Table 2 Characteristics of the clinical studies (n = 69)
| Â | Number of studies |
|---|---|
Types of study | Â |
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 | Â |
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 | Â |
Whole extract | 66 |
Recombinant ML | 3 |
Application route | Â |
Subcutan, intracutan | 50 |
Intravenous * | 10 |
Intrapleural, intraperitoneal, intravesical * | 7 |
Intratumoural * | 2 |
Application frequency | Â |
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 | Â |
≤ 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) | Â |
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 | Â |
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 |