OBJECTIVES: A prospective 3-year observational study has been conducted from 1999 to 2002 to evaluate the pharmacoeconomics of hawthorn-extract treatment of CHF at stage NYHA II. In a cost-utility-analysis (CUA) hawthorn treatment (crataegus extract WS® 1442 as mono- or add-on-therapy) was compared to any other treatment option. Interim results of the study were presented in 2001 and 2002, now the final results are available. METHODS: Open, non-randomized observational cohort study with matched-pairs evaluation. The first cohort (Hawthorn-Cohort, HC) comprised patients receiving hawthorn-extract therapy of CHF; in the second cohort (Conventional-Cohort, CC) patients with any other treatment were observed. A number of 116 pairs were necessary for evaluation. For measuring HRQL the EuroQoL-5D was used. Matching criteria were demographic factors and clinical diagnosis. The perspective of the German statutory health insurance funds was applied. RESULTS: From 140 study centres 614 patients finished the study (HC: 383; CC: 231). Thereof 153 pairs could be established. Mean direct costs per year for HC and CC amounted to 807€ (median: 511€) and 798€ (median: 525€), respectively (p= 0.905). Cost-driving factor was drug acquisition (median HC: 287€, CC: 280€; p=.521). Significantly fewer prescriptions were done in HC for concomitant ACE-inhibitors, diuretics, digitalis, and beta-blockers. The clinical symptoms dyspnea and fatigue in HC were significantly improved in comparison to CC. During 3 years in the HC 0.240 QALYs were gained (CC: 0.234; p=0.867). Costs per QALY gained amounted to 10,113€ and 10,244€ for HC and CC, respectively. CONCLUSIONS: Hawthorn extract WS® 1442 represents an effective treatment alternative in early stages of CHF. Outcomes and costs are comparable to treatment with ACE-inhibitors, diuretics, digitalis, and/or beta-blockers, which are recommended by international guidelines. The symptoms dyspnea and fatigue, which markedly affect the patients’ daily activities, can be improved with WS® 1442.