Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjögren's syndrome in Taiwan--a double-blind, placebo-controlled trial.
OBJECTIVE
Sjögren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant symptoms of dry mouth and dry eye. As genetic predisposition and ethnicity may alter the effectiveness of drug treatment, evaluation of the efficacy and safety of the secretagogue pilocarpine hydrochloride in the treatment of xerostomia in patients with SS in different populations is needed.


METHODS
Forty-four patients with SS were enrolled in this double-blind, placebo-controlled trial. Patients were randomized to receive 5 mg pilocarpine (Salagen) or placebo tablet four times daily for 12 weeks. Global evaluation and subjective responses of patients were assessed by questionnaires with visual analog scales and categorical checkboxes. Saliva production was also measured by modified Saxon's test.


RESULTS
Pilocarpine treatment significantly improved global assessment of dry mouth, symptoms associated with dry mouth (mouth comfort, ability to sleep and ability to speak), and saliva production compared to placebo. The drug was well tolerated and the most common adverse effect was sweating (5/23, 21.7%) resulting from the muscarinic agonist action of the drug. No serious drug-related adverse effect was found in this study.


CONCLUSIONS
The results of this study suggest that therapy with 5 mg pilocarpine four times daily is effective, safe and well tolerated for the relief of oral symptoms in patients with SS in Taiwan.
Wu
Cheng-Han
CH
Division of Immunology, Rheumatology and Allergy, Department of Internal Medicine, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei 100, Taiwan.
Hsieh
Song-Chou
SC
Lee
Kuang-Lun
KL
Li
Ko-Jen
KJ
Lu
Ming-Chi
MC
Yu
Chia-Li
CL
D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010862:Pilocarpine / Q000627:therapeutic use*; D012189:Retrospective Studies; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000453:epidemiology; D013624:Taiwan / Q000453:epidemiology; D016896:Treatment Outcome; D014987:Xerostomia
D010862:Pilocarpine