The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial
Holubarsch CJ, Colucci WS, Meinertz T, Gaus W, Tendera M
Published in European Journal of Heart Failure
Methodology
24-month randomised, double-blind, placebo-controlled morbidity/mortality trial of WS 1442 900 mg daily added to standard therapy in NYHA II-III heart failure
Key Findings
The primary composite endpoint of cardiac mortality and hospitalisation was not significantly reduced; a possible reduction in sudden cardiac death was seen in patients with less severe left-ventricular dysfunction.
Conclusions
Hawthorn extract did not improve hard clinical outcomes in heart failure despite symptomatic benefit in earlier trials.
Limitations
Event-driven trial with modest power for subgroups; background therapy varied.
Supplements Studied
The primary composite endpoint of cardiac mortality and hospitalisation was not significantly reduced.
Outcomes Measured
The primary composite endpoint of cardiac mortality and hospitalisation was not significantly reduced.
Related Health Concerns
Study Details
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