Study wrapper · #566
Combination therapy of Epidermal Growth Factor and Growth Hormone-Releasing Hexapeptide in acute ischemic stroke: a phase I/II non-blinded, randomized clinical trial.
Editor's note
This is one of the few human studies in the batch and the only randomized clinical trial: a phase I/II, non-blinded, controlled trial of epidermal growth factor (EGF) combined with growth hormone-releasing hexapeptide (GHRP-6, here 'GHRP6') in acute ischemic stroke. GHRP-6 is genuinely administered to patients. Researchers reported the combination was well tolerated — serious adverse events occurred less often in treated groups than controls (30% and 20% vs 56%), with only two events in one patient attributed to treatment — and observed favorable neurological and functional trends at 90 and 180 days. Important caveats: the trial was small (10 patients per treatment arm, 16 controls), open-label (non-blinded), and tested a two-drug combination, so GHRP-6's independent contribution cannot be isolated. The authors position it as supporting a future phase III trial. In this early trial no adverse events beyond those noted were attributed to the intervention; efficacy remains preliminary.
Plain-language abstract
This early-stage human trial tested a two-drug combination — epidermal growth factor (EGF) plus the peptide GHRP-6 — in people who had just had an ischemic stroke (a stroke caused by a blocked blood vessel). Thirty-six patients were randomly assigned to receive one of two doses of the combination or standard care, given twice daily for seven days. The main goal was safety over six months. Serious adverse events were less common in the treated groups (30% and 20%) than in the standard-care group (56%), and only two events in one patient were judged to be caused by the treatment. Patients who received the combination also tended to do better on measures of neurological and physical recovery at three and six months, and more survived at six months. The trial was small and not blinded, and it tested two drugs together, so it cannot show GHRP-6's effect on its own. The authors say the results support a larger future trial.