| Study characteristics |
| Methods |
Design: Open‐label 3‐arm RCT with a no‐treatment control (NT)
Recruitment period: 1997‐2000
Observation period: unclear
Ethical approval: unclear |
| Participants |
Number of patients: 64 included and analysed (Arm A [CT]: 21 patients, 16 Dukes C, 5 Dukes D; arm B [MT]: 29 patients, 18 Dukes C, 11 Dukes D; arm C [NT]: 14 patients, 6 Dukes C, 8 Dukes D)
Condition: colorectal cancer patients (40 Dukes C, 24 Dukes D), previously operated
Demographic: Dukes C: 20 men, 20 women, mean age 54.2 years; Dukes D: 15 men, 9 women, mean age 59.9 years
Recruitment and setting: one university departement of surgery, Romania
Informed consent: unclear |
| Interventions |
Intervention (MT): Isorel 5mg/kg in saline solution, 1 hour infusion, 3 days/week + similar chemotherapy as control group CT
Control (CT): 6 cycles of a 5‐FU based chemotherapy according to either the DeGramont or Mayo protocol (not further described).
Control (NT): no treatment.
Basic treatment (see footnotes): surgery (curative or palliative) |
| Outcomes |
Primary outcome measure: not clearly stated
Other: Overall survival, treatment related toxicity |
| Notes |
Poor reporting quality
Participants: Numbers of pats in groups differ
Interventions: Type of mistletoe extract: pharmaceutical process standardized. Dosage and application of Isorel not consistent with the recommendations of the manufacturer.
Outcomes: Number of chemotherapy cycles/chemotherapy sum doses between groups unclear. Statistical analyses for different Dukes stages without prior stratification
Quality Scores (Delphi List/Jadad Score): 2/2 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
