A long-term placebo-controlled study of a herbal remedy’s effect on heart death, extract of Crataegus (WS-1442), also known as hawthorn, failed to show any significant benefit when given with standard drug therapy to patients with chronic systolic heart failure. The trial did suggest, however, that it’s safe to use WS-1442 in combination with standard heart failure (HF) medications such as ACE inhibitors and beta blockers. The Crataegus extract used in the study consisted of 17.3% to 20.1% concentration of oligomeric procyanidins, which are responsible for its cardiovascular effects. The trial, randomized 2681 patients with a New York Heart Association (NYHA) functional class, 2-3 heart failure and an a left ventricular ejection fraction (LVEF) <35% to receive either 900 mg/day WS-1442 (2 film-coated tablets each 450 mg) or placebo for two years; all participants received standard HF drug therapy, which included diuretics, ACE inhibitors, beta blockers, glycosides, and aldosterone blockers. WS-1442 was found to have no significant effect on sudden cardiac death, death due to progressive heart failure, fatal heart attack, nonfatal heart attack, or hospitalization due to HF progression, measured at 24 months. The rates were statistically similar, at 27.9% and for actively treated patients and 28.9% for controls. The average time to first heart event was similar for both groups: 620 days for WS-144 versus 606 days for placebo. Patients taking WS-1442 showed significant relative-risk reductions of cardiac mortality after six months (by 41%, p=0.009) and 18 months (by 20%, p=0.046) but not at the 12-month or 24-month follow-ups (by 18% and 9.7%, respectively). The rates of adverse events and of serious adverse events were about 68% and 40%, respectively, for both groups. In a subgroup analysis, patients who received WS-1442 and had an LVEF equal to 25% or less showed a significantly reduced risk of sudden heart death (by 39.7%). (4)
