Enhanced passive safety surveillance of Influvac® and Influvac® Tetra: Results from seven consecutive seasons.

Background And Objectives: In 2014, the European Medicines Agency (EMA) set out requirements for an enhanced safety surveillance for seasonal influenza vaccines. This paper presents data from the yearly Enhanced Passive Safety Surveillance (EPSS) implemented for Influvac® since season 2014/15 and continued for Influvac® Tetra from season 2018/19 onwards.

Methods: In seven consecutive seasons, an EPSS, aiming for at least 1,000 vaccinees (additional target of 100 vaccinees per five predefined age groups), was conducted in Germany, where market characteristics were expected to allow for a quick generation of representative data.

Increased Prevalence of Polyneuropathy in Parkinson's Disease Patients: An Observational Study.

Background: The independent contribution of levodopa exposure and Parkinson's disease (PD) to the risk of polyneuropathy is not established.

Objective: This study investigated whether patients with newly diagnosed PD without previous exposure to antiparkinsonian drugs have higher prevalence of polyneuropathy than the general population.

Methods: Using the UK General Practice Research Database, presence of polyneuropathy in the previous 3 years was assessed.

[Herb-drugs interactions].

Herbal therapeutics are increasingly associated with herb drug interactions. The vast majority of the purported cases is unsubstantiated and misinterpreted. Pharmacological and clinical studies should only be demanded in cases of reliable evidence.

Effects of black cohosh on estrogen biosynthesis in normal breast tissue in vitro.

Objectives: To investigate the effect of black cohosh on the estrogen biosynthesis in the breast in vitro.

Methods: Steroid sulfatase (STS) activity was studied in normal breast tissue obtained from pre- and postmenopausal women undergoing reduction mammoplasty. STS protein expression was studied by immunohistochemistry and western blotting.

Inhibitory effect of an isopropanolic extract of black cohosh on the invasiveness of MDA-mB 231 human breast cancer cells.

Background: The isopropanolic extract of black cohosh (iCR)b has recently been reported to exert antiproliferative and apoptosis-inducing effects on estrogen receptor-positive MCF-7, as well as estrogen receptor-negative MDA-MB 231 human breast cancer cells. To broaden observations, the anti-invasive effects of iCR and its two major fractions triterpene glycosides (TTG) and cinnamic acid esters (CAE) were tested in highly invasive MDA-MB 231 cells.

Materials And Methods: The effect of drugs upon the invasive potential of MDA-MB231 cells was studied in BD Biocoat Matrigel invasion chambers over a period of 24 h.

Coadministration of the aromatase inhibitor formestane and an isopropanolic extract of black cohosh in a rat model of chemically induced mammary carcinoma.

Non-steroidal as well as steroidal aromatase inhibitors are currently being discussed as alternatives to tamoxifen in the first-line treatment of patients with hormone-dependent breast cancer. Many of these women are in a postmenopausal state and additionally troubled by climacteric complaints. Naturally occurring symptoms like hot flushes and night sweats can be triggered or augmented by anti-hormonal drugs.

Isopropanolic extract of black cohosh stimulates osteoprotegerin production by human osteoblasts.

Unlabelled: An isopropanolic extract (iCR) from the rhizomes of Cimicifuga racemosa (black cohosh) is used an alternative in the treatment of menopausal symptoms, and animal studies suggest positive skeletal effects. iCR stimulated osteoblastic OPG protein secretion by 3- to 5-fold as early as 12 h without affecting RANKL expression. The iCR effect, abrogated by the pure estrogen receptor antagonist ICI 182,780, also enhanced ALP activity (4-fold) and osteocalcin expression (3-fold), possibly contributing to the skeletal effects of black cohosh.

No estrogen-like effects of an isopropanolic extract of Rhizoma Cimicifugae racemosae on uterus and vena cava of rats after 17 day treatment.

The effects of black cohosh extracts (Rhizoma Cimicifugae racemosae) on primary estrogen target organs, like mammary gland and endometrium are better described then those on other estrogen-sensitive systems e.g. the vasculature.

Apoptosis of human prostate androgen-dependent and -independent carcinoma cells induced by an isopropanolic extract of black cohosh involves degradation of cytokeratin (CK) 18.

Background: The inhibitory effects of black cohosh extracts (Cimicifuga syn. Actaea racemosa L.) on the proliferation of human breast cancer cells were reported recently.

Evaluation of cell death caused by triterpene glycosides and phenolic substances from Cimicifuga racemosa extract in human MCF-7 breast cancer cells.

We previously reported that the antiproliferative effect of an isopropanolic-aqueous extract of black cohosh (iCR) on MCF-7 estrogen-responsive breast cancer cell line was due to the induction of apoptosis. Here we address the question to what extent apoptosis induction can be ascribed to one of the two major fractions of iCR, the triterpene glycosides (TTG) or the cinnamic acid esters (CAE). Furthermore, as black cohosh is routinely administered orally, we studied whether its pharmacological effects would withstand simulated liver metabolism.

Concomitant administration of an isopropanolic extract of black cohosh and tamoxifen in the in vivo tumor model of implanted RUCA-I rat endometrial adenocarcinoma cells.

Black cohosh is a well known herbal remedy of long traditional use against menopausal complaints. Recently published studies on postmenopausal hormone replacement with synthetic substances associated severe negative side effects with an increase in duration of administration. The subsequent popularity of alternative treatments, often herbal drugs, made investigations into the safety of these preparations more pressing.

Effects of an isopropanolic extract of Cimicifuga racemosa on urinary crosslinks and other parameters of bone quality in an ovariectomized rat model of osteoporosis.

A potential bone-sparing effect of Rhizoma actaeae (= cimicifugae) racemosae (black cohosh) was evaluated in ovariectomized Sprague-Dawley rats. The rats were ovariectomized at 12 weeks of age (body weight, 219-226 g) and placed on a soy-free diet 6 days after surgery. Animals were randomly assigned the following groups: control (n = 10), soy-free diet only; RAL (n = 10), soy-free diet plus raloxifene 3 mg/kg intragastrically; and REM (n = 10), soy-free diet supplemented with an isopropanolic black cohosh extract (Remifemin) with a daily intake of 4500 micro g triterpeneglycosides.

Lack of promotion of estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract.

Cimicifuga racemosa (CR) is widely used in the treatment of menopausal symptoms. Mechanistic studies suggest that unlike hormone-replacement therapy, CR does not stimulate estrogen-receptor positive breast cancer cells. To evaluate CR safety, we performed an in vivo investigation of a clinically tested isopropanolic CR extract.