OBJECTIVE: The objective of this study was to evaluate the effectiveness and tolerability of paroxetine in patients with burning mouth syndrome (BMS). DESIGN: In a 12-week open-label, noncomparative, prospective study, 71 subjects with primary BMS were assigned to receive an initial dosage of paroxetine (10 or 20 mg/day). The dosage was increased to a maximum of 30 mg/day. Of these patients, 52 were available to examine the efficacy of treatment in this study. RESULTS: The cumulative proportion of responders was 80.8% (42/52). Of those responding, complete remission of pain was observed in 70.4% (19/27) of patients by week 12. The effects of paroxetine were dose-dependent. The incidence of adverse reactions for the initial daily dosage of 10 mg (41%) was significantly lower than that for 20 mg (76%) (chi(2) test). No serious safety issues were observed. CONCLUSION: About 80% of BMS patients experienced pain reduction with 12 weeks of paroxetine treatment with only minor transient side effects. These results suggest that paroxetine may be useful in the treatment of patients with BMS.
RCT Entities:
OBJECTIVE: The objective of this study was to evaluate the effectiveness and tolerability of paroxetine in patients with burning mouth syndrome (BMS). DESIGN: In a 12-week open-label, noncomparative, prospective study, 71 subjects with primary BMS were assigned to receive an initial dosage of paroxetine (10 or 20 mg/day). The dosage was increased to a maximum of 30 mg/day. Of these patients, 52 were available to examine the efficacy of treatment in this study. RESULTS: The cumulative proportion of responders was 80.8% (42/52). Of those responding, complete remission of pain was observed in 70.4% (19/27) of patients by week 12. The effects of paroxetine were dose-dependent. The incidence of adverse reactions for the initial daily dosage of 10 mg (41%) was significantly lower than that for 20 mg (76%) (chi(2) test). No serious safety issues were observed. CONCLUSION: About 80% of BMS patients experienced pain reduction with 12 weeks of paroxetine treatment with only minor transient side effects. These results suggest that paroxetine may be useful in the treatment of patients with BMS.