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patients of different age groups, respective sub-group analyses of the available randomized controlled clinical trials were conducted.
After meta-analyses of the randomized controlled double blind trials had shown compliance to modern standards for a proof of efficacy, in a second step, subgroup analyses were conducted.
The as well as the therapeutic dose (3 x 20 drops/day) were identical in all trials so allowing a uniform evaluation. For the primary outcome variable, the validated gastrointestinal symptom score (GIS) [1] the difference
between placebo and verum after 28 days of treatment showed a highly significant (p < 0.0001) difference between placebo and verum (6.7 resp. 4.7 points). The analyses in different age groups did show a comparable efficacy also in elderly patients.
The meta-analysis clearly shows the efficacy and tolerability of STW 5 (Iberogast) also in elderly patients.
References:
1. Adam et al. 2005. Aliment Pharmacol Ther. 22:357363.
ALTHEA OFFICINALIS L. IN DRY COUGH ASSOCIATED WITH PHARYNGEAL IRRITATION
© Fink Careen2, Müller Jürgen2, Kelber Olaf1, Nieber Karen3, Kraft Karin4
11nnovation and Development, Phytomedicines Supply and Development Center, Bayer Consumer Health Division, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany;
2 Medical and Clinical Affairs Phytomedicines, Innovation and Development, Phytomedicines Supply and Development Center, Bayer Consumer Health Division, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany;
3 Pharmaceutical Institute, Leipzig University, Leipzig, Germany;
4 Chair for Naturopathy, Center for Internal Medicine, University Medicine Rostock, Rostock, Germany
With herbal preparations from Althaea officinalis L., radix (marshmallow root), there exists long-standing experience of use as a demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough, which has also led to the issuing of a monograph of the European regulatory authority EMA [1].
Creating a better documentation of the users' impression of the effectiveness and tolerability and of their satisfaction was the aim of the two prospective, non-interventional surveys reported here.
Altogether 822 users of an aqueous Marshmallow root extract, STW 42, were recruited in pharmacies, in two separate studies, one for lozenges, the other for syrup. They were asked to fill in a questionnaire covering a treatment duration of seven days for the
documentation of the course of symptoms of their dry cough, and the global assessments of effectiveness, tolerability and satisfaction.
The users stated that both preparations showed a good effect with respect to the symptomatic treatment of oral or pharyngeal irritation and associated dry cough with a very rapid onset of effects, in the majority of cases within 10 minutes. The tolerability was very good (3 minor adverse events for the syrup).
The use of Marshmallow root syrup and lozenges for symptomatic treatment of dry cough is strongly supported by these studies.
References:
1. European Union herbal monograph on Althaea officinalis L., radix, EMA/HMPC/436679/2015
ANTI-INFLAMMATORY AND CYTOPROTECTIVE EFFECTS OF A HYPERICUM PERFORATUM EXTRACT, STW 3-VI
© Schwendler A.1, Abdel-Aziz Heba2, Keiber Olaf3, Hüther Julian1, Bonaterra Gabriel A.1, Cordes Andrea1, Kolb Christiane2, Kinscherf Ralf1
1 Philipps-University Marburg, Department of Medical Cell Biology, Marburg, Germany;
2 Bayer Consumer Health, Medicial Affairs, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany;
3 Bayer Consumer Health, Innovation & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany
Glutamate toxicity and inflammation are involved in the antidepressant effects [2] by normalization of an
a variety of disorders, e. g. those involving adaptation to overactive hypothalamic-pituitary-adrenal axis [3].
chronic stress. In this context, the combined antioxidant Thus, the aim of our investigations was to determine
and anti-inflammatory properties [1] of St. John's wort the effects of a St. Johns wort extract, STW 3-VI,
(Hypericum perforatum L.) extract could contribute to on protection of differentiated mouse hippocampal
Obzory po kliniceskoj farmacologii i lekarstvennoj terapii [Reviews of clinical pharmacology and drug therapy]
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HT22 cells from the cytotoxic effects of glutamate or NMDA and the possible anti-inflammatory properties on LPS-activated macrophages (MO).
Differentiated HT22 cells were pre-treated with STW 3-VI to investigate the protective effects against glutamate or NMDA cytotoxicity. The anti-inflammatory properties of STW 3-VI were evaluated by quantification of the TNF release on LPS activated PMA-differentiated THP 1 MO using ELISA assay and the mRNA expression of TNF and IL-6 by qRT-PCR. Glutamate or NMDA (0.1mM) induced 30% cytotoxicity in HT22 cells.
Pre-incubation (24h) of STW 3-VI improved the viability by 30%, compared to the control. Pre-treatment (48h) of LPS-activated MO with STW 3-VI induced a significant lowering (54%, 64% and 53%) of TNF
release. QRT-PCR revealed that 48 h pre-treatment with STW 3-VI inhibits the mRNA expression of IL-6 and TNF respectively by LPS-activated MO.
STW 3-VI protects hippocampal cells from glutamate or NMDA induced cytotoxicity and activates the antiinflammatory defense by inhibition of the cytokine production by MO, These effects might be relevant for the therapeutic effects of STW 3-VI in psychic depression.
References:
1. Breyer A et al. 2007. Phytomedicine. 14:250-255.
2. Denke A et al. 2000. Drug Res. 50 (5):415-419.
3. Gastpar M, Singer A, Zeller K. 2006. Pharmacopsy-chiatry. 39:66-75.
INFLAMMATION AS A TARGET: DIFFERENT MODE OF ACTION OF HERBAL MEDICINES AND NSAIDS
© Kelber Olaf1, Samstag Fabienne1, Nieber Karen2
11nnovation and Development, Phytomedicines Supply and Development Center, Bayer Consumer Health Division, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany; 2 Pharmaceutical Institute, Leipzig University, Leipzig, Germany
Recent studies have shown that systemic responses of increased circulating lymphocytes and elevated proinflammatory cytokines and subtle inflammation are a reason also of many functional diseases, as e.g. functional dyspepsia (FD) and irritable bowel syndrome (IBS). The complexity of these diseases indicates that there are different pathophysiological mechanisms involved.
On the example of the herbal medicinal product STW 5, mechanisms of action involved anti-inflammatory effects were compared to those of NSAIDs.
Data from in vitro studies [1, 2] were revealed and analysed for elucidating possible mechanisms of action underlying the anti-inflammatory effects of STW 5.
STW 5 activated COX-1, but had no effect on COX-2 mRNA expression in contrast to the control substances, like ASS and diclofenac, which inhibited COX-1 and COX-2 mRNA expression. STW 5 inhibited the increased
gene expression and reduced significantly the release of TNF-alpha by activation of adenosine A2A receptors in LPS (100 ng/ml)-stimulated human monocytes, while having no effect in untreated cells. Radiolig and binding assays confirmed the affinity of STW 5 to adenosine A2A receptors.
The mechanism of action of STW 5 as an anti-inflammatory medication without involving COX-1 or COX-2 inhibitory properties is fundamentally different from that of NSAIDs, which may be an important reason for the usefulness of this medicinal product especially in patients with FD and IBS, as indicated by clinical trials and therapeutic use.
References:
1. Michael S et al. 2012. Inflammatory Bowel Disease 3: 41.
2. Bonaterra G A et al. 2008. Z. Phytotherapie 29: S22 therapeutic use.
PRODUCTION AND STANDARDIZATION OF EXTRACTS FROM BIDENS TRIPARTITA, SOLIDAGO CANADENSIS AND AGRIMONIA EUPATORIA
© Kaukhova I.E., Novikova E.K., Chachin D.A.
St. Petersburg State Chemical Pharmaceutical Academy, St-Petersburg, Russia
In the present study, a quantitation of main active substances and antioxidant activity of the dry extracts from Bidens tripartita, Solidago canadensis and Agrimonia eupatoria in the production of medicinal substances was carried out.
The samples of B. tripartite, S. canadensis and A. eupatoria were purchased from a local pharmacy. The dried samples of B. tripartite, S. canadensis and A. eupatoria were extracted by water-alcohol in the ratio 1:20 of different concentrations 40%, 50% and 70%, respectively, in a
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