The given acupoints will be a practical option for both domestic and international doctors and researchers for either their clinical prescriptions or studies. 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 Hydrocortisone buteprate 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 treatment, 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 higher reduction in at least 2 out of 3 items of DPF in Numeric Analog Level (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 Sj?grens Syndrome Patient Reported Index (ESSPRI), EULAR Sj?grens Syndrome Disease Activity Index (ESSDAI), Schirmer test score and unstimulated salivary circulation, 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 Major depression (HAD) scale score. The secondary end result 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 recognized their allocation will also be measured and analyzed. Discussion This study will be the 1st 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 medical proof that acupuncture offers beneficial effects on pSS. Trial sign up ClinicalTrials.gov: “type”:”clinical-trial”,”attrs”:”text”:”NCT02691377″,”term_id”:”NCT02691377″NCT02691377 (February 20, 2016) 0.05 with two-tailed test shows statistical significance. Conversation This trial is designed to assess the effects of acupuncture on DPF of pSS, with the alleviation of the symptoms like a medical priority when severe complications absent in most cases. In this study, we will evaluate if the effect of acupuncture is not worse than that of sham; the characteristics of the individuals who have better reactions to acupuncture in the sensible end points in multiple perspectives, covering the subjectivity and objectivity of individuals feedback. The KITLG objective feedbacks are the structure and function of salivary glands, the disease activity, and complications of pSS. The subjective feedbacks include feelings of DPF and emotions. Pragmatic inclusion criteria Inclusion criteria were held pragmatically to facilitate screening and recruitment. The sign duration is set to be less than 5 years in the inclusion criteria, because the structure and function of the glands would be aggravated with Hydrocortisone buteprate the course of disease, which would be more difficult to be reversed [25] if its over 5 years. To make this trial more similar to the real world where its fairly common for private hospitals to accept individuals while they may be talking other medicine, we Hydrocortisone buteprate consequently recruit those taking medicines. However on the other hand, to keep up the interference from taken medicines during this study as low as possible, we have a very stringent recruitment criteria listed earlier in this article in case the medicines influence the results of the study. Sham needle like a control process Having a blunt end and achieving no pores and skin penetration, the sham needle that we choose like a control process with this trial has the same appearance and gives a likely sense of penetration to a real one (Fig. ?(Fig.1).1). Inside a crossover study [12], needle penetration was experienced by 88.3C100% of volunteers receiving this kind of sham acupuncture which are not penetrating in fact,.