Efficacy and safety of butterbur herbal extract Ze 339 in seasonal allergic rhinitis: Postmarketing surveillance study
University of Basel, Bâle, Basel-City, Switzerland Advances in Therapy
(Impact Factor: 2.27).
02/2006; 23(2):373-84. DOI: 10.1007/BF02850143
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.
Available from: Cemal Cingi
- "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 . 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 . An antiallergic comedication administered to 44% of the patients did not give a better result than that with Ze 339 monotherapy. "
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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.
Available from: Juergen Borlak
- "Nonetheless, mild-to-moderate elevations in biliary duct related chemistry parameters, such as GGT and GLDH, were observed and may point to a possible sensitivity of the biliary duct system to chronic intake of P. hybridus extracts quantified to at least 15% total petasins (calculated as isopetasins). In vitro experiments with primary human and rat hepatocyte cultures did not evidence cytotoxic events upon treatment with extracts 056180 (37% petasin), 096120 (patented new extract with very low petasin content), and 056180/096120 (19.1% petasin) at therapeutic C max level that was determined in a pharmacokinetic study with healthy volunteers (Kaufeler et al., 2006). In contrast, with human hepatocytes and ata concentration of 15 lg/ml, a level as high as 179-fold of the expected plasma concentrations in patients, both cytotoxicity assays and the genomics data evidenced a clear hepatotoxic potential for extracts rich in petasin. "
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ABSTRACT: Butterbur extracts (Petasites hybridus) are recommended for the prevention of migraine, but pharmacovigilance reports may be suggestive of rare hepatobiliary toxicity. To evaluate its hepatotoxic potential, a series of in vivo and in vitro studies were carried out. Essentially, there were no signs of hepatocellular toxicity at estimated therapeutic Cmax levels of 60 ng/ml. Nonetheless, in a 28-day toxicity study at ~200-fold of therapeutic doses, induced liver transaminases and bilirubin elevations were observed. In a subsequent 6-month chronic toxicity study, the initial hepatobiliary effects were reproduced, but at the end of the study, liver function recovered and returned to normal as evidenced by clinical chemistry measurements. To identify possible mechanisms of hepatotoxicity, we investigated liver function in vitro at > 170-fold of therapeutic Cmax levels, including cytotoxicity (lactate dehydrogenase, MTT, and ATP), transaminase activities (alanine aminotransferase and aspartate aminotransferase), albumin synthesis, urea and testosterone metabolism to assay for cytochrome P450 monooxygenase activity. Only with extracts rich in petasin (37% petasin) and at high and well above therapeutic doses, liver toxicity was observed. A toxicogenomic approach applied to hepatocyte cultures enabled hypothesis generation and was highly suggestive for extracts high in petasin content to impair bile acid transport and lipid and protein metabolism. Importantly, neither chronic rat in vivo nor rat in vitro studies predicted reliably hepatotoxicity, therefore reemphasizing the utility of human-based in vitro investigations for the development of safe medicinal products. Finally, toxicogenomics enabled the characterization of a novel butterbur extract with no signals for hepatotoxicity. © The Author 2009. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For permissions, please email: [email protected]
Available from: Rudolf Bauer
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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.
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