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Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339.
Phytother Res 2005; 19(6):530-7PR

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+Show Affiliations

Allergy Clinic, Landquart, Switzerland. andreas@schapowal.chNo affiliation info available

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 -