Cargando…

A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial

BACKGROUND: Amlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. However, it is not yet available in China and has not been generally accepted in clinical treatment. The aim of this study was...

Descripción completa

Detalles Bibliográficos
Autores principales: Meng, Wenxia, Dong, Yi, Liu, Jie, Wang, Zhi, Zhong, Xiaobo, Chen, Ruiyang, Zhou, Hongmei, Lin, Mei, Jiang, Lu, Gao, Feng, Xu, Tao, Chen, Qianming, Zeng, Xin
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690593/
https://www.ncbi.nlm.nih.gov/pubmed/19419555
http://dx.doi.org/10.1186/1745-6215-10-30
_version_ 1782167840222085120
author Meng, Wenxia
Dong, Yi
Liu, Jie
Wang, Zhi
Zhong, Xiaobo
Chen, Ruiyang
Zhou, Hongmei
Lin, Mei
Jiang, Lu
Gao, Feng
Xu, Tao
Chen, Qianming
Zeng, Xin
author_facet Meng, Wenxia
Dong, Yi
Liu, Jie
Wang, Zhi
Zhong, Xiaobo
Chen, Ruiyang
Zhou, Hongmei
Lin, Mei
Jiang, Lu
Gao, Feng
Xu, Tao
Chen, Qianming
Zeng, Xin
author_sort Meng, Wenxia
collection PubMed
description BACKGROUND: Amlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. However, it is not yet available in China and has not been generally accepted in clinical treatment. The aim of this study was to explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, and compare the results with those of amlexanox oral adhesive tablets in order to analyse the difference between the two dosage forms of amlexanox. METHODS: We performed a randomized, blinded, placebo-controlled, parallel, multicenter clinical study. A total of 216 patients with minor recurrent aphthous ulcers (MiRAU) were recruited and randomized to amlexanox pellicles or placebo pellicles. Pellicles were consecutively applied four times per day, for five days. The size and pain level of ulcers were measured and recorded on treatment days 0, 4 and 6. Finally, the results were compared with those of our previous 104 cases treated with amlexanox tablets. RESULTS: Amlexanox oral adhesive pellicles significantly reduced ulcer size (P= 0.017 for day 4, P=0.038 for day 6) and alleviated ulcer pain (P=0.021 for day 4, P=0.036 for day 6). No significant difference was observed in the treatment effectiveness between the pellicle and tablet form of amlexanox. CONCLUSIONS: Amlexanox oral adhesive pellicles are as effective and safe as amlexanox oral adhesive tablets in the treatment of MiRAU for this Chinese cohort. However, pellicles seem to be more comfortable to use when compared with the dosage form of tablets. Therefore, in clinical practice, amlexanox oral adhesive pellicles may be a better choice for RAS patients. TRIALS REGISTRATION: Nederlands Trial Register NTR1727.
format Text
id pubmed-2690593
institution National Center for Biotechnology Information
language English
publishDate 2009
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-26905932009-06-04 A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial Meng, Wenxia Dong, Yi Liu, Jie Wang, Zhi Zhong, Xiaobo Chen, Ruiyang Zhou, Hongmei Lin, Mei Jiang, Lu Gao, Feng Xu, Tao Chen, Qianming Zeng, Xin Trials Research BACKGROUND: Amlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. However, it is not yet available in China and has not been generally accepted in clinical treatment. The aim of this study was to explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, and compare the results with those of amlexanox oral adhesive tablets in order to analyse the difference between the two dosage forms of amlexanox. METHODS: We performed a randomized, blinded, placebo-controlled, parallel, multicenter clinical study. A total of 216 patients with minor recurrent aphthous ulcers (MiRAU) were recruited and randomized to amlexanox pellicles or placebo pellicles. Pellicles were consecutively applied four times per day, for five days. The size and pain level of ulcers were measured and recorded on treatment days 0, 4 and 6. Finally, the results were compared with those of our previous 104 cases treated with amlexanox tablets. RESULTS: Amlexanox oral adhesive pellicles significantly reduced ulcer size (P= 0.017 for day 4, P=0.038 for day 6) and alleviated ulcer pain (P=0.021 for day 4, P=0.036 for day 6). No significant difference was observed in the treatment effectiveness between the pellicle and tablet form of amlexanox. CONCLUSIONS: Amlexanox oral adhesive pellicles are as effective and safe as amlexanox oral adhesive tablets in the treatment of MiRAU for this Chinese cohort. However, pellicles seem to be more comfortable to use when compared with the dosage form of tablets. Therefore, in clinical practice, amlexanox oral adhesive pellicles may be a better choice for RAS patients. TRIALS REGISTRATION: Nederlands Trial Register NTR1727. BioMed Central 2009-05-06 /pmc/articles/PMC2690593/ /pubmed/19419555 http://dx.doi.org/10.1186/1745-6215-10-30 Text en Copyright © 2009 Meng et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Meng, Wenxia
Dong, Yi
Liu, Jie
Wang, Zhi
Zhong, Xiaobo
Chen, Ruiyang
Zhou, Hongmei
Lin, Mei
Jiang, Lu
Gao, Feng
Xu, Tao
Chen, Qianming
Zeng, Xin
A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title_full A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title_fullStr A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title_full_unstemmed A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title_short A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
title_sort clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690593/
https://www.ncbi.nlm.nih.gov/pubmed/19419555
http://dx.doi.org/10.1186/1745-6215-10-30
work_keys_str_mv AT mengwenxia aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT dongyi aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT liujie aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT wangzhi aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zhongxiaobo aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT chenruiyang aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zhouhongmei aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT linmei aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT jianglu aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT gaofeng aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT xutao aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT chenqianming aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zengxin aclinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT mengwenxia clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT dongyi clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT liujie clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT wangzhi clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zhongxiaobo clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT chenruiyang clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zhouhongmei clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT linmei clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT jianglu clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT gaofeng clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT xutao clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT chenqianming clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial
AT zengxin clinicalevaluationofamlexanoxoraladhesivepelliclesinthetreatmentofrecurrentaphthousstomatitisandcomparisonwithamlexanoxoraltabletsarandomizedplacebocontrolledblindedmulticenterclinicaltrial