INTRODUCTION: Although a significant amount of evidence indicates the efficacy 
of some antidepressants in treating psychogenic pain and somatoform disorder, 
very few studies have investigated their possible therapeutic action in burning 
mouth syndrome (BMS). The purpose of this 8-week, single-blind study was to 
provide preliminary data on the efficacy and tolerability of amisulpride and the 
selective serotonin reuptake inhibitors (SSRIs) paroxetine and sertraline for 
patients with BMS.
METHOD: Seventy-six patients with BMS (diagnosed according to the criteria in 
the literature and integrating the Diagnostic Interview Schedule-Revised for a 
complete psychiatric assessment), with no possible local or systemic causes and 
without concurrent major depression, were randomly assigned to receive 
amisulpride (50 mg/day), paroxetine (20 mg/day), or sertraline (50 mg/day). 
Efficacy assessments included a visual analogue scale (VAS) for pain intensity, 
the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for 
Anxiety (HAM-A), and the Clinical Global Impressions scale (CGI).
RESULTS: All 3 treatment regimens resulted in a significant improvement from 
baseline in burning mouth symptoms at week 8 as demonstrated by the quantitative 
(mean reduction in VAS, HAM-D, and HAM-A scores) and qualitative (percentage of 
responders) analyses. Amisulpride showed a shorter response latency than the 
SSRIs. No serious adverse events were reported, and the incidence of side 
effects did not differ among the 3 groups. None of the patients who received 
amisulpride withdrew from the trial, whereas withdrawal from the trial occurred 
within the first week of treatment in 11.5% of patients (N = 3) treated with 
paroxetine and in 21.7% of patients (N = 5) treated with sertraline.
CONCLUSION: The data suggest that amisulpride and SSRIs may be effective 
treatments for BMS; they are equally effective and equally well tolerated in the 
short-term treatment of BMS. Amisulpride is associated with better compliance 
within the first week of treatment and with a shorter response latency in 
comparison with SSRIs. This finding may indicate that amisulpride is especially 
useful at the beginning of drug therapy of BMS. Double-blind, placebo-controlled 
trials are needed to further document the efficacy of amisulpride and SSRIs in 
the treatment of BMS.