PMID- 19789403 OWN - NLM STAT- MEDLINE DCOM- 20100111 LR - 20240417 IS - 1879-0844 (Electronic) IS - 1388-9842 (Print) IS - 1388-9842 (Linking) VI - 11 IP - 10 DP - 2009 Oct TI - Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) trial. PG - 990-9 LID - 10.1093/eurjhf/hfp116 [doi] AB - AIMS: Hawthorn's efficacy when added to contemporary evidence-based heart failure therapy is unknown. We aimed to determine whether hawthorn increases submaximal exercise capacity when added to standard medical therapy. METHODS AND RESULTS: We performed a randomized, double-blind, placebo-controlled trial in 120 ambulatory patients aged > or = 18 years with New York Heart Association (NYHA) class II-III chronic heart failure. All patients received conventional medical therapy, as tolerated, and were randomized to either hawthorn 450 mg twice daily or placebo for 6 months. The primary outcome was change in 6 min walk distance at 6 months. Secondary outcomes included quality of life (QOL) measures, peak oxygen consumption, and anaerobic threshold during maximal treadmill exercise testing, NYHA classification, left ventricular ejection fraction (LVEF), neurohormones, and measures of oxidative stress and inflammation. There were no significant differences between groups in the change in 6 min walk distance (P = 0.61), or on measures of QOL, functional capacity, neurohormones, oxidative stress, or inflammation. A modest difference in LVEF favoured hawthorn (P = 0.04). There were significantly more adverse events reported in the hawthorn group (P = 0.02), although most were non-cardiac. CONCLUSION: Hawthorn provides no symptomatic or functional benefit when given with standard medical therapy to patients with heart failure. This trial is registered in ClinicalTrials.gov ID: NCT00343902. FAU - Zick, Suzanna M AU - Zick SM AD - Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109-0708, USA. szick@umich.edu FAU - Vautaw, Bonnie Motyka AU - Vautaw BM FAU - Gillespie, Brenda AU - Gillespie B FAU - Aaronson, Keith D AU - Aaronson KD LA - eng SI - ClinicalTrials.gov/NCT00343902 GR - M01-RR00042/RR/NCRR NIH HHS/United States GR - P50 HL 061202 01/HL/NHLBI NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 RN - 0 (Plant Preparations) SB - IM MH - Aged MH - Anaerobic Threshold/drug effects MH - Chronic Disease MH - *Crataegus MH - Double-Blind Method MH - Exercise Tolerance/*drug effects MH - Female MH - Follow-Up Studies MH - Heart Failure/diagnosis/*drug therapy/mortality MH - Humans MH - Male MH - Middle Aged MH - Oxygen Consumption/drug effects/physiology MH - Phytotherapy/*methods MH - Plant Preparations/*therapeutic use MH - Probability MH - Quality of Life MH - Reference Values MH - Risk Assessment MH - Severity of Illness Index MH - Stroke Volume/drug effects MH - Survival Rate MH - Treatment Outcome PMC - PMC2754502 EDAT- 2009/10/01 06:00 MHDA- 2010/01/12 06:00 PMCR- 2010/10/01 CRDT- 2009/10/01 06:00 PHST- 2009/10/01 06:00 [entrez] PHST- 2009/10/01 06:00 [pubmed] PHST- 2010/01/12 06:00 [medline] PHST- 2010/10/01 00:00 [pmc-release] AID - hfp116 [pii] AID - 10.1093/eurjhf/hfp116 [doi] PST - ppublish SO - Eur J Heart Fail. 2009 Oct;11(10):990-9. doi: 10.1093/eurjhf/hfp116.