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Table 4 Controlled Clinical Studies on VAE Treatment in Breast and Gynaecological Cancer: Tumour Behaviour or Pleurodesis

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

Site

Stage

Intervention (evaluable patients)

Outcome

P-value

95% CI

Author, year, reference

R EMISSION

      

Randomized controlled trials

Breast, ovary, lung

T1–4, N0–3, M0–1

ChemotherapyI, Helixor A (115)

Remission rate: no difference

  

Piao 2004 [56]

  

ChemotherapyI, Lentinan (109)

    

Ovary, others

Inoperable

Radiation, cisplatin, holoxan, Helixor (23)

10% complete remission

48% partial remission

5% progress

  

Lange 1985 [63]

  

Radiation, cisplatin, holoxan (21)

17% complete remission

48% partial remission

4% progress

   

Pleural effusionII

Advanced

Helixor (11)

82% complete remission

9% partial remission

<0.05 III

 

Kim 1999 [60]

  

Doxycycline, meperidine, lidocaine (15)

40% complete remission

27% partial remission

   

D ISEASE-FREE INTERVAL, TIME TO EVENT, RECURRENCE (H AZARD RATIO )

Randomized controlled trials

Breast

T1a-3, N0, M0

Iscador (38)

Time to local recurrences: 0.44

lymphatic metastases: 0.27

distant metastases: 0.50

all events (incl.death) 0.65

0.18

0.0048

0.061

0.012

0.14–1.44

0.11–0.67

0.24–1.03

0.47–0.91

Grossarth 2006a [52, 53]

  

None (38)

    

Non-randomized controlled trials

Breast

T1–3, N0, M0

Iscador (84)

Time to local recurrences: 0.42

lymphatic metastases: 0.22

distant metastases: 0.36

all event (incl.death) 0.66

 

0.21–0.83

0.10–0.47

0.21–0.62

0.55–0.79

Grossarth 2006b [52, 53]

  

None (84)

    

Cervix

IB-IVA

Iscador (102)

Time to local recurrences: 1.42

lymphatic metastases: None

distant metast.:1 in Iscador group

all event (incl.death) 0.32

0.61

n.a.

n.a.

<0.0001

0.37–5.39

n.a.

n.a.

0.22–0.48

Grossarth 2007f [51]

  

None (102)

    

Retrolective pharmaco-epidemiological cohort study

Breast

I–III

Conventional therapy, Helixor (167)

Recurrence, metastases, reoperation: no difference

  

Beuth 2008 [69]

  

Conventional therapy (514)

    
 

I–III

Conventional therapy, Iscador (710)

Recurrence: 0.98

Dist. metast. 0.65

0.947

0.172

0.60–1.62

0.35–1.21

Bock 2004 [70]

  

Conventional therapy (732)

    
 

I–IV

Conventional therapy, Eurixor (219)

Time to relapse: 0.28

0.012

0.10–0.76

Schumacher 2003 [71, 72]

  

Conventional therapy (470)

    
  1. I Chemotherapy: see table 5
  2. II Plural effusion indicates treatment site (primary cancer site: 4 × breast, 1 × cervix, 23 × lung, 1 × stomach, 1 × unknown primary)
  3. III Side effects in Helixor and doxocycline group: pain in 6 and 14, fever in 3 and 6, burning sensation in 0 and 5 patients respectively; difference statistically significant (p < 0.05)
  4. P-value, 95% CI (confidence interval): Statistical significance of difference between mistletoe (or other verum) and control group.
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Journal of Experimental & Clinical Cancer Research

ISSN: 1756-9966

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