Pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in Sjögren syndrome: a double-blind randomized controlled trial

Abstract

Pilocarpine is more effective than artificial saliva for enhancing salivary and lacrimal secretion in patients with SS. This is the first study to compare the efficacy of pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in SS.

Interventions for dry mouth and hyposalivation in Sjögren’s syndrome: A systematic review and meta‐analysis

“…Cifuentes, Barrio‐Diaz, and Vera‐Kellet () observed in a clinical trial at low risk of bias a significantly higher unstimulated salivary flow rate at 12 weeks in patients taking 10 drops of pilocarpine (5 mg) three times a day versus 10 drops of artificial saliva (oral Schirmer test: 0.924 cm/min vs. 0.297 cm/min; p < 0.05). These results suggest a large effect size but unclear clinical significance.…”

Effects of Xerostom® products on xerostomia in primary Sjögren’s syndrome: A randomized clinical trial

“…The only symptomatic treatment that has clearly shown its efficacy on pSS is pilocarpine, but its level of evidence varies and it is related to the residual glandular parenchyma (Noaiseh et al, ; Papas et al, ; Seror & Mariette, ; Cifuentes et al, , Watanabe et al, , Fernández‐Martínez et al, , Al Hamad et al, ). Common side effects of pilocarpine are sialorrhoea, sweating, urinary frequency, bitter taste, stomatodynia, sickness, sore throat, gastritis and dyspnoea (Cifuentes et al, ; Fernández‐Martínez et al, ). Thus, the use of pilocarpine is contraindicated in patients with chronic illnesses such as cardiovascular disease, kidney failure, asthma and other chronic diseases.…”

“…There are studies (Cifuentes et al, ) that obtained great xerostomia improvement with the use of pilocarpine in pSS, and they observed that non‐responders have a greater duration of the pSS disease. In this study (Cifuentes et al, ), mean duration of the disease was about 22.16–23.28 months. In our study, the duration of the disease was greater 139.38 ± 89.47 months.…”

“…We have to take into account the pSS evolution and other patients’ chronic diseases to choose the appropriate treatment. Sialogogues could not be effective if patients have no functional capacity, which is more frequent in pSS long‐term patients (Cifuentes et al, ; Rosas et al, ). For these reasons, we think that it is important to offer other treatment alternatives such as saliva substitutes and dry mouth treatments to these patients.…”

“…Treatment of xerostomia in pSS patients includes the administration of topical therapies, such as saliva substitutes and stimulants like sugar‐free chewing gum and lozenges (Alpöz et al, ; Furness, Worthington, Bryan, Birchenough, & McMillan, ; Hackett et al, ; Jose et al, ). pSS patients with residual salivary gland function could stimulate salivary flow with different systemic or local sialogogues such as pilocarpine (Papas et al, ; Fernández‐Martínez et al, ; Cifuentes, Barrio‐Díaz, & Vera‐Kellet, ; Watanabe et al, ) and cevimeline (Noaiseh et al, ). These treatments are not always effective and can be associated with side effects.…”