Laser Acupuncture on the Management of Xerostomia in Sjögren's Disease: A Randomized Clinical Trial

OBJECTIVES: This study evaluated the efficacy of photobiomodulation (PBM) at acupuncture points for managing xerostomia in patients with Sjögren's Disease. MATERIAL AND METHODS: In this randomized, double-blind clinical trial, 50 patients were assigned to PBM group (n = 22) or sham-PBM group (n = 28). The primary outcome was xerostomia symptoms assessed using a visual analogue scale (VAS). Secondary outcomes included Xerostomia Inventory, resting salivary flow rate (RSFR), and EULAR Sjögren's Syndrome Patient Reported Index score. Participants received weekly PBM sessions for four consecutive weeks, and evaluations were conducted at baseline, week 8 and 12. RESULTS: PBM showed a marginal tendency toward improvement on VAS (p = 0.0974) (OR = 1.929 95% CI 0.8939-4.525) and in the RSFR (p = 0.09996) (OR = +infinity 95% CI 0.9363-infinity) at week 8 compared with sham-PBM. However, no statistically significant differences were observed between groups at week 12 for any of the assessed outcomes. CONCLUSION: PBM at acupuncture points demonstrated a slight short-term benefit at week 8 in improving xerostomia symptoms and RSFR, although these effects did not persist at 12 weeks. These preliminary results suggest a potential role for PBM at acupuncture points as a safe, noninvasive adjunctive therapy for xerostomia in patients with SjD, warranting further validation in larger, long-term trials. TRIAL REGISTRATION: This study was registered in The Brazilian Registry of Clinical Trials (U1111-1298-9891).