OBJECTIVES: To evaluate the pharmacoeconomics of hawthorn extract (crataegus), compared to any other therapy of congestive heart failure (CHF), NYHA II, a prospective, 3-year, observational cohort study was conducted from 1999 to 2002. A cost-utility-analysis was performed to compare the direct costs of the treatment alternatives proportional to health related quality-of-life (costs per quality-adjusted life year). METHODS: The open observational study with matched-pairs evaluation included general practitioners and internists. The crataegus cohort (CC) comprised patients who received WS® 1442 for CHF (mono or add-on). In the Standard cohort (SC), patients who reveived any other treatment but crataegus were observed. Efficacy and tolerability of the treatment alternatives were evaluated. Calculation of the direct costs of the treatment comprised costs for diagnostic and therapeutic measures, drugs and hospitalisations, cure and rehabilitation measures. For measuring the patients' quality-of-life and calculating the gained quality-adjusted life years (QALY), the EuroQoL-5D was applied. RESULTS: Data of 153 pairs (306 patients) were available for the statistical analysis. The pairs were established based on age, gender and concomitant cardiac diseases. Both efficacy and tolerability of the crataegus therapy were evaluated as significant superior to standard therapy. Mean direct costs per year amounted to €807.15 in cohort C and €798.09 in cohort S. Gained quality-adjusted life years were 0.080 and 0.078 in the C- and the S-cohort, respectively. CONCLUSIONS: Direct costs and gained QALY were similar in both cohorts. Both mono and add-on applications of crataegus extract in the treatment of congestive heart failure, NYHA II, represent a cost-effective alternative compared to standard medication. Crataegus treatment was associated with a substitution of standard medication like ACE-inhibitors and diuretics. Concerning the documented very good tolerability of crataegus and the need of long-term treatment of the considered indication, crataegus therapy provides an additional benefit for the affected patients.