Pilocarpine and Artificial Saliva for the Treatment of Xerostomia and Xerophthalmia of Sjögren's Syndrome: A double blind control trial

Abstract

Background

Sjögren's Syndrome (SS) is associated with xerostomia and xerophthalmia. Pilocarpine stimulates the secretion of saliva.

Objectives

Investigate and compare the efficacy of pilocarpine and artificial saliva as symptomatic treatments for xerostomia and xerophthalmia in patients with SS.

Patients and Methods

A double-blind, randomized, controlled study was performed. 72 patients with SS were assigned randomly to receive ten drops of pilocarpine (5 mg) or 10 drops of artificial saliva, orally, t.i.d.for 12 weeks. Patients were evaluated at baseline and periodically throughout the study by whole saliva and tear flow for global assessment of their dryness as well as for any adverse effects.

Results

Patients receiving pilocarpine had a statistically significant improvement in their salivary flow (p< 0.0001), lachrymal flow (p< 0.0001), and their subjective global assessment (p< 0.0001), compared with patients on artificial saliva. The most common side effects were sialorrhea and nausea.

Limitations

As the pilocarpine was in solution (drops), it was possible for the dosage to become inaccurate.

Conclusions

Pilocarpine is more effective than artificial saliva for enhancing salivary and lachrymal secretion in patients with SS. This is the first study comparing the efficacy of pilocarpine and artificial saliva as treatments for xerostomia and xerophthalmia in SS.

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