[Crataegus Special Extract WS 1442 in NYHA II heart failure. A placebo controlled randomized double-blind study]. [Treatment of decreasing cardiac performance. Therapy using standardized crataegus extract in advanced age]. [Crataegus Special Extract WS 1442. Assessment of objective effectiveness in patients with heart failure (NYHA II)]. Efficacy and safety of crataegus extract WS 1442 in comparison with placebo in patients with chronic stable New York Heart Association class-III heart failure. Efficacy of the Hawthorn (Crataegus) preparation LI 132 in 78 patients with chronic congestive heart failure defined as NYHA functional class II. [The clinical effect of Crataegutt in heart disease of ischemic or hypertensive origin. A multicenter double-blind study].
In 30 patients with stage NYHA II cardiac insufficiency, a placebo-controlled randomized double-blind study was carried out to determine the efficacy of the Crataegus special extract WS 1442. Treatment duration was 8 weeks, and the substance was administered at a dose of 1 capsule taken twice a day. The main target parameters were alteration in the pressure-x-rate product (PRP) under standardised loading on a bicycle ergometer, and a score of subjective improvement of complaints elicited by a questionnaire. Secondary parameters were exercise tolerance and the change in heart rate and arterial blood pressure. The active substance group showed a statistically significant advantage over placebo in terms of changes in PRP (at a load of 50 W) and the score, but also in the secondary parameter heart rate. In both groups, systolic and diastolic blood pressure was mildly reduced. No adverse reactions occurred. nan In a multicenter, placebo-controlled double-blind study, the efficacy of the Crataegus-Specialextrakt WS 1442 in patients with NYHA stage II cardiac insufficiency was investigated. A total of 136 patients with this diagnosis were admitted to the study and, following a 2-week run-in phase, treated with Crataegus-Specialextract or placebo over a period of 8 weeks. The primary target parameter was the change in the difference of the pressure, heart rate product (systolic blood pressure x heart rate/100) (PHRP 50 W load vs. rest) measured at the beginning and end of treatment.
                On the basis of this variable, a clear improvement in the performance of the heart was shown in the group receiving the test substance, while the condition of the placebo group progressively worsened. The therapeutic difference between the groups was statistically significant. The positive result for the objective efficacy parameter was confirmed by a statistically obvious superiority of Crataegus in the patient's own assessment of improvement in the main symptoms (reduced performance, shortness of breath, ankle edema etc.). In addition, active treatment led, in comparison with placebo, to a considerably better quality of life for the patient, in particular with respect to mental well-being. The tolerability of the active substance proved to be very good-as shown by comprehensive laboratory investigations and the recording of undesirable events.
                All in all, the results of the present clinical investigation confirm those of previous studies showing that Crataegus-Specialextrakt WS 1442 is an effective and low-risk phytotherapeutic form of treatment in patients with NYHA II cardiac insufficiency. The purpose of this study was to investigate whether long-term therapy with crataegus extract WS 1442 is efficacious as add-on therapy to preexisting diuretic treatment in patients with heart failure with a more advanced stage of the disease (New York Heart Association [NYHA] class III), whether effects are dose dependent, and whether the treatment is safe and well tolerated.
                Exercise capacity was assessed by use of seated bicycle ergometry with incremental workloads. Scores for subjective symptoms and complaints made by the patients were analyzed. Efficacy and tolerability of the treatments were judged by both the patients and investigators. Safety was assessed by the documentation of adverse events and the safety laboratory.
                A total of 209 patients were randomized to treatment with 1800 mg of WS 1442, 900 mg of WS 1442, or with placebo. After 16 weeks of therapy with 1800 mg of WS 1442 per day, maximal tolerated workload during bicycle exercise showed a statistically significant increase in comparison with both placebo and 900 mg of WS 1442. Typical heart failure symptoms as rated by the patients were reduced to a greater extent by WS 1442 than by placebo. This difference was significant for both doses of WS 1442. Both efficacy and tolerability were rated best for the 1800 mg of WS 1442 group by patients and investigators alike. The incidence of adverse events was lowest in the 1800 mg of WS 1442 group, particularly with respect to dizziness and vertigo.
                The data from this study confirm that there is a dose-dependent effect of WS 1442 on the exercise capacity of patients with heart failure and on typical heart failure-related clinical signs and symptoms. The drug was shown to be well tolerated and safe. 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.
                Copyright © 1994 Gustav Fischer Verlag, Stuttgart · Jena · New York. Published by Elsevier GmbH.. All rights reserved. nan
These results suggest that there is a significant benefit in symptom control and physiologic outcomes from hawthorn extract as an adjunctive treatment for chronic heart failure.