An open-label, noncomparative, dose escalation pilot study of the effect of paroxetine in treatment of burning mouth syndrome

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An open-label, noncomparative, dose escalation pilot study of the effect of paroxetine in treatment of burning mouth syndrome

Yutaka Yamazaki, DDS, PhDaCorresponding Author Informationemail address, Hironobu Hata, DDS, PhDb, Shogo Kitamori, DDSc, Makiko Onodera, DDS, PhDd, Yoshimasa Kitagawa, DDS, PhDe

Received 12 March 2008; received in revised form 27 August 2008; accepted 29 August 2008. published online 11 November 2008.

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%) (χ2 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.

Volume 107, Issue 1, Pages e6-e11 (January 2009)
© 2009 Published by Elsevier Inc.