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Tp52.5
Thymopentin Research
Mostly mechanism / observationalLimited safety
11 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Thymopentin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from mixed-quality meta-analyses and randomised trials published 1985–2022.
Based on 11 studies · 5 meta-analyses · 3 RCTs
Confidence
High
By outcome
Immune support
Mostly mechanism / observational11 studies
Inflammation
Too few graded studies2 studies
Slowing down
Only 1 study in the last 5 years · Latest meta-analysis: 2022
198520032022
1RCT1985
After 3 weeks of treatment the TP-5 group showed improvement (p less than 0.05 or p less than 0.01) in all but one of the clinical variables tested.
The response rate (improvement of a clinical parameter by at least 40%) was significantly greater for all clinical parameters in the thymopentin group.
Lemmel EM, Bach GL, Bolten W, Brackertz D, Fahmy Z, Mattern H, Stroehmann I, Wittenborg A. · Dtsch Med Wochenschr (1988)
Larger multicentre, placebo-controlled, randomized double-blind RA trial (119 patients, 107 evaluable; 50 mg IV three times weekly)
Significant improvement in five of nine clinical criteria after the third week and significantly higher response rates across parameters
Seven thymopentin patients (vs none on placebo) improved to a more favourable functional class
There were very few data suggesting that thymopentin, low-level laser therapy, and hypnotherapy are effective in preventing recurrent HSL, with one to two RCTs for each intervention.
Chi CC, Wang SH, Delamere FM, Wojnarowska F, Peters MC, Kanjirath PP. · Cochrane Database Syst Rev (2015)
Cochrane systematic review of interventions to prevent recurrent herpes labialis (cold sores)
Found only very sparse data (1-2 RCTs) suggesting thymopentin may help prevent recurrence
The review could not confirm efficacy for thymopentin given the thin evidence base
Overall, we found neither evidence that the addition of pTE to antineoplastic treatment reduced the risk of death or disease progression nor that it improved the rate of tumour responses to antineoplastic treatment.
Wolf E, Milazzo S, Boehm K, Zwahlen M, Horneber M. · Cochrane Database Syst Rev (2011)
Cochrane systematic review and meta-analysis of 26 randomized trials (2736 patients) of purified thymus extracts (pTE) and synthetic thymic peptides (sTP, including thymopentin and thymosin-alpha-1) added to chemo/radiotherapy in cancer
Adding thymic peptides did NOT reduce risk of death or disease progression, nor improve tumour-response rate (e.g. pTE overall survival RR 1.00, 95% CI 0.79-1.25)
Only a trend toward benefit for thymosin-alpha-1 specifically, and a reduced risk of severe infectious complications with purified thymus extract
Thymopentin adjuvant treatment for drug-resistant PTB can promote the therapeutic effect and improve the immune indexes in patients with drug-resistant PTB.
Han YR, Wang TH, Gong WP, Liang JQ, An HR. · Ther Clin Risk Manag (2022)
Meta-analysis of 23 RCTs (2031 patients) of thymopentin added to anti-TB drugs for drug-resistant pulmonary tuberculosis
Adjuvant thymopentin significantly increased sputum culture-negative and focal absorption rates and shortened cough remission time
Improved CD3+ and CD4+ T-lymphocyte levels and reduced CD8+ levels at 2-3 and 6-9 months
Most results had good robustness, and their quality ranged from moderate to very low.
Zeng FL, Xiao Z, Wang CQ, Jiang Y, Shan JL, Hu SS, Huang XR, Tang YH, Yao XS, Zhang T, Zeng XT, Feng JH, Xiao X. · Int Immunopharmacol (2019)
Systematic review/meta-analysis of 27 RCTs (1925 patients) of synthetic thymic peptides (including thymopentin) plus chemotherapy for NSCLC
Adding synthetic thymic peptides significantly improved objective response, disease control, quality of life and 1-year survival, with fewer chemotherapy toxicities
The strongest tumour-response signal was for thymosin-alpha-1 specifically, not thymopentin
Pooling of study results did not show a significant increase in seroresponse rate among study (thymopentin plus hepatitis B virus vaccine) vs. control (hepatitis B virus vaccine alone) patients; the pooled odds ratio of failure to respond to hepatitis B virus vaccine was 0.677 (95% confidence intervals: 0.285-1.605).
Fabrizi F, Dixit V, Martin P. · Aliment Pharmacol Ther (2006)
Meta-analysis of 11 prospective controlled trials (272 dialysis patients) of thymopentin as an adjuvant to hepatitis-B vaccine in end-stage renal disease
Overall, thymopentin did NOT significantly improve the hepatitis-B vaccine seroresponse rate (pooled OR for failure to respond 0.677, 95% CI 0.285-1.605, not significant)
Only a subgroup of trials using higher thymopentin doses showed a significant benefit (OR 0.184, 95% CI 0.085-0.398)
its effects were characterized by an increase of CD8+CD11b+ T cells in the CD8 subset parallel to the enhancement of the suppressor-inducer/naive T cells in the CD4 subset with a statistically significant correlation.
Afeltra A, Galeazzi M, Basso P, Pietrucci A, De Pita O, Ferri GM, Porzio F, Bonomo L. · J Biol Regul Homeost Agents (1991)
Mechanistic open-label study of intra-articular thymopentin in rheumatoid-arthritis synovial fluid, where suppressor-inducer/naive T cells were almost absent
Thymopentin increased CD8+CD11b+ T cells and enhanced suppressor-inducer/naive T cells, shifting the dysregulated T-cell subset balance toward normal
Soluble CD8 fell after treatment; clinical parameters reportedly improved
11Observational1991
Thymopentin (TP-5), a synthetic pentapeptide reproducing the biological activity of Thymopoietin... A decrease of the OKT4/OKT8 ratio in both patients (significant in one, p less than 0.01) due to the increase of OKT8 was observed.
Cognazzo A, Seliak D, Fruttero A. · Riv Neurol (1991)
Small open-label observation of TP-5 (a synthetic pentapeptide reproducing the activity of thymopoietin) on T-lymphocyte subsets in 2 multiple-sclerosis patients
TP-5 lowered the elevated OKT4/OKT8 (CD4/CD8) ratio via an increase in OKT8 cells, with clinical improvement in one patient
Illustrates the proposed T-cell-subset-normalizing action of thymopentin