Background: The potential benefit of silymarin (special extract from the fruits of Silybum marianum) in the treatment of liver diseases remains a controversial issue. Methods: For this systematic review electronic databases identified 65 papers for the search terms silymarin, silibinin, silicristin or milk thistle and clinical trial. Only 19 complied with the criteria ‘double-’ or ‘single-blind’. These publications were analysed from a clinical point of view and meta-analytic calculations were performed. Results: The clinical evidence of a therapeutic effect of silymarin in toxic liver diseases is scarce. There is no evidence of a favourable influence on the evolution of viral hepatitis, particularly hepatitis C. In alcoholic liver disease, comparing with placebo, aspartate aminotransferase was reduced in the silymarin-treated groups (p = 0.01) while alkaline phosphatase was not. In liver cirrhosis, mostly alcoholic, total mortality was 16.1% with silymarin vs. 20.5% with placebo (n.s.); liver-related mortality was 10.0% with silymarin vs. 17.3% with placebo (p = 0.01). Conclusions: Based on the available clinical evidence it can be concluded - concerning possible risks / probable benefits - that it is reasonable to employ silymarin as a supportive element in the therapy of Amanita phalloides poisoning but also (alcoholic and grade Child ‘A’) liver cirrhosis. A consistent research programme, consolidating existing evidence and exploring new potential uses, would be very welcome.

Recent years have seen an explosion of scientific papers that deal with drugs from the fruits of milk thistle and its active substances silymarin (standardized mixture of flavonolignanes), thus justifying an updated systematic review. Methods: Electronic databases identified silymarin, silibinin, silicristin or milk thistle as descriptors in >700 papers (34% published in last 5 years; 92% dealt with animal pharmacological). Only papers adequately reporting on experimental conditions, dosing, variables tested and statistics were analysed. Results: Silymarin was found to modify specifically the functions related to various transporters and receptors located in the cell membranes; that is, organic anion uptake transporter peptides (OATP), ABC transporters (P-gp), bile salt export pump, as well as TNF-a-dependent and possibly selectin-dependent phenomena. In the cytoplasm, some antioxidant properties and the inhibition of the lipoxygenase pathway seem quite selective and could concur to the antitoxic effects. Some effects like the inhibition of inducible nitric-oxide synthase, of nuclear factor κ B, and reduction of collagen synthesis are indicative of DNA/RNAmediated effects. Several studies using ‘in vitro’ and ‘in vivo’ cancer models suggest a potential of silymarin in such diseases. Topical and systemic silymarin has skin protective properties against UV-induced damage in epidermis and causes an up-regulation of tumour-suppressor genes p53- and p21CIP1. There were no data on hepatic viral replication, viremia or spontaneous tumours in the data examined. Conclusions: Data presented here do not solve the question about the complex mechanism(s) of action of the medicinal herbal drug silymarin. Silymarin may be a natural multi-functional and multi-target drug.

The use of topical preparations for symptom relief is common in osteoarthritis. The effects of ibuprofen (5%) and arnica (50 g tincture/100 g, DER 1:20), as gel preparations in patients with radiologically confirmed and symptomatically active osteoarthritis of interphalangeal joints of hands, were evaluated in a randomised, double-blind study in 204 patients, to ascertain differences in pain relief and hand function after 21 days' treatment. Diagnosis was according to established criteria; primary endpoints were pain intensity and hand function; statistical design was as per current regulatory guidelines for testing topical preparations. There were no differences between the two groups in pain and hand function improvements, or in any secondary end points evaluated. Adverse events were reported by six patients (6.1%) on ibuprofen and by five patients (4.8%) on arnica. Our results confirm that this preparation of arnica is not inferior to ibuprofen when treating osteoarthritis of hands.

SUMMARYBackground: Despite a long-standing use of herbal drugs with dyspeptic symptoms, little attention has been paid to their clinical evaluation. Aim: To assess efficacy and safety of the herbal drug preparation STW 5 (containing, e.g. Iberis, peppermint, chamomile) in the treatment of functional dyspepsia. Methods: Research in electronic databases, consultation of experts and of the producer identified STW 5 (Iberogast) as descriptor in six randomized-controlled trials. The raw data of three placebo-controlled studies which met the selection criteria, were reanalysed and pooled for meta-analysis; one reference-controlled study

Background: Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role. Patients and Methods: Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables. Results: 18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term ‘mistletoe therapy’. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare. Conclusion: Supportive ‘mistletoe therapy’ seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages.

Ayurveda is playing a growing part in Europe. Questions regarding the role of religion and spirituality within Ayurveda are discussed widely. Yet, there is little data on the influence of religious and spiritual aspects on its European diffusion. Methods. A survey was conducted with a new questionnaire. It was analysed by calculating frequency variables and testing differences in distributions with the χ 2-Test. Principal Component Analyses with Varimax Rotation were performed. Results. 140 questionnaires were analysed. Researchers found that individual religious and spiritual backgrounds influence attitudes and expectations towards Ayurveda. Statistical relationships were found between religious/spiritual backgrounds and decisions to offer/access Ayurveda. Accessing Ayurveda did not exclude the simultaneous use of modern medicine and CAM. From the majority's perspective Ayurveda is simultaneously a science, medicine, and a spiritual approach. Conclusion. Ayurveda seems to be able to satisfy the individual needs of therapists and patients, despite worldview differences. Ayurvedic concepts are based on anthropologic assumptions including different levels of existence in healing approaches. Thereby, Ayurveda can be seen in accordance with the prerequisites for a Whole Medical System. As a result of this, intimate and individual therapist-patient relationships can emerge. Larger surveys involving bigger participant numbers with fully validated questionnaires are warranted to support these results.

Background and Objectives: Changes in the symptoms of cough after treatment with a combined herbal preparation containing dry ivy leaf extract as main active ingredient, decoction of thyme and aniseed, and mucilage of marshmallow root (Weleda Hustenelixier, new formulation) and its tolerability were investigated in an open clinical trial (‘Anwendungsbeleg’). Patients and Methods: Between January and March 2004, 13 general practitioners recruited and treated 62 patients with a mean age of 50 years (range 16-89). The patients had irritating cough in consequence of common cold (n = 29), bronchitis (n = 20) or respiratory tract diseases with formation of viscous mucus (n = 15). The mean daily intake was 10 ml (range 7.5-15) of syrup, and the mean duration of treatment was 12 days (range 3-23 days). Treatment results were assessed on the basis of changes in the symptom scores for cough and expectoration. Safety was evaluated by means of an analysis of adverse events. In addition, efficacy and tolerability were analyzed from the judgments of the doctors and patients. Results: At the final visit, all symptom scores showed an improvement as compared to baseline. Doctors and patients assessed efficacy as good or very good in 86% and 90% of the cases, respectively. Tolerability was assessed as good or very good by 97% of the doctors and patients. Only one adverse event was reported. However, a relation to the medication was classified to be unlikely. Conclusion: Considering the traditional use of ivy leaves, thyme herb, aniseed and marshmallow root in preparations for cough, the reduction in the symptom score as well as the good tolerability the investigated combined herbal cough syrup seems to alleviate cough in consequence of common cold, bronchitis or respiratory tract diseases with formation of mucus.

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