Topical clonazepam in stomatodynia: a randomised placebo-controlled study.
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.
Gremeau-Richard
Christelle
C
INSERM E 0216, Neurobiologie de la Douleur Trigéminale, Faculté de Chirurgie Dentaire, CHU Clermont-Ferrand, Clermont-Ferrand 63000, France.
Woda
Alain
A
Navez
Marie Louise
ML
Attal
Nadine
N
Bouhassira
Didier
D
Gagnieu
Marie Claude
MC
Laluque
Jean François
JF
Picard
Pascale
P
Pionchon
Paul
P
Tubert
Stéphanie
S
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
D000927:Anticonvulsants; D010919:Placebos; D002998:Clonazepam