4 research outputs found

    Safety of higher dosages of Viscum album L. in animals and humans - systematic review of immune changes and safety parameters

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    <p>Abstract</p> <p>Background</p> <p><it>Viscum album </it>L extracts (VAE, mistletoe) and isolated mistletoe lectins (ML) have immunostimulating properties and a strong dose-dependent cytotoxic activity. They are frequently used in complementary cancer treatment, mainly to improve quality of life, but partly also to influence tumour growth, especially by injecting VAE locally and in high dosage. The question is raised whether these higher dosages can induce any harm or immunosuppressive effects.</p> <p>Methods</p> <p>Systematic review of all experiments and clinical studies investigating higher dosages of VAE in animals and humans (<it>Viscum album </it>> 1 mg in humans corresponding to > 0.02 mg/kg in animals or ML > 1 ng/kg) and assessing immune parameters or infections or adverse drug reactions.</p> <p>Results</p> <p>69 clinical studies and 48 animal experiments reported application of higher doses of VAE or ML and had assessed immune changes and/or harm. In these studies, <it>Viscum album </it>was applied in dosages up to 1500 mg in humans and 1400 mg/kg in animals, ML was applied up to 6.4 ÎŒg/kg in humans and in animals up to 14 ÎŒg/kg subcutaneously, 50 ÎŒg/kg nasally and 500 ÎŒg/kg orally. A variety of immune parameters showed fluctuating or rising outcomes, but no immunosuppressive effect. Side effects consisted mainly of dose-dependent flu-like symptoms (FLS), fever, local reactions at the injection site and various mild unspecific effects. Occasionally, allergic reactions were reported. After application of high doses of recombinant ML, reversible hepatotoxicity was observed in some cases.</p> <p>Conclusions</p> <p>Application of higher dosages of VAE or ML is not accompanied by immunosuppression; altogether VAE seems to exhibit low risk but should be monitored by clinicians when applied in high dosages.</p

    A brief instrument to measure health-related quality-of-life in patients with bone metastasis: validation of the German version of Bone Metastases Quality-of-Life-10 (BOMET-QoL-10)

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    <p><b>Aims:</b> This prospective, epidemiologic study was designed to translate the original Spanish Bone Metastases Quality-of-Life-10 (BOMET-QoL-10) questionnaire and undertake a validation of the translated German version of BOMET-QoL-10 in Germany to assess health-related quality-of-life (HRQoL) in patients with bone metastases (BM).</p> <p><b>Methods:</b> The translation process included forward and backward translations, and a linguistic validation. Patients aged ≄18 years with histological confirmation of cancer, diagnosed with BM, life expectancy ≄6 months, and fluency in German were eligible for this study (enrolled consecutively in 33 outpatient centers in Germany). Patients were given the German version of BOMET-QoL-10, together with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and EORTC QLQ-BM22 questionnaires at inclusion, 6 weeks, 3 months, and 6 months after inclusion. A debriefing questionnaire was administered at inclusion to determine patient acceptability and understanding.</p> <p><b>Results:</b> Data include 364 patients with BM (median age = 68 years; females = 71.7%). The BOMET-QoL-10 is brief and clear (median completion time = 5 minutes; >90% of patients completed the questionnaire without assistance). The BOMET-QoL-10 forms only one overall scale. All 10 items showed a substantial correlation with the first factor (factor loading, range = 0.58–0.86). BOMET-QoL-10 exhibits high internal consistency and reproducibility (Cronbach’s alpha = 0.91; intra-class correlation coefficient = 0.76). BOMET-QoL-10 showed significant correlations (range = 0.69–0.79) both with EORTC QLQ-C30 and EORTC QLQ-BM22 within the functioning (physical, social, interference) and symptom (fatigue, pain) scales, displayed significant sensitivity to change in EORTC QLQ-BM22 scores, and proved the potential ability to detect change in HRQoL in patients with different disease status.</p> <p><b>Limitations:</b> There was a high proportion of females in this study, which might represent a limitation.</p> <p><b>Conclusions:</b> The German version of BOMET-QoL-10 is a valid, reliable, brief, and clear instrument able to measure HRQoL in patients with BM.</p
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