Abstract
Introduction
Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18% to 33%.
Methods and outcomes
We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of selected treatments for burning mouth syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2015 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview).
Results
At this update, searching of electronic databases retrieved 70 studies. After deduplication and removal of conference abstracts, 45 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 25 studies and the further review of 20 full publications. Of the 20 full articles evaluated, one systematic review and nine RCTs were added at this update. We performed a GRADE evaluation for five PICO combinations.
Conclusions
In this systematic overview, we categorised the efficacy for six interventions based on information about the effectiveness and safety of alphalipoic acid, benzodiazepines, benzydamine hydrochloride, cognitive behavioural therapy (CBT), selective serotonin re-uptake inhibitors (SSRIs), and tricyclic antidepressants.
Key Points
Burning mouth syndrome is characterised by discomfort or pain of the mouth, with no known medical or dental cause. It is often localised to the tongue and/or lips but can be more widespread and involve all the oral mucosa. It may affect up to one third of postmenopausal women and up to 15% of adults overall. It is a diagnosis of exclusion once other causes of possible burning have been ruled out.
Symptoms of burning mouth can also be caused by infections, allergies, vitamin deficiencies, and ill-fitting dentures, leading to problems identifying effective treatments.
Patients with burning mouth syndrome often also report subjective xerostomia, oral paraesthesia, and/or altered taste.
Psychogenic factors may be involved in some people, such as anxiety, depression, or personality disorders, and could be related to dopaminergic hypofunction.
People with burning mouth syndrome may show altered sensory and pain thresholds, or other signs of neuropathy. However, it remains unclear whether central or peripheral mechanisms are involved.
Complete spontaneous remission occurs in only a small percentage of people, and up to 30% will note moderate improvement with or without treatment.
We searched for evidence from RCTs and systematic reviews of RCTs on selected interventions in people with burning mouth syndrome.
Cognitive behavioural therapy may improve symptom intensity compared with placebo in people with burning mouth syndrome, although we found no good-quality studies.
Clonazepam may reduce pain compared with placebo in people with burning mouth syndrome, but even when it is administered topically it may be absorbed systemically, with increased risk of dependence over time.
We don't know whether tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), or benzydamine hydrochloride can improve symptoms of burning mouth, as we found few studies.
Given the lack of knowledge about mechanisms involved, both local and centrally acting treatments may be effective. Given its significant impact on quality of life and mood, antidepressants may have a role to play.
There is insufficient evidence to show that the dietary supplement alphalipoic acid, used in a variety of forms, has an impact on symptom relief.
Concerning the evidence overall, it was important to ascertain that the diagnostic criteria were fulfilled. Outcome measures are varied and, even if the same ones are used, they are applied differently, thus making comparisons of trials difficult. There is a high risk of bias in the majority of studies.
Clinical context
General background
Burning mouth syndrome is characterised by discomfort or pain of the mouth, with no known medical or dental cause. It is often localised to the tongue and/or lips but can be more widespread and involve all the oral mucosa. It has increasing prevalence in older women, affecting up to one third of postmenopausal women and up to 15% of adults overall.
Focus of the review
Despite being relatively common, burning mouth syndrome is rarely recognised by medical practitioners, and yet it has a significant impact on quality of life. For this update, we have examined the evidence for selected interventions that may be considered to manage the symptoms.
Comments on evidence
Many studies do not provide diagnostic criteria, and it cannot be ascertained whether medical or dental causes for burning mouth were excluded. There is a wide heterogeneity of treatments used, and outcome measures vary, with few providing measures of quality of life, which makes it difficult to compare treatments. The adverse effects of treatments are poorly documented. In some RCTs, there is a high placebo response (one systematic review evaluating the placebo response in studies on treatments for burning mouth syndrome found a positive placebo response in 6 out of 12 RCTs).[1] More attention needs to be paid to this effect when designing trials.
Search and appraisal summary
The update literature search for this overview was carried out from the date of the last search, November 2009, to January 2015. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the overview, please see the Methods section. Searching of electronic databases retrieved 70 studies. After deduplication and removal of conference abstracts 45 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 25 studies and the further review of 20 full publications. Of the 20 full articles evaluated, one systematic review and nine RCTs were added at this update.
Additional information
Acknowledgement that this condition has a neurophysiological basis and is not purely psychiatric helps patients come to terms with the disorder, especially if they meet fellow sufferers.
About this condition
Definition
Burning mouth syndrome (BMS) is an idiopathic burning discomfort or pain affecting people with clinically normal oral mucosa, in whom a medical or dental cause has been excluded.[2] [3] [4] Terms previously used to describe what is now called burning mouth syndrome include glossodynia, glossopyrosis, stomatodynia, stomatopyrosis, sore tongue, and oral dysaesthesia.[5] A survey of 669 men and 758 women randomly selected from 48,500 people aged 20 to 69 years found that people with burning mouth also have subjective dryness (66%), take some form of medication (64%), report other systemic illnesses (57%), and have altered taste (11%).[6] Local and systemic factors (such as infections, allergies, ill-fitting dentures,[7] hypersensitivity reactions,[8] and hormone and vitamin deficiencies[9] [10] [11]), as well as side effects of drugs, may cause the symptom of burning mouth and should be excluded before diagnosing burning mouth syndrome. This overview deals only with idiopathic BMS. The new classification of the International Headache Society (ICHD) supports these criteria.[12]
Incidence/ Prevalence
The epidemiological data are of poor quality. Incidence and prevalence vary according to diagnostic criteria,[5] and many studies have included people with the symptom of burning mouth, rather than with BMS as defined above. BMS mainly affects women,[13] [14] [15] particularly after the menopause, when its prevalence may be 18% to 33%.[16] One study in Sweden found a prevalence of 4% for the symptom of burning mouth without clinical abnormality of the oral mucosa (11/669 [2%] men, mean age 59 years; 42/758 [6%] women, mean age 57 years), with the highest prevalence (12%) in women aged 60 to 69 years.[6] Reported prevalence in general populations varies from 1% to 15%.[13] However, there may be several aetiological factors behind BMS. One oral clinical examination survey in the general adult population in Finland found that 15% of the individuals surveyed had experienced BMS. However, when people with mucosal lesions, oral candidiasis, or both were excluded, the frequency decreased to 8%. Less than 1% of people reported continuous BMS complaints.[13]
Aetiology/ Risk factors
Although the aetiology remains unknown, there are increasing numbers of studies providing evidence that both peripheral and central changes are involved, and that BMS may be a neuropathic pain. Neurophysiological changes have been reported both when using thermal quantitative sensory testing (QST) and with blink reflexes.[17] [18] [19] Electrogustatometric studies have provided evidence for dysfunction of the chordi tympani.[20] [21] [22] Biopsies from the tongue have shown loss of epithelial nerve fibres.[23] [24] [25] [26] Changes on functional MRIs have also been demonstrated; these changes are similar to those seen in neuropathic pain. Positron emission tomography (PET) studies support the theory that there is a decrease of endogenous dopamine.[27] [28] Psychological factors have been extensively studied for many years,[29] [30] and the high psychological or psychiatric comorbidity could be mediated by dysfunctional brain dopamine activity.
Prognosis
We found no prospective cohort studies describing the natural history of BMS.[31] We found anecdotal reports of at least partial spontaneous remission in about 50% of people with BMS within 6 to 7 years. However, a retrospective study assessing 53 people with BMS (48 women and 5 men, mean duration of BMS 5.5 years, mean follow-up 56 months) found a complete spontaneous resolution of oral symptoms in 4% of people who received no treatment. Overall, 28% of people (15/53) experienced a moderate improvement with or without treatment.[32] One study in 32 patients who were provided with individual treatments for BMS did show improvement in all patient-reported outcome measures at 16 weeks.[33]
Aims of intervention
To alleviate symptoms, with minimal adverse effects.
Outcomes
Symptom relief self-reported relief of symptoms (burning mouth, altered taste, dry mouth, pain); visual analogue scale (VAS) (measure of severity of BMS pain/discomfort or relief); incidence and severity of anxiety and depression (e.g., the Beck Depression Inventory, Hospital Anxiety and Depression Scale [HADS], Hamilton Anxiety rating scale); quality of life using a validated ordinal scale (e.g., Medical Outcome Short Form Health Survey [SF-36]) and the impact of oral health on patients' quality of life (Oral Health Impact Profile [OHIP-14 or 49]). Adverse effects.
Methods
Search strategy BMJ Clinical Evidence search and appraisal date January 2015. Databases used to identify studies for this systematic overview include: Medline 1966 to January 2015, Embase 1980 to January 2015, The Cochrane Database of Systematic Reviews 2015, issue 1 (1966 to date of issue), the Database of Abstracts of Reviews of Effects (DARE), and the Health Technology Assessment (HTA) database. Inclusion criteria Study design criteria for inclusion in this systematic overview were systematic reviews and RCTs published in English, at least single-blinded, and containing more than 20 individuals, of whom more than 80% were followed up. There was no minimum length of follow-up. We excluded all studies described as 'open', 'open label', or not blinded unless blinding was impossible. BMJ Clinical Evidence does not necessarily report every study found (e.g., every systematic review). Rather, we report the most recent, relevant, and comprehensive studies identified through an agreed process involving our evidence team, editorial team, and expert contributors. Evidence evaluation A systematic literature search was conducted by our evidence team, who then assessed titles and abstracts, and finally selected articles for full text appraisal against inclusion and exclusion criteria agreed a priori with our expert contributors. In consultation with the expert contributors, studies were selected for inclusion and all data relevant to this overview extracted into the benefits and harms section of the overview. In addition, information that did not meet our pre-defined criteria for inclusion in the benefits and harms section may have been reported in the 'Further information on studies' or 'Comment' section. Adverse effects All serious adverse effects, or those adverse effects reported as statistically significant, were included in the harms section of the overview. Pre-specified adverse effects identified as being clinically important were also reported, even if the results were not statistically significant. Although BMJ Clinical Evidence presents data on selected adverse effects reported in included studies, it is not meant to be, and cannot be, a comprehensive list of all adverse effects, contraindications, or interactions of included drugs or interventions. A reliable national or local drug database must be consulted for this information. Comment and Clinical guide sections In the Comment section of each intervention, our expert contributors may have provided additional comment and analysis of the evidence, which may include additional studies (over and above those identified via our systematic search) by way of background data or supporting information. As BMJ Clinical Evidence does not systematically search for studies reported in the Comment section, we cannot guarantee the completeness of the studies listed there or the robustness of methods. Our expert contributors add clinical context and interpretation to the Clinical guide sections where appropriate. Structural changes this update At this update, we have split the previously reported option on Antidepressants into two separate options, Selective serotonin re-uptake inhibitors and Tricyclic antidepressants. We have removed the previously reported options on HRT, local anaesthetics, and dietary supplements and added the option, Alphalipoic acid. Data and quality To aid readability of the numerical data in our overviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). BMJ Clinical Evidence does not report all methodological details of included studies. Rather, it reports by exception any methodological issue or more general issue that may affect the weight a reader may put on an individual study, or the generalisability of the result. These issues may be reflected in the overall GRADE analysis. We have performed a GRADE evaluation of the quality of evidence for interventions included in this overview (see table ). The categorisation of the quality of the evidence (into high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the BMJ Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table 1.
GRADE evaluation of interventions for burning mouth syndrome
| Important outcomes | Symptom relief, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of selected treatments for burning mouth syndrome? | |||||||||
| 1 (30) [29] | Symptom relief | CBT v control | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and uncertainty about methods of validation of outcomes; directness point deducted for uncertainty about comparisons between the groups |
| 3 (134) [43] [44] [45] | Symptom relief | Benzodiazepines v placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data; directness point deducted for differences in regimens and duration of treatment and follow-up across studies |
| 1 (76) [54] | Symptom relief | SSRIs v each other | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results; directness point deducted for differences in disease state |
| 1 (30) [47] | Symptom relief | Benzydamine hydrochloride v placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and blinding flaws |
| 7 (340) [35] [36] [37] [38] [39] [40] [41] | Symptom relief | Alphalipoic acid v placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for methodological flaws (incomplete reporting of results, imbalance in numbers of people in groups in some RCTs, and lack of statistical assessment of between-group difference in some RCTs); directness point deducted for variation in doses of alphalipoic acid used across studies and variation in outcome assessment |
Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies. Directness: generaliseability of population or outcomes. Effect size: based on relative risk or odds ratio.
Glossary
- Beck Depression Inventory
Standardised scale to assess depression. This instrument consists of 21 items to assess the intensity of depression. Each item is a list of 4 statements (rated 0, 1, 2, or 3), arranged in increasing severity, about a particular symptom of depression. The range of scores possible are 0 = least severe depression to 63 = most severe depression. It is recommended for people aged 13 to 80 years. Scores of more than 12 or 13 indicate the presence of depression.
- Hamilton Anxiety Scale (HAM-A)
The HAM-A is a validated instrument consisting of 14 items scored on a 5-point scale, ranging from 0 (not present) to 4 (severe), to give a total score of between 0 and 56.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Short Form-36 [SF-36] Health Survey
Includes one multi-item scale that assesses eight health concepts: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health (psychological distress and wellbeing), limitations in usual role activities because of emotional problems, vitality (energy and fatigue), and general health perceptions. The survey was constructed for self-administration by people aged 14 years or older, and for administration by a trained interviewer in person or by telephone.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Joanna Zakrzewska, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, UCLH NHS Foundation, London, UK.
John A. G. Buchanan, Barts and The London School of Medicine and Dentistry, Dental Institute, Royal London Hospital, London, UK.
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