Endoscopic Irrigation Brings Long-term Oral Relief to Sjögren’s Patients in Trial

The use of sialendoscopy, an endoscopic tool to examine and treat the salivary glands, can be used to irrigate the major salivary glands with saline to increase salivation and lessen oral dryness in people with Sjögren’s syndrome, with benefits lasting up to 15 months after treatment, a clinical trial reported. 

The results were published in the study, “Sialendoscopy increases saliva secretion and reduces xerostomia up to 60 weeks in Sjögren’s syndrome patients: a randomized controlled study,” in the journal Rheumatology.

Sjögren’s syndrome is an autoimmune disorder in which the immune system attacks the glands that produce tears (the lacrimal glands) and saliva (the salivary glands), leading to dry eyes and dry mouth (xerostomia).

Sialendoscopy is an endoscopic tool used to examine and treat problems in the salivary glands and ducts. It uses a slender, flexible tube with a camera and a small light. 

A series of small, short-term studies have shown improved salivary gland function, and an easing of oral Sjögren’s symptoms after sialendoscopy, in which the glands were rinsed with saline (saltwater) or a combination of saline and anti-inflammatory corticosteroid medication.

However, whether sialendoscopy can help with Sjögren’s symptoms in the long term is still unknown.

Researchers based at Vrije Universiteit Amsterdam designed a clinical trial (NCT02112019) to test the impact of sialendoscopy on oral Sjögren’s symptoms.

The approach had shown benefits in the short (up to eight weeks) and medium term (up to six months), and researchers now reported its effects over a more extended period (up to 60 weeks, or 15 months).

“[The] aim of this study was to assess long-term effects of the use of sialendoscopy with saline or sialendoscopy with saline followed by saline/corticosteroid irrigation on salivary gland function and sensation of oral dryness compared with a non-treatment control group,” the researchers wrote. 

The trial included 45 adults with Sjögren’s syndrome, including 40 (88.9%) women. Their median age was 59.7, and their disease had been diagnosed for a median of seven years prior to the trial.

Participants were randomly assigned to no treatment (control group), an endoscopic saline rinse, or saline rinse followed by applying a corticosteroid. Each group included 15 patients. Due to ethical concerns, the untreated group did not receive a sham sialendoscopy as a blinded control.

In all groups, unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), and the citric acid-stimulated parotid flow (SPF) were collected one week before sialendoscopy, and at several visits up to 60 weeks after treatment.

Clinical measures recorded at each visit included the Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI), and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI). While the first two measure oral dryness, the latter also includes measures of disease symptoms such as pain and fatigue.

Over time, the UWSF and SWSF were found to differ significantly between the three groups. Still, there were no specific time points identified at which UWSF and SWSF in the sialendoscopy groups differed significantly from the control group.

Overall, the XI scores (a dry mouth measure) differed significantly between the groups. Here, the XI scores for both sialendoscopy groups were significantly lower (less dry mouth) than the control group 16 weeks after treatment and onward. 

Similarly, over time, the dryness domain of ESSPRI differed significantly between the groups. Scores for those given saline only were already significantly lower than those of the control group from week one onward, and scores for the saline plus corticosteroid group were significantly lower starting at eight weeks after sialendoscopy.

An analysis of the saline group alone found that UWSF scores rose for up 60 weeks compared with baseline (study’s start) measures, with significant differences beginning to be observed at eight weeks after treatment. 

CODS, which assessed oral dryness by visual inspection, significantly decreased in the first week after treatment, and the mean CODS score after 60 weeks was 1.64 points lower (indicating less dryness) than baseline. XI decreased up to 36 weeks after treatment but increased again from week 48 onwards, while remaining below baseline measures.

An analysis of the saline plus corticosteroid group found that 16 weeks after sialendoscopy, UWSF rose compared with baseline, and remained higher after 60 weeks. SWSF scores also improved over time, with a significant increase starting at 16 weeks after treatment and lasting up to week 48. 

Like in the saline only group, CODS also significantly decreased one week after the intervention in the saline plus corticosteroid group. After 60 weeks, the mean CODS was 1.53 points lower than baseline.

The dryness domain of the ESSPRI was significantly lower from week eight onward, and mean ESSPRI at 60 weeks was 1.80 points lower than baseline measure. In this group, there were no significant changes over time in XI scores.

“Salivary endoscopy of [Sjögren’s syndrome] patients increases salivation and reduces oral dryness up to at least 60 weeks after sialendoscopy,” the investigators concluded.

“Endoscopic irrigation might evolve into a treatment option that might improve salivary gland functioning and thus reduce [dry mouth] complaints in patients,” they added.