Oral Submucous Fibrosis, OSMF: A Novel Therapeutic Approach

   

Nikita Gyakwad^1*, Shilpa Parikh² and Jigna Shah³

Post Graduate Student, Department of oral medicine and radiology, Government Dental college and hospital, Civil hospital, Ahmedabad, India

Professor and PG Guide, Department of oral medicine and radiology, Government Dental college and hospital, Civil hospital, Ahmedabad, India

Professor and HOD, Department of oral medicine and radiology, Government Dental college and hospital, Civil hospital, Ahmedabad, India

Abstract

Oral Submucous Fibrosis (OSMF) is a chronic, progressive, scarring disease associated with chronic areca nut consumption, representing a generalized pathological state of the oral mucosa that significantly increases the risk of cancer. This study aims to evaluate the effectiveness of Tab. Colchicine 0.5 mg along with Intralesional Inj. Placentrex 1500 IU 2 ml in the management of OSMF.

Methodology: A total of 26 patients clinically diagnosed with Grade II (15) and Grade III (11) OSMF were divided into two groups (Group I and Group II). Group I patients were treated by administering Tab. Colchicine 0.5 mg twice daily with Intralesional Inj. Placentrex 1500 IU (2 ml) at a weekly interval for 12 weeks. Group II patients were treated with Intralesional Inj. Placentrex 1500 IU (2 ml) at a weekly interval for 12 weeks.

Results: The results showed an overall significant improvement in burning sensation, mouth opening, and buccal mucosal flexibility in Group I compared to Group II, indicating the efficacy of the combined regimen of Tab. Colchicine 0.5 mg and Intralesional Inj. Placentrex 1500 IU 2 ml.

Conclusion: This study suggests that the use of 0.5mg Tab. Colchicine with Intralesional Inj. Placentrex 1500 IU 2ml is valuable in treating OSMF, showing superior outcomes without any side-effects. Future research with larger sample sizes and histological assessments is recommended to confirm these findings.

 

Keywords

OSMF-Oral Submucous Fibrosis; Colchicine 0.5 mg; Placentrex 1500 IU

Abbreviation

OSMF- Oral Submucous Fibrosis, Tab.-Tablet, Inj.- Injection, mg- milligram.

Introduction

Oral submucous fibrosis (OSMF) was first reported by Schwartz in 1952 as “atrophia idiopathica mucosae oris [1-3]. The WHO defines Oral Submucous Fibrosis as a “precancerous oral condition”—a widespread pathological state of the oral mucosa associated with a significantly increased risk of cancer [4]. The use of areca nut is the primary etiological agent associated with the development of OSMF [1-3,5]. The main alkaloid found in areca nuts is arecoline. Arecaidine, arecoline, guvacoline, and guvacine are other alkaloids found [6]. The aetiology of OSMF also involves other factors such genetic predisposition, nutritional inadequacies, immunological problems, lime, chilies, and collagen abnormalities [1-3,5]. The main objectives in the treatment of OSMF are to improve the signs and symptoms, stop disease progression, and reduce the propensity for malignant transformation [3,7]. Many therapies, including physical therapy, medication, surgery, and habit modification (i.e., cessation of areca nut usage), have been recommended for the treatment of OSMF. However, none have been able to demonstrate the condition's complete regression. Thus, the search for an effective therapeutic approach continues [1, 8, 9]. In the course of disease treatment, convenience of drug administration is one of the factors for successful management of disease. Since oral drug administration is more convenient than intralesional drug administration, it would be ideal to have an oral alternative for managing OSMF [2]. Colchicine is an alkaloid derived from the crocus-like plant Colchicum autumnale, chemically known as colchicum-N-(5,5,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide. Numerous studies have confirmed the role of colchicine as antifibrotic agent by inhibiting collagen synthesis and increasing collagenolytic activity. Besides, it also has some anti‑inflammatory properties. This anti‑inflammatory property is related to the drug’s effect on polymorphonuclear leukocytes and monocyte chemotaxis, as well as leukocyte adhesiveness, and also its effect on prostaglandin E, which suppresses the leukocyte function [1]. Colchicine is toxic in doses greater than 0.1 mg/kg. The most commonly reported toxic side effect of long-standing colchicine therapy is nausea, vomiting, diarrhoea, and abdominal pain due to its effect on the rapidly proliferating epithelial cells of the gastrointestinal tract. These symptoms are especially common at dosage levels of 2–3 mg/day, although they are entirely reversible by appropriate symptomatic management. The side effects are minimal when doses are less than or equal to 1 mg/day [1,5,9-11]. Till date vary few studies have reported the use of colchicine in the management of OSMF. This study is planned to determine the effectiveness of Tab. Colchicine 0.5 mg along with Intralesional Inj. Placentrex 1500 IU 2 ml in the management of OSMF.

Materials and Method

In this study, 26 patients in the age range of 20 to 40 years who visited the oral medicine and radiology department between 2022 and 2023 and were clinically diagnosed with OSMF (Grade II and III) were included. The study protocol received approval from the Institutional Ethical Committee. All ethical guidelines were followed, and written informed consent was obtained from the selected patients who participated in the study. (The identification of various clinical Grades of OSMF was based on Kerr et al.'s (2011) clinical criteria.) [12].

Inclusion criteria involved patients with clinical Grade II and Grade III OSMF, ages ranging from 20 to 40 years of both genders. Patients who have habits of betelnut, pan-masala, gutkha, or mixed habits and present complaints like burning sensation, reduced mouth opening, and restricted tongue movement were involved. Conversely, the exclusion criteria entailed individuals unwilling to participate, those already undergoing or having received treatment for OSMF, and those experiencing difficulty in mouth opening unrelated to OSMF. Additionally, immunocompromised individuals with systemic diseases, pregnant females, individuals on immunosuppressants, and those with drug allergies.

A detailed case history, including their habits (type, frequency per day, and duration), was taken, and a clinical examination was done. All the obtained data was recorded on the standard proforma. After selecting patients based on inclusion and exclusion criteria, all the patients in OSMF (Grade II and III) went for routine blood investigations, including a complete blood count, a liver function test, and a kidney function test. Based on the investigatory findings, patients with OSMF were divided into two groups: Group I and Group II. This investigation was repeated once per month for Group I.

Group I

Patients were prescribed with Tab. Colchicine 0.5mg twice daily orally. Placentrex 1500 IU 2ml was injected using a 26-gauge needle insulin syringe intralesionally in oral mucosa and pterygomandibular raphe once per week.

Group II

Placentrex 1500 IU 2ml was injected using a 26-gauge needle insulin syringe intralesionally in oral mucosa and pterygomandibular raphe once per week.

In the OSMF patients, the following parameters were measured:

• The intensity of the burning sensation using a Numerical Rating 10-point Visual Analogue Scale (VAS).

• The interincisal mouth opening between the mesioincisal edge of the upper-right central incisor to the mesioincisal edge of the lower right central incisor with the help of a vernier caliper, (Figure 1).

Figure 1: Measurement of the mouth opening.

• Buccal mucosal flexibility according to Bailoor and Nagesh [12, 13]. V2 = is marked at 1/3rd the distance from the angle of the mouth on a line joining the tragus of the ear and the angle of the mouth and V1 = the subject is then asked to blow his cheeks, and the distance measured between the two. Buccal mucosal flexibility = V1-V2, (Figure 2).

Figure 2: Measurement of buccal mucosal flexibility.

• Tongue protrusion with the scale from the normal mesioincisal angle of the upper central incisor to the tip of the tongue when maximally extended with mouth wide open [9], (Figure 3).