Milnacipran dose-effect study in patients with burning mouth syndrome.

Objective: The object of this study was to evaluate the dose-dependent efficacy and tolerability of milnacipran in patients with burning mouth syndrome (BMS) with inadequate response at low doses. Methods: A 12-week open-label dose-escalation study was conducted in 56 female patients (aged 20-83 years, with a mean age of 60.8 years). The initial dosage of milnacipran was 30 mg/d, and the dosage was raised up to 60 mg and 90 mg/d every 4 weeks until an improvement of at least 50% reduction of visual analog scale was achieved. Results: The mean +/- SD effective daily dose of milnacipran was 63.9 +/- 16.7 mg. The cumulative improvement rate for the daily dose of 30 mg was 28.6%, and this rate rose (50.8%-67.9%) as the daily dose was increased (from 60 to 90 mg, respectively). The cumulative proportion of responders was significantly greater, with maximal daily doses of 60 and 90 mg, compared with that of 30 mg (P < 0.05, chi(2) test). Most adverse events appeared at the low dose, and there was little evidence for dose-dependence of adverse effects. No serious safety issues were observed. Conclusion: From the result of this study, dose escalation of milnacipran for patients with burning mouth syndrome with inadequate response at low doses may be helpful if the 30-mg daily dose has been tolerated well.