Prospective Sham-Controlled trial: acupuncture for symptom-relieving in patients with Sjögren’s disease

Objective This study aimed to assess the clinical efficacy of acupuncture in relieving sicca symptoms of SjD. Methods A prospective, single-center, randomized, double-blind, controlled trial was conducted on SjD patients experiencing dry eyes and dry mouth. Forty-six patients were randomized and 27 completed the study (acupuncture, n = 15; sham, n = 12). Patients received either acupuncture or sham acupuncture (control) weekly for 8 weeks. Key outcomes, including Schirmer test (ST), corneal fluorescein staining score, tear film break-up time, Ocular Surface Disease Index, unstimulated whole salivary flow (UWSF), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Xerostomia Inventory (XI) score, Oral Health Impact Profile (OHIP-14) score, and Challacombe scale, were measured at baseline, immediately after treatment, and 4 weeks later. Statistical analysis consisted of comparing outcomes between groups over time. Results The acupuncture group exhibited significant improvement in total ESSPRI and ESSPRI dryness scores. The positive effects persisted for at least 4 weeks after the completion of treatment. Furthermore, the acupuncture group exhibited improvement over time in the ESSPRI fatigue domain, ESSPRI pain domain, OHIP-14, XI, UWSF, and ST. No other statistically significant differences were observed. Conclusion Acupuncture is effective in relieving dryness in SjD patients. Larger samples and longer observation periods are necessary to better understand the effectiveness of this intervention in SjD. (NCT04056221/ 18/02/2019).