Clinical trial NCT04056221: Effects of Acupuncture on Sjögren's Syndrome
Official title: Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Sjogren's syndrome
xerostomia
xerophthalmia
acupuncture
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline Xerostomia Inventory score at at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline The Challacombe scale at at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline Ocular Surface Disease Index (OSDI) at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
Secondary outcomes:
measure: Changes from baseline whole unstimulated salivary flow rate at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline Schirmer test scores at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
measure: Changes from baseline ocular surface staining at 2 and 3 months.
timeFrame: Before (baseline), immediately after and 1 month after acupuncture treatment.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Dentistry of Ribeirão Preto, University of São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo, Ribeirão Preto, SP, Brazil.
name: Jaciara M Gomes-Silva, DDS, PhD
role: STUDY_CHAIR
affiliation: University of São Paulo, Ribeirão Preto, SP, Brazil.
name: Maria Cristina Borsato, DDS, PhD
role: STUDY_CHAIR
affiliation: University of São Paulo, Ribeirão Preto, SP, Brazil.
name: Eduardo Melani Rocha, DDS, PhD
role: STUDY_CHAIR
affiliation: University of São Paulo, Ribeirão Preto, SP, Brazil.
name: Fabiola R Oliveira, DDS, PhD
role: STUDY_CHAIR
affiliation: University of São Paulo, Ribeirão Preto, SP, Brazil.
name: Maria da Conceição P Saraiva, DDS, PhD
role: STUDY_CHAIR
References:
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citation: Jiang Q, Zhang H, Pang R, Chen J, Liu Z, Zhou X. Acupuncture for Primary Sjogren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2017 Jan 19;17(1):61. doi: 10.1186/s12906-017-1559-9.
citation: Hackett KL, Deane KH, Strassheim V, Deary V, Rapley T, Newton JL, Ng WF. A systematic review of non-pharmacological interventions for primary Sjogren's syndrome. Rheumatology (Oxford). 2015 Nov;54(11):2025-32. doi: 10.1093/rheumatology/kev227. Epub 2015 Jun 30.
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citation: Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
citation: Kim BH, Kim MH, Kang SH, Nam HJ. Optimizing acupuncture treatment for dry eye syndrome: a systematic review. BMC Complement Altern Med. 2018 May 3;18(1):145. doi: 10.1186/s12906-018-2202-0.