Abstract
Objective
To evaluate the efficacy and safety of acupuncture combined with hydroxychloroquine (HCQ) in patients with primary Sjögren's syndrome (pSS) and to explore the underlying mechanisms of acupuncture effect.Methods
This study was designed as a randomized controlled trial (RCT) and included 138 pSS patients who were equally and randomly assigned to the treatment group or the sham acupuncture control group (69 cases in each group). The control group received HCQ sulfate tablets (0.2 g, twice daily) combined with sham acupuncture, whereas the treatment group received real acupuncture in addition to HCQ treatment. Acupuncture at Baihui (GV 20), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3), etc. was administered. Both groups underwent 8 treatment courses, with a 4-week follow-up. The primary efficacy endpoint was the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score. The secondary endpoints included clinical symptom scores, laboratory indicators, and scores for anxiety (Hospital Anxiety and Depression Scale-anxiety, HADS-A) and depression (HADS-D). Safety assessments including vital signs monitoring and laboratory tests were conducted at weeks 0, 2, 4, 6, and 8, and adverse events were evaluated throughout the study.Results
A total of 57 patients in the treatment group and 62 in the control group completed the full course of treatment. After treatment, both groups presented a reduction in ESSPRI scores, eye dryness numerical rating scale (NRS), mouth dryness NRS, and EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scores compared with the baseline values and an increase in the salivary flow rate, Schirmer test results, and tear film break-up time (BUT) scores compared with the baseline values (P0.05).Conclusions
Acupuncture combined with HCQ treatment is more effective than HCQ alone in improving dry mouth and dry eye symptoms in pSS patients, with a good safety profile. Additionally, acupuncture treatment may indirectly alleviate anxiety and depression symptoms by improving clinical outcomes such as dry mouth and dry eye. (Registration No. TCTR20230116003).