The Effect Of Melatonin On Lacrimal Gland Function And Inflammatory Markers In Patients With Primary Sjögren’S Syndrome: A Case Series

This case series evaluates the impact of oral adminstration of melatonin on lacrimal gland function and inflammatory markers in primary Sjögren’s syndrome. Given its anti-inflammatory and immunomodulatory effects, melatonin may improve tear production, incease tear stability and reduce inflammation in this patient group.

All patients were recruited from the rheumatology and ophthalmology departments. All participants met the diagnostic criteria for primary Sjögren’s syndrome based on the ACR and EULAR guidelines. Mean patient's age was 47.6± 8.7. Baseline ophthalmologic and laboratory assessments was performed on the first visit. All patients were administered oral melatonin therapy (5 mg) once daily for four weeks 60 minutes before bedtime, followed by reassessment of all parameters at the end of therapy. 

Twelve patients with primary Sjögren’s syndrome were enrolled. Baseline ophtalmologic examination included the Schirmer test, TBUT and corneal NEI staining score to evaluate the tear film and corneal sensitivity through cotton tip reflex blink response. Inflammatory markers (CRP, ESR, IL-6, TNF-α, immunoglobulins (IgG, IgM, IgA), protein electrophoresis, and C3 and C4 complement components were analysed. Patient-reported outcomes were assessed using the ESSPRI and OSDI questionnaires. After baseline examination patients received 5 mg melatonin oral daily for 4 weeks. All clinical findings and lab inflammatory markers were compared to baseline levels to evaluate melatonin’s effects on dry eye symptoms and inflammation.

Melatonin administration led to significant improvements in tear production, as shown by increased Schirmer test scores 7(12, 15.0 – 3.0) vs. 10 (12, 6.0 – 18.0) and enhanced TBUT 4.13±2.37 vs. 5.61±3.45. Corneal fluorescein staining revealed significantly reduced ocular surface damage 4 (8, 8.0 – 0.0) vs 2 (6, 6.0 – 0.0). Inflammatory markers were reduced in all patients, indicating a systemic anti-inflammatory effect. Corneal sensitivity remained unchanged. Additionally, improvements in ESSPRI and OSDI scores were observed, reflecting reduced symptoms of dry eye.  These findings demonstrate that melatonin improved both clinical and biochemical measures of Sjögren’s syndrome-related inflammation and dry eye symptoms.

This case series indicates that melatonin has great beneficial effect on tear secretion and ocular surface findings as well as it alleviates inflammatory markers in patients with primary Sjögren’s syndrome. Treatment with melatonin led to improved tear production, tear film stability, reduced ocular surface damage, and decreased systemic inflammation. Improvements in patient-reported outcomes, along with objective clinical measures, suggest that melatonin may serve as an effective adjunctive treatment for managing dry eye and inflammation in Sjögren’s syndrome.