NCT04056221

Effects of Acupuncture on Sjögren's Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ana Carolina Fragoso Motta, DDS, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
OTHER	Acupuncture	Acupuncture stimulation was done manually, using single-use acupuncture needles that will be inserted on the selected acupoints (R6, E6, E2, Ig4, VC24, TA23, B2) once a week,for 8 weeks, 20 minutes sessions with 12 weeks of follow up.
OTHER	Sham acupuncture	The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Timeline

• Start date: 2019-02-18
• Primary completion: 2021-12-06
• Completion: 2022-10-10
• First posted: 2019-08-14
• Last updated: 2023-03-14

Locations

1 site across 1 country: Brazil