Hypericum perforatum extract in burning mouth syndrome: a randomized placebo‐controlled study

Abstract

Burning mouth syndrome (BMS) or stomatodynia is characterized by a spontaneous burning pain in the oral mucosa without known cause or recognized treatment. This double-blind, randomized, placebo-controlled, single-center study evaluated the effects of systemic Hypericum perforatum extract in patients with BMS. Forty-three patients participated, of whom 39 (35 women, four men, aged 64.9 +/- 4.7 years) completed the study. The patients took indistinguishable 300-mg capsules containing either H. perforatum extract (hypericin 0.31% and hyperforin 3.0%) or placebo three times a day for 12 weeks. The intensity of burning pain was evaluated using a 10-cm visual analog scale (VAS) before the first dose and at visits after 4, 8, and 12 weeks. Furthermore, we also recorded the number of oral mucosa sites with reported burning symptoms and the self-reported descriptions of the patient's condition before and after the treatment. Pain, measured using the VAS, was similar at the beginning of the study and even though a slightly better performance in the test group, the difference was not statistically significant (P = 0.2216). The results failed to demonstrate that 300 mg of H. perforatum extract taken three times a day for 12 weeks improved the pain of BMS patients, although the general reduction in the number of sites with reported burning sensation, a less accurate and objective score, was significant.

Randomized trials for the treatment of burning mouth syndrome: an evidence‐based review of the literature

“…Improvement of symptoms was evaluated in most studies by VAS. Quality of life was not evaluated in any of the trials, but anxiety and depression were assessed by the Beck Depression Inventory and/or Hospital Anxiety and Depression in three studies (8, 16, 17). Two studies also evaluated pain using the McGill Pain scale (6, 19).…”

“…(8) were excluded because no control group was included in the first study, the second study investigated dysgeusia instead of BMS, and the third study evaluated the presence of two nervous components (central and peripheral) in BMS instead of the efficacy of treatment. Thus, nine RCTs evaluating treatment strategies for BMS were identified in the PubMed database (1, 2, 6, 10, 14–18) and 11 in the Scopus database (1, 2, 6, 7, 9, 10, 14–16, 18, 19). Final selection of the publications identified in the two databases resulted in 12 articles that met the previously established inclusion criteria and that were submitted to critical analysis: Sardella et al.…”

Burning Mouth Syndrome

“…Sardella et al 46 have conducted a randomized controlled trial to test the therapeutic efficacy of hypericum perforatum (900 mg/d for 12 weeks) in 43 BMS patients. The modification of pain intensity on VAS did not differ between groups (P = 0.2).…”

St. John’s Wort – an Overview

“…No effects over placebo have been found in hyperactive children [65], social phobia [66], pain in polyneuropathy [67], and burning mouth syndrome [68]. A short report described positive findings from two trials in patients with herpes simplex genitalis and labialis [69].…”