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Open Access Research article

Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma – a randomized, controlled pilot study

Kab-Choong Kim1, Jeong-Hwan Yook1, Jürgen Eisenbraun2, Byung-Sik Kim1 and Roman Huber3*

Author affiliations

1 Division of Stomach surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea

2 Abnoba GmbH, Pforzheim, Germany

3 Center for Complementary Medicine, University Medical Center Freiburg, Freiburg, Germany

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Citation and License

BMC Complementary and Alternative Medicine 2012, 12:172  doi:10.1186/1472-6882-12-172

Published: 3 October 2012

Abstract

Background

Mistletoe (Viscum album L.) extracts are widely used in complementary cancer therapy. Aim of this study was to evaluate safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer.

Patients and Methods

32 operated gastric cancer patients (stage Ib or II) who were waiting for oral chemotherapy with the 5-FU prodrug doxifluridine were randomized 1:1 to receive additional therapy with aVQ or no additional therapy. aVQ was injected subcutaneously three times per week from postoperative day 7 to week 24 in increasing doses. EORTC QLQ-C30 and -STO22 Quality of Life questionnaire, differential blood count, liver function tests, various cytokine levels (tumor necrosis factor (TNF)-alpha, interleukin (IL)-2), CD 16+/CD56+ and CD 19+ lymphocytes were analyzed at baseline and 8, 16 and 24 weeks later.

Results

Global health status (p <0.01), leukocyte- and eosinophil counts (p ≤0.01) increased significantly in the treatment group compared to the control group. Diarrhea was less frequently reported (7% vs. 50%, p=0.014) in the intervention group. There was no significant treatment effect on levels of TNF-alpha, IL-2, CD16+/CD56+ and CD 19+ lymphocytes and liver function tests measured by ANOVA.

Conclusion

Additional treatment with aVQ is safe and was associated with improved QoL of gastric cancer patients. ClinicalTrials.Gov Registration number NCT01401075.

Keywords:
Qol; EORTC QLQ-C30; QLQ-STO22; 5-FU; Viscum album