Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing

Stauss-Grabo, Manuela; Atiye, Saynab; Warnke, André; Wedemeyer, Ralph-Steven; Donath, Frank; Blume, Henning

doi:10.1016/j.phymed.2010.11.009

Cited by 39 publications

(33 citation statements)

References 7 publications

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“…The dosage of H. helix preparations is discussed contradictorily in the literature. In a controlled study, the efficacy was shown with low dosages (approximately 300 mg herbal substance), while in the market there are preparations with daily dosages up to approximately 1000 mg herbal substance (Committee on Herbal Medicinal Products, European Medicines Agency) [4,10,14]. The clinical pharmacokinetic data on H. helix extracts is unavailable at present.…”

Section: Discussionmentioning

confidence: 99%

“…The pharmacological data of H. helix extracts, including its bronchodilator, antibacterial, bronchospasmolytic, and expectorant effects, have supported its traditional use as a natural remedy for respiratory illness [2,3]. Currently, it is one of the top-selling herbal respiratory medicines in many countries worldwide, and it is popularly used for the treatment of cough and cough-related problems [4,5]. Bronchospasmolytic activity was exerted by hederacoside C, α-hederin, aglycone hederagenin, kaempferol and quercetin of H. helix extract [6].…”

Section: Introductionmentioning

confidence: 99%

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Time-dependent Inhibition of CYP2C8 and CYP2C19 by Hedera helix Extracts, A Traditional Respiratory Herbal Medicine

et al. 2017

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The extract of Hedera helix L. (Araliaceae), a well-known folk medicine, has been popularly used to treat respiratory problems, worldwide. It is very likely that this herbal extract is taken in combination with conventional drugs. The present study aimed to evaluate the effects of H. helix extract on cytochrome P450 (CYP) enzyme-mediated metabolism to predict the potential for herb–drug interactions. A cocktail probe assay was used to measure the inhibitory effect of CYP. H. helix extracts were incubated with pooled human liver microsomes or CYP isozymes with CYP-specific substrates, and the formation of specific metabolites was investigated to measure the inhibitory effects. H. helix showed significant inhibitory effects on CYP2C8, CYP2C19 and CYP2D6 in a concentration-dependent manner. In recombinant CYP2C8, CYP2C19 and CYP2D6 isozymes, the IC50 values of the extract were 0.08 ± 0.01, 0.58 ± 0.03 and 6.72 ± 0.22 mg/mL, respectively. Further investigation showed that H. helix extract has a positive time-dependent inhibition property on both CYP2C8 and CYP2C19 with IC50 shift value of 2.77 ± 0.12 and 6.31 ± 0.25, respectively. Based on this in vitro investigation, consumption of herbal medicines or dietary supplements containing H. helix extracts requires careful attention to avoid any CYP-based interactions.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Time-dependent Inhibition of CYP2C8 and CYP2C19 by Hedera helix Extracts, A Traditional Respiratory Herbal Medicine

et al. 2017

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“…An analysis of clinical studies with H. helix showed that different extracts of H. helix were safe and effective in the treatment of acute bronchitis and coughing symptoms [23][24][25].…”

Section: Characterization Of the Paediatric Age Subsetsmentioning

confidence: 99%

Clinical trials with herbal medicinal products in children: a literature analysis

Marquardt

Kaft

Nieber

2015

Wien Med Wochenschr

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Herbal medicinal products have been used since several decades for the health care of children. Nevertheless, well-controlled clinical studies with herbal medicinal products for children are rare. The authors' objective therefore was to evaluate clinical trials with herbal medicinal products in children, based on a literature search in PubMed and Web of Science. A total of 133 trials were identified. 90 studies were randomized, 32.2% were randomized and double-blinded. Most studies were performed in China, in the age group 6-12 years, and in children with respiratory diseases, most often herbal medicinal products with Hedera helix were tested. The analysis revealed that studies on herbal medicinal products were feasible in children. Although clinical trials have been found, this literature search have limitations and did not cover all studies performed. However, only few clinical trials of high quality were identified. Further studies therefore are urgently needed to support the good empirical findings.

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“…Particularly, the triterpene saponins, such as α-hederin and HDC, have been demonstrated to be responsible for the therapeutic effect of ivy leaf extract because of their β2-adrenergic effects, which lead to spasmolytic, bronchodilatory, mucolytic, and expectorant activity [1,13]. Among them, hederacoside C is one of the major and predominant bioactive constituents derived from H. helix that exhibits these pharmacological effects [4,14,15].…”

Section: Introductionmentioning

confidence: 99%

“…Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. bronchodilator, antibacterial, and bronchospasmolytic effects [1][2][3][4][5]. Various formulations of H.…”

mentioning

confidence: 99%

An ultra-high-performance liquid chromatography-tandem mass spectrometric method for the determination of hederacoside C, a drug candidate for respiratory disorder, in rat plasma

Rehman

Choi

Kim

et al. 2016

Journal of Pharmaceutical and Biomedical Analysis

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Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing

Cited by 39 publications

References 7 publications

Time-dependent Inhibition of CYP2C8 and CYP2C19 by Hedera helix Extracts, A Traditional Respiratory Herbal Medicine

Time-dependent Inhibition of CYP2C8 and CYP2C19 by Hedera helix Extracts, A Traditional Respiratory Herbal Medicine

Clinical trials with herbal medicinal products in children: a literature analysis

An ultra-high-performance liquid chromatography-tandem mass spectrometric method for the determination of hederacoside C, a drug candidate for respiratory disorder, in rat plasma

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