Benzydamine hydrochloride oral rinses in management of burning mouth syndrome: A clinical trial☆,☆☆

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Abstract

Objective. The purpose of this study was to evaluate the efficacy of the topical use of benzydamine hydrochloride 0.15% oral mouthwashes in the control of burning mouth syndrome symptoms. Study Design. In this double-blind, randomized, longitudinal investigation, each of 30 patients with burning mouth syndrome was assigned to one of 3 management modalities. Those in group A received an oral rinse solution of benzydamine hydrochloride 0.15% 3 times a day for 4 weeks, those in group B received a placebo 3 times a day for 4 weeks, and those in group C did not receive any kind of treatment. A visual analog scale was used for evaluation of the symptoms; a Kruskal-Wallis analysis of variance exact test was performed on the resulting data. Results. The findings of this investigation failed to reveal significant differences among the groups. Conclusions. The clinical application of benzydamine hydrochloride oral rinses in the treatment of patients with burning mouth syndrome did not demonstrate significative efficacy in comparison with use of a placebo solution. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;88:683-6)

Section snippets

PATIENTS AND METHODS

This study was a double-blind, randomized, longitudinal investigation. Protocol and consent forms were evaluated and approved by the University Ethics Committee. Patients referred to the Department of Oral Pathology and Oral Medicine, University of Milan, during the period from January 1996 through July 1998 with a provisional diagnosis of burning mouth syndrome (BMS) were considered for the study.

The criterion for admission was the diagnosis of “idiopathic” or “essential” burning mouth

RESULTS

Thirty patients with “essential” BMS were enrolled in this study. There were 26 women and 4 men (female-male ratio, 6.5:1); the mean age was 69 years (range, 54-85 years). The symptom most frequently reported was burning sensation (28 patients; 93%), followed by bitter taste (8 patients; 26.5%), stinging sensation (6 patients; 20%), pain (4 patients; 13%), and thick saliva (4 patients; 13%). Symptoms were most frequently localized at the tongue (86%), lip (53%), hard and soft palate (43%),

DISCUSSION

Burning mouth is a quite common complaint. It affects postmenopausal women most frequently.2, 3, 14 Despite the high prevalence of the disorder, its features have never been rigidly characterized, and as a consequence, strict diagnostic criteria have never been discussed.

In our opinion and that of other authors,9, 10 it is important to distinguish between a patient experiencing burning mouth syndrome and a patient who has a burning mouth but in whom one or more etiologic factors are

Acknowledgements

We are grateful to Andrea E. Smith for her assistance in the preparation of the manuscript.

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