Herbal medicinal substance delays death in heart failure in SPICE trial
The first morbidity and mortality trial with an herbal medicine proved the safety of the substance and that cardiac death was delayed. The results of the SPICE trial with this novel substance was presented by Dr. Christian J.F. Holubarsch of Germany at the 56th Scientific Sessions of the American College of Cardiology held in New Orleans from March 24-27, 2007. Crataegus Extract WS®1442, an extract of leaves of the Crataegus tree, is a natural antioxidant. The herb is currently approved for use in some European countries to treat early congestive heart failure.
The randomized, double-blind study was conducted at 156 centers in 13 European countries. Inclusion criteria were NYHA class II-III heart failure and a left ventricular ejection fraction (LVEF) </=35%, and follow-up was 24 months. The primary endpoint was time to first cardiac event, including sudden cardiac death, death due to progressive heart failure, fatal heart attack, non-fatal heart attack, or hospitalization due to heart failure.
A total of 2,681 patients (mean age 60 years, 84% male, 44% NYHA class II) were randomized to WS®1442 or placebo on top of optimal medical therapy. The mean LVEF was 24%. The patients were well treated for their heart failure (ACE inhibitors 83%, beta-blockers 64%, glycosides 57%, spironolactone 39%, and diuretics 85%).
Key findings in the SPICE trial were (Figure 1):
A similar occurrence of the primary endpoint (27.9% WS®1442, 28.9% placebo, Hazard ratio 0.95).
A significant 20% reduction in cardiac death at 18 months (p=0.02).
A 4-month delay in cardiac death for the first 18 months.
Postponement in cardiac death was more pronounced for patients with a LVEF >/=25% and for total mortality.
Adverse events and serious adverse events were slightly lower in the WS®1442 group, confirming the safety of the substance.
