Xerostomia and prevention of dryness with a Pycnogenol® mouth spray: a pilot study.

Background: The aim of this pilot, supplement study was the evaluation of primary, idiopathic mucosal mouth dryness (xerostomia or dry mouth) in subjects without systemic diseases.

Methods: Subjects with xerostomia were managed either with standard management (SM) or with SM and a Pycnogenol^® mouth spray (Hankintatukku Oy, Karkkila, Finland), at the dosage of 60 mg/day in 30 spurts, for 2 weeks.

Results: A total of 50 subjects were included in the study: 25 controls using only standard management (SM) and 25 subjects using the Pycnogenol^® mouth spray. No side effects and no tolerability problems were observed with the Pycnogenol^® mouth spray. The groups were comparable for characteristics and symptoms at baseline. These otherwise healthy subjects had a BMI<26. After 2 weeks, salivary flow and salivary oxidative stress (in Carr Units) were improved significantly with Pycnogenol^® mouth spray as compared to controls (P<0.05), whereas minimal improvements in salivary flow were seen with SM. The subjective symptomatic dry mouth score and the number of mucosal breaks and ulcerations (all minimal, <1 mm in length or diameter) were significantly decreased with the Pycnogenol^® mouth spray supplement compared to SM controls (P<0.05). The Pycnogenol^® mouth spray led to significant improvement in salivary lysozyme levels, compared to controls (P<0.05).

Conclusions: Based on these preliminary results, Pycnogenol^® mouth spray could be a new supplementary option for the management of primary xerostomia.