Prospective, randomized, double-blind, clinical evaluation of Aloe vera Barbadensis, applied in combination with a tongue protector to treat burning mouth syndrome Pia López-Jornet, Fabio Camacho-Alonso, Diana Molino-Pagan Department of Oral Medicine, Faculty of Medicine and Dentistry, University of Murcia Murcia, Spain OBJECTIVES: The aim of this study was to evaluate the efficacy of aloe vera (AV) applied in combination with a tongue protector, comparing this with a placebo. METHODS: A total of 75 patients with burning mouth syndrome (BMS) were divided into three groups ran- domly: Group I (tongue protector three times a day), Group II (tongue protector and 0.5 ml AV at 70% three times a day) and Group III (tongue protector and 0.5 ml placebo three times a day). Symptoms were evaluated by visual analogue scale (VAS), while patient psychological profiles were assessed using the Hospital Anxiety- Depression scale and their quality of life using the Oral Health Impact Profile 49 (OHIP-49). Treatment contin- ued for 3 months. RESULTS: Visual analogue scale pain values improved for all three study groups but without statistically significant differences between the groups (P = 0.210). Regarding quality of life, no significant differences were found between groups with the exception of the OHIP-49 score for handicap. The overall clinical improvement was greater for Group II, with a difference almost reaching significance. CONCLUSIONS: The concomitant prescription of ton- gue protector and AV is effective for treating patients with BMS. J Oral Pathol Med (2012) Keywords: aloe vera; efficacy; pain; quality of life; topical treat- ment Introduction Burning mouth syndrome (BMS) is manifested as a subjective burning sensation of the tongue, lips or entire oral cavity, but does not manifest any objective lesions or laboratory test findings capable of accounting for the discomfort (1). BMS is more common among women in middle-aged to elderly age groups (2, 3) and prevalence is estimated to be 0.7–4.6% of the general population. The causes of BMS remain open to controversy. Its aetiological factors have been classified as local and systemic (3–9) BMS is considered to be idiopathic/primary when the cause is impossible to determine and secondary when it is possible to identify the syndrome’s aetiological factors (1). Some researchers have claimed that it is related to neuropathic pain rather than to somatoform chronic pain syndromes (2, 4 –6, 10–12). To date, the treatment for BMS has been largely empirical and depends on the individual patient’s condition and the physician’s preference. No single effective treatment appli- cable to most patients with BMS has been found. Never- theless, many treatments have been recommended for improving the symptoms of BMS, including sialogogues, topical anaesthetics in rinses, anxiolytic drugs, antidepres- sants, anticonvulsivants, alpha-lipoic acid and psychother- apy (13–22), although these have limited results. However, Heckmann et al. (23) have found that clonazepam appears to have a positive effect on pain in BMS patients. Aloe vera (AV – Aloe Barbadensis Miller) is a member of the Liliacea family. It is widely used as a natural treatment and alternative therapy for various disorders and diseases. Clinical studies have confirmed the potential of topical AV in promoting the healing process in the treatment of burns, psoriasis and oral lichen planus (OLP) (24–28). Recently, various studies have reported that patients with OLP treated with topical applications of AV experienced some improvement. In effect, 81% of patients with OLP treated with AV were seen to improve, with 7% undergoing complete remission (24). Nevertheless, topical application of AV has not come into common use. The hypothesis of this study is that the control of oral parafunctional habits together with the application of topical AV can protect the oral mucosa from repetitive trauma and decrease the oral discomfort associated with BMS. This study was designed to evaluate the efficacy of a tongue protector in combination with topical AV applied three Correspondence: Pía López-Jornet DDS, MD, PhD, Hospital Morales Meseguer, Clínica Odontológica Universitaria. Medicina Bucal, Avda. Marques de los Velez s/n, 30008 Murcia, Spain. Tel: +34 + 868 398 588, Fax: +34 + 868 398 576, E-mail: majornet@um.es Accepted for publication July 27, 2012 doi: 10.1111/jop.12002 J Oral Pathol Med © 2012 John Wiley & Sons A/S. All rights reserved wileyonlinelibrary.com/journal/jop