Hawthorn Berry

The large SPICE trial randomized 2,681 adults with NYHA class II-III heart failure and reduced ejection fraction to the standardized extract Crataegus WS 1442 (900 mg/day) or placebo for 24 months. The primary time-to-first-cardiac-event endpoint showed no significant benefit (hazard ratio 0.95, 95% CI 0.82-1.10, P=.476), and the cardiac-mortality trend was not significant (P=.269). A secondary subgroup with less-impaired ejection fraction (LVEF 25% or more) showed a significant 39.7% reduction in sudden cardiac death (hazard ratio 0.59, P=.025), but this favorable subgroup finding does not establish a general cardioprotective effect.^[1]

• Specific standardized extract added to heart-failure treatment; does not test all berry products, unstandardized supplements, or protection against anabolic-steroid injury.
• Abstract-checked; no qualified clinical review.

A 2008 Cochrane systematic review pooling 10 earlier trials (855 patients with NYHA class I-III heart failure) found hawthorn leaf-and-flower extract improved surrogate exercise-capacity and symptom measures versus placebo (for example, maximal workload and shortness of breath/fatigue), while explicitly noting that no relevant mortality or morbidity data were reported apart from one trial that noted deaths without further detail. This review's search predates the later, larger SPICE trial, which specifically tested a hard cardiac-event endpoint and found no significant benefit; the two describe different outcome types and different points in the evidence timeline, not a single settled conclusion.^[2]

• This review's literature search (through June 2006) does not include the SPICE trial (published December 2008); its favorable pooled findings are surrogate/symptom outcomes, not the hard cardiac-event, hospitalization or mortality outcomes that SPICE later tested and did not find significant.
• Abstract-checked; no qualified clinical review.