Quelle: Medline Abstract

Mistelsymposium München 2008

Brustkrebstherapie mit einem standardisiertem
Mistelextrakt (Studie I) :  Am Scientific Research Oncological Institut, St. Petersburg, Russland, wurde eine doppelblind und randomisierte und Placebo kontrollierte Studie durchgeführt an der 272 Patientinnen teilnahmen, die unter einem operablen Brustkrebs litten.
Die Kranken erhielten in den Wochen 1 bis 15  entweder eine Standard-Chemotherapie (CMF-Protokoll) plus einem Scheinmedikament (Placebo) oder aber anstelle des Scheinmedikaments eine von drei unterschiedlichen Konzentrationen eines standardisierten Mistelextrakts (Lektinol ®). Die Patientinnen beurteilten zu mehreren Zeitpunkten anhand standardisierter visueller Verfahren  (GLQ-8 und Spitzer-Uniscale) ihre Lebensqualität. 
Die Auswertung der Antworten ergab für die mittlere Lektinol-Konzentration eine statistisch siognifikante Verbesserung der Lebensqualitäts-Scores.

Der Mistelextrakt PS76A2 wurde gut vertragen und die beobachteten Nebenwirkungen waren milde.

zur zweiten Studie hier

Die vollständige englischsprachige Kurzversion dieser Studie (sog. MEDLINE Abstract) finden Sie hier und hier

Anticancer Res. 2004 Mar-Apr;24(2C):1293-302.

The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

Semiglasov VF, Stepula VV, Dudov A, Lehmacher W, Mengs U.
Scientific Research Oncological Institute, St. Petersburg, Russia.


Patients with breast cancer receiving adjuvant chemotherapy frequently suffer from a restricted quality of life (QoL) due to the side-effects of chemotherapy and the consequences of coping with the diagnosis. Therefore, the objective of this clinical study was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to the galactoside-specific mistletoe lectin, on QoL by performing a placebo-controlled trial.
Overall, 272 patients with breast cancer receiving adjuvant CMF chemotherapy (cyclophosphamide-methotrexate-fluorouracil) were enrolled and randomised to groups receiving placebo or PS76A2 at concentrations of 10, 30 or 70 ng mistletoe lectin (ML) per ml. The patients received 0.5 ml study medication twice weekly subcutaneously for 15 consecutive weeks (4 CMF cycles).
Primary variables were the self-assessment QoL scores GLQ-8 (Global Life Quality) and Spitzer's uniscale.
As a result, statistically significant effects on QoL were obtained with the medium dose (15 ng ML/0.5 ml). The treatment difference between the medium dose and placebo with regard to the GLQ-8 sum was 60.8 mm (95% confidence interval: 19.3 to 102.0 mm). The treatment effect for Spitzer's uniscale between the medium dose and placebo was 16.4 mm (95% confidence interval: 6.3 to 26.6 mm).
The results on QoL were supported by an increase of T helper lymphocytes (CD4+) and the CD4+/CD8+ ratio (p<0.05). Overall, PS76A2 was well tolerated. Local reactions at the injection sites occurred dose-dependently, but were mild at the low and medium dose levels.