Abstract Title:

The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.

Abstract Source:

Eur J Heart Fail. 2008 Dec;10(12):1255-63. Epub 2008 Nov 18. PMID: 19019730

Abstract Author(s):

Christian J F Holubarsch, Wilson S Colucci, Thomas Meinertz, Wilhelm Gaus, Michal Tendera,


BACKGROUND: Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed. AIM: To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS 1442 in patients with congestive heart failure. METHODS: In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEFor =25%, WS 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups. CONCLUSIONS: In this study, WS 1442 had no significant effect on the primary endpoint. WS 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.

Study Type : Human Study

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