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Table 1 Randomized Controlled Clinical VAE Trials on Breast and Gynaecological Cancer: Quality Assessment

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

Author, Year Quality Criteria Fulfilled in StudiesI Participants ARII
  A) B) C) D) E) F) G) H) I) J) K)   
Tröger 2009 [47] + - - (+) + + + + (+) (+) + 95 6%
Büssing 2008 [48] +III -III -III -III (-)III -III (-)III (-)III (-)III (-)III -III 65 No data
Grossarth 2008a [49] + + - (-) + (-) + (+) + + - 76 21%
Grossarth 2008b [49] + + - (-) + + + (+) + + - 52 0%
Grossarth 2007a [50] + + - (-) + (-) + (+) + + - 50 16%
Grossarth 2007b [50] + + - (-) + (-) + (+) + + - 48 17%
Grossarth 2007c [51] + + - (-) + + + (+) + + - 38 0%
Grossarth 2006a [52, 53] + + - (-) + (-) + (+) + + - 118 36%
Semiglasov 2006 [54] + - (+) (+) + + + + + + + 352 4%
Auerbach 2005 [55] + - (+) (+) + - + (+) + (+) + 23 30%
Piao 2004 [56] + + - (-) + + + (+) + + + 233 4%
Semiglasov 2004 [57] + - (+) (+) + + + + + + + 272 4%
Borrelli 2001 [58] + - (+) (+) + + (+) + (-) (+) - 30 0%
Grossarth 2001a [59] + + - (-) + + + (-) + + - 34 0%
Grossarth 2001b [59] + + - (-) + (-) + (-) + + - 98 20%
Kim 1999 [60] + - - - (-) - (+) (+) (-) (-) - 30IV 13%
Heiny 1991 [61] + - (-) (-) + (+) + (+) + + - 46 13%
Gutsch 1988 [62] + - - (-) + (-) + + (+) + - 692 20%
Lange 1985 [63] + + - (-) + (-) + (+) + + - 68 35%
  1. I A) Protection against selection bias, especially by adequate randomization
  2. B) Minimization of heterogeneity by pre-stratification or matching
  3. C) Protection against observer bias by blinding of patient, care provider, and outcome assessor
  4. D) Protection against performance (treatment) bias by standardization of care protocol, documentation of all co-interventions, blinding of patients and care providers
  5. E) Protection against measurement (detection) bias by standardization of outcome assessment
  6. F) Protection against attrition (exclusion) bias, lost patients <10% or by intention-to-treat analysis (including non-adherers as randomized) plus per-protocol analysis (excluding non-adherers) in combination with sensitivity analysis, and by comparison of prognostic characteristics of lost patients and compliers
  7. G) Effect measurement relevant and well described
  8. H) Well-described intervention, patient characteristics, disease (diagnosis, stage, duration), previous therapy
  9. I) Well-described study design
  10. J) Well-described results
  11. K) Data quality assured by ICH-GCP guidelines, especially by monitoring
  12. + = adequately fulfilled, (+) = partly fulfilled, (-) = little fulfilled, - = not fulfilled
  13. II AR: attrition rate (dropouts, protocol deviations, withdrawals, patients did not receive treatment as allocated).
  14. III Assessment based only on an abstract
  15. IV Discrepancy in patient numbers in two presentations (30 and 33), with corresponding discrepancy of results