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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.