Burning mouth syndrome (BMS) presents as a subjective burning sensation of the tongue, lips or entire oral cavity, but does not manifest any objective lesions or laboratory test findings. BMS is more common in middle-aged to elderly age groups. The aim of this study was to evaluate the efficacy of a tongue protector in combination with topical Aloe vera (AV) comparing this treatment with a placebo
Patients diagnosed with BMS were randomised to 3 groups, Group I used a tongue protector alone, group II the tongue protector and AV (0.5 ml applied three times a day at a concentration of 70%) , group III tongue protector and placebo. The protector was worn during the daytime for a period of 3 months. Use of the protector for 15 min/three times a day was recommended with the therapeutic aim of avoiding continuous rubbing against the teeth and/or dentures. The primary outcome was pain measured on a visual analogue scale (VAS). The Spanish version of the Oral Health Impact Profile-49 (OHIP-49) was used to assess oral health. The Hospital Anxiety-Depression (HAD) scale was then used to evaluate patients’ psychological profiles. A Global perceived effect (GPE) was scored by the patient
- 75 Patients were assigned to 3 groups (25 per group). The were 4 drop outs , 3 in group III and 1 in group II).
- During the 3-month treatment period, the number of patients with severe BMS diminished but without statistically significant differences.
- The VAS scores for pain had decreased after 12 weeks although differences were not significant
- Greater changes in OHIP 49 were seen in group II, and they also had the highest GPE scores but these were not significant.
The authors abstract concludes
The concomitant prescription of tongue protector and AV is effective for treating patients with BMS.
The 2005 Cochrane review by Zakrewska included 9 trials and concluded
Given 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
So it is good to see new trials of potential treatments for this condition and this study doe take on board some of the recommendations for research suggested in the Cochrane review by including other outcomes as well as pain.
The authors did describe conducting a sample size calculation but they did not indicate what the group sizes should be so the reader needs to assume that the sample size was large enough to show differences. Unfortunately although all three groups showed a benefit and there were differences between the groups these were not statistically different
Interesting the authors’ note in the discussion that: -
….results showed that the tongue protector and use of topical AV might be used as an ‘alternative initial approach’ to BMS management
while in the abstract they are more positive.
López-Jornet P, Camacho-Alonso F, Molino-Pagan D. Prospective, randomized, double-blind, clinical evaluation of Aloe vera Barbadensis, applied in combination with a tongue protector to treat burning mouth syndrome. J Oral Pathol Med. 2012 Sep 7. doi: 10.1111/jop.12002. [.Epub ahead of print] PubMed PMID: 22957483.
López-Jornet P, Camacho-Alonso F, Andujar-Mateos P. A prospective, randomized study on the efficacy of tongue protector in patients with burning mouth syndrome. Oral Dis. 2011 Apr;17(3):277-82. doi: 10.1111/j.1601-0825.2010.01737.x. Epub 2010 Sep 23. PubMed PMID: 2086076
Zakrzewska JM, Forssell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD002779. DOI: 10.1002/14651858.CD002779.pub2.