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Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: postmarketing surveillance study.
Adv Ther 2006 Mar-Apr; 23(2):373-84AT

Abstract

The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves of Petasites hybridus L., 8 mg petasines per tablet) were tested in patients with seasonal allergic rhinitis. In an open postmarketing surveillance study, 580 patients were treated with an average of 2 tablets of Ze 339 daily for 2 weeks. Symptoms of rhinorrhea, sneezing, nasal congestion, itchy eyes and nose, red eyes, and skin irritation were evaluated on a visual analogue scale. Symptoms of seasonal allergic rhinitis improved in 90% of patients. Differences observed before and after therapy were significant and clinically relevant for all symptoms. Improvement reported by the end of the study was found to be inversely related to symptom severity as described at baseline. Efficacy, tolerability, and improvement in quality of life were positively rated by 80%, 92%, and 80% of patients, respectively. A total of 44% of patients were given an antiallergic comedication. This combination did not result in a better effect than was attained with Ze 339 monotherapy. Adverse events occurred at a rate of 3.8%, and gastrointestinal complaints were predominantly nonspecific. Results of this postmarketing surveillance trial are consistent with observations documented in previous randomized, double-blind, prospective, controlled trials of the same extract that were conducted according to Good Clinical Practice (GCP). Butterbur leaf special extract Ze 339 was confirmed by 3 GCP trials and 2 postmarketing surveillance trials to be safe and efficacious in the treatment of patients with seasonal allergic rhinitis.

Authors+Show Affiliations

Max Zeller Sohne AG, Romanshorn, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16751170

Citation

Käufeler, Robert, et al. "Efficacy and Safety of Butterbur Herbal Extract Ze 339 in Seasonal Allergic Rhinitis: Postmarketing Surveillance Study." Advances in Therapy, vol. 23, no. 2, 2006, pp. 373-84.
Käufeler R, Polasek W, Brattström A, et al. Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: postmarketing surveillance study. Adv Ther. 2006;23(2):373-84.
Käufeler, R., Polasek, W., Brattström, A., & Koetter, U. (2006). Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: postmarketing surveillance study. Advances in Therapy, 23(2), pp. 373-84.
Käufeler R, et al. Efficacy and Safety of Butterbur Herbal Extract Ze 339 in Seasonal Allergic Rhinitis: Postmarketing Surveillance Study. Adv Ther. 2006;23(2):373-84. PubMed PMID: 16751170.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: postmarketing surveillance study. AU - Käufeler,Robert, AU - Polasek,Wolgang, AU - Brattström,Axel, AU - Koetter,Uwe, PY - 2006/6/6/pubmed PY - 2006/7/6/medline PY - 2006/6/6/entrez SP - 373 EP - 84 JF - Advances in therapy JO - Adv Ther VL - 23 IS - 2 N2 - The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves of Petasites hybridus L., 8 mg petasines per tablet) were tested in patients with seasonal allergic rhinitis. In an open postmarketing surveillance study, 580 patients were treated with an average of 2 tablets of Ze 339 daily for 2 weeks. Symptoms of rhinorrhea, sneezing, nasal congestion, itchy eyes and nose, red eyes, and skin irritation were evaluated on a visual analogue scale. Symptoms of seasonal allergic rhinitis improved in 90% of patients. Differences observed before and after therapy were significant and clinically relevant for all symptoms. Improvement reported by the end of the study was found to be inversely related to symptom severity as described at baseline. Efficacy, tolerability, and improvement in quality of life were positively rated by 80%, 92%, and 80% of patients, respectively. A total of 44% of patients were given an antiallergic comedication. This combination did not result in a better effect than was attained with Ze 339 monotherapy. Adverse events occurred at a rate of 3.8%, and gastrointestinal complaints were predominantly nonspecific. Results of this postmarketing surveillance trial are consistent with observations documented in previous randomized, double-blind, prospective, controlled trials of the same extract that were conducted according to Good Clinical Practice (GCP). Butterbur leaf special extract Ze 339 was confirmed by 3 GCP trials and 2 postmarketing surveillance trials to be safe and efficacious in the treatment of patients with seasonal allergic rhinitis. SN - 0741-238X UR - https://www.unboundmedicine.com/medline/citation/16751170/Efficacy_and_safety_of_butterbur_herbal_extract_Ze_339_in_seasonal_allergic_rhinitis:_postmarketing_surveillance_study_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=16751170.ui DB - PRIME DP - Unbound Medicine ER -