• Prevention & Screening Clinical Trials

Millions of patients worldwide purchase herbal supplements for their health and trust the manufacturers' claims. This burgeoning market, however, is often unregulated and a paucity of controlled data exist that support claims of safety and effectiveness. For this reason, the results of the randomized, double-blind, placebo-controlled multicenter Survival and Prognosis: Investigation of Crataegus Extract (SPICE) trial were greatly anticipated. Craetaegus extract in the form of the compound WS 1442 was studied versus placebo in patients with congestive heart failure (CHF). Crataegus extract (more commonly known as hawthorn extract) is available as an over the counter medication for the treatment of mild CHF (NYHA class 1 and class 2). Its purported mechanisms of action include vasodilation, positive inotropic effect, antioxidative properties, anti-ischemic effects, and anti-arrhythmic effects.

Dr. Christian Holubarsch, Median Kliniken Hospitals, Bad Krozingen, Germany presented the results of the study. The objectives of SPICE were to determine 1) if it was safe for patients to take WS 1442 concomitantly with existing medications and 2) what effects WS 1442 would have on measures of mortality and morbidity. The study was conducted at 156 centers in 13 European countries in patients with NYHA Class 3 CHF with a left ventricular ejection fraction of ≤35%. Patients received either WS 1442 900 mg/day or placebo and were followed for 24 months. The primary efficacy endpoint was a composite of cardiac mortality, non-fatal myocardial infarction, or hospitalization due to exacerbation of heart failure.

A total of 1,338 patients were randomly assigned to WS 1442 treatment; 1,343 received placebo. The study did not demonstrate significant differences between the two treatment groups in the composite primary endpoint. In a subanalysis, treatment with WS 1442 showed a significant effect in reduction of sudden cardiac death in patients with an LVEF ≥25% (p=0.025 at 24 months). In terms of safety, adverse event rates were similar between the two groups.

In conclusion WS 1442 is safe when patients take it in addition to their regular therapies, but did not reduce the composite of cardiac mortality, MI, or hospitalization for CHF. WS 1442 may reduce sudden cardiac death in a subpopulation of patients. The investigators were congratulated for undertaking a large controlled study of an herbal treatment, as well designed clinical trials in alternative and complementary medicine are sparse.

• © 2007 MD Conference Express