Effects of Acupuncture on Sjögren's Syndrome

Study Overview
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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.

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.

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

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham acupuncture


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>Acupuncture at the selected points. | Other: Acupuncture<br>* 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.<br>|
| Sham Comparator: Sham acupuncture<br>Similar appearance to conventional acupuncture, however, without needles skin penetration. | Other: Sham acupuncture<br>* The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months. | Instrument of data collection which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation,physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- never to 4- always. | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline Xerostomia Inventory score at at 2 and 3 months. | It is an 11-item questionnaire that covers both experiential and behavioral aspects of xerostomia. Scores to the 11 items are summated, providing a single score representing the subjective severity of xerostomia. | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline The Challacombe scale at at 2 and 3 months. | The purpose of this scale is to be able to visually identify and quantify whether your patient has xerostomia (dry mouth) | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 2 and 3 months. | There is a 0-10 numerical scale for each of the four domains, dryness, discomfort (including pain), global fatigue and mental fatigue | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline Ocular Surface Disease Index (OSDI) at 2 and 3 months. | This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to none of the time and 4 corresponding to all of the time. | Before (baseline), immediately after and 1 month after acupuncture treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline whole unstimulated salivary flow rate at 2 and 3 months. | Samples of total saliva (saliva resulting from all salivary glands) will be collected between 8:00 am and 11:00 am, and evaluation of salivary flow will be determined by means of expectoration of saliva in graduated tube of 15 mL for a period of 15 minutes, and the volume obtained will be calculated. | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline Schirmer test scores at 2 and 3 months. | Objective reflection to the lacrimal gland. Schirmer's test uses paper strips inserted into the eye for several minutes to measure the production of tears | Before (baseline), immediately after and 1 month after acupuncture treatment. | 
| Changes from baseline ocular surface staining at 2 and 3 months. | This is a test that uses orange dye (fluorescein) and a blue light to detect foreign bodies in the eye. This test can also detect damage to the cornea. | Before (baseline), immediately after and 1 month after acupuncture treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's syndrome, xerostomia, xerophthalmia, acupuncture