Glutathione in immune modulation and adjunctive immunotherapy — evidence extract
The Institute's graded assessment of Glutathione for immune modulation and adjunctive immunotherapy, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Immune modulation and adjunctive immunotherapy
§1.1Question and anchor outcome
- Population
- Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
- Intervention
- Glutathione, intravenous, nebulised, topical or oral; subcutaneous and intramuscular in research contexts
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- CD4 and CD8 counts
Additional outcomes the Institute extracts for this indication: Response to vaccination; Infection incidence; Tumour response where applicable.
§1.2Contributing trials
No trial has been identified for Glutathione in immune modulation and adjunctive immunotherapy. The rating below reflects that absence.
§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 outcome is a surrogate whose relationship to the clinical outcome is unvalidated for this indication. |
| Imprecision | Very serious | The confidence interval spans values that would support different decisions. |
| 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
- United States Pharmacopeial Convention. General Chapter ⟨85⟩ Bacterial Endotoxins Test. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
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.