Randomized Double-Blind Placebo-Controlled Study of Salivary Substitute with Enzymatic System for Xerostomia in Patients Irradiated in Head and Neck Region

Abstract

This study aims to compare whether the use of a salivary substitute including an enzymatic system clinically reduces the intensity of xerostomia, as well as exploring the impact that this has on the quality of life, in patients who had received radiotherapy in the head and neck (HNC) region. Forty patients who had completed radiotherapy treatment within 6 months to 1 year previously were allocated into an Enzymatic Spray group (n = 21) or a Placebo arm (n = 19). It should be noted that two patients in the Placebo arm declined to participate during phase 2 of the study. All patients were randomized and used both products three times a day for 30 days. For analysis, xerostomia grade, unstimulated (UWS) and stimulated (SWS) salivary flow rate, and quality of life through the University of Washington Quality of Life Questionnaire validated in Portuguese (UW-QoL) were assessed in two phases: Phase 1 (before the use of the products) and Phase 2 (after 30 days of using the products). All clinical data were collected from medical records. Analyzing the salivary substitute with the enzymatic system, an improvement in xerostomia complaints was observed 30 days after using the product; however, this difference was not statistically significant (p > 0.05). Regarding quality of life, no significant differences were observed in relation to the UW-QoL and saliva domain between the groups in the two phases of the study (p > 0.05). The salivary substitute with the enzymatic system may be effective in reducing radio-induced xerostomia symptoms; however, further research is necessary to evaluate the efficacy of this salivary substitute on oral health.