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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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Allergy Clinic, Landquart, Switzerland. andreas@schapowal.ch

    Source

    Phytotherapy research : PTR 19:6 2005 Jun pg 530-7

    MeSH

    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Double-Blind Method
    Female
    Histamine H1 Antagonists
    Humans
    Liver
    Male
    Middle Aged
    Petasites
    Phytotherapy
    Plant Extracts
    Prospective Studies
    Rhinitis, Allergic, Seasonal
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    16114089

    Citation

    Schapowal, Andreas, and Study Group. "Treating Intermittent Allergic Rhinitis: a Prospective, Randomized, Placebo and Antihistamine-controlled Study of Butterbur Extract Ze 339." Phytotherapy Research : PTR, vol. 19, no. 6, 2005, pp. 530-7.
    Schapowal A, Study Group. Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339. Phytother Res. 2005;19(6):530-7.
    Schapowal, A. (2005). Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339. Phytotherapy Research : PTR, 19(6), pp. 530-7.
    Schapowal A, Study Group. Treating Intermittent Allergic Rhinitis: a Prospective, Randomized, Placebo and Antihistamine-controlled Study of Butterbur Extract Ze 339. Phytother Res. 2005;19(6):530-7. PubMed PMID: 16114089.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339. AU - Schapowal,Andreas, AU - ,, PY - 2005/8/23/pubmed PY - 2005/10/21/medline PY - 2005/8/23/entrez SP - 530 EP - 7 JF - Phytotherapy research : PTR JO - Phytother Res VL - 19 IS - 6 N2 - 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. SN - 0951-418X UR - https://www.unboundmedicine.com/medline/citation/16114089/full_citation L2 - https://doi.org/10.1002/ptr.1705 DB - PRIME DP - Unbound Medicine ER -