Steuer‐Vogt 2001.

Study characteristics
Methods	Design: Open‐label 2‐arm RCT with two strata in each arm (stratum A: surgery without/with mistletoe treatment; stratum B: surgery+radiotherapy without/with mistletoe treatment) with a no treatment control Recruitment period: 1993‐97 Observation period: 6 years (treatment period 1 year, follow‐up 5 years) Ethical approval: yes
Participants	Number of patients: 495 included, 477 randomised and analysed Condition: operable head‐and‐neck squamous cell cancer (stage I‐IV [AJCC]) Demographics: mean ages range between 54 and 58 years (four strata), 437 men, 40 women Recruitment and setting: 4 university hospital departements of Otorhinolaryngology, Germany Informed consent: yes
Interventions	Intervention (MT, stratum A + B): Eurixor, 1ng ML‐1 per kg body weight twice weekly for 60 weeks, treatment cycles of 12 weeks followed by a break of 4 weeks. Control: no treatment (stratum A)/ radiotherapy (stratum B) Basic treatment: surgical procedure
Outcomes	Primary outcome measure: disease‐free survival Other: disease‐specific survival, quality of life (EORTC QLQ‐C30), adverse effects of mistletoe extracts; immunological parameters
Notes	Participants: Flow chart according to the CONSORT guidelines. Interventions: Type of mistletoe extract: standardized for mistletoe‐lectin I. Comparability of sum doses of radiotherapy in stratum B between groups unclear. 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

5‐FU = 5‐Fluorouracil; ADM = Adriamycin; Basic treatment = tumor specific treatment given in all groups; BRM = Biologic response modifier; CBP = C‐PPD = Carboplatin; CTX = Cyclophosphamid; EADM: Epiadriamycin; EORTC = European organisation for research and treatment of cancer; FA = Folinic acid; FACT = Functional assessment of cancer treatment; IFO = Ifosfamid; MMC = Mitomycin; n.a./n.r. = not assessed or not reported; NVB = Vinorelbin; PDD = cis‐Diaminodichloroplatinum; POM = Primary outcome measure; QLQ‐C30 = EORTC Quality of life questionnaire; QLI = Quality of Life Index (Spitzer); QLU = Quality of LIfe Uniscale (Spitzer); QoL = Quality of life; TCM = Traditional chines medicine; VDS = Vindesine;