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 Sjögren'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). Key Points • Acupuncture is a low-cost method with few side effects • Acupuncture exerts a symptom-relieving effect in primary Sjögren's disease patients.