title: Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjögren's syndrome in Taiwan--a double-blind, placebo-controlled trial.
abstract: 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.
authors.affiliation: Division of Immunology, Rheumatology and Allergy, Department of Internal Medicine, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei 100, Taiwan.
authors.forename: Cheng-Han
authors.initials: CH
authors.lastname: Wu
authors.forename: Song-Chou
authors.initials: SC
authors.lastname: Hsieh
authors.forename: Kuang-Lun
authors.initials: KL
authors.lastname: Lee
authors.forename: Ko-Jen
authors.initials: KJ
authors.lastname: Li
authors.forename: Ming-Chi
authors.initials: MC
authors.lastname: Lu
authors.forename: Chia-Li
authors.initials: CL
authors.lastname: Yu
mesh_terms: 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
chemical_list: D010862:Pilocarpine