TUESDAY, March 27, 2007 (HealthDay News) -- An herbal preparation derived from tree leaves offered some benefits to patients being treated for congestive heart failure, according to a new German study presented to American cardiologists Tuesday.
But at least one U.S. heart expert said the substance needs far more study before it can be deemed of any value to patients.
The substance, dubbed Crataegus Extract WS 1442, is an extract of the leaves of the Crataegus, or hawthorne, tree, and is a natural antioxidant. It's currently approved for use in some European countries as a treatment for early congestive heart failure, which is the heart's inability to adequately pump blood throughout the body.
"This is the first heart failure trial conducted with an herbal product," lead researcher Dr. Christian J.F. Holubarsch, of the Median Kliniken Hospitals in Bad Krozingen, said during a teleconference Tuesday at the American College of Cardiology's annual meeting in New Orleans.
In the trial, called the SPICE study and conducted at 156 centers in Europe, Holubarsch and his colleagues randomly assigned 2,681 patients with advanced congestive heart failure to receive either WS 1442 or a placebo for two years. All the patients were already receiving medications for heart failure.
The researchers wanted to see if WS 1442 could extend the time to a first cardiac event, including sudden cardiac death, death due to progressive heart failure, fatal heart attack, non-fatal heart attack or hospitalization because of heart failure, Holubarsch said.
The researchers found that for patients taking WS 1442, there was a 20 percent reduction in cardiac-related death. The lives of these patients were extended by four months in the first 18 months of the study. But after two years, about the same number of people in both groups had died. This was a secondary endpoint, Holubarsch said.
However, WS 1442 was not effective when it came to death due to progressive heart failure, fatal heart attack, non-fatal heart attack and hospitalization because of heart failure.
"We did not meet the primary endpoint," the researcher said.
Holubarsch cautioned that the findings were preliminary. "We cannot prove that the compound extends life of these patients, but I think it's promising," he said.
One heart expert said he thought that because the study failed to meet the primary goal, it raises a red flag.
"If the specified primary endpoint did not have a significant impact, any observation from a secondary endpoint should be considered hypothesis-generating, rather than evidence that this therapy is beneficial," said Dr. Gregg Fonarow, a cardiologist at the University of California, Los Angeles.
"As this is a single, modestly sized trial, these finding will require confirmation in other independently conducted, randomized, double-blind, placebo-controlled trials," he said.
For more information on heart failure, visit the American Heart Association.