World Workshop on Oral Medicine VII: Burning mouth syndrome: A systematic review of disease definitions and diagnostic criteria utilized in randomized clinical trials

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.

General health status of a sample of patients with burning mouth syndrome: A case–control study

“…The different classifications such as those of the IHS, the International Association for the Study of Pain (IASP, 2016) or the most recent International Classification of Orofacial Pain (ICOP, 2020) and their continuous updates make it difficult to discern what the limits of the BMS are and even what its diagnostic criteria and comorbidities are. This considerable variability in BMS definitions and diagnostic criteria has been reported by Ariyawardana et al (2019). Furthermore, Miller et al, 2019 questioned whether BMS should be considered a syndrome or a disorder, since patients who have BMS do not always suffer a consistent set of clinical features and in many cases patients suffering from it have other previous diseases.…”

“…The controversy regarding the different definitions (Ariyawardana et al, 2019; IHS, 2018; IASP, 2016; ICOP, 2020) for BMS and the description of which are its clinical and laboratory characteristics have influenced and, in many cases, biased the design of many of the articles published in recent years. The lack of consensus makes it difficult to unify results and conclusions of the different studies.…”

“…The relationship of BMS with possible alterations in patients’ general health and different comorbidities has been subject of study and controversy during past years (Ariyawardana et al, 2019; Suga, Takenoshita, & Toyofuku, 2019). BMS, like other persistent pains, is usually accompanied by depression, anxiety (Adamo et al, 2018; Galli, Lodi, Sardella, & Vegni, 2017; IHS, 2018; Jaaskelainen & Woda, 2017; Mitsikostas, Ljubisavljevic, & Deligianni, 2017) and poor sleep quality (Adamo et al, 2018).…”

<p>Therapeutic Dose of Amitriptyline for Older Patients with Burning Mouth Syndrome</p>

“…The most common cancer was breast cancer (10 patients). Ariyawardana et al 21 reported that patients with Parkinson's disease, autoimmune diseases, and diabetes were often excluded from BMS studies. In our study, there were no patients with Parkinson's disease or autoimmune diseases.…”

Salivary Biomarkers and Their Correlation with Pain and Stress in Patients with Burning Mouth Syndrome

“…The epidemiological data on BMS are largely contradictory, in part because of a lack of strict compliance with the diagnostic criteria of the disorder. Nevertheless, BMS is estimated to affect 4% of the general population and 18-33% of all postmenopausal women [2][3][4][5][6]. The symptoms are generally focused on the tongue and lips and are almost always bilateral.…”