Abstract
The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves ofPetasites 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.
Similar content being viewed by others
References
Savage J, Roy D. Allergic rhinitis: an update.J R Soc Health. 2005; 125: 172–175.
Smolensky MH, Reinberg A, Labrecque G. Twenty-four hour pattern in symptom intensity of viral and allergic rhinitis: treatment implications.J Allergy Clin Immunol. 1995; 95: 1084–1096.
Noonan MJ, Raphael GD, Nayak A, et al. The health related quality of life effects of once-daily cetirizine-HCl in patients with seasonal allergic rhinitis. A randomized double-blind, placebo-controlled trial.Clin Exp Allergy. 2003; 33: 351–358.
Dutau G. Allergic rhinitis: new concepts of seasonal or perennial affections?Médecine et Enfrance. 2001; 23: 155–160.
Antihistamines, hyposensitisation, and allergic emergencies. In: British Medical Association and Royal Pharmaceutical Society of Great Britain, ed.British National Formulary. London: British Medical Association; 2002.
Thomet OA, Wiesmann UN, Schapowal A, Bizer C, Simon HU. Role of petasin in the potential anti-inflammatory activity of a plant extract ofPetasites hybridus.Biochem Pharmacol. 2001; 61: 1041–1047.
Thomet OA, Wiesmann UN, Blaser K, Simon HU. Differential inhibition of inflammatory effector functions by petasin, isopetasin and neopetasin in human eosinophils.Clin Exp Allergy. 2001; 31: 1310–1320.
Käufeler R, Thomet OA, Simon HU, Meier B, Brattström A. The butterbur extract Ze 339—principle of action and pharmacology. In: Rietbrock N, Donath E, Loew D, Roots I, Schulz V, eds.Phytopharmaka VII. Darmstadt: Steinkopff; 2001: 237–246.
Bickel D, Roder T, Bestmann HJ, Brune K. Identification and characterization of inhibitors of peptido-leukotriene-synthesis fromPetasites hybridus.Planta Med. 1994; 60: 318–322.
Schapowal A. Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis.BMJ. 2002; 324: 144–146.
Schapowal A. Treating intermittent allergic rhinitis: a prospective, randomized, placebo- and antihistamine-controlled study of butterbur extract Ze 339.Phytother Res. 2005; 19: 530–537.
Schapowal A. Butterbur Ze 339 for the treatment of intermittent allergic rhinitis. Dose-dependent efficacy in a prospective, randomized, double-blind, placebo-controlled study.Arch Otolaryngol Head Neck Surg. 2004; 130: 1381–1386.
Keusch A, Notter D, Brattström A, Morandell D, Polasek W. Therapy of allergic rhinitis with the butterbur special extract Ze 339.Ars Medici. 2004; 10: 509–515.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
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 Therapy 23, 373–384 (2006). https://doi.org/10.1007/BF02850143
Issue Date:
DOI: https://doi.org/10.1007/BF02850143