Acupuncture for Primary Sjögren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial

Quan Jiang, Huadong Zhang, Ran Pang, Jinzhou Chen, Zhishun Liu, Xinyao Zhou, Quan Jiang, Huadong Zhang, Ran Pang, Jinzhou Chen, Zhishun Liu, Xinyao Zhou

Abstract

Background: Currently, feasible medical treatments are hitherto not satisfying to relieve pSS symptoms, which concerns numbers of clinical doctors. Acupuncture seems to be an alternative to treat pSS and conduces to good symptomatic results. However further research is necessary. This trial is to investigate the efficacy of acupuncture on improving the key symptoms of pSS, which are dryness, pain and fatigue (DPF).

Methods & design: The study is designed as a randomized controlled trial of two arms with a single centre. We compare acupuncture with sham acupuncture on symptomatic improvements of pSS. A total of 120 pSS patients, aged at least 18, with DPF, will be randomly assigned to acupuncture or sham acupuncture groups, where they will have needle intervention for 8 weeks with 16 weeks of follow-up. Subjects will be assessed each time before interventions during the 8-week intervention, in week 8 after all interventions and in week 12, 16, 20 and 24 for follow-up with different measurements. The primary outcome are the proportions of subjects that have 30% or greater reduction in at least 2 out of 3 items of DPF in Numeric Analog Scale (NAS) scores (0 = the best, 10 = the severest), calculated between the baseline and the average scores of week 2 to 8. The secondary outcome are related to individual items of NAS scores, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Schirmer test score and unstimulated salivary flow, serum Immunoglobulin G, A and M levels, Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36), Salivary glands ultrasounds, Hospital Anxiety and Depression (HAD) scale score. The secondary outcome scores are to be collected at baseline, in week 8, 16, and 24. Besides, individual items of NAS will also be collected in week 12 and 20. Moreover, subjects' satisfaction and the proportion of the subjects who identified their allocation will also be measured and analyzed.

Discussion: This study will be the first randomized and controlled pilot trial of acupuncture on alleviating the symptoms of pSS with relatively long-term follow-up. The result of the study might offer a new option to treat pSS and might be a clinical proof that acupuncture has beneficial effects on pSS.

Trial registration: ClinicalTrials.gov: NCT02691377 (February 20, 2016).

Keywords: Acupuncture; Fatigue; Pain; Randomized controlled trial; Sjogren’s syndrome; Xerostomia.

Figures

Fig. 1
Fig. 1
The sham and real acupuncture we use in this study. a: sham acupuncture as control; b: real acupuncture. 1. needle handle; 2. needle body; 3. adhesive pad; 4. blunt tip; 5. Cutis
Fig. 2
Fig. 2
The acupoints we picked in this study and their indications
Fig. 3
Fig. 3
Trial flow & study design. General information = age, sex, weight, time when symptoms emerge, time when diagnosed, anti-SSA antibodies, abnormal Schirmer test results, decreased unstimulated salivary flow, previous systemic involvement, previous treatment with another immunosuppressant, current systemic involvement. 1st outcome = numeric analog scale (NAS) (Dryness, Pain and Fatigue). 2nd outcome = EULAR Sjogren Syndrome Patient Reported Index (ESSPRI), EULAR Sjogren Syndrome Disease Activity Index (ESSDAI), Medical Outcome Study Short From 36 Short-Form Health Survey (SF-36), Hospital Anxiety and Depression (HAD), Serum Immunoglobulin (IgG), IgA and IgM, Schirner test score and unstimulated salivary flow, salivary glands untrasounds

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Source: PubMed

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