Efficacy of the Hawthorn (Crataegus) preparation LI 132 in 78 patients with chronic congestive heart failure defined as NYHA functional class II.

Seventy-eight male and female patients between the ages of 45 and 73, who were affected by chronic heart failure defined as NYHA functional class II, were treated either with Crataegus extract or with a placebo preparation. The extract LI 132 was administered to the patients in the form of 3 dragées a day (verum preparation) corresponding to a daily dose of 600 mg. Treatment was continued over a period of 8 weeks, with a wash-out phase of one week. The confirmatory parameter used to asses the efficacy of the preparation was the patients' working capacity which was measured using an ergometer bicycle. Before the start of the study, an increase in the patients' working capacity of at least half an exercise step on the ergometer bicycle (12.5 watt) was determined to be clinically relevant. Apart from the compatibility of the preparation, a score system was used to assess the severity level of the typical symptoms. From day 0 to day 56 of the trial, the median values obtained for the working capacity of the patients treated with the verum preparation were found to have increased by 28 watt, while the increase in the working capacity of the placebo patients was as little as 5 watt. The difference was statistically significant (p < 0.001). Apart from that, a significant reduction of the systolic blood pressure, of the heart rate and of the pressure/rate product was observed for the patients treated with the verum preparation, compared to the patients treated with the placebo preparation. Also, the clinical symptoms (score system) were found to have improved significantly. There were no severe side effects observed.