|Year : 2018 | Volume
| Issue : 4 | Page : 376-379
Evaluation of the role of a mouth rinse containing turmeric, triphala, and honey in the treatment of oral submucous fibrosis: An open label clinical study
Ritesh Aich1, Soumi Ghanta1, Anirban Das1, Debanti Giri1, Madhumita Majumdar1, Simantini Bhattacharjee2
1 Department of Oral Medicine, Radiology and Diagnosis, Dr. R. Ahmed Dental College and Hospital, Kolkata, West Bengal, India
2 Department of Periodontics and Oral Implantology, A.M.E'S Dental College and Hospital, Raichur, Karnataka, India
|Date of Submission||19-May-2018|
|Date of Acceptance||20-Jul-2018|
|Date of Web Publication||15-Jan-2019|
Dr. Debanti Giri
Department of Oral Medicine, Radiology and Diagnosis, Dr. R. Ahmed Dental College and Hospital, Kolkata, West Bengal
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Oral submucous fibrosis (OSMF) is a chronic disease affecting any part of oral mucosa. A proper cure of this disease is of utmost requirement. Our aim of this study is to explore the effectiveness of a novel herbal mouth rinse containing curcumin, triphala and honey in the treatment of OSMF. Methods: Subjects were included in this study from the outpatient department of Dr. R Ahmed Dental College and Hospital. Clinical assessments of the oral condition were done at subsequent follow up visits (at entry, end of 30 days and end of 60 days). Results: Out of 12 females and 28 males included in the study, all showed significant reduction in regards to difficulty in mouth opening, blanched mucosa, pain at rest and lesion size. Results were analyzed using ANOVA Friedman test followed by Dunn's multiple comparisons test to observe the statistical significance. Conclusion: Efficacy and safety of mouth rinse containing curcumin, triphala and honey in relieving symptoms associated with OSMF was established in this study.
Keywords: Curcumin, honey, oral submucous fibrosis, triphala
|How to cite this article:|
Aich R, Ghanta S, Das A, Giri D, Majumdar M, Bhattacharjee S. Evaluation of the role of a mouth rinse containing turmeric, triphala, and honey in the treatment of oral submucous fibrosis: An open label clinical study. J Indian Acad Oral Med Radiol 2018;30:376-9
|How to cite this URL:|
Aich R, Ghanta S, Das A, Giri D, Majumdar M, Bhattacharjee S. Evaluation of the role of a mouth rinse containing turmeric, triphala, and honey in the treatment of oral submucous fibrosis: An open label clinical study. J Indian Acad Oral Med Radiol [serial online] 2018 [cited 2019 Feb 19];30:376-9. Available from: http://www.jiaomr.in/text.asp?2018/30/4/376/250259
| Introduction|| |
Oral submucous fibrosis (OSMF) is defined as an “insidious, chronic disease affecting the mucosa of any part of oral cavity and occasionally extending into the pharynx and oesophagus. Although sometimes preceded by and/or associated with vesicle formation, there is always a juxta-epithelial inflammatory reaction followed by a fibro-elastic change of the lamina propria with epithelial atrophy leading to stiffness of oral mucosa and causing trismus and inability to eat” (Pindborg and Sirsat, 1966).
This (OSMF) condition, first described in the 1950s in the modern literature still remains elusive of a cure. For many years OSMF had been confined to countries like India, Pakistan, Bangladesh, etc., but now it is being reported from Western countries as well. In spite of intensive research over the years into the etiologic factors of OSMF, a single etiologic factor cannot be pointed out with certainty rather several causative factors have been proposed. Since the time it was first described in the modern literature in 1952 by Schwartz there have been numerous articles regarding the various aspects of OSMF till date.
This epidemic in part is due to the sudden spurt in the number of industries involved in the convenient and inexpensive packaging and vigorous advertising of products like gutkha and pan masala which was commercially started in 1980 in India.,, It is estimated that roughly 1 million people die due to tobacco-related diseases in India annually with a little difference to the gutkha industry which is flourishing with approximately 375 brands and a turnover of about 25 billion USD.,,,
Onset of OSMF is insidious over a 2- to 5-year period. The salient features include burning sensation while consuming spicy food, dryness of the mouth, blanched, and slightly opaque oral mucosa with palpable fibrous bands.
Histopathologically, OSMF is characterized by juxta-epithelial fibrosis, along with atrophy or hyperplasia of the overlying epithelium, accumulation of hyalinized collagen beneath the basement membrane with a progressive loss of vascularity, and chronic inflammatory cell infiltration in the lamina propria.
OSMF classifications are done based on clinical, functional, histopathological, and physiological diagnosis.
Katharia et al. have given different scores assigned to the patients on the basis of mouth opening between upper and lower central incisors as follows; scores from 0–10 with a difference of 3 mm in each grade, where score 0 is for mouth opening of 41 mm or more and score 10 is for mouth opening equal to 0–4 mm.
Ranganathan and Mishra also divided OSMF based on mouth opening as follows:
Group I: Only symptoms, with no demonstrable restriction of mouth opening; Group II: Limited mouth opening of 20 mm and above; Group III for <20 mm; and Group IV isOSMF advanced with limited mouth opening, precancerous, or cancerous changes seen throughout the mucosa.
Although the pathogenesis of the disease is not well established, the cause of OSMF is believed to be multifactorial with number of triggering factors (e.g., areca nut chewing, ingestion of chillies, nutritional deficiencies, and so on) supporting the disease progression by causing juxta-epithelial inflammatory reaction in the oral mucosa. Areca nut chewing may lead to increased connective tissue growth factor (CTGF) synthesis accompanied by an increased local transforming growth factor beta (TGF-β) concentration due to inflammation.
Recent statistical data reveals that OSMF has a high rate of morbidity because it causes a progressive inability to open the mouth, resulting in difficulty to eat and consequent nutritional deficiencies. OSMF also has a significant mortality rate because of which it can transform into oral cancer, particularly to squamous cell carcinoma at a rate of 7.6%.
Considering the above severity and prognosis of the condition, a novel herbal agent that can facilitate reversing of the underlying pathophysiology and relieve the clinical symptoms of the condition is of high need. This mouth rinse is one such novel agent consisting of turmeric, triphala, and honey is believed to pacify the clinical symptoms of the condition. It is a clinical study to evaluate the safety and efficacy of this mouth rinse in OSMF.
| Methods|| |
Aims of the study
This is an open label clinical study to evaluate the efficacy and safety of a novel mouth rinse containing turmeric (curcuma longa- 10.5 mm), triphala (400 mg), and honey (10 gm) in the treatment of OSMF.
Subject selection criteria
Subjects suffering from chronic OSMF characterized by difficulty in opening mouth, blanched mucosa, and pain at rest in the oral cavity were included in the study from the outpatient department of Dr. R. Ahmed Dental College and Hospital. Adult subjects of either sex aged between 18 to 50 years, who have not participated in a similar investigation in past 4 weeks and willing to give a written informed consent and follow the schedule were included.
Subjects with severe systemic disorders pertaining to cardiac, respiratory, central nervous system, renal or hepatic disorders, known history or present condition of allergic response to similar pharmaceutical products, its components or ingredients in the test products, pre-existing systemic disease necessitating long-term medications, and subjects with genetic and endocrinal disorders were excluded from the study. Those who have participated in a similar clinical investigation in the past 4 weeks or have used a similar product in the past 4 weeks, subjects who refused to sign the informed consent, pregnant, and lactating women were also excluded from the study.
All the subjects were instructed regarding the study procedure, study investigations, monthly follow-up visits (at entry, end of 30 days, and end of 60 days), and information regarding the contact person during an emergency. Subjects were advised to use 10 ml of the mouth rinse for 1 min 4 times daily for a period of 60 days.
At follow-up visit, subjects were asked about the frequency of usage of the mouth rinse and overall compliance to the product. Clinical assessment of oral condition were done objectively for lesion size and mouth opening measurement and also subjectively for symptom analysis [Figure 1] and [Figure 2].
Subjects were also questioned for any untoward effects of the product such as erythema, edema, pain, and burning sensation. These untoward effects were rated on a scale expressed as 0 (none), mild – 1, moderate – 2, and severe – 3.
Results were analyzed statistically for comparison within the groups using the analysis of variance (ANOVA) Friedman test followed by Dunn's multiple comparisons test to find out the statistical significance. Analysis was performed using the GraphPad Prism software Version 6.07, San Diego, California, USA.
| Results|| |
[Table 1] summarizes the demographic data. There were 12 females and 28 males among enrolled subjects. The mean age of the subjects was 39.7 ± 10.1 years. The mean weight of subjects was 63.75 ± 8.25 kg. There were 11 smokers, 14 subjects who take alcohol, 15 tobacco chewers, and 14 areca nut chewers out of 40 subjects. There were no drop outs in this clinical study.
|Table 1: Demographic and other baseline characteristics on entry into the study|
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Effect of this mouth rinse on the clinical symptoms of OSMF was assessed by within group analysis [Table 2]. A significant reduction in symptoms of OSMF was noted in subjects after treatment.
|Table 2: Effect of Oro-T mouth rinse on the clinical parameters of oral submucous fibrosis|
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The mean score of the clinical symptom, difficulty in opening the mouth at entry was 6.23 ± 1.76, which reduced to 4.95 ± 1.66 at day 30 with a significance of P < 0.0001, which further significantly reduced to 3.90 ± 1.60 at the end of day 60 with the significance of P < 0.0001.
The mean score of the clinical feature blanched mucosa at entry was 5.33 ± 1.61, which reduced to 4.25 ± 1.42 at day 30 with a significance of P < 0.0016, which further significantly reduced to 3.50 ± 1.22 at the end of day 60 with a significance of P < 0.0001 as compared to values at entry.
The mean score of the symptom, pain at rest [on Visual Analogue Scale (VAS) scale] in the oral cavity at entry was 4.85 ± 2.07, which reduced to 3.50 ± 2.05 at day 30 with a significance of P < 0.0002, which further significantly reduced to 2.42 ± 1.79 at the end of day 60 with a significance of P < 0.0001. There was statistically significant reduction in the symptom pain at rest in the oral cavity.
OSMF lesion size at entry was 5.48 ± 1.56 cm, which reduced to 4.09 ± 1.31 cm at day 30 with a significance of P < 0.0003, which further reduced to 3.07 ± 1.52 cm at the end of day 60 with a significance of P < 0.0001.
Mouth opening at entry was 25.22 ± 7.17 mm, which improved to 27.38 ± 6.84 mm at day 30 with a significance of P < 0.0001, which further improved to 28.58 ± 6.95 mm at the end of day 60 with a significance of P < 0.0001. There was significant reduction in mouth opening and the result was statistically significant.
It is also noteworthy that none of the subjects necessitated surgical intervention for relief of symptoms. All the subjects showed good overall compliance for this mouth rinse and there were no adverse effects either reported or observed by the investigator. After use of this mouth rinse mouth opening of all subjects were significantly increased. Clinically and statistically significant improvements in all clinical parameters were observed. No placebo was used in this study.
| Discussion|| |
Treatment modalities both medical and surgical, for relieving the symptoms have been advocated, but have not been successful so far. Therefore, the search for an effective treatment modality still continues. Many natural plants extracts, herbal extracts, synthetic drugs etc have been introduced and tried for the treatment of OSMF which promotes wound healing, and also has anti-inflammatory, immunomodulatory, and antioxidant properties.
Curcumin, a chief component of Curcuma longa wasresponsible for the majority of turmeric's therapeutic effects. Turmeric has also been widely used for its antioxidant, analgesic, and anti-inflammatory properties. Curcumin's potent antioxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. In addition to the inhibitory effects on the production of nitric oxide (NO) and the ability to scavenge DNA damaging superoxide radicals, curcumin also suppresses the expression of extracellular matrix genes in activated hepatic stellate cells by inhibiting CTGF gene expression by suppressing ERK and NF-kB signalling. On the other hand, triphala which is a polyherbal ayurvedic preparation contains Terminalia chebula, Terminalia belerica, and Embilica officinalis used in cancer as anti-cancer, chemoprotective, and radioprotective agent. Anti-inflammatory effect of triphala shows significant inhibition in levels of lysosomal enzymes, lipid peroxidation (LPO), and inflammatory mediator tumor necrosis factor-alpha (TNF-α). Triphala produces excellent analgesic and antipyretic effect without any gastric damage. The effect of honey on infection is not only related to antibacterial agents but also to its effect on the immune system by stimulating antibodies in primary and secondary immune response. It also stimulates the production of inflammatory cytokines. Thus, the positive outcome observed in the study subjects might be due to the synergistic mechanism of action of all the ingredients of this mouth rinse.
Currently, in India studies using natural products such as curcumin, aloe vera, and stem cells are ongoing and the results of these are eagerly awaited. Clinical evidence of Oxitard, a polyherbal formulation, suggests for its safety and efficacy in OSMF as an oral nutritional and immune support.,,,
| Conclusion|| |
The present study indicates good clinical efficacy of this mouth rinse to help relieve the symptoms associated with OSMF. There were no clinically significant short- and long-term adverse events, either reported or observed, during the entire study period. Hence, it may be concluded that the mouth rinse containing turmeric, triphala, and honey is safe and effective in relieving the symptoms associated with OSMF.
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.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]