Al Hamad, AFM; (2016) Management of salivary gland hypofunction of Sjogren's syndrome: the evidence behind available therapies and results of a feasibility study on a novel intra-oral electro-stimulator of salivary glands. Doctoral thesis , UCL (University College London).

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Abstract

Objective: The effectiveness of available treatments of Sjogren’s syndrome (SS) induced xerostomia remains unclear. The present thesis was aimed at determining the evidence of current therapies and to assess the efficacy of using an electrostimulation device for the treatment of xerostomia in patients with SS. Hence it comprises two studies to address the problem (a) a systematic review and (b) a clinical trial. Methods: For the systematic review the following databases were searched in November 2013 and in August 2015: MEDLINE, Cochrane Central, EMBASE and AMED. Randomized controlled trials comparing any topical or systemic intervention for the treatment of SS-induced xerostomia were included. The clinical trial was a six-month double-blinded randomized sham-controlled feasibility trail of 30 patients with SS. Outcome measures were collected at baseline, month 1, month 3, and at end of the study. This was followed by a 6-month open label extension. Results: The systematic review identified 33 randomized controlled trials. The meta-analysis included 9 studies. The principal measure of effect size was the mean difference for continuous data and the odd ratio of improvement for categorical data. Results suggest that oral sialogogues are more effective than placebo in ameliorating dry mouth symptoms. The clinical study found that unstimulated salivary flow increased more in participants receiving active devices compared to sham stimulation (1g/15min higher). The xerostomia inventory score reduced more in the active group by 3.3 points. Xerostomia VAS scores did not show any significant difference. Conclusion: The findings of the systematic review display statistically significant evidence that SS-induced xerostomia may be lessened by systemic pilocarpine, cevimeline or electrostimulation. The clinical trial reported that the electrostimulating device was well tolerated, increased salivary function and reduced dry mouth symptoms of SS. Thus there is merit in future studies being focused upon the use of sialagogues and electrostimulation devices.

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