Pilocarpine trials in Sjögren’s syndrome for alleviating oral dryness
| Trial design | Treatment regime | Patients | Results | Reference |
|---|---|---|---|---|
| double blind, placebo controlled, crossover | single dose, 5 mg capsule | 2 primary SS + 4 chronic non-specific sialadenitis | subjective 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 controlled | three times daily oral administration of an ophthalmic 2% pilocarpine solution (eq. 5 mg) | 3 primary SS + 6 secondary SS | no 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, crossover | three times daily, 5 mg capsule | 18 primary SS + 3 secondary SS + 18 others with hyposalivation | 26 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 controlled | unknown | 11 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 |
| open | single dose, 5 mg tablet | 9 primary SS + 9 secondary SS | twofold increase of mean whole salivary output | 54 |
| double blind, placebo controlled | 5 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.