Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjögren's Syndrome: A Randomized Controlled Trial

Xinyao Zhou; Haodong Xu; Jinzhou Chen; Hengbo Wu; Yi Zhang; Feng Tian; Xiaopo Tang; Huadong Zhang; Lin Ge; Kesong Li; Wen Jiang; Zhishun Liu; Quan Jiang

doi:10.3389/fmed.2022.878218

Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjögren's Syndrome: A Randomized Controlled Trial

Front Med (Lausanne). 2022 May 6:9:878218. doi: 10.3389/fmed.2022.878218. eCollection 2022.

Authors

Xinyao Zhou¹, Haodong Xu^{1

2}, Jinzhou Chen^{1

3}, Hengbo Wu^{1

4}, Yi Zhang^{1

5}, Feng Tian⁶, Xiaopo Tang¹, Huadong Zhang¹, Lin Ge¹, Kesong Li¹, Wen Jiang¹, Zhishun Liu⁷, Quan Jiang¹

Affiliations

¹ Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
² Postgraduate School, China Academy of Chinese Medical Sciences, Beijing, China.
³ Intensive Care Unit, Meishan Hospital of Traditional Chinese Medicine, Meishan, China.
⁴ Postgraduate School, Beijing University of Chinese Medicine, Beijing, China.
⁵ College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.
⁶ Beijing CreateMed Medicine Technology Co., Ltd., Beijing, China.
⁷ Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Abstract

Aim: We sought to evaluate the efficacy of acupuncture in treating the main symptoms of primary Sjögren's syndrome, specifically dryness, pain, and fatigue.

Methods: A total of 120 patients with primary Sjögren's syndrome were randomized in a parallel-group, controlled trial. Participants received acupuncture or sham acupuncture for the first 8 weeks, then were followed for 16 weeks thereafter. The primary outcome was the proportion of participants with a ≥ 30% reduction in ≥ 2 of 3 numeric analog scale scores for dryness, pain, and fatigue. The secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-reported Index (ESSPRI); the EULAR Sjögren's Syndrome Disease Activity Index; the Schirmer test score; unstimulated saliva flow; serum immunoglobulin G, A, and M concentrations; the Medical Outcome Study Short Form 36 score; salivary gland ultrasound imaging; and the Hospital Anxiety and Depression Scale score.

Results: The proportions of patients meeting the primary endpoint were 28.33% (17/60) in the acupuncture group and 31.66% (19/60) in the sham group, without a statistically significant difference (P = 0.705). The IgG concentration at week 16 and the homogeneity in ultrasonography of the salivary glands at week 8 showed significant differences between the 2 groups (P = 0.0490 and P = 0.0334, respectively). No other differences were observed between the 2 groups. ESSPRI and unstimulated saliva flow were improved in both groups compared to baseline, albeit with a significant difference between them.

Conclusion: In patients with primary Sjögren's syndrome, acupuncture did not satisfactorily improve symptoms compared to placebo. However, interesting discoveries and possible underlying reasons were demonstrated and discussed, which may be useful to studies in the future.

Clinical trial registration: [www.ClinicalTrials.gov], identifier [NCT02691377].

Keywords: Sjögren’s syndrome; acupuncture; dryness; fatigue; pain.

Associated data

ClinicalTrials.gov/NCT02691377