Acupuncture for Primary Sjögren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial.
Acupuncture for Primary Sjögren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial.
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原发性Sjögren综合征（PSS）的针灸对症状改进：随机对照试验的研究方案。
DOI：
10.1186/s12906-017-1559-9
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发表时间：
2017-01-19
影响因子：
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通讯作者：
Zhou X
中科院分区：
文献类型：
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作者：
Jiang Q;Zhang H;Pang R;Chen J;Liu Z;Zhou X
目前，可行的药物治疗尚不能令人满意地缓解pSS症状，这是许多临床医生所关心的。针灸似乎是治疗 pSS 的一种替代方法，并能取得良好的症状效果。然而，还需要进一步的研究。本试验旨在探讨针灸改善 pSS 的主要症状，即干燥、疼痛和疲劳 (DPF) 的功效。该研究被设计为单中心、双组的随机对照试验。我们比较了针灸与假针灸对 pSS 症状改善的影响。总共 120 名年龄至少 18 岁、患有 DPF 的 pSS 患者将被随机分配到针灸组或假针灸组，接受为期 8 周的针刺干预和 16 周的随访。在为期 8 周的干预期间，每次干预前、所有干预后的第 8 周以及第 12、16、20 和 24 周都会对受试者进行评估，以进行不同测量的随访。主要结果是在数字模拟量表 (NAS) 评分中，DPF 3 项中的至少 2 项降低 30% 或以上的受试者比例（0 = 最好，10 = 最严重），在基线和第 2 至 8 周的平均分数之间计算。次要结果与 NAS 评分的各个项目、EULAR 干燥综合征患者报告指数相关。 (ESSPRI)、EULAR 干燥综合征疾病活动指数 (ESSDAI)、Schirmer 测试评分和未刺激唾液流量、血清免疫球蛋白 G、A 和 M 水平、医疗结果研究简表 36 简表健康调查 (SF-36)、唾液腺超声检查、医院焦虑和抑郁 (HAD) 量表评分。次要结局评分将在基线时、第8周、第16周和第24周收集。此外，还将在第12周和第20周收集NAS的各个项目。此外，还将测量和分析受试者的满意度和确定其分配的受试者的比例。这项研究将是第一个针灸缓解 pSS 症状的随机对照试验，并进行相对长期的随访。该研究的结果可能为治疗 pSS 提供一种新的选择，并可能成为针灸对 pSS 具有有益作用的临床证据。 ClinicalTrials.gov：NCT02691377（2016 年 2 月 20 日）
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). 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. 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. ClinicalTrials.gov: NCT02691377 (February 20, 2016)