Epithalon — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Biological ageing and healthspan endpoints
Anchor outcome. Epigenetic age acceleration.
Effect as recorded. Russian observational and small controlled reports describe mortality and functional differences over multi-year follow-up; not extractable to the Institute's standard; allocation and follow-up methodology are not described adequately.[1,2]
Certainty. Very low certainty The Institute assesses these reports as not permitting a certainty rating above very low. It records that mortality claims of this magnitude from studies of this design would require independent replication before any weight could be placed on them.
Contributing trials. EPI-RU-ELDERLY. Full structured abstracts are published for each.
Full evidence extract for biological ageing and healthspan endpoints · Indication assessment
§3.2Cognitive performance and neuroprotection
Anchor outcome. Domain-specific cognitive test scores.
Effect as recorded. No assessable evidence identified; —.[2,3]
Certainty. Very low 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
§3.3Immune modulation and adjunctive immunotherapy
Anchor outcome. CD4 and CD8 counts.
Effect as recorded. No assessable evidence identified; —.[3,4]
Certainty. Very low certainty —
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for immune modulation and adjunctive immunotherapy · 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.
- Khavinson VK, Kuznik BI, Tarnovskaya SI, Linkova NS. Peptides and CCL11 and HMGB1 as differently expressed age-dependent proinflammatory biomarkers of ageing. Advances in Gerontology 2020;10(1):1–8. doi:10.1134/S2079057020010063
- 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
- Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. doi:10.1136/bmj.l4898 · PMID 31462531
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