Treatment of xerostomia with the bile secretion-stimulating drug anethole trithione: A clinical trial

Background: Saliva protects the oral mucosa, inhibiting microbial overgrowt h. Hyposalivation, therefore, induces multiple oral disorders, although tre atment of hyposalivation is very difficult. Methods: A cholagogue, anethole trithione (AT) was administered to patients with symptomatic hyposalivatio n (xerostomia) caused by senile hypofunction (4 men and 17 women; senile gr oup), medications (6 men and 17 women; drug group), and oral cancer therapy (two men and three women; cancer group). For control groups, an artificial saliva was administered to 45 patients consisting of senile hypofunction ( 10 men and 16 women), drug-induced xerostomia (3 men and 10 women) and oral cancer therapy-induced xerostomia (four men and two women). Results: Two w eeks after administration of AT (6 tablets per day), both nonstimulated sal ivary flow rate (SFR) and stimulated SFR increased in a statistically signi ficantly manner from 0.76 +/- 0.41 and 5.18 +/- 3.02 to 1.54 +/- 1.33 (P<0. 05) and 9.07 +/- 4.10 mL/10 min (P<0.05), respectively. Of the three groups , the drug group showed the largest increases in both SFRs, from 0.90 +/- 0 .54 and 6.29 +/- 4.12 to 1.69 +/- 1.65 and 12.09 +/- 5.10 mL/10 min (P<0.05 and P<0.02, respectively). Patients in the control group had almost consta nt SFRs. After AT administration, the salivary viscosity was, however, mild ly decreased and concentrations of secretory-immunoglobulin A, lactoferrin, potassium, and chloride in nonstimulated saliva were almost constant. Corr esponding with the increase of salivation, oral discomfort and inflammation were improved or resolved in 41 patients of the AT group within about 4 we eks, whereas improvement was observed in only nine patients of the control group. Conclusions: These results indicate that AT sufficiently stimulates salivation and improves xerostomia.