Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients

Phytomedicine. 2009 Jan;16(1):17-24. doi: 10.1016/j.phymed.2006.05.003. Epub 2006 Jul 24.

Abstract

In this postmarketing study 9657 patients (5181 children) with bronchitis (acute or chronic bronchial inflammatory disease) were treated with a syrup containing dried ivy leaf extract. After 7 days of therapy, 95% of the patients showed improvement or healing of their symptoms. The safety of the therapy was very good with an overall incidence of adverse events of 2.1% (mainly gastrointestinal disorders with 1.5%). In those patients who got concomitant medication as well, it could be shown that the additional application of antibiotics had no benefit respective to efficacy but did increase the relative risk for the occurrence of side effects by 26%. In conclusion, it is to say that the dried ivy leaf extract is effective and well tolerated in patients with bronchitis. In view of the large population considered, future analyses should approach specific issues concerning therapy by age group, concomitant therapy and baseline conditions.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bronchi / drug effects*
  • Bronchitis / drug therapy*
  • Child
  • Child, Preschool
  • Female
  • Hedera*
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Phytotherapy* / adverse effects
  • Plant Extracts / adverse effects
  • Plant Extracts / pharmacology
  • Plant Extracts / therapeutic use*
  • Plant Leaves
  • Prospective Studies
  • Treatment Outcome
  • Young Adult

Substances

  • Plant Extracts