Effects of Acupuncture on Sjögren's Syndrome

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.

Conditions

• Sjogren's Syndrome

Interventions

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.

Sponsors & Collaborators

• Ana Carolina Fragoso Motta, DDS, PhD

  lead OTHER

Principal Investigators

• Jaciara M Gomes-Silva, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Maria Cristina Borsato, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Eduardo Melani Rocha, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Fabiola R Oliveira, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Maria da Conceição P Saraiva, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-18

Primary Completion

2021-12-06

Completion

2022-10-10

Countries

• Brazil

Study Locations