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Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

Suboptimal or underactive thyroid function can lead to a condition known as hypothyroidism, which affects approximately 4.6% of people in the US (age 12 and older). (4) Hashimoto’s thyroiditis is the most common cause of an underactive thyroid in developed countries, while iodine deficiency is the most common cause worldwide. (10) Other causes might include goiter, genetic disorders, or radiation treatment/exposure.

Conventional treatment tends to focus on replacing the low levels of thyroid hormones with pharmaceutical sources such as levothyroxine. Supporting thyroid function can be achieved through other methods as well. Based on current research findings, the ingredients in the protocol below have demonstrated efficacy in improving a variety of factors associated with an underactive or suppressed thyroid.

Selenium

200 μg, total per day of selenomethionine, minimum 3 months (1)(8)(16)

  • A decrease between 20% and 63.6% in anti-TPO marker was observed (1)(8)(16)(20
  • Meta-analysis of 16 randomized controlled trials found supplementation of selenium to decreased TPOAb (serum thyroid peroxidase) in people receiving LT4 therapy and newly diagnosed untreated patients (20)
  • Meta-analysis of 4 studies found selenium decreased TPOab and increased chance of reporting improved well-being or mood compared to control while having no impact on LT4 therapy in patients with Hashimoto’s (18)
  • 17.2% of patients with autoimmune thyroiditis and mild subclinical hypothyroidism demonstrated restored euthyroidism, and 31.3% of patients responded to treatment (83 mcg selenomethionine/day for four months) compared to 3.1% in control (16
  • Decreased anti-TPO (anti-thyroid peroxidase) in women with Hashimoto’s who were given 200 mcg of l-selenomethionine per day for 6 months (8)
  • Zinc, in addition to selenium supplementation, increased fT3 mean serum, fT4 mean serum, and decreased TSH; when compared to selenium alone, additional zinc improved thyroid function in overweight or obese female hypothyroid patients (7)
Selenium in the Fullscript catalog

2000 IU, total per day, minimum 6 months (5)(6)(9)

  • It has been demonstrated that low levels of serum 25-hydroxyvitamin D is related to thyroid auto-immune diseases like Hashimotos (19
  • Vitamin D has been linked to a decrease in thyroid autoimmunity in Hashimoto’s thyroiditis treated with levothyroxine. The impact is more significant for thyroid peroxidase than thyroglobulin antibodies (5)(6)(9)
  • The combination of Simvastatin and vitamin D supplementation had a stronger effect in reducing concentrations of thyroid peroxidase and thyroglobulin antibodies than vitamin D supplementation alone (6
  • Improved disease control in female patients with Hashimoto’s was demonstrated by a decrease in Th17/Tr1 ratio compared to placebo when given 50,000 IU once per week for 6 months as cholecalciferol (11)
  • Women treated with levothyroxine demonstrated reduced thyroid autoimmunity when given 2000 IU per day of vitamin D compared to control as demonstrated by a decrease in titers for thyroid antibodies and improved thyroid peroxidase to thyroglobulin (5)
  • Patients with Hashimoto’s who have a euthyroid state were tested for vitamin D deficiency and found that 85.3% of patients were deficient at the beginning of the study; supplementation improved condition as shown by a decrease in serum anti-tpo by 20.3% when supplemented 1200-4000 IU of vitamin D for 4 months (9)
Vitamin D in the Fullscript catalog

Myo-inositol

600 mg, total per day, minimum 6 months (12)(13)(14)(15)

  • Thyroid nodules decreased in size, number, and elasticity and TSH decreased in patients with subclinical hypothyroidism when given myo-inositol with selenium for 6 months (14)
  • Myo-inositol supplementation in addition to selenium decreased TSH, TPOAb, and TgAb, as well as decreased size and stiffness of thyroid nodules compared to selenium alone (13)
  • Supplementation was effective in achieving euthyroidism for patients with Hashimoto’s as shown by improved thyroid panel (TSH, TPOAb, TgAb, fT3, fT4) and improved QOL (12)
  • When given in addition to selenomethionine, myo-inositol supplementation decreased TSH more effectively compared to selenomethionine alone in patients with subclinical hypothyroidism (15)
Myo-inositol in the Fullscript catalog

Ashwagandha

600 mg once per day for a minimum of 8 weeks (17)

  • 600 mg per day of ashwagandha was effective for achieving euthyroidism as shown by improved TSH, T3, and T4 compared to placebo in patients with subclinical hypothyroid  (17)
  • Patients with bipolar disorder experienced secondary thyroid benefits as shown by improved TSH and T4 compared to baseline when given ashwagandha extract for 8 weeks (2)
Ashwagandha in the Fullscript catalog

6 g, total per day, minimum 24 weeks (3)

  • Preliminary research shows that Cordyceps sinensis may balance the proportion between helper T cells and cytotoxic T cells (3)
  • In addition, Cordyceps sinensis may contribute to a significant decrease in anti-TPO antibodies in Hashimoto’s thyroiditis patients (3)
Cordyceps sinensis in the Fullscript catalog

Disclaimer

The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

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References
  1. de Farias, C. R., Cardoso, B. R., de Oliveira, G. M. B., de Mello Guazzelli, I. C., Catarino, R. M., Chammas, M. C., Cozzolino, S. M. F., & Knobel, M. (2015). A randomized-controlled, double-blind study of the impact of selenium supplementation on thyroid autoimmunity and inflammation with focus on the GPx1 genotypes. Journal of Endocrinological Investigation, 38(10), 1065–1074. https://pubmed.ncbi.nlm.nih.gov/25894865/ (B)
  2. Gannon, J. M., Forrest, P. E., & Roy Chengappa, K. N. (2014). Subtle changes in thyroid indices during a placebo-controlled study of an extract of Withania somnifera in persons with bipolar disorder. Journal of Ayurveda and Integrative Medicine, 5(4), 241–245. https://pubmed.ncbi.nlm.nih.gov/25624699/ (C)
  3. He, T., Zhao, R., Lu, Y., Li, W., Hou, X., Sun, Y., Dong, M., & Chen, L. (2016). Dual-Directional Immunomodulatory Effects of Corbrin Capsule on Autoimmune Thyroid Diseases. Evidence-Based Complementary and Alternative Medicine: eCAM, 2016, 1360386. https://pubmed.ncbi.nlm.nih.gov/27721890/ (C)
  4. Hypothyroidism (Underactive Thyroid). (n.d.). Retrieved March 31, 2021, from https://www.niddk.nih.gov/health-information/endocrine-diseases/hypothyroidism https://www.niddk.nih.gov/health-information/endocrine-diseases/hypothyroidism (F)
  5. Krysiak, R., Szkróbka, W., & Okopień, B. (2017). The Effect of Vitamin D on Thyroid Autoimmunity in Levothyroxine-Treated Women with Hashimoto’s Thyroiditis and Normal Vitamin D Status. Experimental and Clinical Endocrinology & Diabetes: Official Journal, German Society of Endocrinology [and] German Diabetes Association, 125(4), 229–233. https://pubmed.ncbi.nlm.nih.gov/28073128/ (C)
  6. Krysiak, R., Szkróbka, W., & Okopień, B. (2018). Moderate-dose simvastatin therapy potentiates the effect of vitamin D on thyroid autoimmunity in levothyroxine-treated women with Hashimoto’s thyroiditis and vitamin D insufficiency. Pharmacological Reports: PR, 70(1), 93–97. https://pubmed.ncbi.nlm.nih.gov/29331793/ (C)
  7. Mahmoodianfard, S., Vafa, M., Golgiri, F., Khoshniat, M., Gohari, M., Solati, Z., & Djalali, M. (2015). Effects of Zinc and Selenium Supplementation on Thyroid Function in Overweight and Obese Hypothyroid Female Patients: A Randomized Double-Blind Controlled Trial. Journal of the American College of Nutrition, 34(5), 391–399. https://pubmed.ncbi.nlm.nih.gov/25758370/ (B)
  8. Mazokopakis, E. E., Papadakis, J. A., Papadomanolaki, M. G., Batistakis, A. G., Giannakopoulos, T. G., Protopapadakis, E. E., & Ganotakis, E. S. (2007). Effects of 12 months treatment with L-selenomethionine on serum anti-TPO Levels in Patients with Hashimoto’s thyroiditis. Thyroid: Official Journal of the American Thyroid Association, 17(7), 609–612. https://pubmed.ncbi.nlm.nih.gov/17696828/ (C)
  9. Mazokopakis, E. E., Papadomanolaki, M. G., Tsekouras, K. C., Evangelopoulos, A. D., Kotsiris, D. A., & Tzortzinis, A. A. (2015). Is vitamin D related to pathogenesis and treatment of Hashimoto’s thyroiditis? Hellenic Journal of Nuclear Medicine, 18(3), 222–227. https://pubmed.ncbi.nlm.nih.gov/26637501/ (C)
  10. Mincer, D. L., & Jialal, I. (2020). Hashimoto Thyroiditis. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK459262/ (F)
  11. Nodehi, M., Ajami, A., Izad, M., Asgarian Omran, H., Chahardoli, R., Amouzegar, A., Yekaninejad, S., Hemmatabadi, M., Azizi, F., Esfahanian, F., Mansouri, F., Mazaheri Nezhad Fard, R., & Saboor-Yaraghi, A. A. (2019). Effects of vitamin D supplements on frequency of CD4+ T-cell subsets in women with Hashimoto’s thyroiditis: a double-blind placebo-controlled study. European Journal of Clinical Nutrition, 73(9), 1236–1243. https://pubmed.ncbi.nlm.nih.gov/30696977/ (C)
  12. Nordio, M., & Basciani, S. (2017). Treatment with Myo-Inositol and Selenium Ensures Euthyroidism in Patients with Autoimmune Thyroiditis. International Journal of Endocrinology, 2017, 2549491. https://pubmed.ncbi.nlm.nih.gov/28293260/ (C)
  13. Nordio, M., & Basciani, S. (2017). Myo-inositol plus selenium supplementation restores euthyroid state in Hashimoto’s patients with subclinical hypothyroidism. European Review for Medical and Pharmacological Sciences, 21(2 Suppl), 51–59. https://pubmed.ncbi.nlm.nih.gov/28724185/ (C)
  14. Nordio, M., & Basciani, S. (2018). Evaluation of thyroid nodule characteristics in subclinical hypothyroid patients under a myo-inositol plus selenium treatment. European Review for Medical and Pharmacological Sciences, 22(7), 2153–2159. https://pubmed.ncbi.nlm.nih.gov/29687875/ (C)
  15. Nordio, M., & Pajalich, R. (2013). Combined treatment with Myo-inositol and selenium ensures euthyroidism in subclinical hypothyroidism patients with autoimmune thyroiditis. Journal of Thyroid Research, 2013, 424163. https://pubmed.ncbi.nlm.nih.gov/24224112/ (C) 
  16. Pirola, I., Gandossi, E., Agosti, B., Delbarba, A., & Cappelli, C. (2016). Selenium supplementation could restore euthyroidism in subclinical hypothyroid patients with autoimmune thyroiditis. Endokrynologia Polska, 67(6), 567–571. https://pubmed.ncbi.nlm.nih.gov/28042649/ (B)
  17. Sharma, A. K., Basu, I., & Singh, S. (2018). Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial. Journal of Alternative and Complementary Medicine , 24(3), 243–248. https://pubmed.ncbi.nlm.nih.gov/28829155/ (B)
  18. Toulis, K. A., Anastasilakis, A. D., Tzellos, T. G., Goulis, D. G., & Kouvelas, D. (2010). Selenium supplementation in the treatment of Hashimoto’s thyroiditis: a systematic review and a meta-analysis. Thyroid: Official Journal of the American Thyroid Association, 20(10), 1163–1173. https://pubmed.ncbi.nlm.nih.gov/20883174/ (A)
  19. Wang, J., Lv, S., Chen, G., Gao, C., He, J., Zhong, H., & Xu, Y. (2015). Meta-analysis of the association between vitamin D and autoimmune thyroid disease. Nutrients, 7(4), 2485–2498. https://pubmed.ncbi.nlm.nih.gov/25854833/ (A)
  20. Wichman, J., Winther, K. H., Bonnema, S. J., & Hegedüs, L. (2016). Selenium Supplementation Significantly Reduces Thyroid Autoantibody Levels in Patients with Chronic Autoimmune Thyroiditis: A Systematic Review and Meta-Analysis. Thyroid: Official Journal of the American Thyroid Association, 26(12), 1681–1692. https://pubmed.ncbi.nlm.nih.gov/27702392/ (A)

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