Thymosin alpha-1 — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Immune modulation and adjunctive immunotherapy
Anchor outcome. CD4 and CD8 counts.
Effect as recorded. Meta-analyses of hepatitis B trials report higher sustained virological response with thymosin alpha-1 as monotherapy or adjunct; a large Chinese randomised trial in sepsis reported a mortality difference that a subsequent larger trial did not confirm; hepatitis B: pooled odds ratio approximately 1.7 (95 % CI 1.1 to 2.7) across small trials; sepsis: discordant results.[1,2]
Certainty. Moderate certainty Rated moderate for the immune-reconstitution effect on lymphocyte subsets, which is consistently reproduced, and low for any clinical outcome, which is not. The Institute separates these two claims deliberately.
Contributing trials. TA1-HBV-1 · TA1-HCV-1 · TA1-VACCINE-ELDERLY · TA1-SEPSIS-CN. Full structured abstracts are published for each.
Full evidence extract for immune modulation and adjunctive immunotherapy · Indication assessment
§3.2Cognitive performance and neuroprotection
Anchor outcome. Domain-specific cognitive test scores.
Effect as recorded. No evidence identified; —.[2,3]
Certainty. Not rated certainty —
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for cognitive performance and neuroprotection · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin α1 and cancer: action on immune effector and tumor target cells. Annals of the New York Academy of Sciences 2007;1112:225–234. doi:10.1196/annals.1415.025 · PMID 17567944
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi:10.1136/bmj.n71 · PMID 33782057
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