Semax in sleep initiation and maintenance disorders — evidence extract
The Institute's graded assessment of Semax for sleep initiation and maintenance disorders, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Sleep initiation and maintenance disorders
§1.1Question and anchor outcome
- Population
- Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.
- Intervention
- Semax, intranasal in the approved russian presentations; also supplied for subcutaneous use
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Sleep-onset latency
Additional outcomes the Institute extracts for this indication: Wake after sleep onset; Total sleep time; Pittsburgh Sleep Quality Index.
§1.2Contributing trials
No trial has been identified for Semax in sleep initiation and maintenance disorders. The rating below reflects that absence.
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | Serious | An outcome that would answer the question was not measured in any contributing trial. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| 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.
- 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
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- 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
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.