Clinical trial of ambroxol (Mucosolvan) in Sjögren's syndrome.

A clinical trial is described in which twelve patients with Sjögren's Syndrome (SS) were given a dose of 135 mg ambroxol (Mucosolvan) daily for eight weeks. Nine of the patients completed the trial. Three patients dropped out because they developed side effects (generalized rashes in two patients and stomatitis in one). The side effects, however, were mild and cleared off after cessation of treatment. Ambroxol improved sicca symptoms, especially ocular symptoms, in the SS patients, although lacrimal and salivary gland functions measured by Schirmer test or gum test were not changed. Furthermore, the treatment did not alter any chemical findings determined in the stimulated tear and saliva. Our results suggest that ambroxol is useful for the management of sicca symptoms in some patients with SS.