Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial

Ana Carolina Fragoso Motta, DDS, PhD2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2019年2月18日最近更新: 2023年3月14日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 50
试验地点: 2
主要终点: Changes from baseline The Challacombe scale at at 2 and 3 months.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Sjögren's syndrome (SS) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. Xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. Although some drugs may improve symptoms and prevent SS complications, they can cause significant adverse effects and even fail to relieve symptoms. Integrative and complementary techniques have become a therapeutic option for SS patients. Scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. Due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for SS patients' symptoms relief.

详细描述

The present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). The research will be conducted following the CONSORT recommendations and the STRICTA extension. The study care protocol will consist in acupuncture or control intervention at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) for 8 weeks, 20 minutes sessions with 12 weeks of follow up. Complementary clinical approaches (sialometry, sialochemistry, Schirmer test, staining with topical lissamine green), and the questionnaires (OHIP-14, Eular Sjögren's Syndrome Patient Reported Index (ESSPRI), Xerostomia Inventory, ocular surface disease index (OSDI) will be performed in weeks 1, 8 and 12. The control group will consist of superficial acupuncture, or placebo, or sham. After all interventions and evaluation methods completed, data will be analyzed for their distribution and homogeneity in order to choose the most appropriate statistical test.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adults ≥ 18 years old, both genres, who consent to participate of the study
•Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism

排除标准

•Patients who have undergone head and neck radiation therapy;
•Patients with a history of neoplasias and salivary gland infections;
•Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;
•Patients with inability to undergo total saliva collection by established techniques;
•Patients who can not attend regular acupuncture sessions;
•Patients who had a change in the dosage of medications in use within 6 weeks before the start of the study.
•Patients who received acupuncture therapy up to 6 weeks prior to the start of the study.