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FACT
Focus on Alternative and Complementary Therapies

The Hawthorn Extract Randomised, Blinded Chronic Heart Failure (HERB–CHF) trial

Aaronson KD1, Zick SM2, Gillespie B3
1Department of Internal Medicine, Division of Cardiology, University of Michigan, L3623 Women’s Hospital, Ann Arbor, MI 48109-0271, USA
2Department of Family Medicine, University of Michigan, 1018 Fuller St., Ann Arbor, MI 48109-0708, USA
3Department of Biostatistics, University of Michigan, Center for Statistical Consultation and Research, 3550 Rackham Bldg, Ann Arbor, MI 48109-1070, USA

Objective

The aim of this study was to investigate the effect of a standardised Crataegus oxycantha (hawthorn) product, Crataegus Special Extract WS 1442, when added to standard medical therapy in 120 patients with mild to moderately severe systolic heart failure.

Materials and methods

A randomised, double-blind, placebo-controlled trial.

Results

We will be reporting on the results of C. oxycantha Special Extract vs. placebo at 6 months on submaximal exercise capacity as determined by the 6-min walk test as well as on the following secondary objectives: (i) physician and patient global assessment, (ii) disease specific quality of life as determined by the Minnesota Living with Heart Failure Questionnaire, (iii) functional capacity as accessed by peak exercise oxygen consumption (peak VO2) and anaerobic threshold during maximal cardiopulmonary treadmill exercise testing, (iv) functional capacity as subjectively assessed by New York Heart Association functional classifications, (v) left ventricular ejection fraction, (vi) mortality risk as determined by the Heart Failure Survival Score, (vii) neurohormone profile, (viii) cytokine profile, (ix) oxidative stress, (x) inflammation, (xi) global quality of life and utility for health status (as determined by the EuroQol-5D questionnaire, (xii) hospitalisations (heart failure-related, cardiovascular and total) and (xiii) hospital days (heart-failure-related, cardiovascular and total).

Conclusion

Based on these results we will be presenting implications for clinical and further research with C. oxycantha Special Extract WS 1442 in chronic heart failure.

Acknowledgements

Funding was provided by the University of Michigan General Clinical Research Center and a grant from the National Center for Complementary and Alternative Medicine P50-AT-00011.

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