I will readily admit I am stepping outside the bounds of my expertise with this post – with respect to the “shenfu injection” and its effects on physiology. The authors describe shenfu as “originated from Shenfu decoction, a well-known traditional Chinese formulation restoring ‘Yang’ from collapse, tonifying ‘Qi’ for relieving desertion”. More specifically, from a physiologic standpoint: “Ginsenosides and aconite alkaloids are the main active ingredients in Shenfu. Ginsenosides are the determinant contributor to the vasodilator benefit of Shenfu, whereas the alkaloids play a vital role in the cardiac electrophysiological effect of Shenfu by blocking ion channels”. In China, a pharmacologic shenfu distillate is used routinely to treat sepsis and septic shock as a 100mL daily injection – and this is a placebo-controlled trial endeavoring to demonstrate its efficacy.

At face value, the trial appears reasonable – a targeted enrollment of 160 patients with a goal of detecting a 20% difference in mortality at 28-days, based on an expected overall mortality of 40%. Their primary outcome, however, were the co-primary outcomes of “length of ICU stay, the duration of vasopressor use, illness severity, and the degree of organ dysfunction.” A proper study, of course, has a single primary outcome – and, considering the study was powered for a mortality difference, this patient-oriented outcome probably ought to have been made primary.

Regardless, from the results presented here, it is reasonable to suggest this is promising and worthy of additional evaluation. Several outcomes – ICU LOS, APACHE II score, and duration of vasopressor us – reached statistical significance favoring the intervention. The mortality outcome did not meet statistical significance with the intervention at 20.5% and the placebo at 27.8%. However, an absolute mortality improvement of 7.3% is nothing to sneeze at – and I would be happy to see more work performed to replicate or generalize these results.

“Shenfu injection for improving cellular immunity and clinical outcome in patients with sepsis or septic shock”