Efficacy of Sublingual Therapeutic Bacterial Vaccine in Patients with Recurrent Sore Throat: A Randomized Controlled Trial

Abstract

Introduction: Recurrent sore throat is a significant burden on the healthcare system. It is associated with significant morbidity and antimicrobial resistance due to frequent antibiotic use. The sublingual live-attenuated polyvalent bacterial vaccine has been used as an adjunct treatment in these patients for its immunomodulatory properties, increasing immune responses, and boosting the innate immune system. Objective: To determine the efficacy of the sublingual live-attenuated polyvalent bacterial vaccine in patients with recurrent sore throats. Materials and Methods: This randomized control trial was conducted at the Department of ENT, Services Institute of Medical Sciences, Lahore from July, 2019 to January 2020 A Total of 60 patients full filling the inclusion criteria were included in the study and were equally divided into two groups. Each group had 30 patients to compare the mean number of sore throat episodes in the treatment and control groups. After approval from the hospital ethical review committee (No. Estt/ 20980/S.H), informed consent was obtained from each patient. Group A patients received a sublingual live-attenuated polyvalent bacterial vaccine and whereas group B were given placebo (normal saline 0.9%). Treatment response was noted for a period of 3 months. Results: The mean number of sore throat episodes was 0.53 ± 0.63 in the sublingual polyvalent live-attenuated bacterial vaccine group compared to 1.67 ± 0.92 in the placebo group (p-value =0.0001). The mean duration of disease in Group A was 3.20 ± 1.56 years compared to 3.40 ± 1.63 years in Group B. Conclusion: Sublingual live-attenuated polyvalent bacterial vaccine is effective in reducing the number of recurrent sore throat episodes and need for frequent antibiotic use and/or tonsillectomies