Table 3

Pilocarpine trials in Sjögren’s syndrome for alleviating oral dryness

Trial designTreatment regimePatientsResultsReference
double blind, placebo controlled, crossoversingle dose, 5 mg capsule2 primary SS + 4 chronic non-specific sialadenitissubjective dryness decreased in all patients (interview score). In all patients the salivary flow was at least 10-fold after pilocarpine use compared to the placebo. 49
single blind, placebo controlledthree times daily oral administration of an ophthalmic 2% pilocarpine solution (eq. 5 mg)3 primary SS + 6 secondary SSno changes in salivary flow in primary SS; whole salivary flow increase of 0.18 ml/min (p<0.05), stimulated parotid salivary flow increase of 0.34 ml/min (p<0.01) 52
double blind, placebo controlled, crossoverthree times daily, 5 mg capsule18 primary SS + 3 secondary SS + 18 others with hyposalivation26 of 39 reported an increase of parotid and sublingual/submandibular saliva. Seven patients withdrew from the study because of adverse effects. 50
multicentre, double blind, placebo controlledunknown11 SS3-150 improvement in 9 patients on xerostomia and in 8 patients on oral discomfort using a 20 point XOS scale. Mean stimulated salivary flow rate increased about threefold (p<0.08) 53
opensingle dose, 5 mg tablet9 primary SS + 9 secondary SStwofold increase of mean whole salivary output 54
double blind, placebo controlled5 mg four times daily (7.5 mg after 6 weeks if tolerated by the patient)60 SS3-150 64.3 % of the treatment groupv 25.0% of the placebo group indicated improvement in a global dry mouth assessment on a VAS scale (p<0.005). Mean salivary flow increase was 0.14 ml/minv zero of the placebo group. 51
  • 3-150 Discrimination between primary or secondary Sjögren’s syndrome was not reported.