Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: Postmarketing surveillance study

Max Zeller Sohne AG, Romanshorn, Switzerland.
Advances in Therapy (Impact Factor: 2.27). 02/2006; 23(2):373-84. DOI: 10.1007/BF02850143
Source: PubMed


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.

19 Reads
  • Source
    • "In an experimental study, an aqueous ethanol extract of the aerial parts of Japanese butterbur (JBE) directly suppressed smooth muscle contraction and inhibited cutaneous anaphylactic reactions; LT C4, D4, and E4 synthesis; TNF-α production; and mast cell degranulation [27]. An open postmarketing surveillance study on 580 patients (Ze 339; 2 tablets/day for 2 weeks) showed significant improvement in rhinorrhea, sneezing, nasal congestion, itchy eyes and nose, red eyes, and skin irritation associated with SAR in 90% of the patients [28]. An antiallergic comedication administered to 44% of the patients did not give a better result than that with Ze 339 monotherapy. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective. To determine the prevalence of herbal treatment of allergic rhinitis. Methods. In this prospective study, patients who were diagnosed with perennial allergic rhinitis were questioned about their use of natural products/herbal therapies for their symptoms. Results. In total, 230 patients were enrolled. Overall, 37.3% of the patients stated that they had used natural products/herbal therapies at least once. Women were more likely than men to use herbal supplements (38.3% versus 32.4%). Ten different types of herbal supplements were identified, with stinging nettle (Urtica dioicath), black elderberry (Sambucus nigra), and Spirulina being the most common (12.6%, 6.1%, and 5.7%, resp.). Conclusion. This study found a high prevalence of herbal treatment usage for the relief of allergic rhinitis symptoms in Turkey. The herbal products identified in this study and in the literature are discussed.
    11/2013; 2013(2):938751. DOI:10.1155/2013/938751
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: In the European Union, the use of traditional herbal medicinal products has recently been regulated in Directive 2004/24/EC. According to this regulation, clinical studies and pre-clinical tests are not obligatory, but quality needs to be demonstrated in any individual case. Echinacea and butterbur (Petasites) will be used as examples for demonstrating the progress in medicinal plant research. Alkamides, the major lipophilic constituents of Echinacea, have recently been found to be rapidly absorbed after oral application. Using LC-MS their pharmacokinetics have been studied and ex-vivo effects have been measured. Alkamides have also been shown to bind to cannabinoid receptors (CB2) which may represent a molecular mechanism of action of Echinacea. Extracts of the rhizomes of Petasites hybridus have been shown to inhibit 5-lipoxygenase and cyclooxygenase-2 and COX-2 expression. They are useful for the prevention of migraine and for the treatment of asthma and seasonal allergic rhinitis.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Plants are one of the most important resources of human foods and medicines. Rapidly increasing knowledge on nutrition, medicine, and plant biotechnology has dramatically changed the concepts about food, health and agriculture, and brought in a revolution on them. Nutritional therapy and phytotherapy have emerged as new concepts and healing systems have quickly and widely spread in recent years. Strong recommendations for consumption of nutraceuticals, natural plant foods, and the use of nutritional therapy and phytotherapy have become progressively popular to improve health, and to prevent and treat diseases. With these trends, improving the dietary nutritional values of fruits, vegetables and other crops or even bioactive components in folk herbals has become targets of the blooming plant biotechnology industry. This review attempts to display and remark on these aspects. It summarizes the progress made on nutraceuticals, nutritional therapy, phytonutrients, phytotherapy, and their related epidemiological investigations and clinical studies. It also covers markets of these health-promoting products and disease-preventing or healing systems, as well as regulations behind them that direct the development of biotechnology study and application. Finally, related patents are listed and briefly analyzed, regarding of plant biotechnological research and progress on transgenic crops to improve nutritional value, phytotherapy efficiency, or to produce pharmaceutically important secondary metabolites or high-valued protein medicines such as vaccines and antibodies.
    02/2007; 1(1):75-97. DOI:10.2174/187220807779813893
Show more