The efficacy of Xialine® in patients with Sjögren’s syndrome: a single-blind, cross-over study

Abstract

Sjögren syndrome (SS) is a chronic inflammatory autoimmune disease of unknown cause whose main characteristic is severe dryness of the eyes and the mouth. The decreased functional capacity of the lacrimal and salivary glands which is the result of the inflammatory process and lymphocytic infiltration observed in SS is accountable for this complication. Twenty-nine patients with SS whose ages were ranging between 24-77, who were under treatment in Ege University Faculty of Medicine Department of Rheumatology, participated in the study, and their informed consents were obtained upon enrollment. Each patient recorded their subjective complaints on a separate questionnaire. The baseline and subsequent evaluation of the subjective findings on predetermined times (1 h after application of the material, at the end of the 1st, 7th, and 14th days) were also recorded on separate questionnaire sheets. Throughout the 14-day treatment period, no statistically significant differences were noted between the Xialine and placebo groups with regard to burning tongue, diminished taste, and waking up at night to sip water (p = 0.925, 0.527, and 0.066, respectively). However, patients' satisfaction with placebo decreased by 25.63% at the end of the test period, whereas it increased by 16.37% after Xialine administration. Overall, the patients preferred Xialine at the end of the study (p = 0.011). The main motive to administer saliva substitute is to improve lubrication and hydration of oral tissues. The results of this study indicated that Xialine is helpful in the management of xerostomia-related symptoms of SS patients. However, further investigations in larger scale group of patients are recommended to provide the effects of these agents on various complaints of xerostomia.

Queixas fonoaudiológicas e verificação da fala de indivíduos com diagnóstico de ardência bucal e xerostomia

“…Dry mouth can affect the oral mucosa as a whole (20) , but subjects also state that structures such as the lips (21) and the oropharynx (16,22) are also affected. The symptom can occur continuously (23) , with periods of considerable discomfort (20) .…”

“…Xerostomia is constantly described in association with burning mouth (2,15,23,24) and change in taste (4,8) . The presence of taste disorders can exacerbate oral discomfort and impair both the appetite and food intake, affecting the individual's quality of life (24) .…”

“…The presence of taste disorders can exacerbate oral discomfort and impair both the appetite and food intake, affecting the individual's quality of life (24) . Subjects also inform the use of strategies and/or medication in order to try to alleviate oral discomfort, to minimize the symptomatology (19,23) . Because xerostomia is related to multiple factors, and due to its frequent association with other oral symptoms, treatments have palliative effects and aim to reduce oral discomfort, in order to diminish the several complaints of individuals with dry mouth symptom (14,18,19,23) .…”

“…Many studies refer to the impact of dry mouth on speech, mastication and swallowing (14)(15)(16)(17)(18)(19)(23)(24)(25)(26) , as well as on the voice (27) . Complaints referring to xerostomia are usuallly identified by means of questionnaires (15)(16)(17)19,23,25) .…”

“…Complaints referring to xerostomia are usuallly identified by means of questionnaires (15)(16)(17)19,23,25) . Some studies try to investigate objectively the impairment of the oral functions related to dry mouth and/or hyposalivation (17,28) ; however, few studies have reported the association of this symptom and speech (29,30) .…”