title: An evaluation on the efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulceration in a Chinese cohort: a randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial.
abstract: OBJECTIVE
  The objectives of this study were to clinically determine the topical efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulcerations (MiRAU) in a Chinese cohort.
  
  
  METHODS
  A randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial was carried out. The tablets were applied by subjects themselves 4 times a day for 5 days. Four parameters (pain scale, size change, degree of erythema and exudation, and efficacy index) were recorded both before (baseline) and during the trial (on the morning of days 4 and 6).
  
  
  RESULTS
  There were 104 and 108 subjects who fulfilled the trial in the amlexanox group and the vehicle-control group, respectively. Group differences for all parameters but degree of erythema and exudation of day 4 were statistically significant both for the day 4 visit and the day 6 visit (P < .05). No systemic side effects were reported.
  
  
  CONCLUSIONS
  Amlexanox oral adhesive tablets are effective and safe in reducing aphthous ulcer pain and lesion size, as well as erythema and exudation in this Chinese cohort.
authors.affiliation: Department of Oral Medicine, West China College of Stomatology, Suchuan University, Sichuan, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Liu
authors.forename: Xin
authors.initials: X
authors.lastname: Zeng
authors.forename: Qianming
authors.initials: Q
authors.lastname: Chen
authors.forename: Yang
authors.initials: Y
authors.lastname: Cai
authors.forename: Fangchun
authors.initials: F
authors.lastname: Chen
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.forename: Hongmei
authors.initials: H
authors.lastname: Zhou
authors.forename: Mei
authors.initials: M
authors.lastname: Lin
authors.forename: Jing
authors.initials: J
authors.lastname: Shi
authors.forename: Zhi
authors.initials: Z
authors.lastname: Wang
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D000269:Adhesives; D000293:Adolescent; D000328:Adult; D000368:Aged; D000631:Aminopyridines / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D004890:Erythema / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D014677:Pharmaceutical Vehicles; D013281:Stomatitis, Aphthous / Q000188:drug therapy*; D013607:Tablets
chemical_list: D000269:Adhesives; D000631:Aminopyridines; D018926:Anti-Allergic Agents; D014677:Pharmaceutical Vehicles; D013607:Tablets; C045742:amlexanox