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Butterbur Ze339 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(12):1381-6AO

Abstract

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.

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

15611396

Citation

Schapowal, Andreas, and Petasites Study Group. "Butterbur Ze339 for the Treatment of Intermittent Allergic Rhinitis: Dose-dependent Efficacy in a Prospective, Randomized, Double-blind, Placebo-controlled Study." Archives of Otolaryngology--head & Neck Surgery, vol. 130, no. 12, 2004, pp. 1381-6.
Schapowal A, Petasites Study Group. Butterbur Ze339 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(12):1381-6.
Schapowal, A. (2004). Butterbur Ze339 for the treatment of intermittent allergic rhinitis: dose-dependent efficacy in a prospective, randomized, double-blind, placebo-controlled study. Archives of Otolaryngology--head & Neck Surgery, 130(12), pp. 1381-6.
Schapowal A, Petasites Study Group. Butterbur Ze339 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(12):1381-6. PubMed PMID: 15611396.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Butterbur Ze339 for the treatment of intermittent allergic rhinitis: dose-dependent efficacy in a prospective, randomized, double-blind, placebo-controlled study. AU - Schapowal,Andreas, AU - ,, PY - 2004/12/22/pubmed PY - 2005/1/22/medline PY - 2004/12/22/entrez SP - 1381 EP - 6 JF - Archives of otolaryngology--head & neck surgery JO - Arch. Otolaryngol. Head Neck Surg. VL - 130 IS - 12 N2 - 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. SN - 0886-4470 UR - https://www.unboundmedicine.com/medline/citation/15611396/Butterbur_Ze339_for_the_treatment_of_intermittent_allergic_rhinitis:_dose_dependent_efficacy_in_a_prospective_randomized_double_blind_placebo_controlled_study_ L2 - https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/10.1001/archotol.130.12.1381 DB - PRIME DP - Unbound Medicine ER -