| Study characteristics |
| Methods |
Design: Two open‐label, parallel, 3‐arm (EORTC 18871) and 4‐arm (DKG 80‐1) RCTs each with a no‐treatment control
Recruitement period: 1/88 ‐ 3/96
Observation period: 6 years
Ethical approval: unclear |
| Participants |
Number of patients: 45 included, 44 analysed
Condition: bladder cancer, transurethrally resected (pTa G1‐2; stage 0a [AJCC])
Demographics: mean ages 65 years, 33 men, 12 women
Recruitment: unclear
Setting: 1 university hospital departement of urology, Essen, Germany
Informed consent: yes |
| Interventions |
Intervention (MT): 1ml mistletoe extract standardized for ML‐1 (Eurixor) s.c. twice weekly for three months followed by a therapy‐free interval of 3 months (one treatment cycle), max. 3 cycles.
Control (NT): no treatment
Basic treatment: transurethral resection |
| Outcomes |
Primary outcome measure: Disease‐free survival/Tumor recurrence
Other: adverse effects of mistletoe extracts |
| Notes |
Methods: Pilot study designated as phase II study.
Quality Scores (Delphi List/Jadad Score): 6/3 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
