Romanshorn, Switzerland
Romanshorn, Switzerland

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Simon D.,University of Bern | Eng P.A.,Childrens Hospitals Aarau | Eng P.A.,Childrens Hospitals Lucerne | Borelli S.,Triemli Hospital | And 9 more authors.
Advances in Therapy | Year: 2014

Introduction: Atopic dermatitis (AD) has been related to a deficiency of delta-6-desaturase, an enzyme responsible for the conversion of linoleic acid to gamma-linolenic acid (GLA). Evening primrose oil (EPO) contains high amounts of GLA. Therefore, this study investigated whether EPO supplementation results in an increase in plasma GLA and its metabolite dihomo-gamma-linolenic acid (DGLA) correlating with clinical improvement of AD, assessed by the SCORing Atopic Dermatitis (SCORAD) index. Methods: The open study included 21 patients with AD. EPO (4-6 g) was administered daily for 12 weeks. Before treatment, and 4 and 12 weeks after initiation of EPO supplementation, objective SCORAD was assessed and plasma concentrations of GLA and DGLA were determined by gas chromatography. Results: A significant increase in plasma GLA and DGLA levels and a decrease in the objective SCORAD were observed 4 and 12 weeks after initiation of EPO treatment. In the per-protocol population (n = 14), a significant inverse correlation between the changes in plasma GLA levels and SCORAD was found (P = 0.008). Conclusion : The clinical disease activity under EPO treatment correlates with the individual increase in plasma GLA levels. Thus, the results of this pilot study indicate that an increase in plasma GLA might be used as predictive parameter for responsiveness of AD to EPO therapy. © The Author(s) 2014.


Dumitru A.F.,Imperial College London | Shamji M.,Imperial College London | Wagenmann M.,Heinrich Heine University Düsseldorf | Hindersin S.,Heinrich Heine University Düsseldorf | And 12 more authors.
Journal of Allergy and Clinical Immunology | Year: 2011

Background: Allergic rhinitis symptoms of itching, sneezing, rhinorrhea, and nasal obstruction significantly decrease patients' quality of life. Compared with histamine and leukotriene receptor antagonists, the petasol butenoate complex Ze 339 displays pharmacologically distinct properties. In vitro it inhibits the biosynthesis of leukotrienes and mediator release from activated eosinophils. Objective: This study aimed to assess the efficacy and mode of action of Ze 339, desloratadine, and placebo on allergic rhinitis symptoms, nasal airflow, and local mediator levels after unilateral nasal allergen provocation. Methods: In this double-blind, randomized, crossover study 18 subjects with allergic rhinitis to grass pollen received Ze 339, desloratadine, and placebo for 5 days before nasal allergen challenge with grass pollen extract. Rhinomanometry, symptom assessment, and local inflammatory mediator measurement were performed during the 24 hours after allergen challenge. Results: With Ze 339, the patient's time to recovery (5.4 ± 1.6 hours) from nasal obstruction after allergen challenge (time for return to 90% of baseline value ± SEM) was significantly shorter than with placebo (9.1 ± 2.3 hours, P = .035) and desloratadine (10.7 ± 2.5 hours, P = .022). Likewise, Ze 339's standardized symptom assessment for nasal obstruction (3.2 ± 1.3 hours) showed significantly faster relief (time for return to baseline value ± SEM compared with placebo, 8.3 ± 2.4 hours; P = .027) and desloratadine (4.5 ± 1.2 hours, P = .030). One interesting finding was that Ze 339 significantly reduced IL-8 and leukotriene B4 levels in nasal secretions before challenge. Conclusion: When compared with desloratadine and placebo, Ze 339 shows better efficacy in relieving nasal obstruction symptoms and inhibiting critical components of the chemokine network and as such represents a novel symptomatic and possible prophylactic treatment for allergic rhinitis. © 2011 American Academy of Allergy, Asthma & Immunology.


Eltbogen R.,Praxis fur Gynakologie und Geburtshilfe | Litschgi M.,Praxis fur Gynakologie und Geburtshilfe | Gasser U.E.,ClinResearch Ltd. | Flueli A.,Max Zeller Sohne AG | And 2 more authors.
Journal fur Gynakologische Endokrinologie | Year: 2015

Principle: This noninterventional, observational study (NIS) had been conducted by Swiss gynaecologists and general practitioners in primary medical routine care. The objective of this NIS was to evaluate the efficacy and safety of Vitex agnus-castus (VAC) extract (Ze 440: premens, Zeller Medical AG, Romanshorn, Switzerland) in women suffering from menstrual cycle irregularities, such as polymenorrhea, oligomenorrhea, or amenorrhea. Methods: A total of 211 patients were included in this NIS and symptoms associated with menstrual cycle irregularities (MCIs) and menstrual bleeding were assessed at baseline visit (BV) and at a follow-up visit (FV) after treatment with VAC extract during 3 subsequent menstrual cycles. Results: The proportion of patients with remission or improvement of MCIs (all in all) and specific symptoms such as polymenorrhea, oligomenorrhea, and amenorrhea was 79-85% at the FV. The proportion of patients with remission or improvement of symptoms related to menstrual bleeding such as dysmenorrhea, intermenstrual bleeding, hypermenorrhea, menometrorrhagia, ovulation bleeding, premenstrual or postmenstrual bleeding was 60-88% at FV. Out of 53 patients who reported an unfulfilled desire to have children at BV, 12 women (23%) got pregnant during treatment with VAC extract. At the FV, 91% of the physicians and 92% of the patients were "satisfied" or "very satisfied"with the achieved treatment outcomes, and 80% of the patients confirmed their preference to continue treatment with VAC extract. Conclusion: This observational study in routine medical care showed that treatment with VAC extract (Ze 440) clearly ameliorated MCIs, polymenorrhea, oligomenorrhea, and amenorrhea and was well tolerated. The majority of patients decided to continue treatment with VAC extract. © 2015, Krause und Pachernegg GmbH. All rights reserved.


Moll C.,Max Zeller Sohne AG | Zahnera C.,Max Zeller Sohne AG | de Marquis M.R.,Laboratorios Leti Sav | Yibirin M.G.,Laboratorios Leti Sav | Ruiz Rodriguez J.J.,Laboratorios Leti Sav
Archivos Venezolanos de Farmacologia y Terapeutica | Year: 2015

Background: Allergic rhinitis (AR) is one of the most prevalent chronic allergic diseases in children, with a high impact on a child’s quality of life and co-morbidities like asthma. Objective: The objective of this analysis was to investigate the effectiveness and tolerability of the Petasites hybridus leaf extract Ze 339 (Ze 339) in the treatment of AR in paediatric patients. Methods: We present a paediatric sub-analysis of a recent Venezuelan observational study, which investigated the effect of Ze 339 on clinical symptoms of AR in patients treated under conditions of daily practice. Among those 927 previously studied patients, 92 patients were less than 18 years old. Thereof, we included 53 children and adolescents in this intention-to-treat sub-analysis. Patients were advised to take one tablet of Ze 339 (corresponding to 8 mg petasins) two or three times a day up to one month. Symptoms of AR were recorded at every medical visit using a 4-point rating scale to indicate the level of severity. Single symptoms of AR (rhinorrhoea, nasal congestion, sneezing, itchy eyes, red eyes, itchy throat) and several composite scores (total symptom score, total nasal symptom score, total nasal and ocular symptom score) were evaluated. The overall therapeutic response of patients to the medication indicating effectiveness and tolerability was evaluated by a 5-point rating scale by both the physician and patient. Results: Full recovery and a significant improvement of symptoms were seen in 86.8% of patients. This was also reflected in a significant improvement of the different composite scores (p<0.001). Overall, the results showed that Ze 339 is effective and well tolerated in the treatment of AR in paediatric patients. Conclusion: Ze 339 is effective and well tolerated in the relief of all symptoms of AR. Beneficial effects were reported by patients and physicians. Ze 339 may be considered for the treatment of AR in paediatric patients. © 2015, Sociedad Latinoamericana de Hipertension. All rights reserved.


Schellenberg R.,Institute for Health Care and Science | Saller R.,University of Zürich | Hess L.,Brunner and Hess | Melzer J.,University of Zürich | And 3 more authors.
Evidence-based Complementary and Alternative Medicine | Year: 2012

Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients' self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65-19.35) score points, P < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55-11.39) score points, P = 0.0003 for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women. © 2012 Ruediger Schellenberg et al.


PubMed | Helmholtz Center Munich, TU Munich and Max Zeller Sohne AG
Type: | Journal: BioFactors (Oxford, England) | Year: 2017

Ze339, an herbal extract from Petasites hybridus leaves is effective in treatment of allergic rhinitis by inhibition of a local production of IL-8 and eicosanoid LTB


Drewe J.,Max Zeller Sohne AG | Zimmermann C.,Max Zeller Sohne AG | Zahner C.,Max Zeller Sohne AG
Phytomedicine | Year: 2013

Background: Root extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints. Method: In this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions. Physicians were suggested to treat patients for the first 3 months with 13 mg/d CR (high dose, HD) and to continue over additional 6 months either with this treatment or to switch to 6.5 mg/d CR (low dose, LD). The choice of treatment and its dose, however, was fully at the discretion of the physician. Results: After 3-months treatment with HD, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p < 0.001) from baseline values. Continuation of treatment with HD or LD decreased total KMI and its sub-item scores further (HD, LD: p < 0.001). However, more patients (84.9%) responded to HD than to LD (78.4%) and showed an improvement of symptoms (p = 0.011). Conclusion: This observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial. © 2013 Elsevier GmbH. All rights reserved.


Schenk A.,Max Zeller Sohne AG | Siewert B.,Max Zeller Sohne AG | Toff S.,Max Zeller Sohne AG | Drewe J.,Max Zeller Sohne AG
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2015

Due to increasing regulatory awareness of their hepatotoxic, genotoxic and possibly carcinogenic potential, pyrrolizidine alkaloid (PA) content has to be thoroughly monitored in herbal medicinal preparations. Recently, new very low PA regulatory threshold concentrations have been requested by the authorities. Therefore, a highly sensitive and reproducible UPLC TOF MS method for the quantification of the PAs senkirkine, senecionine, seneciphylline, senecionine-N-oxide and seneciphylline-N-oxide in a CO2-extract of Petasites hybridus leaves (Ze 339) has been developed.The limit of quantification (LOQ) was 2. ppb for all PAs. Recovery at the LOQ was between 88.9 and 141.9%, the repeatability precision between 3.5 and 13.6%. Linearity of the five PAs showed correlation coefficients between 0.9995 and 0.9998 and coefficients of variation between 7.44 and 8.56%. A working range between 2 ppb and 200 ppb could be fixed. In the tested batches of the P. hybridus extract Ze 339, the absence of PAs could be demonstrated. In conclusion, this assay allows to determine trace PA concentrations in P. hybridus extract Ze 339, making it suitable for analytical PA monitoring in accordance with regulatory requirements. © 2015 The Authors.


PubMed | Max Zeller Sohne AG
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2015

Due to increasing regulatory awareness of their hepatotoxic, genotoxic and possibly carcinogenic potential, pyrrolizidine alkaloid (PA) content has to be thoroughly monitored in herbal medicinal preparations. Recently, new very low PA regulatory threshold concentrations have been requested by the authorities. Therefore, a highly sensitive and reproducible UPLC TOF MS method for the quantification of the PAs senkirkine, senecionine, seneciphylline, senecionine-N-oxide and seneciphylline-N-oxide in a CO2-extract of Petasites hybridus leaves (Ze 339) has been developed. The limit of quantification (LOQ) was 2ppb for all PAs. Recovery at the LOQ was between 88.9 and 141.9%, the repeatability precision between 3.5 and 13.6%. Linearity of the five PAs showed correlation coefficients between 0.9995 and 0.9998 and coefficients of variation between 7.44 and 8.56%. A working range between 2 ppb and 200 ppb could be fixed. In the tested batches of the P. hybridus extract Ze 339, the absence of PAs could be demonstrated. In conclusion, this assay allows to determine trace PA concentrations in P. hybridus extract Ze 339, making it suitable for analytical PA monitoring in accordance with regulatory requirements.

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