title: The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.
abstract: 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.
  
  
  OBJECTIVE
  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 (LVEF< or =35%) were included and received 900 mg/day WS 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event.
  
  
  RESULTS
  2681 patients (WS 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF> or =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.
authors.affiliation: Median Clinics Bad Krozingen, Bad Krozingen, Germany. c.holubarsch@median-bk.de
authors.forename: Christian J F
authors.initials: CJ
authors.lastname: Holubarsch
authors.forename: Wilson S
authors.initials: WS
authors.lastname: Colucci
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinertz
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Gaus
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
mesh_terms: D002302:Cardiac Output / Q000187:drug effects; D016001:Confidence Intervals; D027825:Crataegus / Q000009:adverse effects*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D004311:Double-Blind Method; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D013318:Stroke Volume / Q000187:drug effects; D016019:Survival Analysis; D016277:Ventricular Function, Left / Q000187:drug effects
chemical_list: D010936:Plant Extracts