Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339.

Abstract

BACKGROUND:

Intermittent allergic rhinitis (IAR) causes patients distress and impairs their work performance and quality of life. A variety of medicines are used by sufferers whose anguish frequently leads to trying new treatments, increasingly from herbal sources.

METHODS:

Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. The primary efficacy variable was a change in symptoms from baseline to endpoint during daytime. The secondary efficacy variables were: (a) as per primary variable (evening/night); (b) Physician's global assessment; (c) Responder rates. Safety was closely monitored.

FINDINGS:

Both active treatments were individually significantly superior to placebo (p<0.001) in improving symptoms of IAR, while there were no differences between the two active treatments (p=0.37). Superiority to placebo was similarly shown during the evening/night (p<0.001), by physicians' own assessment and by responder rates. Both treatments were well tolerated.

INTERPRETATION:

Butterbur Ze 339 and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur Ze 339 has now been subject to a series of well controlled trials and should be considered as an alternative treatment for IAR.

• Authors: Andreas Schapowal, Study Group
• Journal: Phytotherapy research : PTR (Phytother Res) Vol. 19 Issue 6 Pg. 530-7 (Jun 2005) ISSN: 0951-418X [Print] England
• PMID: 16114089 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2005 John Wiley & Sons, Ltd.

Chemical References

• Histamine H1 Antagonists
• Plant Extracts

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Histamine H1 Antagonists (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Humans
• Liver (enzymology)
• Male
• Middle Aged
• Petasites
• Phytotherapy
• Plant Extracts (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Prospective Studies
• Rhinitis, Allergic, Seasonal (pathology, prevention & control)
• Treatment Outcome