Anura Ariyawardana1,2, Milda Chmieliauskaite3, Arwa M Farag4,5, Rui Albuquerque6, Heli Forssell7, Cibele Nasri-Heir8, Gary D Klasser9, Andrea Sardella10, Michele D Mignogna11, Mark Ingram12, Charles R Carlson13, Craig S Miller14. 1. College of Medicine and Dentistry, James Cook University, Queensland, Australia. 2. Clinical Principal Dentist, Metro South Oral Health, Brisbane, Queensland, Australia. 3. Department of Oral and Maxillofacial Medicine and Diagnostic Sciences, School of Dental Medicine, Case Western Reserve University, Cleveland, Ohio. 4. Department of Oral Diagnostic Sciences, Faculty of Dentistry, King AbdulAziz University, Jeddah, Saudi Arabia. 5. Division of Oral Medicine, Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, Massachusetts. 6. Oral Medicine Department, Guy's and St Thomas Hospital NHS Foundation Trust, King's college London, London, UK. 7. Department of Oral and Maxillofacial Surgery, Institute of Dentistry, University of Turku, Turku, Finland. 8. Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Center for Temporomandibular Disorders and Orofacial Pain, Rutgers The State University of New Jersey, Newark, New Jersy. 9. Department of Diagnostic Sciences, School of Dentistry, Louisiana State University Health Sciences Center, New Orleans, Louisiana. 10. Department of Biomedical, Surgical and Dental Sciences, Unit of Oral Medicine, Oral Pathology and Gerodontology, University of Milan, Milano, Italy. 11. Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, Federico II University of Naples, Naples, Italy. 12. Medical Center Library, University of Kentucky, Lexington, Kentucky. 13. Department of Psychology, College of Art & Sciences, College of Dentistry, Orofacial Pain Clinic, University of Kentucky, Lexington, Kentucky. 14. Department of Oral Health Practice, College of Dentistry, University of Kentucky, Lexington, Kentucky.
Abstract
OBJECTIVE: To conduct a systematic review analyzing disease definitions and diagnostic criteria used in randomized controlled trials (RCTs) involving burning mouth syndrome (BMS). METHODS: A systematic search conducted in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar that included RCTs on BMS published between 1994 and 2017 was performed. RESULTS: Considerable variability in BMS disease definitions and diagnostic criteria used created substantial heterogeneity in the selection of participants and weakened the rigor of the 36 RCTs identified. The analyzed RCTs routinely under-reported the methods used to rule in or out study participants and the number of individuals excluded from BMS RCTs. CONCLUSIONS: Our findings indicate that a large proportion of participants enrolled in these studies may have had an underlying condition that could have explained their BMS symptoms. Thus, outcomes of therapeutic interventions from these BMS RCTs should be interpreted with caution due to heterogeneous disease definitions and diagnostic criteria. In order to improve the quality of clinical trials, future research should focus on establishing consensus for a single definition of BMS that includes specific inclusion and exclusion criteria that should be used to select study participants for clinical trials.
OBJECTIVE: To conduct a systematic review analyzing disease definitions and diagnostic criteria used in randomized controlled trials (RCTs) involving burning mouth syndrome (BMS). METHODS: A systematic search conducted in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar that included RCTs on BMS published between 1994 and 2017 was performed. RESULTS: Considerable variability in BMS disease definitions and diagnostic criteria used created substantial heterogeneity in the selection of participants and weakened the rigor of the 36 RCTs identified. The analyzed RCTs routinely under-reported the methods used to rule in or out study participants and the number of individuals excluded from BMS RCTs. CONCLUSIONS: Our findings indicate that a large proportion of participants enrolled in these studies may have had an underlying condition that could have explained their BMS symptoms. Thus, outcomes of therapeutic interventions from these BMS RCTs should be interpreted with caution due to heterogeneous disease definitions and diagnostic criteria. In order to improve the quality of clinical trials, future research should focus on establishing consensus for a single definition of BMS that includes specific inclusion and exclusion criteria that should be used to select study participants for clinical trials.
Authors: Milda Chmieliauskaite; Elisabeth A Stelson; Joel B Epstein; Gary D Klasser; Arwa Farag; Barbara Carey; Rui Albuquerque; Lina Mejia; Anura Ariyawardana; Cibele Nasri-Heir; Andrea Sardella; Charles Carlson; Craig S Miller Journal: Pain Date: 2021-10-01 Impact factor: 6.961