Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research

Table 6 Single-Arm Cohort Studies (e.g. Phase II Trials) on VAE Treatment in Breast and Gynaecological Cancer

Author, Year	Treatment^I					Site^II	Outcome^III					N^IV	Quality Criteria Fulfilled^VI
	Preparation	Injection site	Dosage	Escalating dosage	Duration		CR	PR	NC	PD	QoL		L	M	N	O	P	Q
Breast, Ovary, CIN
Mansky 2008 [44, 73]	Helixor (& gemcitabine)	sc	Up to 250 mg, daily	Yes	9 w	Breast, others	0%	10%	47%	43%		27	(+)	+	+	-^V	(+)	(+)
Schink 2006 [45]	Helixor (& surgery)	sc	3/week, varying individually	Yes	Up to 2 years	Breast, colon	-	-	-	-	↗^IIIa	40	+	+	(+)	(+)^V	(+)	-
Schöffski 2004 [32]	Aviscumine	iv	10 – 6400 ng/kg, 2/w	Yes	3–24 w, median 6 w	Ovary, breast, others	0%	0%	30%	70%		37	+	(+)	+	+	+	+
Mahfouz 1999 [74]	Viscum fraxini	sc or it	1 × 45 mg/w	No	16–136 w	Breast	8%	54%	35%	4%	↗	26	(+)	(+)	+	(+)	+	+
Mahfouz 1998 [75]	Abnobaviscum Fr	sc	1 × 45 mg/w	No	17 w	Breast	0%	44%	33%	22%	↗	9	-	(-)	(+)	-	-	(+)
Finelli 1998 [76]	Lektinol	sc	2,5 μl/kg, 2/w	No	Up to 12 w	Breast, others	-	-	-	-	↗	884	+	+	+	-	+	+
Portalupi 1995 [77]	Iscador M	sc	2 × 1 ng MLI/kg bw × w	No	16 w	CIN I–III	41%	27%	27%	5%		22	+	+	+	+	+	(+)
Malignant effusion
Bar-Sela 2006 [46]	Iscador M	ip	10 mg	No	repeatedly	Ascites (ovary, others)	Increase of interval between two successive paracenteses from 7 to 12 days, p = 0.001^IIIb				↗^IIIc	23	(+)	(+)	+	(+)	+	+
Werner 1999 [78]	Abnobaviscum Fr	ipl	1 × 75 mg/w	No	3–8 w	Pleural effusion (breast, others)	88%				↗	32	+	+	+	-	(+)	(+)
Stumpf 1994 [79]	Helixor A, M or P	ipl	100–1000 mg	Yes	repeatedly	Pleural effusion (breast, others)	61%	11%	22%			18	+	+	+	(+)	+	+
Friedrichson 1995 [80]	Helixor A, M	ip	100–1000 mg, 2/w	Yes	repeatedly	Ascites (ovary, others)	70%				↗	12	(+)	(-)	+	-	(-)	+

^I sc: subcutaneous, it: intratumoural, ipl: intrapleural, ip: intraperitoneal; iv: intravenous infusion; bw; body weight; w: week
^II CIN: cervical intraepithelial neoplasia. Stage: advanced, except in Portalupi 1995, and partly Schink 2006 and Finelly 1998; plural effusion and ascites indicates treatment site
^III CR: complete, PR: partial remission, NC: no change, PD: progredient disease, QoL: quality of life, ↗: improved, ↘ impaired
^IIIa Especially physical functioning, role, fatigue, appetite
^IIIb Median values, comparable abdominal circumference and symptom score or drained fluid before or during each paracentesis respectively
^IIIcTrend improvement in symptom score, especially abdominal pain, abdominal pressure, and waking up at night due to shortness of breath
^IV N: Number of participants
^V Concomitant conventional oncological cytoreductive therapies in some of the patients
^VI L Well-described patient characteristic and disease (diagnosis, stage, duration), prognostic factors
M Outcome parameter relevant and well described
N Well-described intervention
O Concomitant therapies well described
P Outcome clearly described, temporal relationship between applied therapy and observed outcome precisely described
Q Selection of patients excluded
+ = adequately fulfilled, (+) = partly fulfilled, (-) = little fulfilled, - = not fulfilled

ISSN: 1756-9966