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 Table of Contents  
SYSTEMATIC REVIEW
Year : 2022  |  Volume : 34  |  Issue : 2  |  Page : 223-227

Topical herbal therapeutic formulation used in the management of oral potentially malignant disorders – A systematic review


Department of Oral Medicine and Radiology, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University, Chennai, Tamil Nadu, India

Date of Submission19-Apr-2021
Date of Decision18-Dec-2021
Date of Acceptance27-Mar-2022
Date of Web Publication22-Jun-2022

Correspondence Address:
T N Uma Maheswari
Department of Oral Medicine, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Saveetha University, 162, PH Road, Chennai, Tamil Nadu - 600 077
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jiaomr.jiaomr_101_21

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   Abstract 


Background: Oral potentially malignant disorders (OPMDs) are divided into two groups precancerous lesions, a benign lesion with morphologically altered tissue, which has a greater than normal risk of transforming into malignancy, and precancerous conditions, a disease or patient's habit that does not necessarily alter the appearance of local tissues but is associated with a greater or normal risk of precancerous lesion or cancer development in that tissue. Aim: This systematic review aims to evaluate the effectiveness of topical herbal therapeutics in the management of potentially malignant oral disorders. Objective: Primary objective was to evaluate the efficiency of tulsi, aloe vera, and turmeric in the management of OPMDs, and the secondary objective was to determine the herbal therapeutic response in patients with oral leukoplakia oral sub, mucous fibrosis, and lichen planus. Data Sources and Search Methods: The search was done using the MeSH [medical subject headings] terms and keyword search in the electronic databases, namely Pub Med and Google Scholar. The studies included in this systematic review were identified by a comprehensive search from the electronic search engines like Pub Med Advanced search (from April up to January 2021) and Google scholar. The search yielded 39 articles out of which 11 articles were only included based on the inclusion criteria. Data Collection and Analysis: All the studies included were based on the data extraction and analysis of the studies for quality. The outcome measure evaluated the reduction in burning sensation, mouth opening, and clinical resolution of the lesion. Results: A total of 39 articles were included in this systematic review from electronic searches using Pub Med advanced search and Google scholar. Conclusion: For management of oral submucous fibrosis topical aloe vera gel showed 90% of complete clinical response, oral lichen planus topical tulsi and turmeric gel showed 90% complete clinical response, and only two studies were conducted on oral leukoplakia which had a high risk of bias; hence, this systematic review does not yield to a piece of conclusive evidence for the management of oral leukoplakia using topical herbal therapeutics.

Keywords: Burning sensation, mouth opening, oral potentially malignant disorders, oral precancerous lesion, topical herbal medications


How to cite this article:
Dhanvanth M, Maheswari T N. Topical herbal therapeutic formulation used in the management of oral potentially malignant disorders – A systematic review. J Indian Acad Oral Med Radiol 2022;34:223-7

How to cite this URL:
Dhanvanth M, Maheswari T N. Topical herbal therapeutic formulation used in the management of oral potentially malignant disorders – A systematic review. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 Dec 7];34:223-7. Available from: http://www.jiaomr.in/text.asp?2022/34/2/223/347907




   Introduction Top


Oral potentially malignant disorders (OPMDs) are a group of disorders of varying etiologies, usually tobacco, which leads to clinical and histological alterations of the oral epithelium and has a potential risk of malignant transformation.[1],[2],[3] OPMDs are divided into two groups precancerous lesions, a benign lesion with morphologically altered tissue, which has a greater than normal risk of transforming into malignancy, and precancerous conditions, a disease or patient's habit that does not necessarily alter the appearance of local tissues but is associated with a greater or normal risk of precancerous lesion or cancer development in that tissue.[4],[5],[6] The most common OPMDs are oral leukoplakia, oral submucous fibrosis, and oral lichen planus. The global prevalence of oral leukoplakia is around 2.06% and the transformation rate of oral leukoplakia per year is 1.36%.[7],[8] The risk of malignant transformation in oral leukoplakia is around 15.6–39.2%, in oral submucous fibrosis (7–26%), and in oral lichen planus (0.4–3.7%). Early detection and prevention of OPMD will decrease the incidence of oral cancer and increases the survival rate of oral cancer patients. The treatment modalities for OPMD management are observation, systemic and topical medications, herbal medications, surgical excision, laser surgery, cryosurgery, photodynamic therapy, and many more.[9],[10],[11] Herbal therapeutics is a substance having medicinal or healing properties alternatively it is any substance used for the prevention, diagnosis, and treatment of a disease or to modify a physiological process.[12],[13]


   Materials and Methods Search Methodology Top


The studies included in this systematic review were identified by a comprehensive search from the following search engines using the keywords up to January 2021. Prospero registration ID: 274797.

  • Pub Med Advanced search using MeSH terms (up to January 2021)
  • Google scholar.


Selection of studies

Study type

Clinical trials.

Eligibility criteria

Inclusion criteria

  • Studies that used topical herbal therapeutics mainly tulsi, Aloe vera, and turmeric/curcumin for the treatment of OPMDs especially leukoplakia, OSMF and Lichen planus.
  • Hand search articles with herbal formulation on OPMD included.
  • Only clinical trials are included.


Exclusion criteria

  • Studies were done in oral cancer and other mucosal lesions are excluded.
  • Studies are done other than tulsi, turmeric/curcumin, and aloe vera excluded.
  • Studies done with systemic drugs were excluded.
  • Systematic review/Meta-analysis studies excluded.


Data extraction

Data extraction for characteristics of the included studies and the variables of outcome are tabulated [Table 1].
Table 1: Data extraction and characteristics of the included studies

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   Results Top


A total of 39 articles were included in this systematic review from electronic searches using Pub Med advanced search and Google scholar. A literature search revealed a systematic review on chemoprevention for oral cancer whereas systematic reviews on topical herbal therapeutics in OPMDs were not identified. A total of 557 OPMDs patients were reported in all 11 clinical trials and their distribution. The combination of aloe vera and turmeric works better in OPMDs due to a high rate of improvement in outcomes such as burning sensation, mouth opening, and reduction in the size of the lesion. In the mouth opening, it showed improvement before and after treatment.


   Discussion Top


Oral mucosa is easily accessible, and it offers flexibility for drug application. Topical medications may provide lower costs and higher convenience for patients.[14] Topical therapeutics is an alternative to systemic therapy as it reduces or eliminates systemic toxicities and avoids first-pass metabolism.

The most common studies done were from India (five studies); southeast Asia has the highest prevalence of OPMDs; oral submucous fibrosis is highly prevalent in India; there are only two studies on topical management of OSMF. The most common treatment approach reported was topical gels applied with gauze. The use of gauze increases the residence time of the drug. Turmeric and aloe vera combination topical gel is more effective than tulsi, aloe vera, and turmeric for the management of OPMDs. This concept has been recently reviewed by Vishwambhar et al. as a strategy to formulate turmeric and aloe vera as topical therapeutic agents in OPMD.[15] Quality assessment was done with the Cochrane risk of bias tool using Revmann review manager, A “Risk of bias” table is available in RevMan for inclusion in a Cochrane review [Figure 1] and [Graph 1]. A total of 10 dropped out from 557 patients. The main reason was because of the adverse effects. The reported adverse effects of topical herbal therapy included burning sensation, pain, and an increase in the size of the lesion. Some patients reported mild headaches and bad taste. These adverse effects underline the need for further study where adverse effects should not occur or occur at a lower rate in topical therapies than systemic therapies. The study's limitations are the follow-up of OPMDs which is important to check the prognosis of the treatment, risk of malignant transformation, recurrence rate, and long-term effectiveness of topical medications in the treatment of OPMDs. This systematic review highlights that the follow-up time was only three months. It should be a five years follow-up, and the long-term effects have not yet been established. The interincisal distance before the treatment was 23.99 ± 1.44. After the treatment, it was 30.83 ± 2.011 P-value (0.000945). In burning sensation using VAS showed 8.06 ± 0.45 before treatment and 5.66 ± 0.77 after treatment with a P value (0.0003). The lesion's reduction in size is based on the thongprasom sign score shown five before treatment, which is white striae with the erosive area is 1 cm. After the treatment, the score was 0, which is mild strain only. Hence, comparing all the outcomes, the combination of Aloe vera and turmeric has a better outcome for the management of OPMDs.
Figure 1: Risk of bias summary

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   Conclusion Top


This systematic review of 11 studies and a large sample of 557 cases have shown that in the treatment of oral leukoplakia, oral submucous fibrosis, and lichen planus the most common herbal formulated drug used was Aloe vera. A proper study design evaluation based on the outcome measures like burning sensation, mouth opening, cheek flexibility, and tongue protrusion with a follow-up of 3 months and minimal side effects are done with lycopene gel study; hence this medication can be used in the treatment of OPMDs. The most commonly used and the most effective topical herbal drug in treating OPMDs with no adverse effects reported is aloe vera and turmeric. The high risk of bias was conducted. Four studies were oral submucous fibrosis and two studies were lichen planus; hence, this systematic review does not have any conclusive evidence for the management of OPMDs. The combination of aloe vera and turmeric can be an adjuvant treatment for the management of OPMDs.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Anuradha A, Patil B, Asha VR. Evaluation of efficacy of Aloe vera in the treatment of oral submucous fibrosis–A clinical study. J Oral Pathol Med 2017;46:50-5.  Back to cited text no. 1
    
2.
Chau L, Jabara JT, Lai W, Svider PF, Warner BM, Lin HS, et al. Topical agents for oral cancer chemoprevention: A systematic review of the literature. Oral Oncol 2017;67:153-9.  Back to cited text no. 2
    
3.
Hsieh CJ. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res 2001;21:e2900.  Back to cited text no. 3
    
4.
Harris D, Robinson JR. Drug delivery via the mucous membranes of the oral cavity. J Pharm Sci 1992;81:1-10.  Back to cited text no. 4
    
5.
Kumar A, Bagewadi A, Keluskar V, Singh M. Efficacy of lycopene in managing oral submucous fibrosis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2007;103:207-13.  Back to cited text no. 5
    
6.
Lu R, Dan H, Wu R, Meng W, Liu N, Jin X, et al. Lycopene: Features and potential significance in oral cancer and precancerous lesions J Oral Pathol Med 2011;40:361-8.  Back to cited text no. 6
    
7.
Mathew AK. Oral local drug delivery: An overview. Pharm Pharmacol Res 2015;3:1.  Back to cited text no. 7
    
8.
Mortazavi H, Baharvand M, Mehdipour M. Oral potentially malignant. Dent Prospects 2014;8:6-14.  Back to cited text no. 8
    
9.
Sarode SC, Sarode GS, Tupkari JV. Oral potentially malignant disorders: A proposal for terminology and definition with a review of the literature. J Oral Maxillofac Pathol 2014;18(Suppl 1):S77-80.  Back to cited text no. 9
    
10.
Singh V, Pal M, Gupta S, Tiwari SK, Malkunje L, Das S. Turmeric-A new treatment option for lichen planus: A pilot study. Natl J Maxillofac Surg 2013;4:198-201.  Back to cited text no. 10
[PUBMED]  [Full text]  
11.
Warnakulasuriya S, Kovacevic T, Madden P, Coupland VH, Sperandio M, Odell E, et al. Factors predicting malignant transformation in or potentially malignant disorders among patients accrued over a 10-year period in South East England. J Oral Pathol Med 2011;40:677-83.  Back to cited text no. 11
    
12.
Piattelli A, Fioroni M, Santinelli A, Rubini C. bcl-2 expression and apoptotic bodies in 13-cis-retinoic acid (isotretinoin)-topically treated oral leukoplakia: A pilot study. Oral Oncol 1999;35:31420.  Back to cited text no. 12
    
13.
Hegarty AM, Hodgson TA, Lewsey JD, Porter SR. Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: A randomized crossover study for the treatment of symptomatic oral lichen planus. J Am Acad Dermatol 2002;47:271-9.  Back to cited text no. 13
    
14.
Petruzzi M, De Benedittis M, Grassi R, Cassano N, Vena G, Serpico R. Oral lichen planus: A preliminary clinical study on treatment with azarotene. Oral Dis 2002;8:291-5.  Back to cited text no. 14
    
15.
Singh V, Agrawal U, Humtsoe EL, Seetohul YB. Use of Aloe vera and turmeric paste as a supplementary medicine in oral submucosal fibrosis: A pilot study. Indian J Otolaryngol Head Neck Surg2019;71(Suppl 1):883-6.  Back to cited text no. 15
    


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