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Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autoimmune Thyroiditis

Intervention: Low-level Laser therapy (Device)

Phase: Phase 2

Status: Completed

Sponsored by: University of Sao Paulo General Hospital

Official(s) and/or principal investigator(s):
Danilo B Höfling, Dr., Principal Investigator, Affiliation: University of São Paulo General Hospital

Summary

The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.

Clinical Details

Official title: Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal.

Secondary outcome:

Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.

Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.

Detailed description: Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that lead progressively to thyroiditis. There is no effective therapy available that can change the natural history of CAT, which presents a high incidence of hypothyroidism and requires continuous treatment with levothyroxine (LT4). Laser light can be valuable since the local and systemic actions of low-level laser therapy (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate regeneration of various tissues and, in animal thyroids, can lead to improvement in microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels. Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function, their concentration of thyroid autoantibodies, and the parameters of their ultrasonography study.

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients previously diagnosed with hypothyroidism induced by chronic autoimmune

thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.

- Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or

thyroglobulin (TgAb) autoantibodies

- Ultrasonography results consistent with CAT

- Patients undergoing LT4 treatment

- Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4

and thyrotropin (TSH) Exclusion Criteria:

- Use of immunosuppressants, immunostimulants, or other drugs that could interfere with

the production, metabolism and transport of thyroid hormones

- CAT with normal thyroid function

- CAT with subclinical hypothyroidism

- Thyroid nodules

- Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after

gestation)

- History of Graves' disease

- Thyrotropin receptor antibody (TRAb) detectable

- Prior treatment with radioiodine

- Tracheal stenosis

- Pregnancy

- History of ionizing irradiation and/or neoplasia in the cervical area

- Previous surgical intervention in the thyroid

- Thyroid hypoplasia

- Ectopic thyroid

- Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver

failure, etc.)

Locations and Contacts

University of Sao Paulo General Hospital, São Paulo 05403-001, Brazil
Additional Information

Starting date: March 2006
Last updated: May 21, 2010

Page last updated: August 20, 2015

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