Combination of alpha lipoic acid and gabapentin, its efficacy in the treatment of Burning Mouth Syndrome: a randomized, double-blind, placebo controlled trial.

UNLABELLED Burning Mouth Syndrome (BMS) is a disease that manifests as burning in the tongue or in any area of the oral mucosa, in the absence of clinically verifiable injuries. OBJECTIVES To verify the efficacy of alpha lipoic acid (ALA) and gabapentin (GABA), used individually and jointly, to reduce the burning in patients with burning mouth and establish a drug therapy for the BMS. STUDY DESIGN During April and May 2008, we conducted a randomized, double-blind, placebo-controlled trial in the Department of Clinical Stomatology, Faculty of Dentistry, Rosario, Argentina. The gathering of patients was between those ones with BMS who were treated in our service between March 2003 and March 2008 without complying with the applied treatments. The 120 patients were randomly divided into 4 groups and were provided, by lot and in a blinded fashion, with four different treatment cycles consisting of the following drugs: Group A (n = 20) 600 mg / day of alpha lipoic acid for two months, Group B (n = 20) 300 mg / day of gabapentin for two months, Group C (n = 20) a combination of both drugs for two months and Group D (n = 60) 100 mg / day of cellulose starch for two months (control group). RESULTS AND CONCLUSIONS all 120 patients completed the treatment. The best response was obtained with the combination of ALA + GABA, with a 70% of the cases with reduced burning in this group and a 13.2 times greater chance of presenting positive changes for these patients than those taking placebo. The combined use of drugs that act at different levels of the nociceptive system can be useful for the treatment of this syndrome.