Prevalence, Risk Factors, Awareness, and Response to Pharmacological Treatment of Oral Potentially Malignant Disorders and Gutka Dependence among Gutka Users in Karachi: A Mixed-Method Interventional Study

Abstract

Background: Oral potentially malignant disorders (OPMDs), including Oral Submucous Fibrosis (OSMF) and leukoplakia, represent major clinical challenges in South Asia. In Karachi, Pakistan, the widespread consumption of gutka smokeless tobacco product containing areca nut, drives high rates of OPMDs and chemical dependence. This study evaluated the prevalence, risk factors, baseline awareness, and response to combined pharmacological therapy alongside addiction cessation counselling among habitual gutka users in Karachi.

Methodology: A mixed-method interventional study was conducted over a 12-month period involving 280 habitual gutka users. Quantitative evaluation assessed baseline demographic data, gutka dependence severity (using a modified Fagerström Test for Nicotine Dependence adapted for smokeless tobacco), clinical OPMD prevalence, and pre/post-intervention mouth opening (interincisal distance in mm). Qualitative data were gathered via focus group discussions to explore socio-cultural drivers of addiction. Participants diagnosed with OPMDs received a 12-week standardized pharmacological regimen consisting of oral lycopene systemic alpha-lipoic acid, intralesional triamcinolone acetonide (10 mg/mL) plus hyaluronidase (1500 IU) for advanced trismus, alongside nicotine replacement therapy (NRT gum) and behavioral cessation support. Outcomes were evaluated using paired ttt-tests and Chi-square analysis (p<0.05).

Results: The overall prevalence of clinically confirmed OPMDs among enrolled gutka users was 64.3% (n=180), with OSMF accounting for 48.6% (n=136) and leukoplakia 15.7% (n=44). High daily frequency (>5 packets/day}, OR=4.25,p<0.001 and long duration of use >5 years, OR=5.12,p<0.001 were key independent risk factors. Baseline awareness regarding the malignant transformation risk of OPMDs was low (31.4%). Following 12 weeks of pharmacological intervention and NRT support, 58.3% (n=105n = 105n=105) achieved successful gutka cessation. Pharmacological therapy resulted in a significant improvement in mean interincisal distance (21.4±4.2 mm to 31.8±4.6 mm, p<0.001) and a 74.5% reduction in burning mucosal sensation scores.

Conclusion: Gutka dependence in Karachi is associated with a high prevalence of OPMDs, driven by low community awareness and intense chemical addiction. Combined pharmacological management pairing systemic antioxidants and anti-fibrotic therapies with structured NRT and behavioural cessation support effectively reduces lesion severity, improves mouth opening, and facilitates gutka cessation.

Keywords: Oral Potentially Malignant Disorders; Gutka Dependence; Oral Submucous Fibrosis; Pharmacotherapy; Nicotine Replacement Therapy; Lycopene; Karachi.