Effectiveness of Alpha Lipoic Acid and Pregabalin, for the Treatment of Burning Mouth Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background: Burning mouth syndrome (BMS) is a chronic neuropathic pain disorder with no clear etiology. Alpha-lipoic acid (ALA) and pregabalin are individually used to manage neuropathic pain, but their combined effect in BMS remains underexplored.

Objective: To evaluate and compare the therapeutic efficacy and safety of ALA, pregabalin, and their combination versus placebo in BMS patients.

Methods In a double-blind, randomized controlled study, 40 patients with Burning Mouth Syndrome (BMS) were assigned to four groups, each receiving medicine for a duration of two months as follows: pregabalin (300 mg/day), ALA (600 mg/day), combination therapy (ALA + pregabalin), and placebo. Burning intensity was measured using a custom 0–4 geographic burning scale and VAS score at baseline, 1 month, and 2 months. Safety was assessed via adverse effects of medications  reporting and laboratory tests.

Results: After 2 months, favorable outcomes were observed in 10% (placebo), 60% (ALA), 80% (pregabalin), and 90% (combination therapy) of patients. Combination therapy yielded the highest odds of symptom improvement (OR = 81; p < 0.001). Side effects were mild and comparable across all groups.

Conclusion: Both ALA and pregabalin significantly reduced BMS symptoms, with combination therapy showing superior efficacy. These findings suggest synergistic neuroprotective effects and support further large-scale, long-term studies.