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FACT
Focus on Alternative and Complementary Therapies

Efficacy and safety of Crataegus extract WS 1442 following self-treatment in patients with mild congestive heart failure – interim results of a multicentre, pharmacy-based, prospective cohort study

Belgardt C1, Funk P2, Niestroj M2, Malek FA2
1Otavi-Apotheke, Müller-Str. 64, 13349 Berlin, Germany
2Clinical Research Department, Dr Willmar Schwabe Pharmaceuticals, Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany

Objective

The study objective was to assess efficacy and safety of a standardised extract from hawthorn leaves with flowers (WS 1442, marketed in Germany as Crataegutt novo 450, manufactured by Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany) following pharmacist-guided self-treatment in patients with congestive heart failure (CHF) according to the New York Heart Association (NYHA) class II, causing slight limitation of physical activity.

Materials and methods

A questionnaire comprising 17 items was used to assess existing physical limitations and their severity at the beginning and after 5–6 weeks of treatment. Adverse events were recorded, and the efficacy and safety assessed by the study participant as well as the attending pharmacist. So far, 140 participants with slight limitation of physical activity caused by CHF according to NYHA class II have been included in this study.

Results

An improvement in symptoms was observed in 90.2% of the participants. In the majority of patients (77.3%), improvement occurred within the first 3 weeks of treatment. Most (79.5%) study participants reported an improvement in their most impairing physical symptoms (exhaustibility, fatigue and lack of energy); 65.1% observed increased physical fitness. The majority of participants and pharmacists rated efficacy and safety as good or very good.

Conclusion

In accordance with previous clinical studies, the interim results of the present pharmacy-based cohort study confirm efficacy and safety of Crataegus extract WS 1442 in self-treatment of patients. Furthermore, this is the first study that imposingly shows that there is a considerable benefit for the patient from pharmacist-guided self-medication with WS 1442.

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