Effects of Acupuncture on Sjögren's Syndrome

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

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.

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.

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.

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

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.

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

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".

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.

The purpose of this scale is to be able to visually identify and quantify whether your patient has xerostomia (dry mouth)

There is a 0-10 numerical scale for each of the four domains, dryness, discomfort (including pain), global fatigue and mental fatigue

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."

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.

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

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.

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.

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