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Fromberg A.,University of Marburg | Gutsch D.,University of Marburg | Schulze D.,University of Marburg | Vollbracht C.,Pascoe Pharmazeutische Praparate GmbH | And 3 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2011

Purpose: While the benefits of ascorbic acid (vitamin C, ascorbate) as an essential nutrient are well established, its effects on tumor cells and in tumor treatment are controversial. In particular, conflicting data exist whether ascorbate may increase the cytotoxic effects of antineoplastic drugs or may rather exert adverse effects on drug sensitivity during cancer treatment. Findings are further obscured regarding the distinction between ascorbate and dehydroascorbate (DHA). Thus, the purpose of this study was to evaluate and directly compare the cytotoxic efficacy of ascorbate compared to DHA, and to analyse if ascorbate at pharmacological concentrations affects the efficacy of antineoplastic agents in prostate carcinoma cells. Methods: We directly compare the effects of ascorbate (supplied as 'Pascorbin® solution for injection') and DHA on tumor cell viability, and determine IC50 values for various cell lines. At concentrations well below the IC50, ascorbate effects on cell proliferation and cell cycle are analysed. We furthermore determine changes in cellular sensitivity towards various cytostatic drugs upon pre-treatment of cells with ascorbate. Results: We demonstrate higher therapeutic efficacy of ascorbate over DHA in various cell lines, independent of cell line-specific differences in ascorbate sensitivity, and identify the extracellular generation of H2O2 as critical mechanism of ascorbate action. We furthermore show that, in addition to pro-apoptotic effects described previously, ascorbate treatment already at concentrations well below the IC50 exerts anti-proliferative effects on tumor cells. Those are based on interference with the cell cycle, namely by inducing a G0/G1 arrest. Pre-treatment of tumor cells with ascorbate leads to increased cellular sensitivity towards Docetaxel, Epirubicin, Irinotecan and 5-FU, but not towards Oxaliplatin and Vinorelbin. For Docetaxel and 5-FU, a linear correlation between this sensitizing effect and the ascorbate dosage is observed. Conclusions: The redox-active form of vitamin C, ascorbate, shows therapeutic efficacy in tumor cells. These antitumor effects of ascorbate are mainly based on its extracellular action and, in addition to the induction of apoptosis, also include an anti-proliferative effect by inducing cell cycle arrest. Furthermore, ascorbate treatment specifically enhances the cytostatic potency of certain chemotherapeutics, which implicates therapeutic benefit during tumor treatment. © 2010 The Author(s).


Schencking M.,Heart Jesus Hospital | Schencking M.,University of Rostock | Vollbracht C.,Pascoe Pharmazeutische Praparate GmbH | Weiss G.,Pascoe Pharmazeutische Praparate GmbH | And 4 more authors.
Medical Science Monitor | Year: 2012

Background: Vitamin C is an immune-relevant micronutrient, which is depleted in viral infections and this deficiency seems to play a critical role in the pathogenesis of herpes infections and in the development of postherpetic neuralgia. The objective of this observational multicenter study was to evaluate the utilization, safety and efficacy of intravenously administrated vitamin C in patients with shingles. Material/Methods: Between April 2009 and December 2010 16 general practitioners recorded data of 67 participants with symptomatic herpes zoster who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment. The assessment of pain (VAS) and the dermatologic symptoms of shingles such as hemorrhagic lesions and the number of efflorescences were investigated in a follow-up observation phase of up to 12 weeks. Results: Mean declines of pain scores (VAS), number of affected dermatomes and efflorescences, and the presence of hemorrhagic vesicles between the baseline and follow-up assessments at 2 and 12 weeks were statistically significant. Overall, 6.4% of the participants experienced post-herpetic neuralgia. Common complaints such as general fatigue and impaired concentration also improved during the study. The effects and the tolerability of the treatment were evaluated positively by the physicians. The risk of developing PHN was reduced. Conclusions: The data presented here provide evidence that concomitant use of intravenously administered ascorbic acid may have beneficial effects on herpes zoster-associated pain, dermatologic findings and accompanying common complaints. To confirm our findings, randomized, placebo-controlled clinical studies are necessary. © Med Sci Monit, 2012.


Doehmer J.,GenPharmTox Biotech AG | Weiss G.,PASCOE pharmazeutische Praparate GmbH | McGregor G.P.,PASCOE pharmazeutische Praparate GmbH | Appel K.,Porsche
Toxicology in Vitro | Year: 2011

The effect of a standardised dry extract from Silybum marianum (HEPAR-PASC®) on the enzyme kinetics of cytochrome-P450 isoenzymes (CYP) was investigated with primary human hepatocytes and human liver microsomes in order to assess the potential for drug-drug interactions. A cytotoxic effect on hepatocytes was observed at concentrations at and above 50μg/ml. The EC50 value was calculated to be 72.0μg/ml. Therefore, the chosen test concentrations for CYP induction on human hepatocytes were 50, 10, and 1.5μg/ml, which allowed for interpretation of the clinical significance of the data with a range of 50-1-fold cmax at maximal recommended doses. No induction was observed at the lowest concentration of 1.5μg/ml, which is close to cmax. The extract did not induce CYP 3A4 at any of the tested concentrations. A low or marginal induction of 1A2, 2B6, and 2E1 at the maximum concentration of 50μg/ml was observed. CYP inhibition on human microsomes was tested at concentrations of 150, 15, and 1.5μg/ml. No or minor CYP inhibition was observed for all CYPs tested at the lowest concentration of 1.5μg/ml, i.e. CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4. At concentrations of 15 and 150μg/ml the extract significantly inhibited CYP 2B6, 2C8, 2C9, 2C19, 2E1, and 3A4. In these cases, Ki values were determined. All Ki values exceeded cmax by at least a factor of 10-fold. According to FDA regulations 1>cmax/Ki>0.1 indicates, that drug-drug interactions are possible for CYPs 2C8, and 2C9, but not likely, and are remote for CYPs 2C19, 2D6, and 3A4. © 2010 Elsevier Ltd.


Hoffmann C.,PASCOE pharmazeutische Praparate GmbH
Zeitschrift fur Phytotherapie | Year: 2014

Summary Passionflower: shedding light on the mechanism of action Passionflower has been used in the treatment of stress-related symptoms for several centuries. In the last decade the efficacy was proved in clinical studies, however, the mechanism of action was still unclear. Recent non-clinical studies show that passionflower extracts inhibit GABA-reuptake, bind to the GABA binding site of the GABAA- receptor and do not interact with the ethanol or benzodiazepine binding side. © Haug Verlag in MVS Medizinverlage Stuttgart GmbH & Co.


Weiss G.,PASCOE Pharmazeutische Praparate GmbH
Zeitschrift fur Phytotherapie | Year: 2011

In medical practice, psychic disorders such as depression, burnout, anxiety or sleep disturbances are often difficult to differentiate, especially in milder manifestations. The similarity of symptoms is due to the biochemistry these diseases have in common, i.e. the physiological imbalance of neurotransmitter systems which include serotonin, noradrenaline, GABA, dopamine and/or melatonin neurotransmission. The large number of involved neurotransmitter systems requires a multi-target treatment. A combination of dry extracts of St. Johns wort, passion flower, and valerian (Neurapas« balance) not only inhibits serotonin reuptake, as most chemically defined antidepressants do, but also exerts effects on all other mentioned neurotransmitter systems. Furthermore, a synergistic effect of the passion flower extract on the antidepressant effect of St. Johns wort was shown. Thereby, this herbal combination counters the complexity of depression symptoms by a broad spectrum of pharmacological effects. © Georg Thieme Verlag KG Stuttgart New York.


Dimpfel W.,Justus Liebig University | Koch K.,NeuroCode AG | Weiss G.,Pascoe Pharmazeutische Praparate GmbH
BMC Psychiatry | Year: 2011

Psychiatric patients often suffer from stress, anxiety and depression. Various plant extracts are known to fight stress (valerian), anxiety (passion flower) or depression (St. John's wort). NEURAPAS®balance is a mixture of these three extracts and has been designed to cover this complex of psychiatric conditions. The study was initiated to quantitatively assess the effect of this combination on brain electric activity.Method: Quantitative electroencephalogram (EEG) current source density (CSD) recording from 16 healthy male and female human volunteers (average age 49 years) was used in a randomized, placebo-controlled cross over study. Recordings were performed 0. 5, 1. 5, 3 and 4 hours after administration of the preparations under the conditions of 6 min eyes open and 5 min d2 concentration test, mathematical calculation test and memory test, respectively. All variables (electric power within 6 frequency ranges at 17 electrode positions) were fed into a linear discriminant analysis (eyes open condition). In the presence of mental load these variables were used to construct brain maps of frequency changes.Results: Under the condition of mental load, centro-parietal spectral power remained statistically significantly lower within alpha1, alpha2 and beta1 frequencies in the presence of verum in comparison to placebo. Discriminant analysis revealed a difference to placebo 3 and 4 hours after intake of 6 tablets of NEURAPAS®balance. Data location within the polydimensional space was projected into the area of the effects of sedative and anti-depressive reference drugs tested earlier under identical conditions. Results appeared closer to the effects of fluoxetine than to St. John's wort.Conclusions: Analysis of the neurophysiological changes following the intake of NEURAPAS®balance revealed a similarity of frequency changes to those of calming and anti-depressive drugs on the EEG without impairment of cognition. Trial registration: ClinicalTrials.gov: NCT01047605. © 2011 Dimpfel et al; licensee BioMed Central Ltd.


Trompetter I.,PASCOE Pharmazeutische Praparate GmbH | Lebert J.,PASCOE Pharmazeutische Praparate GmbH | Weiss G.,PASCOE Pharmazeutische Praparate GmbH
Forschende Komplementarmedizin | Year: 2015

Background: Seasonal allergic rhinitis (SAR), also known as hay fever, is a widespread chronic respiratory disease. In treatment of SAR the use of complementary therapies is increasing, but little has been published about homeopathic complex remedies so far. Therefore, we think it is time to conduct and publish an appropriate observational study. Methods: Course of single symptoms, impairment of quality of life, general efficacy, and tolerability of a homeopathic complex remedy containing active substances on a low dilution level have been assessed and analyzed. Altogether, 123 patients with a history of allergic rhinitis of up to 45 years have been observed for about 4 weeks. Results: The majority of symptoms were shown to improve substantially and the patients' quality of life increased clearly. The overall symptom score decreased significantly from 10.3 ± 4.7 to 3.9 ± 3.1 points (p < 0.0001), and reduction of impairment of quality of life from 5.7 ± 2.3 to 1.9 ± 1.8 score points was also significant (p < 0.0001). Rating of efficacy of study medication was markedly better than efficacy rating of previous therapies (p = 0.0193). Apart from one temporary allergic reaction, the treatment was well tolerated. Conclusion: The homeopathic complex remedy (Pascallerg®) tested in this observational study offers a useful option in treatment of SAR in children and adults. © 2015 S. Karger GmbH, Freiburg.


Vollbracht C.,Pascoe Pharmazeutische Praparate GmbH | Schneider B.,Leibniz University of Hanover | Leendert V.,University of Cologne | Weiss G.,Pascoe Pharmazeutische Praparate GmbH | And 2 more authors.
In Vivo | Year: 2011

Aim: The aim of the study was to evaluate under praxis conditions the safety and efficacy of intravenous (i.v.) vitamin C administration in the first postoperative year of women with breast cancer. Patients and Methods: Epidemiological multicentre cohort study, including 15 gynaecologists and general practitioners representatively distributed in Germany. Data from 125 breast cancer patients in UICC stages IIa to IIIb were selected for the study. A total of 53 of these patients were treated with i.v. vitamin C (supplied as Pascorbin® 75 g) additional to standard tumour therapy for at least 4 weeks (study group) and 72 without this additional therapy (control group). Main outcome measures were efficacy in regard to outcome and severity of disease- or therapy-induced complaints during adjuvant chemo- and radiotherapy and aftercare. Results: Comparison of control and study groups revealed that i.v. vitamin C administration resulted in a significant reduction of complaints induced by the disease and chemo-/radiotherapy, in particular of nausea, loss of appetite, fatigue, depression, sleep disorders, dizziness and haemorrhagic diathesis. After adjustment for age and baseline conditions (intensity score before adjuvant therapy, chemotherapy, radiotherapy), the overall intensity score of symptoms during adjuvant therapy and aftercare was nearly twice as high in the control group compared to the study group. No side-effects of the i.v. vitamin C administration were documented. Discussion: Oxidative stress and vitamin C deficiency play an important role in the etiology of adverse effects of guideline-based adjuvant chemo-/radiotherapy. Restoring antioxidative capacity by complementary i.v. vitamin C administration helps to prevent or reduce disease-, or therapy-induced complaints in breast cancer patients. Conclusion: Complementary treatment of breast cancer patients with i.v. vitamin C was shown to be a well tolerated optimization of standard tumour-destructive therapies, reducing quality of life-related side-effects.


PubMed | Pascoe Pharmazeutische Praparate GmbH and Medical University of Vienna
Type: Journal Article | Journal: Vascular pharmacology | Year: 2014

Acute inflammation induced by administration of Escherichia coli lipopolysaccharide endotoxin (LPS) reduces plasma concentrations of vitamin C and impairs vascular endothelium-derived nitric oxide (NO) bioactivity. We tested the hypothesis that systemically administered high dose vitamin C restores the endogenous anti-oxidant potential and improves NO-dependent vasodilatation in the forearm vasculature.36 male subjects were enrolled in this balanced, placebo controlled cross-over study. Forearm blood flow (FBF) reactivity to acetylcholine (ACh) and glyceryl-trinitrate (GTN), a sensitive test for endothelial function, was assessed at baseline and 4h after LPS-administration (20 IU/kg i.v). The effect of two different doses of intravenous vitamin C (Vitamin C-Injektopas), 320 mg/kg and 480 mg/kg over 2h, or placebo on forearm vascular function was studied after LPS.LPS caused transient flu-like symptoms, decreased plasma vitamin C concentrations and reduced the ACh-dependent increase in FBF by up to 76%. Vitamin C at a mean plasma concentration of 3.2 or 4.9 mmol/L restored the response to ACh compared to baseline.High dose systemic vitamin C recovers LPS-induced endothelium-dependent vasodilation in the forearm resistance vasculature. This provides a rationale for a further clinical study of the systemic vitamin C effect under inflammatory conditions.


PubMed | PASCOE pharmazeutische Praparate GmbH
Type: Clinical Study | Journal: Forschende Komplementarmedizin (2006) | Year: 2015

Seasonal allergic rhinitis (SAR), also known as hay fever, is a widespread chronic respiratory disease. In treatment of SAR the use of complementary therapies is increasing, but little has been published about homeopathic complex remedies so far. Therefore, we think it is time to conduct and publish an appropriate observational study.Course of single symptoms, impairment of quality of life, general efficacy, and tolerability of a homeopathic complex remedy containing active substances on a low dilution level have been assessed and analyzed. Altogether, 123 patients with a history of allergic rhinitis of up to 45 years have been observed for about 4 weeks.The majority of symptoms were shown to improve substantially and the patients quality of life increased clearly. The overall symptom score decreased significantly from 10.3 4.7 to 3.9 3.1 points (p < 0.0001), and reduction of impairment of quality of life from 5.7 2.3 to 1.9 1.8 score points was also significant (p < 0.0001). Rating of efficacy of study medication was markedly better than efficacy rating of previous therapies (p = 0.0193). Apart from one temporary allergic reaction, the treatment was well tolerated.The homeopathic complex remedy (Pascallerg) tested in this observational study offers a useful option in treatment of SAR in children and adults.

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