Table 5 Controlled Clinical Studies on VAE Treatment in Breast and Gynaecological Cancer: Reduction of side effects of chemotherapy, radiation or surgery; QoL

Randomized controlled trials

Breast

T_1–3, N_0–2, M₀

CAF, Iscador or Helixor (59)

Neutropenia

15%

0.195

EORTC QLQ-C30* (Pain*, diarrhoea*, role*, insomnia*, nausea/vomiting*)

0.0438 to

0.0003

Tröger 2009 [47]

CAF (30)

27%

No data

(F)EC, Iscador M (32)

EC-associated inhibition of granulocyte function: no difference.

Reduction of EC-related side effects (nausea, constipation, pain, stomatitis).

Lymphocytes, retching, emesis: no difference

>0.27

EORTC QLQ-C30*, BR 23*, Rhodes Index*: no difference

No data

No data

Büssing 2008 [48]

(F)EC (33)

"significant"

T_1a-3, N₀, M₀

Iscador (38)

Self-regulation questionnaire,

Hazard-ratio

0.35

0.05–0.60

Grossarth 2006a [52, 53]

None (38)

T_1–3, N₀-N₊, M₀

CMF, Lektinol 15 ng ML (169)

Haematological parameters, hospitalization, paracetamol, metoclopramid: no difference.

Leucopenia ↓ (trend)

FACT-G*

↑ 4.4

GLQ-8* sum

↓ 28.9

Spitzer uniscale*

↓ 12.2

KPS*

No difference

<0.0001

Semiglasov 2006 [54]

CMF, placebo (168)

FACT-G*

↓ 5.11

GLQ-8* sum

↑ 94.8

Spitzer uniscale*

↑ 10.8

T_1–2, N_0–1, M₀

CMF, radiation, Helixor A (11)

CMF-induced NK-cell decrease ↓ SCE-increase ↓

other immune markers: no difference

0.005

n.s.

EORTC QLQ-C30*

No difference, data not shown

not shown

Auerbach 2005 [55]

CMF, radiation, placebo (9)

T_1–3, N₀-N₊, M₀

CMF, Lektinol 5 ng ML (66)

Haematological parameters, hospitalization, paracetamol, metoclopramid: no difference. immune markerers: CD4, CD4/CD8, NK-cell-activity: significant ↑

GLQ-8* sum

No difference

Spitzer uniscale*

No data

QLQ C-30*

No difference

<0.05

Semiglasov 2004 [57]

CMF, Lektinol 15 ng ML (65)

GLQ-8* sum

Superior 60,8mm

Spitzer uniscale*

Superior 16,4 mm

CMF, Lektinol 35 ng ML (64)

GLQ-8* sum

No difference

Spitzer uniscale*

No data

CMF, placebo (66)

IIIA–IIIB

Iscador (17)

Self-regulation questionnaire (score 1–6)

2.92 → 3.7

0.13

Grossarth 2001a [59]

None (17)

2.87 → 2.99

IV

Iscador spezial (20)

Spitzer score questionnaire

~5 → 7.2

<0.05

Borrelli 2001 [58]

Placebo (10)

~5.2 → 4.8

Advanced

VEC, Eurixor (21)

Leukopenia ↓

Platelets: no difference

≤ 0.001

QoL index* (superior)

Anxienty scale* (superior)

≤ 0.01

Heiny 1991 [61]

VEC, placebo (19)

Breast, others

All stages

Iscador (39)

Self-regulation questionnaire

(score 1–6)

3.41 → 3.87

0.02

Grossarth 2001b [59]

None (39)

3.85 → 3.62

Breast, ovary, lung

T_1–4, N_0–3, M_0–1

Chemotherapy^I, Helixor A (115)

Chemotherapy-related adverse events

28

not shown

FLIC-score*

↑ 9

TCM-score*

↑ -1

KPS* increase in % of patients

50%

FLIC 0.014

TCM 0.0007

KPS 0.002

Piao 2004 [56]

Chemotherapy^I, Lentinan (109)

Chemotherapy-related adverse events

77

FLIC-score*

↑ 4,7

TCM-score*

0

KPS* increase in % of patients

32%

Ovary

IA–IC

Iscador (21)

Self-regulation questionnaire, (score 1–6) median difference

0.58

0.0002

0.30–0.90

Grossarth 2007a [50]

None (21)

Ovary, others

Inoperable

Radiation, cisplatin, holoxan, Helixor (23)

Nausea ↓,

vomiting ↓,

depression of leucopoiesis ↓

0.005, 0.08,

0.003

KPS*

67% → 76% (p = 0.0008^II)

not shown

Lange 1985 [63]

Radiation, cisplatin, holoxan (21)

70% → 74% (p = 0.12^II)

Cervix

IVA-B

Iscador (19)

Self-regulation questionnaire, (score 1–6) median difference

0.7

0.014

0.15–1.05

Grossarth 2007c [51]

None (19)

Uterus

IA-C

Iscador (30)

Self-regulation questionnaire, (score 1–6) median difference

0.4

0.0012

0.15–0.70

Grossarth 2008a [49]

None (30)

Non-randomized controlled studies

Breast

T_1–3, N₀, M₀

Iscador (84)

Self-regulation questionnaire

Hazard-ratio

0.20

0.031

0.00–0.35

Grossarth 2006b [52, 53]

None (84)

I–II

Surgery, CMF/EC, Iscador (33)

CMF/EC-induced lymphocyte decrease ↑,

platelet decrease ↓

n.s,

0.01

EORTC QLQ-C30*, BR 23*

Reduced increase of nausea/vomiting, general side effects of CMF/EC

0.02

0.02

Loewe-Mesch [64]

Surgery, CMF/EC (33)

Breast (suspected)

Surgery, Iscador M spezial (47)

Prevention of surgery-associated inhibition of granulocyte function (PMA- and E.coli-stimulated oxidative burst)

<0.0001,<0.001

Büssing 2005 [65]

Surgery (51)

Ovary

IA–IC

Iscador (75)

Self-regulation questionnaire, (score 1–6) median difference

0.30

<0.026

0.10–0.60

Grossarth 2007d [50]

None (75)

Cervix

IB-IVA

Iscador (102)

Self-regulation questionnaire, (score 1–6) median difference

0.25

<0.0005

0.15–0.35

Grossarth 2007f [51]

None (102)

Uterus

IA-C

Iscador (103)

Self-regulation questionnaire, (score 1–6) median difference

0.65

<0.0005

0.4–0.95

Grossarth 2008d [49]

None (103)

Retrolective pharmaco-epidemiological cohort study

Breast

I–III

Conventional therapy, Helixor (167)

Odds ratio for occurrence of disease- or treatment associated symptoms: 0.508

0.319–0.811

Beuth 2008 [69]

Conventional therapy (514)

I–III

Conventional therapy, Iscador (710)

Adverse drug reactions ↓, Odds ratio: 0.47

95% CI 0.32–0.67

Odds ratio for being symptom-free 3.56 (vomiting, headache, exhaustion, depression, concentration, sleep, dizziness, irritability) ↑

2.03–6.27

Bock 2004 [70]

Conventional therapy (732)

I–IV

Conventional therapy, Eurixor (219)

Symptom mean score improved (nausea, appetite, stomach pain, tiredness, depression, concentration, irritability, sleep)

<0.0001

Schumacher 2003 [71, 72]

Conventional therapy (470)