WWOM VII: Effectiveness of systemic pharmacotherapeutic interventions in the management of BMS: A systematic review and meta-analysis

Arwa M. Farag, Michal Kuten-Shorrer, Zuhair Natto, Anura Ariyawardana, Lina M. Mejia, Rui Albuquerque, Barbara Carey, Milda Chmieliauskaite, Craig S. Miller, Mark Ingram, Cibele Nasri-Heir, Andrea Sardella, Charles R. Carlson, Gary D. Klasser

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Objectives: To determine the effectiveness of systemic pharmacotherapeutic interventions compared to placebo in burning mouth syndrome (BMS) randomized controlled trials (RCTs) based on the core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Methods: A systematic literature review of RCTs, concerning systemic pharmacotherapeutic interventions for BMS, published from January 1994 through October 2019, and meta-analysis was performed. Results: Fourteen RCTs (n = 734 participants) were included. Of those, nine were eligible for the quantitative assessment due to the availability/homogeneity of data for at least one of the IMMPACT domains. Pain intensity was the only domain reported in all RCTs. Weighted mean changes in pain intensity, based on visual analogue scale (ΔVAS), were reported in three RCTs at 6 ± 2 weeks and only one RCT at 10+ weeks follow-ups. Quantitative assessment, based on ΔVAS, yielded very low evidence for the effectiveness of alpha-lipoic acid and clonazepam, low evidence for effectiveness of trazodone and melatonin, and moderate evidence for herbal compounds. Conclusions: Based on the RCTs studied, variable levels of evidence exist that suggest that select pharmacological interventions are associated with improved symptoms. However, the underreporting of IMMPACT domains in BMS RCTs restricts the multidimensional assessment of systemic interventions outcomes. Standardized outcome measures need to be applied to future RCTs to improve understanding of intervention outcomes.

Original languageEnglish
Pages (from-to)343-368
Number of pages26
JournalOral Diseases
Issue number2
StatePublished - Mar 2023

Bibliographical note

Funding Information:
This project is a continuation for the BMS projects that stemmed from the World Workshop in Oral Medicine VII (WWOM VII). The authors express their appreciation for the opportunity to work and collaborate with the WWOM VII Steering Committee that conceptualized and supported the WWOM VII Conference in September 2018 in Gothenburg, Sweden. The Steering Committee is listed below, in alphabetical order: Martin S. Greenberg (USA), Timothy A. Hodgson (UK), Siri Beier Jensen (Denmark), A. Ross Kerr (USA), Peter B. Lockhart (USA), Giovanni Lodi (Italy), Douglas E. Peterson (USA). Moreover, the authors acknowledge the following companies/organizations that provided financial support for the WWOM VII: American Academy of Oral Medicine, European Association of Oral Medicine, The National Institute of Dental and Craniofacial Research, The British Society for Oral Medicine, Xerostom, Dermtreat, Oral Diseases, Henry Schein Cares, Colgate, Unilever, and The World Dental Education Foundation.

Publisher Copyright:
© 2021 Wiley Periodicals LLC.


  • burning mouth syndrome
  • clinical trials
  • outcomes
  • systemic interventions

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Dentistry (all)


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