol Trace Elem Res 2005;8:185–95.
lesions and the oral quality of life of the patients with OLP.33 13. Gupta R, Flora SJ. Protective value of Aloe vera against some toxic
In our study, AV solution consisting of 94.5% of AV juice was effects of arsenic in rats. Phytother Res 2005;19:23– 8.
used proposed by Su et al.34 The better efficacy achieved in ourstudy compared with that in the above-mentioned study may be 14. Baechler BJ, Nita F, Jones L, et al. A novel liquid multi-phytonutrient
due to the difference in concentration.
supplement demonstrates DNA-protective effects. Plant Foods Hum Nowadays, orotransmucosal drug delivery methods are at the forefront of treatment of oral diseases. In addition, some 15. Portugal-Cohen M, Soroka Y, et al. Protective effects of a cream
regions in the oral cavity, including buccal, sublingual, palatal containing Dead Sea minerals against UVB-induced stress in human and gingival sites, could effectively absorb drugs. It seems skin. Exp Dermatol 2009;18:781– 8.
reasonable to assume that gel form of a same medication should 16. Langmead L, Makins RJ, Rampton DS. Anti-inflammatory effects of
confer better efficacy in comparison with mouthwash because aloe vera gel in human colorectal mucosa in vitro. Aliment Pharmacol of more time of exposure. However, it depends strongly on its bioadhesive properties, bioavailability, solubility and external 17. Im SA, Lee YR, Lee YH, et al. In vivo evidence of the immunomodu-
factors such as mechanical stress and washing effect of saliva.35 latory activity of orally administered Aloe vera gel. Arch Pharm Res Further studies are needed to compare the efficacy of different orotransmucosal drug delivery methods concerning AV.
18. Kim K, Kim H, Kwon J, et al. Hypoglycemic and hypolipidemic
In conclusion, our study demonstrated that AV has effects of processed Aloe vera gel in a mouse model of non-insulin- similar therapeutic effects with TA in the treatment of OLP dependent diabetes mellitus. Phytomedicine 2009;16:856 – 63.
lesions. AV has both antioxidant and anti-inflammatory effects, 19. Clement YN, Williams AF, Aranda D. Medicinal herb use among
which may significantly contribute to its clinical effects. Con- asthmatic patients attending a specialty care facility in Trinidad. BMC sidering the chronicity of the disease, and the need for the long-term treatment modalities, AV can be proposed as a good 20. World Health Organization. Definition of leukoplakia and related
treatment for OLP. Our results provide practical hints for better lesions: an aid to studies on oral precancer. Oral Surg 1978;46:518 –39.
management of OLP, particularly in patients who prefer to useherbal medicine instead of synthetic drugs. Further studies in 21. World Medical Association. Declaration of Helsinki: ethical princi-
other populations and with more duration of follow-up are ples for medical research involving human subjects. JAMA 2000;284:3043–5.
22. Thongprasom K, Luangjarmekorn L, Sererat T, et al. Relative
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2011 Lippincott Williams & Wilkins

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