Action of homeopathic treatment in the Symptoms of burning mouth syndrome in two phases: double-blind placebo controlled study and open trial study

Burning mouth syndrome (BMS) is defined as a burning sensation mainly on the tongue, palate and/or gingival or in any other region of the oral mucosa, in the absence of specific oral lesions. BMS is typically characterized by a continuous, spontaneous, and often intense burning sensation as if the mouth or tongue were scaled or on fire. The etiology of this disorder is poorly understood even though new evidence of involvement of neurological, emotional and hormonal alterations. The correct diagnosis of BMS and the exclusion of possible local or systemic factors that can be associated with the symptoms are fundamental. It is most common among postmenopausal women and causes intense discomfort and suffering. This condition often affects the health related quality of life in patients. Tricyclic antidepressants, benzodiazepines and antipsychotic drugs are the most accepted options in treatment and show variable results. The aims of this study were to investigate the action of homeopathy treatment in the symptomatological burning mouth syndrome in two phases: double-blind placebo controlled study and open trial study. Association of BMS with level of anxiety and depression had been considered. This study comprised data from 31 patients diagnosed with BMS in the outpatients Clinic of the Department of Stomatology, FOUSP, between July, 2011 and September, 2012. Thirty-one patients (25 women, 6 men median age 58.93 years, range 34-85), were randomized in two groups G1 (Arsenicum album) and G2 (Placebo) during 90 days, with washout for 30 days (PHASE 1).The oral symptoms and the treatment response were assessed using visual analogue scale (VAS) before and after the treatment and the global perceived effect (GPE) score using 5 point scale at the end of the PHASE 1. The level of burning reduction assessed by VAS was significant (44.50% with Arsenicum album and 12.65% with Placebo). In the PHASE 2, twenty-eight patients that participate of the PHASE 1, received individualized homeopathic medication during 7 months, with monthly visits and washout for 60 days. The symptoms and therapeutic response were assessed using VAS before and after treatment and the global perceived effect (GPE) at the end of PHASE 2. The level of burning reduction assessed by VAS was 64.60%. We concluded that both treatment PHASE1 and PHASE 2 had therapeutic effectiveness with statistical significance. The use of arsenicum album was better than Placebo to control the BMS symptoms. PHASE 2 showed the best results when compared to PHASE 1. The medication Group in PHASE 2 was more effective when compared to the groups, arsenicum album and Placebo of the PHASE 1, with statistical significance. The best results were observed in the patients between 6-36 months under treatment.