Efficacy of lycopene‐enriched virgin olive oil for treating burning mouth syndrome: a double‐blind randomised

Burning mouth syndrome (BMS) is an intensive chronic oral mucosal pain condition of unknown aetiology. The aim of this study was to evaluate the clinical performance of lycopene‐enriched virgin olive oil used to treat the condition, comparing this with a placebo. This study took the form of a double‐bind, randomised clinical trial. A total of 60 patients with BMS were randomly divided into two groups: Group I (n = 30) treated with lycopene‐enriched virgin olive oil (300 ppm) (1·5 mL three times a day) and Group II (n = 30) treated with a placebo (1·5 mL three times a day). Evaluations were made before and after 12 weeks of product/placebo application. Symptoms were evaluated by VAS, whilst patient psychological profiles were assessed using the HAD scale and patient quality of life using the Oral Health Impact Profile‐14 (OHIP‐14) and the Medical Outcome Short Form Health Survey questionnaire (SF36). Fifty patients completed the 12‐week treatment (26 in Group I and 24 in Group II). Visual analogue scale pain values improved in both groups but without statistically significant differences between the groups (P = 0·57). Oral quality of life also improved. Four patients in Group I (treatment) left the study and six left Group II (placebo). No patients experienced any adverse effects resulting from treatment at any of the evaluation times. Patients were lost from the sample due to lack of compliance. It was found that the lipid profile did not change during the 3‐month study period as a result of the application of lycopene‐enriched olive oil (Group I); nor did any change occur in the placebo group (Group II). In this way, the placebo effect was seen to be strong. The topical lycopene‐enriched virgin olive oil is a very safe and an effective similar way that the placebo for treating patients with BMS. However, future studies are required to establish the treatment for patients with chronic and painful syndrome.