Effect of an herbal compound for treatment of burning mouth syndrome: randomized, controlled, double-blind clinical trial

Abstract

Objective: This randomized, double-blind, placebo-controlled clinical study aimed at evaluating the effect of the systemic use of an herbal compound (Catuama) on the symptoms of burning mouth syndrome (BMS).

Study design: Seventy-two patients with BMS were randomly allocated into test (n = 38) and control (n = 34) groups. Patients were instructed to take 2 capsules each day for 8 weeks. They were reassessed at 4, 8, and 12 weeks after treatment onset using a faces scale (FS) and a visual numeric scale (VNS).

Results: Although both groups demonstrated a reduction in symptoms, the improvement observed in the test group was significantly greater than in the control group after 4 (FS: P = .010) and 8 (VNS: P = .03; FS: P < .001) weeks of treatment. This significant reduction was maintained 12 weeks after treatment onset (FS, VNS: P = .001).

Conclusions: The systemic administration of Catuama reduces the symptoms of BMS and may be a novel therapeutic strategy for the treatment of this disease.