Clinical evidence for growth-hormone secretagogues supplied for research — included and excluded studies
The included-studies table with extracted data, the exclusions with reasons, and the risk-of-bias judgements.
§3Included and excluded studies
Every study contributing to this review is listed below with the data extracted from it. The extraction table is published at the level of the individual outcome and study so that the synthesis can be checked without the reader having to retrieve each source.
§3.1Included studies
Table 4. Included studies with the characteristics extracted from each.
| Study | Design | Randomised | Duration | Anchor outcome as reported | Year |
|---|---|---|---|---|---|
| CJC-PH1-ASCENDINGCJC-1295 | Phase 1 ascending dose | — | Up to 49 days | Sustained elevation of insulin-like growth factor 1 for one to two weeks after a single dose | 2006 |
| CJC-PH1-MULTIDOSECJC-1295 | Phase 1 ascending dose | — | Multiple weekly doses | Cumulative elevation of insulin-like growth factor 1 with repeated dosing. Development was not continued | 2006 |
| GHRP2-JP-DIAGNOSTICGHRP-2 | Diagnostic accuracy | — | Single test | Approved in Japan as a diagnostic stimulation agent. The Institute records that a diagnostic authorisation is not a therapeutic authorisation | 2006 |
| IPA-PH1-GHIpamorelin | Phase 1 ascending dose | — | Single dose | Dose-dependent growth-hormone release without a measurable rise in cortisol or prolactin | 1998 |
| HEX-PH2-ELDERLYHexarelin | Randomised, double-blind, placebo-controlled | — | 16 weeks | Tachyphylaxis of the growth-hormone response limited the achievable effect | 1997 |
| GHRP6-PH1-GHGHRP-6 | Phase 1 ascending dose | — | Single dose | Dose-dependent growth-hormone release with a marked orexigenic effect | 1995 |
| HEX-PH1-GHHexarelin | Phase 1 ascending dose | — | Single dose | Marked growth-hormone release with attenuation on repeated administration | 1995 |
| SERM-DIAGNOSTICSermorelin | Diagnostic accuracy | — | Single test | Formerly marketed as a diagnostic agent; withdrawn for commercial reasons | — |
| 8 included studies. Each links to its structured abstract, which carries a field-by-field provenance table distinguishing extracted figures from Institute reconstructions. | |||||
Contributing participants across studies reporting a randomised total: 0. Studies for which the Institute does not hold a randomised total contribute to the qualitative synthesis and not to any pooled figure.
§3.2Excluded at full text, with reasons
Table 5. Reports excluded at full text, by reason. A review that reports an exclusion count without reasons cannot be checked against its own protocol.
| Reason for exclusion | Reports |
|---|---|
| Not a randomised comparison | 1 |
| Population outside the review question | 1 |
| Intervention outside the review question | 3 |
| Comparator not eligible | 4 |
| No eligible outcome reported | 3 |
| Duplicate report of an included study | 2 |
| Conference abstract without extractable data | 2 |
| Retracted or subject to an expression of concern | 2 |
| 13 reports excluded at full text in total. | |
§3.3Risk of bias across included studies
Table 6. Risk-of-bias judgement recorded for each included study on the review's anchor outcome.
| Study | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias |
|---|---|---|---|---|---|
| CJC-PH1-ASCENDING | Low | Low | High | Low | Low |
| CJC-PH1-MULTIDOSE | Some | Low | Some | Low | Low |
| GHRP2-JP-DIAGNOSTIC | Low | Low | Low | Some | Low |
| IPA-PH1-GH | Low | Low | Some | Low | Some |
| HEX-PH2-ELDERLY | Some | Low | Some | Low | Low |
| GHRP6-PH1-GH | Low | Low | Low | Some | Some |
| HEX-PH1-GH | High | Low | Low | Low | Low |
| SERM-DIAGNOSTIC | Low | Low | Low | Low | Some |
| Judgements are the Institute's own and are recorded per outcome. A study may carry a different judgement in a different review that assesses a different outcome from it. | |||||