Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Summary

Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.

Timeline

Start

2012-05

Primary completion

2014-05

Completion

2014-05

Publications

• Background Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. doi: 10.1016/S0140-6736(04)15696-1.
• Background Cooper DS, Biondi B. Subclinical thyroid disease. Lancet. 2012 Mar 24;379(9821):1142-54. doi: 10.1016/S0140-6736(11)60276-6. Epub 2012 Jan 23.
• Background Lowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.
• Background Sawin CT, Hershman JM, Fernandez-Garcia R, Ghazvinian S, Ganda OP, Azukizawa M. A comparison of thyroxine and desicatted thyroid in patients with primary hypothyroidism. Metabolism. 1978 Oct;27(10):1518-25. doi: 10.1016/s0026-0495(78)80024-9. No abstract available.
• Background Biondi B, Wartofsky L. Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 2012 Jul;97(7):2256-71. doi: 10.1210/jc.2011-3399. Epub 2012 May 16.
• Background Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.
• Background Hennemann G, Docter R, Friesema EC, de Jong M, Krenning EP, Visser TJ. Plasma membrane transport of thyroid hormones and its role in thyroid hormone metabolism and bioavailability. Endocr Rev. 2001 Aug;22(4):451-76. doi: 10.1210/edrv.22.4.0435.
• Background Salvatore D, Bartha T, Harney JW, Larsen PR. Molecular biological and biochemical characterization of the human type 2 selenodeiodinase. Endocrinology. 1996 Aug;137(8):3308-15. doi: 10.1210/endo.137.8.8754756.
• Background Kim BW, Bianco AC. For some, L-thyroxine replacement might not be enough: a genetic rationale. J Clin Endocrinol Metab. 2009 May;94(5):1521-3. doi: 10.1210/jc.2009-0410. No abstract available.
• Background Panicker V, Saravanan P, Vaidya B, Evans J, Hattersley AT, Frayling TM, Dayan CM. Common variation in the DIO2 gene predicts baseline psychological well-being and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients. J Clin Endocrinol Metab. 2009 May;94(5):1623-9. doi: 10.1210/jc.2008-1301. Epub 2009 Feb 3.
• Background Nygaard B, Jensen EW, Kvetny J, Jarlov A, Faber J. Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study. Eur J Endocrinol. 2009 Dec;161(6):895-902. doi: 10.1530/EJE-09-0542. Epub 2009 Aug 7.
• Background Grozinsky-Glasberg S, Fraser A, Nahshoni E, Weizman A, Leibovici L. Thyroxine-triiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2006 Jul;91(7):2592-9. doi: 10.1210/jc.2006-0448. Epub 2006 May 2.
• Background Escobar-Morreale HF, Botella-Carretero JI, Escobar del Rey F, Morreale de Escobar G. REVIEW: Treatment of hypothyroidism with combinations of levothyroxine plus liothyronine. J Clin Endocrinol Metab. 2005 Aug;90(8):4946-54. doi: 10.1210/jc.2005-0184. Epub 2005 May 31.
• Background Appelhof BC, Fliers E, Wekking EM, Schene AH, Huyser J, Tijssen JG, Endert E, van Weert HC, Wiersinga WM. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial. J Clin Endocrinol Metab. 2005 May;90(5):2666-74. doi: 10.1210/jc.2004-2111. Epub 2005 Feb 10.
• Background Saravanan P, Simmons DJ, Greenwood R, Peters TJ, Dayan CM. Partial substitution of thyroxine (T4) with tri-iodothyronine in patients on T4 replacement therapy: results of a large community-based randomized controlled trial. J Clin Endocrinol Metab. 2005 Feb;90(2):805-12. doi: 10.1210/jc.2004-1672. Epub 2004 Dec 7.
• Background Escobar-Morreale HF, Botella-Carretero JI, Gomez-Bueno M, Galan JM, Barrios V, Sancho J. Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone. Ann Intern Med. 2005 Mar 15;142(6):412-24. doi: 10.7326/0003-4819-142-6-200503150-00007.
• Background Walsh JP, Shiels L, Lim EM, Bhagat CI, Ward LC, Stuckey BG, Dhaliwal SS, Chew GT, Bhagat MC, Cussons AJ. Combined thyroxine/liothyronine treatment does not improve well-being, quality of life, or cognitive function compared to thyroxine alone: a randomized controlled trial in patients with primary hypothyroidism. J Clin Endocrinol Metab. 2003 Oct;88(10):4543-50. doi: 10.1210/jc.2003-030249.
• Background Clyde PW, Harari AE, Getka EJ, Shakir KM. Combined levothyroxine plus liothyronine compared with levothyroxine alone in primary hypothyroidism: a randomized controlled trial. JAMA. 2003 Dec 10;290(22):2952-8. doi: 10.1001/jama.290.22.2952.
• Background Sawka AM, Gerstein HC, Marriott MJ, MacQueen GM, Joffe RT. Does a combination regimen of thyroxine (T4) and 3,5,3'-triiodothyronine improve depressive symptoms better than T4 alone in patients with hypothyroidism? Results of a double-blind, randomized, controlled trial. J Clin Endocrinol Metab. 2003 Oct;88(10):4551-5. doi: 10.1210/jc.2003-030139.
• Background Bunevicius R, Kazanavicius G, Zalinkevicius R, Prange AJ Jr. Effects of thyroxine as compared with thyroxine plus triiodothyronine in patients with hypothyroidism. N Engl J Med. 1999 Feb 11;340(6):424-9. doi: 10.1056/NEJM199902113400603.
• Background Bunevicius R, Prange AJ. Mental improvement after replacement therapy with thyroxine plus triiodothyronine: relationship to cause of hypothyroidism. Int J Neuropsychopharmacol. 2000 Jun;3(2):167-174. doi: 10.1017/S1461145700001826.
• Background Smith RN, Taylor SA, Massey JC. Controlled clinical trial of combined triiodothyronine and thyroxine in the treatment of hypothyroidism. Br Med J. 1970 Oct 17;4(5728):145-8. doi: 10.1136/bmj.4.5728.145.
• Background Lanni A, Moreno M, Lombardi A, Goglia F. Calorigenic effect of diiodothyronines in the rat. J Physiol. 1996 Aug 1;494 ( Pt 3)(Pt 3):831-7. doi: 10.1113/jphysiol.1996.sp021536.
• Background Jackson IM, Cobb WE. Why does anyone still use desiccated thyroid USP? Am J Med. 1978 Feb;64(2):284-8. doi: 10.1016/0002-9343(78)90057-8.
• Background ROBERTSON JD, KIRKPATRICK HF. Changes in basal metabolism, serumprotein-bound iodine, and cholesterol during treatment of hypothyroidism with oral thyroid and L-thyroxine sodium. Br Med J. 1952 Mar 22;1(4759):624-8. doi: 10.1136/bmj.1.4759.624. No abstract available.
• Background Means JH, Lerman J, Salter WT. THE ROLE OF THYROXIN IODINE AND TOTAL ORGANIC IODINE IN THE CALORIGENIC ACTION OF WHOLE THYROID GLAND. J Clin Invest. 1933 Jul;12(4):683-8. doi: 10.1172/JCI100529. No abstract available.
• Background Thompson WO, McLellan LL, Thompson PK, Dickie LF. THE RATES OF UTILIZATION OF THYROXINE AND OF DESICCATED THYROID IN MAN: THE RELATION BETWEEN THE IODINE IN DESICCATED THYROID AND IN THYROXINE. J Clin Invest. 1933 Jan;12(1):235-46. doi: 10.1172/JCI100492. No abstract available.
• Background Thompson WO, Thompson PK, Brailey AG, Cohen AC. THE CALORIGENETIC ACTION OF THYROXIN AT DIFFERENT LEVELS OF BASAL METABOLISM IN MYXEDEMA. J Clin Invest. 1929 Aug;7(3):437-63. doi: 10.1172/JCI100237. No abstract available.
• Background McDowell I, Newell C. The General Health Questionnaire. Measuring Health. A Guide to Rating Scales and Questionnaires. 2nd Ed, Oxford, 1996
• Background Cooper DS, Halpern R, Wood LC, Levin AA, Ridgway EC. L-Thyroxine therapy in subclinical hypothyroidism. A double-blind, placebo-controlled trial. Ann Intern Med. 1984 Jul;101(1):18-24. doi: 10.7326/0003-4819-101-1-18.
• Background Jaeschke R, Guyatt G, Cook D, Harper S, Gerstein HC. Spectrum of quality of life impairment in hypothyroidism. Qual Life Res. 1994 Oct;3(5):323-7. doi: 10.1007/BF00451724.
• Background BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
• Background Benson N, Hulac DM, Kranzler JH. Independent examination of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): what does the WAIS-IV measure? Psychol Assess. 2010 Mar;22(1):121-30. doi: 10.1037/a0017767.
• Background Wechsler DA. The Wechsler Memory Scale-III. 3rd ed. San Antonio, Tex:Psychological Corp;1997.

Drugs

Indications