Long‐term effectiveness of a novel intra‐oral electro‐stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: A randomised sham‐controlled feasibility study (LEONIDAS‐1)

Abstract

AbstractBackgroundEffective treatments for dry mouth of Sjogren's syndrome are limited and hampered by adverse effects. The aim of LEONIDAS‐1 was to explore the feasibility of salivary electrostimulation in individuals with primary Sjogren's syndrome, as well as parameters required to inform the design of a future phase III trial.MethodsMulticentre, parallel‐group, double‐blind, randomised sham‐controlled trial in two UK centres. Participants were randomised (1:1, computer‐generated) to active or sham electrostimulation. The feasibility outcomes included screening/eligibility ratio, consent, and recruitment and drop‐out rates. Preliminary efficacy outcome included dry mouth visual analogue scale, Xerostomia Inventory, the EULAR Sjögren's syndrome patient reported index‐Q1, and unstimulated sialometry.ResultsForty‐two individuals were screened, of whom 30 (71.4%) met the eligibility criteria. All eligible individuals consented to recruitment. Out of the 30 randomised participants (active n = 15, sham n = 15), 4 dropped out and 26 (13 vs. 13) completed all study visits as per protocol. Recruitment rate was 2.73 participants/month. At 6‐month post‐randomisation the difference in mean reduction in visual analogue scale, xerostomia inventory and EULAR Sjögren's syndrome patient reported index‐Q1 scores between groups were 0.36 (95% CI: −0.84, 1.56), 3.31 (0.43, 6.18), and 0.23 (−1.17, 1.63), respectively; unstimulated salivary flow increased by a mean of 0.98 mL/15 min, all in favour of the active group. No adverse events were reported.ConclusionLEONIDAS‐1 results support progression to a phase III definitive randomised controlled trial of salivary electrostimulation in individuals with Sjogren's syndrome. Xerostomia inventory could be considered the primary patient‐centred outcome measure and the corresponding observed treatment effect could inform the sample size of a future trial.