Epithalon in biological ageing and healthspan endpoints — evidence extract
The Institute's graded assessment of Epithalon for biological ageing and healthspan endpoints, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Biological ageing and healthspan endpoints
§1.1Question and anchor outcome
- Population
- Interventions proposed to modify rate of biological ageing, assessed by composite biomarker clocks, functional measures, or mortality.
- Intervention
- Epithalon, subcutaneous, intramuscular or intranasal in research contexts
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Epigenetic age acceleration
Additional outcomes the Institute extracts for this indication: Frailty index; Functional capacity; All-cause mortality.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Epithalon in biological ageing and healthspan endpoints.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| EPI-RU-ELDERLY | — | Observational | — | Multi-year | — |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | The enrolled population differs materially from the population of the assessment question. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Very serious | Too few contributing studies for a formal assessment; the risk cannot be excluded. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§1.4What this extract does not establish
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
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.