Aims: To carry out a systematic review of previous studies to determine the effectiveness of any intervention vs placebo for relief of symptoms and improvement in quality of life of patients with burning mouth syndrome (BMS) and to assess the quality of the studies. Methods: Electronic databases, conference proceedings, and bibliographies of identified publications were searched (up to September 2001) to identify relevant literature, irrespective of language of publication. Randomized controlled trials and controlled clinical trials of interventions used for the treatment of BMS in comparison to a placebo were included. The primary outcome was relief of burning/discomfort. The screening of studies, validity assessment, and data extraction were undertaken independently and in duplicate. Since statistical pooling of data was inappropriate, a qualitative assessment was undertaken. Results: Seven trials, evaluating antidepressants, cognitive behavioral therapy, analgesics, hormone replacement therapy, and vitamin complexes, met the inclusion criteria. None of the trials was able to provide conclusive evidence of effectiveness. However, cognitive behavioral therapy may be beneficial in reducing the intensity of the symptoms. Conclusion: Given that the research evidence is, as yet, unable to provide clear, conclusive evidence of an effective intervention, clinicians need to provide support and understanding when dealing with BMS sufferers. Psychological interventions that help patients to cope with symptoms may be of some use, but promising and new approaches to treatment still need to be evaluated in good-quality randomized controlled trials. Schlagwörter: burning mouth syndrome, randomized controlled trials, systematic review