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Table 2 Characteristics of the clinical studies (n = 69)

From: Safety of higher dosages of Viscum album L. in animals and humans - systematic review of immune changes and safety parameters

  Number of studies
Types of study  
Controlled studies, comparing outcome to control group (2912 patients included) 25
Randomized 22
Double blind 6
Single blind 1
Single-arm studies, comparing outcome pre-post (1347 patients included) 44
Diagnoses  
Healthy participants 10
Cancer 48
Others: Hepatitis C, immunosuppression, HIV infection, osteoarthritis, anal condyloma (4 × mixed: HIV & healthy; 1 × mixed: HIV & healthy & cancer) 11
Treatment  
Whole extract 66
Recombinant ML 3
Application route  
Subcutan, intracutan 50
Intravenous * 10
Intrapleural, intraperitoneal, intravesical * 7
Intratumoural * 2
Application frequency  
Applied just once 7
Applied more than once in constant dosage (up to 3 years) 12
Applied more than once in escalating dosage (up to 6 years) 50
Maximum dose per application  
≤ 20 mg VAE 36
> 20 - 100 mg VAE 15
> 100 mg VAE (maximum dose: 1500 mg; maximum ML content: 45000 systemically, 250000 ng intravesically) 15
> 100000 ng rML (maximum dose: 448000 ng) 2
< 100000 ng rML 1
Observation time < 1 month 14
Treatment of control group (n = 25)  
No additional treatment 14
Placebo 6
Active (multivitamins, Lentinan, Etoposide, BCG, non-stimulating skin control test/immignost) 5
Immune outcomes investigated 57
Clinical infections 4
Peripheral blood: CBC, DBC, lymphocytes & subsets, mitogen-induced proliferation, cytokine release, NK-cells & activity, ADCC, phagocytosis of granulocytes, cytokines; immunoglobulins, CRP, haptoglobin, others 55
Immune parameters in tumour tissue, pleural effusion, saliva, urine 6
Safety outcomes investigated 61
Safety as primary objective of the study 6
Systematic and regular assessment of clinical and laboratory parameter (electrolytes, urea, AST, ALT, γ-GT, AP, bilirubin, creatinine, creatine kinase, LDH, protein, albumin, glucose, cholesterol, triglycerides, α-amylase) 29
Recorded according to NCI CTC, WHO toxicity criteria, Likert scale, Lilly tables 17
Other modalities of recording 16
No details on recording 16
Time schedule of safety assessment  
Daily (e.g. diary) 6
Weekly, biweekly 12
Monthly, every 3 weeks 13
Quarterly 4
Once 2
„Regular" 7
No details or no systematic plan 25
  1. * Partly concomitant sc application
  2. Abbreviations: ADCC: antibody-dependent-cell-mediated cytotoxicity, ALT: Alanine transaminase, AP: alkaline phosphatase, AST: aspartate transaminase, CBC complete blood count, CRP: C-reactive protein, DBC: differential blood count, γ-GT: γ-glutamyltransferase, LDH: lactate dehydrogenase, NCI CTC: National Cancer Institute - Common Toxicity Criteria