An open-label, noncomparative, dose escalation pilot study of the effect of paroxetine in treatment of burning mouth syndrome.
OBJECTIVE
The objective of this study was to evaluate the effectiveness and tolerability of paroxetine in patients with burning mouth syndrome (BMS).


METHODS
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.


CONCLUSIONS
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.
Yamazaki
Yutaka
Y
Graduate School of Dental Medicine, Hokkaido University, Sapporo, Japan.
Hata
Hironobu
H
Kitamori
Shogo
S
Onodera
Makiko
M
Kitagawa
Yoshimasa
Y
D000328:Adult; D000368:Aged; D002054:Burning Mouth Syndrome / Q000188:drug therapy*; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D017374:Paroxetine / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors