title: Baseline severity but not gender modulates quantified Crataegus extract effects in early heart failure--a pooled analysis of clinical trials.
abstract: OBJECTIVE
  The efficacy of quantified Crataegus extract in chronic heart failure (CHF) has been assessed in numerous clinical studies. The present pooled analysis evaluates the impact of baseline severity and gender on objective and patient-reported endpoints and associations between both types of outcomes in patients with early CHF.
  
  
  METHODS
  Available data from 687 individual patients treated with quantified Crataegus extract or placebo in ten studies were pooled. Treatment effects on physiologic outcome parameters and on symptoms were analysed for their association with baseline severity and gender. Changes in symptom scores were investigated with respect to their relation to physiologic outcome parameters. Results were compared with observations in a 3-year cohort study.
  
  
  RESULTS
  Physiologic outcome parameters maximal workload (MWL), left ventricular ejection fraction (LVEF) and pressure-heart rate product increase (PHRPI) at 50 W ergometric exercise improved more in active treatment than in placebo patients. Magnitude of improvement was independent from baseline for LVEF but increased for MWL and PHRPI with baseline severity. Improvement of typical symptoms like reduced exercise tolerance, exertional dyspnea, weakness, fatigue, and palpitations improved more with active treatment and in patients with more severe symptoms. A weak association between improvements in MWL, PRHP, and symptoms could be demonstrated. Gender differences in treatment effects could be explained by baseline differences. Results of the pooled analysis are in agreement with observations in the cohort study.
  
  
  CONCLUSIONS
  Crataegus extract treatment effects on physiologic outcomes and typical symptoms were modulated by baseline severity. Taking baseline differences into account, benefits were comparable in male and female patients with impaired exercise-tolerance in early chronic heart-failure.
authors.affiliation: Kardiologie Köln, Gemeinschaftspraxis Kardiologie, Köln, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Eggeling
authors.forename: Vera
authors.initials: V
authors.lastname: Regitz-Zagrosek
authors.forename: Andrea
authors.initials: A
authors.lastname: Zimmermann
authors.forename: Martin
authors.initials: M
authors.lastname: Burkart
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D027825:Crataegus; D004417:Dyspnea / Q000188:drug therapy / Q000503:physiopathology; D005080:Exercise Test; D017079:Exercise Tolerance; D005221:Fatigue / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006334:Heart Function Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D005419:Flavonoids; D010936:Plant Extracts; C421782:WS 1442; C007145:crataegus extract