Efficacy of a standardized extract of fresh crataegus berries on exercise tolerance and quality of life in patients with congestive heart failure (NYHA II)

Efficacy of a Standardized Extract of Fresh Crataegus Berries on Exercise T olerance and Quality of Life In Patients with Congestive Heart Failure (NYH A II) Standardized extracts of Crataegus leaves and blossoms are said to have pos itive Inotropic, positive dromotropic and negative bathmotropic effects. Cl inical trials produce evidence for an Improvement of symptoms In patients w ith congestive heart failure (NYHA II). In this trial the efficacy of a sta ndardized extract of fresh Crataegus berries (Rob 10) on exercise tolerance and quality of life was studied In 88 patients. In a three-month placebo-c ontrolled, randomized, double-blind trial these patients were treated with Rob 10 (3 x 25 drops daily). Total exercise time In bicycle ergometry was d efined as primary efficacy variable, while quality of life (Minnesota Quest ionnaire), Dyspnea-Fatigue Index and the assessment of dyspnea by the patie nt on a visual analogous scale were chosen as secondary parameters. Investi gations were performed after a two week placebo run-in period as well as 6 and 12 weeks after the onset of the study. Treatment with Rob 10 led to a i ncrease of exercise time of 38.9 s vs placebo (95 % confidence interval 5.7 -72.1 s). Quality of life Improved accordingly in favour of Rob 10. In the Minnesota Questionnaire, the total score fell by 31 % (30.6 vs 44.1) under Rob 10 vs 18 % (34.6 vs 42.4) under placebo. The Dyspnea-Fatigue Index demo nstrated an increase of the total score of 12 % (9.41 vs 8.37) vs 8 % (8.92 vs 8.26) under administration of placebo. According to findings of the ass essment of dyspnea by the patient, dyspnea decreased by 11 % (50.5 vs 56.6 mm) vs 4 % (54.8 vs 57.3 mm) under placebo. The present study proves the ef ficacy and safety of a standardized extract of fresh Crataegus berries (Rob 10) In patients with congestive heart failure (NYHA II) regarding the para meters evaluated.