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

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

Site Stage Intervention (evaluable patients) Reduction of side effects of chemotherapy, radiation or surgery QoL (*during chemotherapy, radiation) Author, year, reference
    Outcome P-value Measurement scale and outcome P-value 95% CI  
Randomized controlled trials
Breast T1–3, N0–2, 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"        
  T1a-3, N0, M0 Iscador (38)     Self-regulation questionnaire,
Hazard-ratio
0.35   0.05–0.60 Grossarth 2006a [52, 53]
   None (38)           
  T1–3, 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
    
  T1–2, N0–1, 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)           
  T1–3, 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 T1–4, N0–3, M0–1 ChemotherapyI, 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]
   ChemotherapyI, 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 = 0.0008II)    not shown   Lange 1985 [63]
   Radiation, cisplatin, holoxan (21)      70% → 74% (p = 0.12II)      
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 T1–3, 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)           
  1. I Chemotherapy (referring to the study by Piao et al.) – breast cancer: CAP, CAF (CAP: Cyclophosphamide, doxorubicin, cisplatin; CAF: Cyclophosphamide, doxorubicin, 5-fluorouracil); ovarian cancer: CP, IcP (CP: Cyclophosphamide, cisplatin, IcP: Ifosfamid, carboplatin); non-small cell-lung cancer: VP, MViP (VP: Vinorelbine, cisplatin; MViP: Mitomycin, vindesine, cisplatin).
  2. II Statistical significance of pre-post difference within each group
  3. QoL: Quality of life; KPS: Karnofsky Performance Status Scale SCE: Sister chromatid exchange; ↑: increase; ↓: decrease. P-value, 95% CI: Statistical significance of difference between mistletoe (or other verum) and control group; n.s.: not statistically significant; EC: Epirubicin, cyclophosphamide (F: 5-fluorouracil); VEC: Vindesine, epirubicin, cyclophosphamide; CMF: Cyclophosphamide, methotrexate 5-fluorouracil; CAF: Cyclophosphamide, doxorubicin, 5-fluorouracil.