Efficacy of pilocarpine lozenge for post-radiation xerostomia in patients with head and neck cancer

Background: Patients with radiation-induced xerostomia produce little or no saliva. Several studies have demonstrated the efficacy of systemic administration of pilocarpine hydrochloride in individuals with post-radiation xerostomia. However, analysis of pilocarpine lozenges for treatment of post-radiation xerostomia in patients with head and neck cancer has not been reported. Methods: The aim of this study was to quantify improvement in clinical symptoms and salivary function after treatment of post-radiation xerostomia with pilocarpine lozenges. In a double-blinded, placebo-controlled trial, 33 head and neck cancer patients were assigned randomly to receive Salagen(R) tablet, pilocarpine hydrochloride lozenge (3 or 5 mg) or placebo lozenge every 10 days. At each visit, a subjective evaluation was undertaken through the use of visual analog scales before and at 180 minutes after treatment. Whole resting saliva was collected before and at 0, 30, 60, 90, 120, 150 and 180 minutes after treatment. Results: The percentage of patients with decreased feeling of oral dryness, sore mouth or speaking difficulties after taking 5-mg pilocarpine lozenge was greater than Salagen(R) or placebo. There were statistically significant increases in salivary production in pilocarpine treatment groups vs. placebo (P<0.05). Conclusion: The 5-mg pilocarpine lozenge produced the best clinical results, but further investigation with a larger group of patients is required.