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

Abstract

AimWe sought to evaluate the efficacy of acupuncture in treating the main symptoms of primary Sjögren’s syndrome, specifically dryness, pain, and fatigue.MethodsA 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.ResultsThe 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.ConclusionIn 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].

Effect of acupuncture on regulating IL‐17, TNF‐ɑ and AQPs in Sjögren's syndrome

“…The unsatisfactory results of many SS treatments have led many doctors and patients to try acupuncture. SS disease is caused by an immune balance disorder and previous reports, including the current study, have confirmed the therapeutic effect of acupuncture on this syndrome (Liu et al, 2017;Zhou et al, 2022). While the mechanism by which acupuncture affects SS remains unclear, studies indicate that this treatment stimulates the production of innate immune cytokines such as IL-1, IL-6, IL-18, and TNFα, and adaptive immune cytokines including IL-2, IFN-, IL-5, IL-10, and IL-17, to initiate an immune response and repair rheumatoid arthritis (RA)-related injury (Dong et al, 2018;Du et al, 2019;Li et al, 2021;Su et al, 2019;Xu et al, 2018;Yu et al, 2020).…”

“…The mean NAS score at Weeks 2–8 was used as the primary endpoint, while the mean score at Week 0 was considered the baseline score. The methods and evidence required to establish a ≥30% improvement in at least two of the three measures is closely related to clinical efficacy and are consistent with previous clinical trial study findings (Jiang et al, 2017; Ng & Bowman, 2010; Zhou et al, 2022). Serum IL‐17, TNF‐ɑ, and anti‐AQP1, 5, 8, and 9 antibody expression levels changed between Week 0 and Week 8 after the intervention.…”

“…However, no robust studies on the effects of acupuncture on SS symptom resolution have been conducted to date. Thus, the current study tested the efficacy of acupuncture on SS patients using a rigorous randomized controlled trial (Jiang et al, 2017; Zhou et al, 2022). This technique improved the European League Against Rheumatism (EULAR) Sjogren's syndrome Patient‐reported Index (ESSPRI) (Seror et al, 2015), reduced unstimulated salivary flow, and effectively controlled dry mouth.…”

Commentary: Efficacy and safety of acupuncture on symptomatic improvement in primary Sjögren's syndrome: A randomized controlled trial

“…In the prospective study titled “Efficacy and safety of acupuncture on symptomatic improvement in primary Sjögren's syndrome: a randomized controlled trial” ( 1 ), Prof. Jiang and colleagues evaluated acupuncture treatment of the main symptoms of primary Sjögren's syndrome (pSS), specifically dryness, pain, and fatigue. Their results suggested that acupuncture did not improve these symptoms more than a placebo did.…”

The Efficacy and Safety of Acupuncture on Xerostomia in Patients with Sjogren’s Syndrome: A Systematic Review and Network Meta-analysis Protocol

“…Speci cally with regard to xerostomia in patients with SS, there is a meta-analysis in 2019 discussing different kinds of pharmacological therapies and found out that interferon -α 150IU thrice daily and cevimeline 30mg thrice daily had considerable therapeutic effect and the former was proven to be effective in increasing salivary ow rate attributing to its immunomodulatory action [31]. Nonetheless, there has been none review or meta-analysis speci cally focusing on xerostomia induced by SS under intervention of acupuncture while new clinical trials have been conducted and published with acupuncture on xerostomia in SS patients [32]. Therefore, with direct and indirect comparisons between different types of acupuncture, an up-to-date systematic review and network meta-analysis is in urgent need.…”