Butterbur Ze339 for the Treatment of Intermittent Allergic Rhinitis: Dose-Dependent Efficacy in a Prospective, Randomized, Double-blind, Placebo-Controlled Study | Allergy and Clinical Immunology | JAMA Otolaryngology–Head & Neck Surgery | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
Bousquet  JVan Cauwenberge  PKhaltaev  NAria Workshop Group, World Health Organization, Allergic rhinitis and its impact on asthma.  J Allergy Clin Immunol 2001;108(suppl)S147- S334Google ScholarCrossref
Smolensky  MHReinberg  ALabrecque  G Twenty-four hour pattern in symptom intensity of viral and allergic rhinitis: treatment implications.  J Allergy Clin Immunol 1995;95(5 pt 2)1084- 1096Google ScholarCrossref
Petasites hybridus The Royal Horticultural Society Web site. 2001. Available at: http://www.rhs.org.uk. Accessed September 20, 2004
Meier  BMeier-Liebi  M Drogenmonographie Petasites.  In: Hänsel  R, Keller  K, Rimpler  H, Schneider  G, eds.  Hagers Handbuch der pharmazeutischen Praxis.5th ed. Berlin, Germany: Springer Verlag; 1994Google Scholar
Brune  KBickel  DPeskar  BA Gastro-protective effects by extracts of Petasites hybridus: the role of inhibition of peptido-leukotriene synthesis.  Planta Med 1993;59494- 496PubMedGoogle ScholarCrossref
Bickel  DRoder  TBestmann  HJBrune  K Identification and characterization of inhibitors of peptido-leukotriene-synthesis from Petasites hybridus Planta Med 1994;60318- 322PubMedGoogle ScholarCrossref
Thomet  OAWiesmann  UNSchapowal  ABizer  CSimon  HU Role of petasin in the potential anti-inflammatory activity of a plant extract of Petasites hybridus.  Biochem Pharmacol 2001;611041- 1047PubMedGoogle ScholarCrossref
Schapowal  APetasites Study Group, Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis.  BMJ 2002;324144- 146PubMedGoogle ScholarCrossref
 Antihistamines: hyposensitisation and allergic emergencies.  In: Mehta  DK, ed.  British National Formulary. London, England: British Medical Association and Royal Pharmaceutical Society of Great Britain; 1998Google Scholar
Steiner  R  inventorHauk  A  inventorTratz  W  inventor Verfahren zur Herstellung von Heilpflanzenextrakten (Petasites hybridus).  European patent EP 1023079 B1. September 29, 2001
 Allergic rhinitis: clinical development programs for drug products.  US Department of Health and Human Services, Food and Drug Administration Web site. April 2000. Available at: http://www.fda.gov/cder/guidance/2718dft.pdf. Accessed September 20, 2004
 pollenallergie.de.  Available at: http://www.pollenallergie.de. Accessed September 22, 2004
Bousquet  JBullinger  MFayol  CMarquis  PValentin  BBurtin  B Assessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire.  J Allergy Clin Immunol199494(2 pt 1)182188Google Scholar
 028 CGI Clinical Global Impressions.  In: Guy  W, ed.  ECDEU Assessment for Psychopharmacology. Rev ed. Rockville, Md: National Institute of Mental Health; 1976:217-222Google Scholar
Abt  K Descriptive data analysis: a concept between confirmatory and exploratory data analysis.  Methods Inf Med 1987;2677- 88Google Scholar
Wheatley  D LI 160, an extract of St John’s wort, versus amitriptyline in mildly to moderately depressed outpatients: a controlled 6-week clinical trial.  Pharmacopsychiatry 1997;30(suppl 2)77- 80PubMedGoogle ScholarCrossref
Woelk  H Comparison of St John’s wort and imipramine for treating depression: randomised controlled trial.  BMJ 2000;321536- 539PubMedGoogle ScholarCrossref
Schellenberg  R Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study.  BMJ 2001;322134- 137PubMedGoogle ScholarCrossref
Thomet  OASchapowal  AHeinisch  IVWiesmann  UNSimon  HU Anti-inflammatory activity of an extract of Petasites hybridus in allergic rhinitis.  Int Immunopharmacol 2002;2997- 1006PubMedGoogle ScholarCrossref
Thomet  OASimon  HU Petasins in the treatment of allergic diseases: results of preclinical and clinical studies.  Int Arch Allergy Immunol 2002;129108- 112Google ScholarCrossref
Thomet  OAWiesmann  UNBlaser  KSimon  HU Differential inhibition of inflammatory effector functions by petasin, isopetasin and neopetasin in human eosinophils.  Clin Exp Allergy 2001;311310- 1320PubMedGoogle ScholarCrossref
Original Article
December 2004

Butterbur Ze339 for the Treatment of Intermittent Allergic Rhinitis: Dose-Dependent Efficacy in a Prospective, Randomized, Double-blind, Placebo-Controlled Study

Andreas Schapowal, MD, PhD; Petasites Study Group
Arch Otolaryngol Head Neck Surg. 2004;130(12):1381-1386. doi:10.1001/archotol.130.12.1381

Objectives  To investigate whether the efficacy and safety of Butterbur extract Ze339 are related to dosage when administered to patients with intermittent allergic rhinitis.

Design  Prospective, randomized, double-blind, placebo-controlled, parallel-group comparison.

Setting  Multicenter, including 6 outpatient general medicine and allergy clinics.

Patients  One hundred eighty-six patients were randomized (Butterbur Ze339 high dose, 60; low dose, 65; and placebo, 61 patients). Established diagnostic criteria for intermittent allergic rhinitis were confirmed by skin allergy tests in all patients.

Interventions  High-dose group, 1 tablet 3 times daily; low-dose group, 1 tablet twice daily; or matching placebo. All groups were treated for 2 consecutive weeks.

Main Outcome Measures  The main efficacy variable was change in symptoms from baseline to end point during the daytime. The secondary efficacy variables were Clinical Global Impression score, change in symptoms from baseline to treatment day 7, and responder rates. Statistical analysis was prospective, on an intention-to-treat basis.

Results  Improvement in the main efficacy variable was significantly superior in the Butterbur Ze339 groups, relative to placebo, and a significant dose relationship was observed between the 2 Butterbur doses. The clinicians’ assessment of efficacy and the overall responder rates were significantly superior for the active groups compared with placebo. The incidence and type of adverse events were indistinguishable across the herbal treatment and placebo groups.

Conclusions  Butterbur Ze339 is an effective treatment for intermittent allergic rhinitis symptoms and is well tolerated. The effects of this herbal medicine are clear to patients and physicians in a double-blind evaluation against placebo.