|Year : 2022 | Volume
| Issue : 3 | Page : 276-280
Comparison of effects of honey and 0.1% triamcinolone acetonide in the management of recurrent aphthous stomatitis - A randomised, single-blind study
Amit A Mhapuskar, Shweta Thakare, Isha P Kale, Pradnya Karmarkar, Darshan R Prasad Hiremutt, Abhijeet Jadhav
Department of Oral Medicine and Radiology, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune, Maharashtra, India
|Date of Submission||24-May-2022|
|Date of Decision||30-Aug-2022|
|Date of Acceptance||04-Sep-2022|
|Date of Web Publication||26-Sep-2022|
Isha P Kale
‘Govind’ 1621, Sadashiv Peth, Gopal Gayan Samaj Road, Pune - 30, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease known to humans and are characterized by the development of painful, recurring solitary or multiple ulcers confined to the oral mucosa. RAS is often painful and worsens during drinking and talking. Aim: To evaluate and compare the effects of honey and 0.1% triamcinolone acetonide in patients with ulcers of recurrent aphthous stomatitis minor. Materials and Methods: Sixty patients having RAS minor were divided into two groups of 30 participants each by simple random sampling. Group A was treated with application of 0.5 ml of honey thrice a day for a week or until complete healing of the ulcer. Group B was treated with application of 5 g of 0.1% triamcinolone acetonide oral paste thrice a day for a week or until complete healing of the ulcer. For all the individuals, baseline parameters like the size of the ulcer, pain, and burning sensation were recorded on day 0, reassessment was done on day 4 and day 7, followed by statistical analysis. Results: The study showed that the reduction in the size of ulcers, VAS score for pain, and VAS score for burning sensation were similar in patients receiving honey as compared to patients receiving 0.1% triamcinolone acetonide. No adverse effects were reported in patients receiving honey, and there were mildly adverse reactions in some patients receiving 0.1% triamcinolone acetonide oral paste. Conclusion: Honey, a natural anti-inflammatory agent, seems to hold immense potential as an alternative medication for managing RAS minor ulcers. It has better patient compliance as compared to 0.1% triamcinolone acetonide.
Keywords: Alternative medicine, honey, recurrent aphthous stomatitis, triamcinolone acetonide, ulcer
|How to cite this article:|
Mhapuskar AA, Thakare S, Kale IP, Karmarkar P, Hiremutt DR, Jadhav A. Comparison of effects of honey and 0.1% triamcinolone acetonide in the management of recurrent aphthous stomatitis - A randomised, single-blind study. J Indian Acad Oral Med Radiol 2022;34:276-80
|How to cite this URL:|
Mhapuskar AA, Thakare S, Kale IP, Karmarkar P, Hiremutt DR, Jadhav A. Comparison of effects of honey and 0.1% triamcinolone acetonide in the management of recurrent aphthous stomatitis - A randomised, single-blind study. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 Dec 10];34:276-80. Available from: http://www.jiaomr.in/text.asp?2022/34/3/276/356952
| Introduction|| |
Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease known to humans. It is characterized by the development of painful, recurring solitary or multiple ulcers confined to the oral mucosa. RAS are classified into four types: recurrent aphthous minor, major, recurrent herpetiform ulcerations, and recurrent ulcers associated with Bechet's syndrome. RAS causes pain, which is constantly excruciating and worsens on eating, drinking, and talking.
Symptomatic treatment modalities such as antibiotics (tetracycline and minocycline) and corticosteroids (triamcinolone 0.1%) have been proposed for aphthous ulcers, but recurrence is commonly seen after stoppage of the treatment.
Honey is a micronutrient with anti-bacterial, anti-oxidant, anti-inflammatory, and wound-healing properties. These properties of honey suggest its use in the symptomatic management of RAS. Therefore, this study was conducted to assess the potential of honey in the resolution of RAS minor.
To evaluate and compare the effects of natural honey and triamcinolone acetonide in patients with ulcers of RAS minor.
- To evaluate the healing of RAS minor ulcers following the application of honey.
- To evaluate healing following application of 0.1% triamcinolone acetonide.
- To compare the effect of both honey and 0.1% triamcinolone acetonide.
- To compare the acceptance of both honey and 0.1% triamcinolone acetonide.
| Methodology|| |
This randomized, single-blind study was carried out in the department of oral medicine and radiology of Bharati Vidyapeeth Dental College in Pune, Maharashtra, from January 2015 to June 2016, following the approval of the institutional ethics and research committee (ECR/328/Inst/MH/2013) with the Helsinki Declaration of 1975 that was revised in 2000.
The study consisted of 60 patients (the power of the sample size was 80%) who were clinically diagnosed with RAS minor as per the diagnostic criteria given by Natah et al. and who were willing to participate in the study. They were further divided into group A (30 patients receiving honey) and group B (30 patients receiving 0.1% triamcinolone acetonide) by simple random sampling carried out by the chit system.
- Patients diagnosed with RAS minor with a single oral ulcer measuring ≤5 mm in size.
- Patients in age group of 16–50 years.
- Patients who gave written consent for participation in the study.
- Patients with any history of systemic illness and/or any other medications.
- Patients with any oral ulcers other than RAS minor.
- Patients who have received any treatment for similar ulcers in the past six months.
- Patients with a history of tobacco use in any form.
Sixty patients included in our study were assigned to the study group (group A) and control group (group B) based on a chit system.
Concealment of allocation and single blinding
The principal investigator carried out the initial evaluation of all participants having RAS minor and who fulfilled the inclusion and exclusion criteria. Following the initial assessment, the co-investigator divided the patients into groups A or B based on the chit system. Group A patients were given honey, and group B patients were given 0.1% triamcinolone acetonide oral paste. All the patients were instructed not to disclose the medications given to them or reveal the taste of the medication in the follow-up appointments to the principal investigator. The principal investigator was blinded for the assessment. The principal investigator carried out the periodic assessment of the size, pain, and burning sensation of the ulcers.
After obtaining the informed consent, data was recorded in the predesigned case proforma. The assessment criteria were pain, burning sensation, and lesion size. The side effects, if any, due to either was also noted. All the above-mentioned parameters were assessed on days 0, 4, and 7 by the primary investigator.
- Size of ulcer (in mm): The size of the ulcer was measured using William's graduated probe [Figure 1].
- Pain: The intensity of pain was determined using the visual analogue scale (VAS).
- Burning Sensation: Burning sensation was recorded using the VAS as follows.
0–3: Mild burning sensation,
4–7: Moderate burning sensation,
8–10: Severe burning sensation.
Interventions of both groups
Group A consisted of 30 patients with RAS minor who received Forever Bee HoneyTM (Forever Living Products, India, containing only organic honey) thrice a day for a week or until complete healing of the ulcer. A quantified amount of 12 ml of honey was measured with a measuring scoop. The patients were instructed to apply 0.5 ml of honey thrice a day for a week (1.5 ml per day and 10.5 ml for 7 days) or until complete healing of the ulcer [Figure 2]a. Honey was applied over the ulcer with a cotton swab, and the patient was advised to avoid solid and liquid diet for 15 minutes after the application of honey. Patients were instructed to rinse their mouth with water after 15 minutes. In cases where the ulcers healed before a period of 7 days, the patients were requested not to apply honey.
Group B consisted of 30 patients with RAS minor who received a 5-mg tube of 0.1% triamcinolone acetonide (Kenacort oral paste, manufactured by Abbott Healthcare Pvt. Ltd.) three times a day for seven days [Figure 2]b. The patients were instructed to apply 0.1% triamcinolone acetonide oral paste on the aphthous ulcer with a cotton swab. They were advised to avoid a solid and liquid diet for 15 minutes after application of Kenacort oral paste. Patients were instructed to rinse their mouth with water after 15 minutes. In cases where the ulcers healed before a period of 7 days, the patients were requested not to apply Kenacort.
All the patients were asked to report to the department in case of any side effects.
Data analysis and statistics
The entire data was collected and entered into Microsoft Excel. Statistical analysis was done using the Statistical Package for the Social Sciences (SPSS version 16, Inc. Chicago, USA) for Microsoft Windows. The results were obtained using the Chi-squared test and t-test. P < 0.05 was considered statistically significant.
| Results|| |
[Table 1] shows that the percentage decrease in size of the ulcer was 59% from 2.83 to 1.13 mm between visit 1 and visit 2 and 100% (complete resolution) in size of ulcer seen till visit 3 for patients receiving honey [Figure 3]a, [Figure 3]b, [Figure 3]c.
|Table 1: Comparison between size of ulcers between two study groups (n=60)|
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|Figure 3: (a) Group A first visit (day 0); size of the ulcer is 4 mm. (b) Group A second visit (day 4); size of the ulcer is 2 mm. (c) Group A third visit (day 7); complete resolution of ulcer|
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The percentage of decrease in size of the ulcer was 60.83% from 3.01 to 1.16 mm between visit 1 and visit 2 and 100% (complete resolution) in size of the ulcer by visit 3 for patients receiving 0.1% triamcinolone acetonide [Figure 4]a, [Figure 4]b, [Figure 4]c. The P value for the size of the ulcer was statistically non-significant.
|Figure 4: (a) Group B first visit (day 0); size of ulcer is 4 mm. (b) Group B second visit (day 4) size of ulcer is 2 mm. (c) Group B third visit (day 7) complete resolution of ulcer|
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[Table 2] shows that the percentage decrease in VAS score for pain was 47.78%, from 2.20 to 1.16 between visit 1 and visit 2 and there was a 100% reduction in VAS score for pain by visit 3 for patients receiving honey.
|Table 2: Comparison between VAS score for pain between two study groups (n=60)|
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The percentage reduction in VAS score for pain was 48.89%, from 2.23 to 1.16 between visit 1 and visit 2. There was a 100% reduction in VAS score for pain by visit 3 for patients receiving 0.1% triamcinolone acetonide.
The P value for the VAS score for pain was not statistically significant.
[Table 3] shows that the percentage decrease in VAS score for burning sensation was 55%, from 1.50 to 0.66 between visit 1 and visit 2 for patients receiving honey. In comparison, the same was 30% from 1.86 to 1.16 between visit 1 and visit 2 for patients receiving 0.1% triamcinolone acetonide, and this was statistically moderately significant.
|Table 3: Comparison between VAS score for burning sensation between two study groups (n=60)|
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[Table 4] shows that three patients (10%) in group B experienced adverse effects in the form of itching and erythema, which persisted even after healing of the ulcers. No adverse effects were seen in group A patients using honey.
|Table 4: The distribution incidence of adverse effects between two study groups (n=60)|
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| Discussion|| |
Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease known to human beings, which is characterized by the development of painful, recurring solitary or multiple ulcers confined to the oral mucosa.
In our study, reduction in the size of the ulcer, pain, and burning sensation were similar in honey and 0.1% triamcinolone acetonide groups, and the difference was not statistically significant.
In similar studies by Mohamed et al., Gichki et al., and El-Haddad et al., honey was found to be more effective in reducing the pain and size of ulcers than triamcinolone acetonide, and the difference was statistically significant due to the smaller sample size in their study.
Honey is a micronutrient with anti-bacterial, anti-oxidant, anti-inflammatory, and wound healing properties. Honey aids in the healing of infected wounds by decreasing bleeding and vascular permeability. The anti-bacterial mechanism of honey is because of the production of hydrogen peroxide, which is related to its low pH level and high sugar content (high osmolality), which in turn hinders the growth of microbes.
Honey is a natural adhesive that adheres for a longer time to the oral mucosa.
Our study used triamcinolone acetonide (0.1%) with an orabase that has good oral mucosal adherence. Probably because of this reason, our study showed no statistically significant difference between the two groups in reducing pain and burning sensation.
Giroh, et al. conducted a study comparing aloe vera gel with 0.1% triamcinolone acetonide and found that the reduction of VAS scores for burning sensation was more in the aloe vera group compared to the triamcinolone group. This was due to the gel form of aloe vera being used, which could also adhere well to the oral mucosa.
Deshmukh et al. compared the efficacy of curcumin gel with triamcinolone acetonide in gel form in the treatment of RAS minor. They found a decrease in the pain score, size, number, and duration of ulcers in both the groups but the results were statistically non-significant. Both the medicines in their gel form were found to have equal efficacy due to their adherence to the oral mucosa.
Our study showed no side effects in the honey group, which was in accordance with the studies by Halim et al. and Gupta et al. who found that the anti-inflammatory and anti-oxidant properties of honey made it a suitable natural remedy for the healing of RAS ulcers without any side effects.
In our study, side effects like erythema and irritation were found in the 0.1% triamcinolone group compared to the honey group. Honey accelerates the healing process, which is related to its main constituent, fructose. Fructose is very hygroscopic; hence honey does not show allergic reactions and side effects.
| Conclusion|| |
With changing trends in research, we are moving ahead to use naturally occurring remedies like honey, aloe vera, and curcumin for the treatment of oral mucosal lesions.
Topical corticosteroids are frequently used for symptomatic management of RAS minor. Honey is a natural remedy that can be used as an adjuvant treatment option for RAS minor.
The study did not focus on the rate of recurrence in either group, and the sample size was relatively small.
Future studies are required with a larger sample size, longer follow-up evaluating the recurrence, and honey used in different drug delivery systems.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Naturally occurring remedies can also be used in the treatment of oral ulcers. Honey is a micro nutrient having anti-bacterial, anti-oxidant, anti-inflammatory, and wound healing properties. These properties suggest its use as a natural remedy in the symptomatic management of RAS.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]