Dose escalation effectiveness and tolerability of paroxetine in patients with burning mouth syndrome and depressive conditions

Abstract

ObjectiveTo evaluate gradual dose escalation and tolerability of paroxetine in patients with burning mouth syndrome (BMS). MethodsThis 12-week, open-label, non-comparative, prospective study involved 43 subjects with depressive condition. The initial dosage of paroxetine was 10mg/day, but was raised to 20mg/day and 30mg/day if efficacy was not sufficient. Pain was assessed using the visual analog scale (VAS) at baseline and at weeks 2, 4, 8, and 12 of the study treatment. ResultsThe mean VAS score at each time point was significantly lower than at baseline (P<0.0001, paired t-test) after paroxetine treatment. The effects of paroxetine were dose-dependent. The cumulative improvement rates for daily doses of 10mg, 20mg, and 30mg were 37.2%, 67.4%, and 74.4%, respectively. The cumulative proportion of responders was significantly higher for patients with maximal daily doses of 20mg and 30mg than in patients receiving 10mg/day (P<0.01, χ2 test). Adverse events were observed in 26 of 49 (53%) patients evaluated for safety, with most adverse events appearing when patients were taking 10mg/day. The incidence of adverse events did not show a time- or dose-dependent increase, except for constipation. No serious safety issues were noted. ConclusionsDose escalation of paroxetine may be useful in treating patients with BMS and depressive conditions.