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Quality-of-life (QoL) of cancer patients is an issue both in conventional and in complementary/alternative medicine (CAM). In clinical studies, QoL is usually estimated by questionnaires, which represent a possibility to objectively quantify it in a wide number of patients, but lack the subjective dimension of each patient's QoL perception. Mistletoe (Viscum album) preparations are often used in the adjuvant setting and several clinical studies have shown that mistletoe – often in combination with standard treatments – can improve QoL [1]. In our previous work, we have detected a tendency for an improvement of the patients’ QoL as detected by various questionnaires (EORTC QLQ-C30 Version 3.0 [2], SELT-M [3] and HLQ Version 2.5 [4]), in a cohort of 25 patients with different types of malignant diseases during treatment with subcutaneous applications of mistletoe preparations [5]. This cohort study, which was authorized by the ethical commission of the canton Zurich, included an additional questionnaire focusing on the therapies used (mistletoe, conventional and others) and on their impact on the QoL as perceived by the patient. The patients filled in the questionnaire at the beginning of the mistletoe therapy (n=25), and approximately 3 months later (n=21), to document the evolution during this time period. When the patients agreed, they were interviewed by the researchers at both occasions (n=12). For comparison reasons, only the questionnaires data of the patients, which were as well interviewed, are considered in the present analysis. The analysis of the questionnaires showed that the patients had most expectations concerning the improvement of QoL on the mistletoe therapy. Furthermore, they perceived the mistletoe therapy as the one leading to an improvement of QoL and to a better coping – including dimensions like positive thinking and a conscious lifestyle – with the disease. These results were supported by those of the interviews’ analysis, which further revealed that the successful coping with a cancer disease is associated with secondary (indirect) but effective components of the QoL, such as the interpretation of the disease (both of the patient and of the loved ones), the perceived sense or meaning of the disease, the received treatment (preferences, concept, setting) and the personal world's view. The coping with the disease was in some cases associated with changes in the private (psychosocial) space and in other cases in the professional space. Taken together, our results show that the patients adopt the mistletoe therapy with a supportive goal rather then as an anti-tumour therapy. Mistletoe therapy seems to offer a platform for an integrative coping with the disease, which might be important to reconcile the perceived shock of an existential disease with a good QoL, by releasing forces of motivational origin.

Background Mistletoe treatment has a long tradition, especially in the German-speaking world, and is one of the most frequently used complementary medical treatments in patients with cancer. The clinical evidence, however, stands in contrast to experimental anti-tumour effects (in vitro, in vivo). How efficacious is mistletoe treatment against solid tumours? Methods Potentially relevant clinical trials on mistletoe treatment in patients with solid tumours were located using electronic databases (e.g. Cochrane Library, MEDLINE) and defined search terms (e.g. mistletoe, Viscum). For a trial to be included in the analysis, mistletoe preparations had to be evaluated in a randomized, placebo-controlled manner, or within a comparative control study. The interventions had to be described in a clear and comprehensible fashion. For purposes of external validity, cohort studies were also considered. Results A total of 19 clinical studies satisfied the inclusion criteria and were evaluated. In terms of methodology, the internal validity of the controlled studies varied considerably and was usually low. The heterogeneity of the studies (e.g. different mistletoe preparations, interventions, tumour entities) made it impossible to conduct a meta-analysis. The results of the studies were inconsistent with regard to efficacy as measured in terms of survival times. Most of the studies, however, showed improved quality of life in patients on mistletoe treatment in addition to oncological therapy, thus underscoring the role of mistletoe as an adjuvant. In terms of safety, one serious adverse event was reported in association with mistletoe treatment. Frequent adverse events were local reactions (e.g. redness, induration); allergic reactions were rare. Conclusion Despite the methodological limitations of the included clinical trials, improved quality of life appears to be the most important measure of efficacy in adjuvant mistletoe treatment. The mistletoe preparations analysed in the studies showed good tolerability. Aspects related to quality of life are probably conditional on immunomodulatory (among other) effects. To date, however, clinical research has overlooked the potential of mistletoe treatment as a patient-oriented approach within a complex oncological setting. This should be investigated systematically in future studies, with an eye to quality of life.

Herbals drugs – single or in combination – are often used in patients with somatoform disorders, yet the available evidence is limited. Aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185=4-combination versus 3-combination without butterbur versus placebo) in patients with somatoform disorders. A total of 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo) for a 2-week treatment in patients with somatisation disorder (F45.0) and undifferentiated somatoform disorder (F45.1). Anxiety (visual analogue scale—VAS) and depression (Beck's Depression Inventory—BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter. The 4-combination was significantly superior to the 3-combination and placebo (4 combination >3 combination >placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety no serious adverse events (AE) occurred. In total 9 non-serious AE were documented but the distribution did not differ significantly between the treatment groups. Butterbur had an additional benefit on the short-term treatment in patients with somatoform disorders. Thus the herbal 4-combination (Ze185) showed to be efficacious and safe.

Mistletoe ( Viscum album ) preparations are often used in the adjuvant setting, together with standard chemo- or radiotherapy. Several clinical studies have shown that treatment with mistletoe preparations—often in combination with standard treatment—can improve the quality-of-life and even prolongs relapse-free intervals in cancer patients [1]. Furthermore, some patients can better stand aggressive chemotherapies if they receive mistletoe preparations at the same time. In the present clinical study, which was authorized by the ethical commission of the canton Zurich, questionnaires were used to characterise the alterations in the quality-of-life experienced by cancer patients during the treatment with mistletoe preparations. Furthermore, the patients were interviewed by the researchers to unveil their goals while accepting this therapy. A small ( N =25) cohort of patients with different types of malignant diseases received subcutaneous applications of mistletoe preparations in the course of their treatment at the Paracelsus Hospital in Richterswil. All patients filled in the following questionnaires on quality-of-life at the beginning of the treatment: EORTC QLQ-C30 Version 3.0, SELT-M and HLQ Version 2.5. Approximately 3 months later, 21 of the 25 patients filled in the questionnaires a second time, to document the variation in the quality-of-life during this time period. The scores of the different questionnaires, as well as the differences between the scores at the two visits, were determined. The statistical analysis (merely descriptive) was performed with SAS 9.1. When the patients agreed, they were interviewed by the researchers. These interviews included questions on why the patients used the mistletoe therapy including objective and subjective reasons. Another goal of the interviews was to characterise the functional meaning of the mistletoe therapy within the context of the whole therapeutic concept and some questions attempted to find out how this meaning should be interpreted. Finally, the relevance of the mistletoe therapy with respect to the maintenance/improvement of the quality-of-life was approached. The evaluation of the questionnaires showed a tendency for an improvement of the patients’ quality-of-life, which was revealed by all three types of questionnaires. The interviews’ analysis indicated that the patients adopt the mistletoe therapy with a supportive goal rather then as an anti-tumour therapy. Moreover, psychosocial considerations and ideal reasons do often play an immediate role.

Background The respiratory epithelium is a major portal of entry for pathogens and applies various defense mechanisms. Recruitment of neutrophils in airway inflammation may account for the generation of interleukin 8 (IL-8), which is also generated by tissue cells after stimulation by endotoxin (LPS) or proinflammatory cytokines. This study was designed to evaluate the effectiveness of the commercial herbal medicinal product (Imupret®, Bionorica AG) in the modulation of airway inflammation. For the production of IL-8 and human β-defensin 2 (hBD-2), LPS and interleukin-1β (IL-1β) activated A549 bronchial epithelial cells were analyzed. Materials and methods A549 cells, which express toll-like receptor 4 (TLR4), were used. The cytotoxicity and antiproliferative effect of Imupret® (50–2000 μg/ml) were investigated (propidium iodide uptake, WST-1 assay). LPS from Pseudomonas aeruginosa (100 μg/ml) or IL-1β (50 ng/ml) were used as stimulating agents. Dexamethasone (10−7 M) served as positive anti-inflammatory control. IL-8 and hBD-2 production were detected in the supernatants of A549 cells after 18 h with commercially available ELISA test kits (Bender MedSystems, CA; Phoenix Pharmaceuticals, CA). Imupret® dissolved in single solvents (bidest H2O, cell culture medium, 70% (v/v) ethanol and DMSO) was investigated at nontoxic concentrations in the range between 0.01 and 100 μg/ml. Results Imupret® (50–2000 μg/ml) in different solvents showed dose-dependent growth inhibitory effect on A549 cells. Comparative studies indicate quantitative differences concerning 50% growth inhibitory (GI50) concentrations ranging between 122–823 μg/ml. Viability of cells was not affected. The growth inhibitory effect of water and DMSO extracts was significantly diminished in LPS-primed cells at concentrations above 100 μg/ml in contrast to medium and ethanol preparations. Production of IL-8 after stimulation by LPS or IL-1β in A549 cells was significantly inhibited by pre-treatment with Imupret®. IL-8 level of LPS-stimulated cells was decreased about 20–40% by Imupret® (1–100 μg/ml ) treatment; however in Il-1β-primed cells 30% (100 μg/ml) and 20% (10 μg/ml) decreases were detected. IL-1β up-regulated level of hBD-2 was inhibited by Imupret® at concentrations between 0.1 and 100 μg/ml. Conclusion Imupret® may help to suppress airway inflammation by inhibiting IL-8 production and down-regulation of hBD-2 (increased level in chronic inflammatory diseases) in epithelial cells.