The effect of Crataegus oxycantha Special Extract WS 1442 on clinical progression in patients with mild to moderate symptoms of heart failure.

AIM To examine whether hawthorn (Crataegus Special Extract WS 1442 {CSE}) inhibits progression in heart failure (HF) patients. METHODS We performed a retrospective analysis of data from the HERB CHF study in which patients with mild to moderate HF were randomised to either CSE 900 mg or placebo for 6 months. The primary outcome was time to progression of HF (HF death, hospitalisation, or sustained increase in diuretics) as assessed by log-rank tests and by Cox modelling. RESULTS Progression of HF occurred in 46.6% of the CSE and 43.3% of the placebo groups (OR 1.14, 95% CI=0.56, 2.35: p=0.86). Patients receiving CSE were 3.9 times (95% CI=1.1-13.7: p=0.035) more likely to experience HF progression at baseline. In adjusted analysis, the risk of having early HF progression in the CSE group increased to 6.4 (95% CI=1.5, 26.5: p=0.011). In patients with LVEF< or =35%, those taking CSE were at significantly greater risk (3.2, 95% CI=1.3, 8.3: p=0.02) than the placebo group. CONCLUSIONS CSE does not reduce heart failure progression in patients who have HF. CSE appears to increase the early risk of HF progression.