Cevimeline hydrochloride, a specific agonist of the
M3 muscarinic receptor, is beneficial in the treatment of symptoms of
xerostomia and
xerophthalmia associated with Sjögren's syndrome (SS).
Cevimeline has not been evaluated in southern Chinese patients. Furthermore, the effects of
cevimeline on health-related quality of life and oral health status are not known. In this randomised, double-blind, placebo-controlled crossover study, patients received
cevimeline 30 mg or matched placebo three times per day over 10 weeks followed by a 4-week washout period before treatment crossover. Participants self-completed the following questionnaires:
Xerostomia Inventory (XI), the General Oral Health Assessment Index (GOHAI), the Ocular Surface Disease Index (OSDI) and the Medical Outcomes Short Form (SF-36). Clinical assessments included sialometry, examination of the oral cavity for the degree of
xerostomia and dental complications of
xerostomia. Fifty patients (22 primary SS and 28 secondary SS) were enrolled in the trial. Forty-four patients completed the study. There was a significant improvement in the XI and GOHAI scores as well as the objective rating of xerostomic signs of the oral cavity
after treatment with
cevimeline. However, there was no improvement in salivary flow rates and
dry eye symptoms. SS patients had lower SF-36 scores, but these did not improve
after treatment with
cevimeline.