title: Topical clonazepam in stomatodynia: a randomised placebo-controlled study.
abstract: Stomatodynia is characterised by a spontaneous burning pain in the oral mucosa without known cause or recognised treatment. The purpose of this double-blind, randomised, multicentre parallel group study was to evaluate the efficacy of the topical use of clonazepam. Forty-eight patients (4 men and 44 women, aged 65+/-2.1 years) were included, of whom 41 completed the study. The patients were instructed to suck a tablet of 1 mg of either clonazepam or placebo and hold their saliva near the pain sites in the mouth without swallowing for 3 min and then to spit. This protocol was repeated three times a day for 14 days. The intensity was evaluated by a 11-point numerical scale before the first administration and then after 14 days. Two weeks after the beginning of treatment, the decrease in pain scores was 2.4+/-0.6 and 0.6+/-0.4 in the clonazepam and placebo group, respectively (P = 0.014). Similar effects were obtained in an intent-to-treat analysis (P = 0.027). The blood concentration of clonazepam was similar whether it was measured 14 days after sucking a tablet three times a day or during the 5 h that followed sucking a single tablet (n = 5). It is hypothesised that clonazepam acts locally to disrupt the mechanism(s) underlying stomatodynia.
authors.affiliation: INSERM E 0216, Neurobiologie de la Douleur Trigéminale, Faculté de Chirurgie Dentaire, CHU Clermont-Ferrand, Clermont-Ferrand 63000, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Gremeau-Richard
authors.forename: Alain
authors.initials: A
authors.lastname: Woda
authors.forename: Marie Louise
authors.initials: ML
authors.lastname: Navez
authors.forename: Nadine
authors.initials: N
authors.lastname: Attal
authors.forename: Didier
authors.initials: D
authors.lastname: Bouhassira
authors.forename: Marie Claude
authors.initials: MC
authors.lastname: Gagnieu
authors.forename: Jean François
authors.initials: JF
authors.lastname: Laluque
authors.forename: Pascale
authors.initials: P
authors.lastname: Picard
authors.forename: Paul
authors.initials: P
authors.lastname: Pionchon
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Tubert
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000097:blood; D002054:Burning Mouth Syndrome / Q000188:drug therapy*; D002998:Clonazepam / Q000008:administration & dosage* / Q000097:blood; D004311:Double-Blind Method; D005157:Facial Pain / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D002998:Clonazepam