Alpha lipoic acid in burning mouth syndrome--a randomized double-blind placebo-controlled trial.
The burning mouth syndrome (BMS) is a chronic condition characterized by oral burning pain in the absence of clinical abnormalities and without established therapy.


OBJECTIVE
The purpose of this study was to evaluate the effectiveness of alpha lipoic acid (ALA) in the management of BMS symptoms through a randomized double-blind placebo-controlled trial.


METHODS
Thirty-eight patients (34 women and four men, median age 62.9 years, range 36-78) were included and 31 completed the study. The patients were randomized into two cycles of treatment: one with alpha lipoic acid and one with placebo both administered in identical capsules. These cycles were separated by a washout period of 20 days. The oral symptoms and the treatment response were assessed using a 100-mm visual analog scale before and after each cycle and the global perceived effect score, using a 5-point scale after each treatment cycle.


RESULTS
The level of reduction on burning was significant for both treatments (paired t-test: P < 0.05; rp = 0.011; ral < 0.001). Considering the two cycles together, 22 patients reported at least some improvement after ALA use and 23 patients after placebo.


CONCLUSIONS
Comparison of the oral assessment scores of the two cycles failed to demonstrate the effectiveness of ALA over placebo (t-test: P > 0.05; r = 0.75).
Cavalcanti
Desirée Rosa
DR
Department of Oral Diagnosis, Dentistry School, University of Sao Paulo, Sao Paulo, Brazil. dcavalcanti@usp.br
da Silveira
Fernando Ricardo Xavier
FR
D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D002054:Burning Mouth Syndrome / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D008063:Thioctic Acid / Q000627:therapeutic use*
D000975:Antioxidants; D008063:Thioctic Acid