Clinical trial NCT01129492: Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis
Official title: Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune Thyroiditis
Keywords: Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2010-05-24
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.)

Primary outcomes:
measure: 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.
timeFrame: LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.
Secondary outcomes:
measure: Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.
timeFrame: Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal.
measure: Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.
timeFrame: The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of São Paulo General Hospital
name: Danilo B Höfling, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofling DB, Chavantes MC, Acencio MM, Cerri GG, Marui S, Yoshimura EM, Chammas MC. Effects of low-level laser therapy on the serum TGF-beta1 concentrations in individuals with autoimmune thyroiditis. Photomed Laser Surg. 2014 Aug;32(8):444-9. doi: 10.1089/pho.2014.3716.