Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2

Conditions: Autoimmune Thyroiditis

Treatments: Device: Low-level Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01129492

CAPPesq 375/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Sham Laser

Placebo Comparator group

Description:

Ten applications of placebo were performed (twice a week) with the same method and Laser equipment, which has a placebo function available with a red ordinary light indistinguishable of the Laser light.

Treatment:

Device: Low-level Laser therapy

Active Laser

Active Comparator group

Description:

Ten applications of low-level Laser therapy (twice a week) were performed with a continuous wave diode laser device (830nm, beam area of 0.2827cm2), using the punctual method, continuous emission mode, output power of de 50 mW and fluence of 70J/cm2.

Treatment:

Device: Low-level Laser therapy