Effects of Acupuncture on Sjögren's Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2022-10-10

Brief Summary

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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.

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Detailed Description

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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

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Sjogren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sjogren syndrome's patients will be randomly assigned to either acupuncture (experimental group) at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) or sham acupuncture (control group), where the needles do not penetrate the skin into non acupuncture points, for 8 weeks, 20 minutes sessions with 12 weeks of follow up.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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acupuncture

Acupuncture at the selected points.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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.

Sham acupuncture

Similar appearance to conventional acupuncture, however, without needles skin penetration.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type OTHER

The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Interventions

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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.

Intervention Type OTHER

Sham acupuncture

The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No