Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial

Abstract Background Recurrent Aphthous Stomatitis (RAS) is painful oral ulceration frequently treated with topical steroids. There is limited published evidence for the efficacy of any treatment for RAS and there remains a need for longitudinal randomised clinical trials to evaluate and compare the...

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Main Authors: Surab Alsahaf, Khlood A. Alkurdi, Stephen J. Challacombe, Anwar R. Tappuni
Format: Article
Language:English
Published: BMC 2023-10-01
Series:BMC Oral Health
Subjects:
Online Access:https://doi.org/10.1186/s12903-023-03335-x
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author Surab Alsahaf
Khlood A. Alkurdi
Stephen J. Challacombe
Anwar R. Tappuni
author_facet Surab Alsahaf
Khlood A. Alkurdi
Stephen J. Challacombe
Anwar R. Tappuni
author_sort Surab Alsahaf
collection DOAJ
description Abstract Background Recurrent Aphthous Stomatitis (RAS) is painful oral ulceration frequently treated with topical steroids. There is limited published evidence for the efficacy of any treatment for RAS and there remains a need for longitudinal randomised clinical trials to evaluate and compare the effectiveness of different therapies in the management of RAS. The aim of the current project was to assess the efficacy of betamethasone mouthwash and colchicine tablets, individually and combined, for the treatment of RAS, and to establish the optimum treatment period necessary for a significant reduction in the disease severity. Methodology A randomised, prospective, parallel-group clinical trial was conducted over one year, to compare the efficacy of three therapies in RAS. One hundred and six patients were randomized into three groups; 35 received betamethasone mouthwash, 35 had colchicine tablets and 36 received both therapies. The response was evaluated quantitatively every 3 months for 1 year, using the Ulcer Severity Score (USS). Results For all three treatment regimes, the mean USS decreased by about 30% in the first 3 months (p < 0.001). Further improvement was noted for up to 9 months. At the end of the study, the mean USS had improved by 50% from 34.9 ± 7.2 before treatment to 17.5 ± 8.9 after treatment (p < 0.001). Of included participants, 86% showed significant clinical improvement by the end of the study. There were no significant differences in outcomes between the three regimes (p < 0.05). Conclusions This clinical trial has provided evidence for the efficacy of betamethasone mouthwash and for colchicine tablets in the treatment of RAS and has shown that at least six months of treatment may be required for optimum effect. Clinical trial registration number: ISRCTN3267716. Date of clinical trial registration: 15/04/2018
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spelling doaj.art-5290806f23f640b9ae68d33932228efc2023-12-10T12:34:01ZengBMCBMC Oral Health1472-68312023-10-0123111010.1186/s12903-023-03335-xTopical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trialSurab Alsahaf0Khlood A. Alkurdi1Stephen J. Challacombe2Anwar R. Tappuni3Oral Medicine, Centre for Host Microbiome Interactions, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, and Guys and St Thomas’ NHS Foundation TrustInstitute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of LondonOral Medicine, Centre for Host Microbiome Interactions, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, and Guys and St Thomas’ NHS Foundation TrustInstitute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of LondonAbstract Background Recurrent Aphthous Stomatitis (RAS) is painful oral ulceration frequently treated with topical steroids. There is limited published evidence for the efficacy of any treatment for RAS and there remains a need for longitudinal randomised clinical trials to evaluate and compare the effectiveness of different therapies in the management of RAS. The aim of the current project was to assess the efficacy of betamethasone mouthwash and colchicine tablets, individually and combined, for the treatment of RAS, and to establish the optimum treatment period necessary for a significant reduction in the disease severity. Methodology A randomised, prospective, parallel-group clinical trial was conducted over one year, to compare the efficacy of three therapies in RAS. One hundred and six patients were randomized into three groups; 35 received betamethasone mouthwash, 35 had colchicine tablets and 36 received both therapies. The response was evaluated quantitatively every 3 months for 1 year, using the Ulcer Severity Score (USS). Results For all three treatment regimes, the mean USS decreased by about 30% in the first 3 months (p < 0.001). Further improvement was noted for up to 9 months. At the end of the study, the mean USS had improved by 50% from 34.9 ± 7.2 before treatment to 17.5 ± 8.9 after treatment (p < 0.001). Of included participants, 86% showed significant clinical improvement by the end of the study. There were no significant differences in outcomes between the three regimes (p < 0.05). Conclusions This clinical trial has provided evidence for the efficacy of betamethasone mouthwash and for colchicine tablets in the treatment of RAS and has shown that at least six months of treatment may be required for optimum effect. Clinical trial registration number: ISRCTN3267716. Date of clinical trial registration: 15/04/2018https://doi.org/10.1186/s12903-023-03335-xOral ulcersUlcer severityClinical outcomesBetamethasoneColchicine
spellingShingle Surab Alsahaf
Khlood A. Alkurdi
Stephen J. Challacombe
Anwar R. Tappuni
Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
BMC Oral Health
Oral ulcers
Ulcer severity
Clinical outcomes
Betamethasone
Colchicine
title Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
title_full Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
title_fullStr Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
title_full_unstemmed Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
title_short Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial
title_sort topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis a randomised clinical trial
topic Oral ulcers
Ulcer severity
Clinical outcomes
Betamethasone
Colchicine
url https://doi.org/10.1186/s12903-023-03335-x
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