Evidence-Based Hormone Therapies

Elderly men: the immune stimulation with thymosin-alpha-1 (1 trial, 85 patients)

1. Gravenstein S1, Duthie EH, Miller BA, Roecker E, Drinka P, Prathipati K, Ershler WB. Augmentation of influenza antibody response in elderly men by thymosin alpha one. A double-blind placebo-controlled clinical study. J Am Geriatr Soc. 1989 Jan;37(1):1-8.

Sepsis: the improvement with thymosin-alpha-1 and ulinastatin (increased survival, improved immune parameters) (6 trials, 915 patients )

2. Chen H, He MY, Li YM. Treatment of patients with severe sepsis using ulinastatin and thymosin alpha1: a prospective, randomized, controlled pilot study. Chin Med J (Engl). 2009 Apr 20;122(8):883-8.
3. Li Yumin, Chen Hao, Li Xun, Zhou Wence, He Minyan, Chiriva-Internati M, Wachtel MS, Frezza EE. A new immunomodulatory therapy for severe sepsis: Ulinastatin Plus Thymosin {alpha} 1. J Intensive Care Med. 2009 Jan-Feb;24(1):47-53.
4. Zhang Y, Chen H, Li YM, Zheng SS, Chen YG, Li LJ, Zhou L, Xie HY, Praseedom RK. Thymosin alpha1- and ulinastatin-based immunomodulatory strategy for sepsis arising from intra-abdominal infection due to carbapenem-resistant bacteria. J Infect Dis. 2008 Sep 1;198(5):723-30.

+ 3 other trials mentioned in meta-analysis talks of 6 trials

5. Han D, Shang W, Wang G, Sun L2, Zhang Y, Wen H, Xu L. Ulinastatin- and thymosin α1-based immunomodulatory strategy for sepsis: A meta-analysis. Int Immunopharmacol. 2015 Dec;29(2):377-82.

Chronic obstructive pulmonary disease (acute exacerbation): the improvement with thymosin-alpha-1 (1 trial, 84 patients)

6. Jia Z, Feng Z, Tian R, Wang Q, Wang L. Thymosin α1 plus routine treatment inhibit inflammatory reaction and improve the quality of life in AECOPD patients. Immunopharmacol Immunotoxicol. 2015;37(4):388-92.

Chronic hepatitis B: the improvement with thymosin-alpha-1 (2 trials)

7. Lim SG, Wai CT, Lee YM, Dan YY, Sutedja DS, Wee A, Suresh S, Wu YJ, Machin D, Lim CC, Fock KM, Koay E, Bowden S, Locarnini S, Ishaque SM. A randomized, placebo-controlled trial of thymosin-alpha1 and lymphoblastoid interferon for HBeAg-positive chronic hepatitis B. Antivir Ther. 2006;11(2):245-53.
8. Mutchnick MG1, Lindsay KL, Schiff ER, Cummings GD, Appelman HD, Peleman RR, Silva M, Roach KC, Simmons F, Milstein S, Gordon SC, Ehrinpreis MN. Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study. J Viral Hepat. 1999 Sep;6(5):397-403.

 + 3 other trials mentioned in meta-analysis:

9. Chan HL, Tang JL, Tam W, Sung JJ. The efficacy of thymosin in the treatment of chronic hepatitis B virus infection: a meta-analysis. Aliment Pharmacol Ther. 2001 Dec;15(12):1899-905.

Chronic hepatitis C: the improvement with thymosin-alpha-1 (1 trial, 103 patients)

10. Sherman KE, Sjogren M, Creager RL, Damiano MA, Freeman S, Lewey S, Davis D, Root S, Weber FL, Ishak KG, Goodman ZD. Combination therapy with thymosin alpha1 and interferon for the treatment of chronic hepatitis C infection: a randomized, placebo-controlled double-blind trial. Hepatology. 1998 Apr;27(4):1128-35.

Chronic hepatitis C: no significant improvement with thymosin-alpha-1 (1 trials, 571 patients)

11. Ciancio A, Andreone P, Kaiser S, Mangia A, Milella M, Solà R, Pol S, Tsianos E, De Rosa A, Camerini R, McBeath R, Rizzetto M. Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role? J Viral Hepat. 2012 Jan;19 Suppl 1:52-9.
12. Andreone P, Cursaro C, Gramenzi A, Buzzi A, Covarelli MG, Di Giammarino L, Miniero R, Arienti V, Bernardi M, Gasbarrini G. A double-blind, placebo-controlled, pilot trial of thymosin alpha 1 for the treatment of chronic hepatitis C. Liver. 1996 Jun;16(3):207-10.

Cancer (overall) after radiotherapy or chemotherapy (immune depression): trend toward improvement with thymosin-alpha-1 or thymopentin (4trials, > 100 patients)

13. Chretien PB, Lipson SD, Makuch R, Kenady DE, Cohen MH, Minna JD. Thymosin in cancer patients: in vitro effects and correlations with clinical response to thymosin immunotherapy. Cancer Treat Rep. 1978 Nov;62(11):1787-90.

Mentions 3 more placebo-controlled trials in review

14. Wolf E, Milazzo S, Boehm K, Zwahlen M, Horneber M. Thymic peptides for treatment of cancer patients. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD003993.

Cancer (lung) after radiotherapy (immune depression): the improvement with thymosin-alpha-1 (2 trials, 63 patients)

15. Schulof RS, Lloyd MJ, Cleary PA, Palaszynski SR, Mai DA, Cox JW Jr, Alabaster O, Goldstein AL. A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha 1 in patients with lung cancer. J Biol Response Mod. 1985 Apr;4(2):147-58.
16. Schulof RS, Chorba TL, Cleary PA, Palaszynski SR, Alabaster O, Goldstein AL. -cell abnormalities after mediastinal irradiation for lung cancer. The in vitro influence of synthetic thymosin alpha-1. Cancer. 1985 Mar 1;55(5):974-83.

Fertility: the association with higher thymosin-alpha-1 levels in women (2 references)

1. Naz RK, Naylor PH, Goldstein AL. Thymosin alpha 1 levels in human seminal plasma and follicular fluid: implication in germ cell function. Int J Fertil. 1987 Sep-Oct;32(5):375-9.
2. Kaufmann RA, Welch RA, Mutchnick MG. Low periconceptional maternal serum thymosin alpha 1 levels are associated with blighted pregnancies. Am J Reprod Immunol. 1993 Apr;29(3):171-5.

Fertility: the association with higher thymosin-alpha-1 levels in men (1 reference)

1. Naz RK, Naylor PH, Goldstein AL. Thymosin alpha 1 levels in human seminal plasma and follicular fluid: implication in germ cell function. Int J Fertil. 1987 Sep-Oct;32(5):375-9.

Fertility: the improvement with thymosin-alpha-1 treatment in men (1 reference)

1. Naz RK, Menge AC, Sacco A. Treatment with thymosin alpha-1 increases fertilizing capacity of sperm of infertile men: a multicenter trial. Arch Androl. 1995 Sep-Oct;35(2):149-54.

Low quality of life: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Yang YM, Lu XY, Huang WD, Shen MY. Effect of thymosin alpha 1 on cellular immune function in elderly patients with malignant tumor. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2003 Aug;32(4):339-41

Age-related and other diseases:

Psoriatic arthritis: the association with low thymosin-alpha-1 levels (1 reference)

1. Pica F, Gaziano R, Casalinuovo IA, Moroni G, Buè C, Limongi D, D’Agostini C, Tomino C, Perricone R, Palamara AT, Sinibaldi Vallebona P, Garaci E. Serum thymosin alpha 1 levels in normal and pathological conditions. Expert Opin Biol Ther. 2018 Jul;18(sup1):13-21.

Rheumatoid arthritis: the association with low thymosin-alpha-1 levels (1 reference)

1. Pica F, Chimenti MS, Gaziano R, Buè C, Casalinuovo IA, Triggianese P, Conigliaro P, Di Carlo D, Cordero V, Adorno G, Volpi A, Perricone R, Garaci E. Serum thymosin α 1 levels in patients with chronic inflammatory autoimmune diseases. Clin Exp Immunol. 2016 Oct;186(1):39-45.

Lupus: the association with low thymosin-alpha-1 levels (1 reference)

1. Pica F, Chimenti MS, Gaziano R, Buè C, Casalinuovo IA, Triggianese P, Conigliaro P, Di Carlo D, Cordero V, Adorno G, Volpi A, Perricone R, Garaci E. Serum thymosin α 1 levels in patients with chronic inflammatory autoimmune diseases. Clin Exp Immunol. 2016 Oct;186(1):39-45.

Multiple sclerosis: the association with low thymosin-alpha-1 levels (1 reference)

1. Pica F, Gaziano R, Casalinuovo IA, Moroni G, Buè C, Limongi D, D’Agostini C, Tomino C, Perricone R, Palamara AT, Sinibaldi Vallebona P, Garaci E. Serum thymosin alpha 1 levels in normal and pathological conditions. Expert Opin Biol Ther. 2018 Jul;18(sup1):13-21.

Cystic fibrosis: the association with low thymosin-alpha-1 levels (1 reference)

1. Pica F, Gaziano R, Casalinuovo IA, Moroni G, Buè C, Limongi D, D’Agostini C, Tomino C, Perricone R, Palamara AT, Sinibaldi Vallebona P, Garaci E. Serum thymosin alpha 1 levels in normal and pathological conditions. Expert Opin Biol Ther. 2018 Jul;18(sup1):13-21.

Pancreatitis: the improvement with thymosin-alpha-1 treatment (2 references)

1. Yang N, Ke L, Tong Z, Li W. The effect of thymosin α1 for prevention of infection in patients with severe acute pancreatitis. Expert Opin Biol Ther. 2018 Jul;18(sup1):53-60. (v)
2. Wang X, Li W, Niu C, Pan L, Li N, Li J. Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study. Inflammation. 2011 Jun;34(3):198-202

Infections:

Immune deficiency: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Gravenstein S1, Duthie EH, Miller BA, Roecker E, Drinka P, Prathipati K, Ershler WB. Augmentation of influenza antibody response in elderly men by thymosin alpha one. A double-blind placebo-controlled clinical study. J Am Geriatr Soc. 1989 Jan;37(1):1-8.

Chronic obstructive pulmonary disease: the improvement with thymosin-alpha-1 treatment (2 references)

1. Zheng BX, Cheng DY, Xu G, Fan LL, Yang Y, Yang W. [The prophylactic effect of thymosin alpha 1 on the acute exacerbation of chronic obstructive pulmonary disease]. Sichuan Da Xue Xue Bao Yi Xue Ban. 2008 Jul;39(4):588-90.
2. Jia Z, Feng Z, Tian R, Wang Q, Wang L. Thymosin α1 plus routine treatment inhibit inflammatory reaction and improve the quality of life in AECOPD patients. Immunopharmacol Immunotoxicol. 2015;37(4):388-92.

Herpes simplex infection: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Aiuti F, Sirianni MC, Paganelli R, Stella A, Turbessi G, Fiorilli M. A placebo-controlled trial of thymic hormone treatment of recurrent herpes simplex labialis infection in immunodeficient hosts. Int J Clin Pharmacol Ther Toxicol. 1983 Feb;21(2):81-6.

CMV infection: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Ji SM, Li LS, Sun QQ, Chen JS, Sha GZ, Liu ZH. Immunoregulation of thymosin alpha 1 treatment of cytomegalovirus infection accompanied with acute respiratory distress syndrome after renal transplantation. Transplant Proc. 2007 Jan-Feb;39(1):115-9.

Chronic hepatitis B virus: the association with lower thymosin-alpha-1 levels (2 references)

1. Sherman KE, Jones CC, Goldstein AL, Naylor PH. Low thymosin alpha-1 concentrations in patients chronically infected with the hepatitis B virus. Viral Immunol. 1991 Fall;4(3):195-9.
2. Pica F, Gaziano R, Casalinuovo IA, Moroni G, Buè C, Limongi D, D’Agostini C, Tomino C, Perricone R, Palamara AT, Sinibaldi Vallebona P, Garaci E. Serum thymosin alpha 1 levels in normal and pathological conditions. Expert Opin Biol Ther. 2018 Jul;18(sup1):13-21.

Chronic hepatitis B virus: the improvement with thymosin-alpha-1 treatment (2 references)

1. Lim SG, Wai CT, Lee YM, Dan YY, Sutedja DS, Wee A, Suresh S, Wu YJ, Machin D, Lim CC, Fock KM, Koay E, Bowden S, Locarnini S, Ishaque SM. A randomized, placebo-controlled trial of thymosin-alpha1 and lymphoblastoid interferon for HBeAg-positive chronic hepatitis B. Antivir Ther. 2006;11(2):245-53.
2. Mutchnick MG, Lindsay KL, Schiff ER, Cummings GD, Appelman HD, Peleman RR, Silva M, Roach KC, Simmons F, Milstein S, Gordon SC, Ehrinpreis MN. Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study. J Viral Hepat. 1999 Sep;6(5):397-403.

HIV infection: the improvement with thymosin-alpha-1 treatment (2 references)

1. Chadwick D, Pido-Lopez J, Pires A, Imami N, Gotch F, Villacian JS, Ravindran S, Paton NI. A pilot study of the safety and efficacy of thymosin alpha 1 in augmenting immune reconstitution in HIV-infected patients with low CD4 counts taking highly active antiretroviral therapy. Clin Exp Immunol. 2003 Dec;134(3):477-81.
2. Matteucci C, Minutolo A, Pollicita M, Balestrieri E, Grelli S, D’Ettorre G, Vullo V, Bucci I, Luchini A, Aquaro S, Sinibaldi-Vallebona P, Macchi B, Perno CF, Mastino A, Garaci E. Thymosin α 1 potentiates the release by CD8(+) cells of soluble factors able to inhibit HIV-1 and human T lymphotropic virus 1 infection in vitro. Expert Opin Biol Ther. 2015;15 Suppl 1:S83-100.

Cancer :

Sepsis: the improvement with thymosin-alpha-1 and ulinastatin (3 references)

1. Chen H, He MY, Li YM. Treatment of patients with severe sepsis using ulinastatin and thymosin alpha1: a prospective, randomized, controlled pilot study. Chin Med J (Engl). 2009 Apr 20;122(8):883-8.
2. Li Yumin, Chen Hao, Li Xun, Zhou Wence, He Minyan, Chiriva-Internati M, Wachtel MS, Frezza EE. A new immunomodulatory therapy for severe sepsis: Ulinastatin Plus Thymosin {alpha} 1. J Intensive Care Med. 2009 Jan-Feb;24(1):47-53.
3. Zhang Y, Chen H, Li YM, Zheng SS, Chen YG, Li LJ, Zhou L, Xie HY, Praseedom RK. Thymosin alpha1- and ulinastatin-based immunomodulatory strategy for sepsis arising from intra-abdominal infection due to carbapenem-resistant bacteria. J Infect Dis. 2008 Sep 1;198(5):723-30.

Malignant melanoma: the improvement with thymosin-alpha-1 treatment (3 references)

1. Favalli C. Presentation at the Third International Symposium on Combination Therapies, Houston, Texas, 1993.
2. Rasi G, Terzoli E, Izzo F, Pierimarchi P, Ranuzzi M, Sinibaldi-Vallebona P, Tuthill C, Garaci E. Combined treatment with thymosin-alpha1 and low dose interferon-alpha after dacarbazine in advanced melanoma. Melanoma Res. 2000;10:189-192.
3. Lopez M, Carpano S, Cavaliere R, Di Lauro L, Ameglio F, Vitelli G, Frasca AM, Vici P, Pignatti F, Rosselli M, et al. Biochemotherapy with thymosin alpha 1, interleukin-2 and dacarbazine in patients with metastatic melanoma: clinical and immunological effects. Ann Oncol. 1994;5:741-746.

Metastases of malignant melanoma: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Maio M, Mackiewicz A, Testori A, Trefzer U, Ferraresi V, Jassem J, Garbe C, Lesimple T, Guillot B, Gascon P, Gilde K, Camerini R, Cognetti F; ThymosinMelan oma Investigation Group. Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma. J Clin Oncol. 2010 Apr 1;28(10):1780-7.

Lung cancer: the improvement with thymosin-alpha-1 treatment (2 references)

1. Schulof RS, Lloyd MJ, Cleary PA, Palaszynski SR, Mai DA, Cox JW Jr, Alabaster O, Goldstein AL. A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha 1 in patients with lung cancer. J Biol Response Mod. 1985 Apr;4(2):147-58.
2. Schulof RS, Chorba TL, Cleary PA, Palaszynski SR, Alabaster O, Goldstein AL. -cell abnormalities after mediastinal irradiation for lung cancer. The in vitro influence of synthetic thymosin alpha-1. Cancer. 1985 Mar 1;55(5):974-83.

Breast cancer: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Lao X, Li B, Liu M, Shen C, Yu T, Gao X, Zheng H. A modified thymosin alpha 1 inhibits the growth of breast cancer both in vitro and in vivo: suppressment of cell proliferation, inducible cell apoptosis and enhancement of targeted anticancer effects. Apoptosis. 2015 Oct;20(10):1307-20.

Liver cancer: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Stephanini Stefanini GF, Foschi FG, Castelli E, Marsigli L, Biselli M, Mucci F, Bernardi M, Van Thiel DH, Gasbarrini G. Alpha-1-thymosin and transcatheter arterial chemoembolization in hepatocellular carcinoma patients: a preliminary experience. Hepatogastroenterology. 1998;45:209-215.

Colorectal cancer: the improvement with thymosin-alpha-1 treatment in vitro (1 reference)

1. Ni C, Wu P, Wu X, Zhang T, Zhang T, Wang Z, Zhang S, Qiu F, Huang J. Thymosin alpha1 enhanced cytotoxicity of iNKT cells against colon cancer via upregulating CD1d expression. Cancer Lett. 2015 Jan 28;356(2 Pt B):579-88.

Leukemia: the improvement with thymosin-alpha-1 treatment (1 reference)

1. Eckert K, Schmitt M, Garbin F, Wahn U, Maurer HR. Thymosin-alpha-1 effects, in vitro, on lymphokine-activated killer cells from patients with primary immunodeficiencies: preliminary results. Int J Immunopharmacol. 1994 Dec;16(12):1019-25