• J M Zakrzewska, A M Glenny, and H Forssell.
• Oral Medicine, St Bartholomew's and the Royal London, Turner Street, London, UK, E1 2AD.
• Cochrane Db Syst Rev. 2001 Jan 1(3):CD002779.

BackgroundThe complaint of a burning sensation in the mouth can be said to be a symptom of other disease or a syndrome in its own right of unknown aetiology. In patients where no underlying dental or medical causes are identified and no oral signs are found, the term burning mouth syndrome (BMS) should be used. The prominent feature is the symptom of burning pain which can be localised just to the tongue and/or lips but can be more widespread and involve the whole of the oral cavity. Reported prevalence rates in general populations vary from 0.7% to 15%. Many of these patients show evidence of anxiety, depression and personality disorders.ObjectivesThe objectives of this review are to determine the effectiveness and safety of any intervention versus placebo for relief of symptoms and improvement in quality of life and to assess the quality of the studies.Search StrategyElectronic databases (The Cochrane Library, the Cochrane Oral Health Group's Specialised Register, MEDLINE, EMBASE), Clinical Evidence Issue No. 3, conference proceedings and bibliographies of identified publications were searched to identify the relevant literature, irrespective of language of publication.Selection CriteriaStudies were selected if they met the following criteria: study design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) which compared a placebo against one or more treatments; participants - patients with burning mouth syndrome, that is, oral mucosal pain with no dental or medical cause for such symptoms; interventions - all treatments that were evaluated in placebo-controlled trials; primary outcome - relief of burning/discomfortData Collection And AnalysisArticles were screened independently by two reviewers to confirm eligibility and extract data. The reviewers were not blinded to the identity of the studies. The quality of the included trials was assessed independently by two reviewers, with particular attention given to allocation concealment, blinding and the handling of withdrawals and drop-outs. Due to differences in patient type, treatment and outcome measures, statistical pooling of the data was inappropriate.Main ResultsSix trials were included in the review. The interventions examined were antidepressants (two trials), cognitive behavioural therapy (one trial), analgesics (one trial), hormone replacement therapy (one trial) and vitamin complexes (one trial). The participants included in the six identified trials reported suffering from BMS from six months to 20 years. Diagnostic criteria were not always clearly reported. Out of the six trials included in the review, only two interventions demonstrated a reduction in BMS symptoms; vitamin complexes and cognitive behavioural therapy. Neither of these studies reported using blind outcome assessment. Although none of the other treatments examined in the included studies demonstrated a significant reduction in BMS symptoms, this may be due to methodological flaws in the trial design, or small sample size, rather than a true lack of effect.Reviewer's ConclusionsGiven the chronic nature of BMS, the need to identify an effective mode of treatment for sufferers is vital. However, there is little research evidence that provides clear guidance for those treating patients with BMS. Further trials, of high methodological quality, need to be undertaken in order to establish effective forms of treatment for patients suffering from BMS.

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