| Study |
Randomisation |
Concealment |
Comparability |
Eligibility |
Blinding |
Attrition |
Scores |
Comment |
| Auerbach 2005 |
Method of sequence generation not reported |
Unclear |
No information about relevant prognostic factors given |
In‐/exclusion criteria reported |
Patient: unclear
Care provider: designed as double‐blind, but deblinding in 16/20 patients due to local reactions
Outcome assessor: unclear |
7 dropouts, 3 after screening, 4 during study (2 of each study arm), reasons reported. |
Delphi List:
1‐1‐0‐1‐0‐0‐0‐0‐0
Jadad List:
2‐0‐1 |
Selection bias possible: allocation concealment unclear, comparability of groups unclear
Participant/observer bias possible: unblinding of intervention in the majority of patients.
Poor reporting quality. |
| Borrelli 1999 |
Method of sequence generation not reported; 2:1 randomisation |
Unclear |
Baseline QoL similar between groups. Distribution of prognostic factors unclear |
In‐/exclusion criteria reported |
Patient: study probably designed as single‐blind (use of a placebo treatment), but no further information presented (intervention probably unblinded due to local reactions)
Care provider: no (see above)
Outcome assessor: unclear |
No dropouts or withdrawals reported |
Delphi List:
1‐0‐0‐1‐0‐0‐0‐1‐1
Jadad List:
1‐0‐1 |
Selection bias possible: allocation concealment unclear.
Participant/observer bias possible: unblinded evaluation of QoL.
Poor reporting quality |
| Cazacu 2003 |
Method of sequence generation not reported |
Unclear |
Uneven distribution of Dukes stages between groups, no further information on relevant prognostic factors |
No in‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
No dropouts or withdrawals reported |
Delphi List:
1‐0‐0‐0‐0‐0‐0‐0‐1
Jadad List:
1‐0‐1 |
Selection bias possible: allocation concealment unclear, uneven numbers of patients in groups, comparability of groups unclear.
Poor reporting quality |
| Dold 1991 |
Balanced randomisation lists,
stratified |
Central randomisation |
Groups comparable regarding important prognostic factors |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: assessment performed centrally |
71 Dropouts/withdrawals, balanced between the groups, detailed record of reasons. Reasons imbalanced among groups. |
Delphi List:
1‐1‐1‐1‐1‐0‐0‐1‐0
Jadad List:
2‐0‐1 |
Attrition bias possible due to number of drop‐outs
Performance bias possible: Concomitant treatments unclear
Participant/observer bias possible: unblinded investigation of measures of subjective outcomes |
| Douwes 1986a |
Method of sequence generation not reported |
Unclear |
Distribution of relevant prognostic factors among groups unclear |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: no |
No dropouts or withdrawals reported |
Delphi List:
1‐0‐0‐1‐0‐0‐0‐1‐1
Jadad List:
1‐0‐1 |
Selection bias possible: allocation concealment unclear/comparability of groups unclear, chemotherapeutic pretreatment not further described (intervention group 4/20, control (XP) goup 2/20, control (CX) group 3/20) .
Participant/observer bias possible: unblinded outcome assessment.
Poor reporting quality. |
| Goebell 2002 |
Permuted blocks |
Biostatistic core facility |
Slight imbalance regarding tumour characteristics at resection: 11 recurrent lesions (intervention group) vs. 8 in the control group and 13 multiple lesions in the intervention group vs. 10 in the control group |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: no |
Except of one death in the control group no dropouts/withdrawals |
Delphi List:
1‐1‐1‐1‐0‐0‐0‐1‐1
Jadad List:
2‐0‐1 |
Observer bias possible: no blinding of outcome assessment |
| Grossarth 2001a |
Blinded drawing of lots |
Unclear |
Matching procedure did not warrant balanced distribution of relevant prognostic factors |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
Dropouts/withdrawals: 10 patients in the intervention group (+ their 10 respective matches), reasons stated |
Delphi List:
1‐0‐0‐1‐0‐0‐0‐1‐0
Jadad List:
1‐0‐1 |
Performance bias possible: not controlled for concomitant oncologic therapies
Long recruitement period (>9 years). |
| Grossarth 2001b |
Blinded drawing of lots |
Unclear |
Matching procedure did not warrant balanced distribution of relevant prognostic factors |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
No dropouts and withdrawals reported |
Delphi List:
1‐0‐0‐1‐0‐0‐0‐1‐1
Jadad List:
1‐0‐1 |
Statistical analyses which show favorable results for the "intervention group" are based on mean survival times, whereas no difference is to be seen regarding the median survival presented in the curves. |
| Heiny 1991 |
Random table |
Unclear |
No data of the baseline quality of life assessment reported |
In‐/exclusion criteria reported |
Patient: study probably designed as single‐blind (use of a placebo treatment), but no further information presented (intervention probably unblinded due to local reactions)
Care provider: no
Outcome assessor: unclear |
Four dropouts in the intervention and 2 in the control group, reasons stated |
Delphi List:
1‐0‐0‐1‐0‐0‐0‐0‐0
Jadad List:
1‐0‐1 |
Selection bias possible: unblinded allocation of treatment/unclear distribution of prognostic factors at baseline, exclusion of patients with allergic reactions to mistletoe extracts during pretest
Participant/observer bias possible: unblinded analysis of quality of life and anxiety
Attrition bias possible: numbers of dropouts unevenly distributed between groups
Statistics: Data presented only in figures without standard deviations.
Poor reporting quality |
| Heiny 1997 |
Random generator |
Unclear |
No difference in baseline quality of life between groups stated (no data presented) |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: no |
Overall, 28 dropouts/withdrawals, distribution between groups unclear, reasons not reported |
Delphi List:
1‐0‐1‐1‐0‐0‐0‐1‐0
Jadad List:
1‐0‐0 |
Selection bias possible: unblinded allocation of treatment
Participant/observer bias possible: unblinded assessment of quality of life.
Attrition bias possible: reasons for and number of patients dropping out from each group not reported.
Statistics: Incorrect calculation of P‐value concerning reduction of mucositis in intervention group [see 'Results'])
Poor reporting quality |
| Kleeberg 2004 |
Stratified, method of sequence generation not reported |
Central randomisation |
Balanced distribution of key factors, but slightly imbalanced distribution of males, localisation of primary and initial stage between groups |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
Dropouts/withdrawals: 30 in the intervention (mistletoe) group, 18 in the control group. Reasons partly reported |
Delphi List:
1‐1‐1‐1‐0‐0‐0‐1‐1
Jadad List:
2‐0‐1 |
No sample size calculation reported for the DKG‐80‐1 trial (4‐arm trial including the mistletoe group)
Selection bias possible: slight imbalance in prognostic relevant factors.
Contamination possible: not controlled for concurrent mistletoe treatment in control groups (ML antibodies etc.)
Slight preponderance of males (64,4 vs 53,5%), non‐limb localisation of primary melanoma 54,9 vs. 52,9%), initial stage III (15,4 vs. 9,4%) in the intervention group (MT). |
| Lange 1993 |
Method of sequence generation not reported |
Central randomisation |
Baseline performance index, gender distribution, pretreatment similar between groups, mean age slightly higher in the control group (60,2 vs 58,3), sightly unequal distribution of tumour types between groups |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: no |
24 Dropouts/withdrawals (6 died within 1st chemotherapy, 6 refused further chemotherapy, 3 refused Helixor, 1 refused radiotherapy, 8 incomplete histories) |
Delphi List:
1‐1‐1‐1‐0‐0‐0‐1‐0
Jadad List:
2‐0‐1 |
Participant/observer bias possible: no patient/care provider blinding, no placebo control. |
| Lenartz 2000 |
Method of sequence generation not reported |
Unclear |
No information on prognostic relevant factors; baseline QoL (presented in a figure) comparable between groups |
Only histological verification of diagnosis as inclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: no |
Both publications of the trial mentioned 9 patients who were excluded during the trial, but no further information reported |
Delphi List:
1‐0‐0‐0‐0‐0‐0‐0‐0
Jadad List:
1‐0‐0 |
Selection bias possible: method and concealment of allocation not reported/no data concerning the balance of prognostic relevant data given.
Attrition bias possible: no detailed description of drop‐outs.
Participant/observer bias possible: no patient/care provider blinding, no placebo control
Statistics (survival): Number of patients in the subgroups analysed unclear.
Poor reporting quality. |
| Luemmen 2001 |
Method of sequence generation not reported |
Unclear |
Balanced distribution of metastatic sites, age and sex stated |
No eligibility criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
No dropouts/withdrawals reported |
Delphi List:
1‐0‐1‐0‐0‐0‐0‐0‐1
Jadad List:
1‐0‐1 |
Quality assessment based on three abstract publications
Selection bias possible: no information on concealment of treatment allocation
Observer bias possible: no blinding of outcome assessment |
| Piao 2004 |
Computer generated lists with varying block size |
Unclear |
Baseline FLIC score balanced between groups with a tendency to higher scores in 3 subscales in the mistletoe group. TCM baseline score balanced. Groups balanced in terms of age, gender, recruitement centers. Due to the way of presentation (separately for pT, pN, and M status), comparability in terms of stage unclear |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
9 dropouts/withdrawals, slightly unbalanced (6 in control, 3 in intervention group), reasons not stated |
Delphi List:
1‐0‐1‐1‐0‐0‐0‐1‐0
Jadad List:
1‐0‐1 |
Selection bias possible: no information on concealment of treatment allocation.
Participant/observer bias possible: unblinded assessment of quality of life.
Poor reporting quality. |
| Salzer 1983 |
Method of sequence generation not reported; 3:3:4 randomisation |
Central randomisation |
Slight imbalance among distribution of stages and histologic subtypes between groups. |
No eligibility criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
118 dropouts/withdrawals (intervention group 43, control group 38), reasons reported |
Delphi List:
1‐1‐1‐0‐0‐0‐0‐1‐0
Jadad List:
2‐0‐1 |
Selection bias possible: staging not corresponding to then‐international standards.
Attrition bias possible: in 13 patients intervention treatment not applicated (reason not stated)
Statistics: Survival data only analysed within subgroups (post‐hoc analyses). |
| Salzer 1991 |
Randomisation lists |
Sealed envelopes |
Slight imbalance among distribution of histologic subtypes between groups. Slightly more men in intervention group. Age evenly distributed |
No eligibility criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
35 dropouts/withdrawal, balanced between the groups, reasons for non‐participation reported. |
Delphi List:
1‐1‐1‐0‐0‐0‐0‐1‐0
Jadad List:
2‐0‐1 |
Selection/attrition bias possible: staging not corresponding to then‐international standards
Statistics: no stratification, but subgroup analysis (i.e. post hoc analysis). |
| Schwiersch 1999 |
Computer‐generated random lists |
Unclear |
No significant difference in the quality of life between groups at baseline |
In‐/exclusion criteria reported |
Patient: designed as double‐blind, but intervention unblinded due to local reactions
Care provider: unclear (see above)
Outcome assessor: unclear |
8 dropouts/withdrawals in the intervention group, 4 in the control group, reasons not reported |
Delphi List:
1‐1‐1‐1‐0‐0‐0‐0‐1
Jadad List:
2‐1‐1 |
Quality assessment and data extraction limited to submission manuscript
Quality of life analysis preliminary.
Performance bias possible: Not controlled for the rehabilitation interventions.
Comparison of the sociodemographic parameters of both groups indicates balanced randomisation. |
| Semiglasov 2004 |
Computer‐generated random lists |
Unclear |
Baseline QoL data of both instruments different among groups |
In‐/exclusion criteria reported |
Patient: designed as double‐blind, but intervention unblinded due to local reactions
Care provider: unclear (see above)
Outcome assessor: unclear |
18 dropouts and withdrawals because of major protocol violations, 11 withdrawals (4 adverse events, 4 decision of the patient, 3 other reasons) |
Delphi List:
1‐1‐0‐1‐0‐0‐0‐1‐0
Jadad List:
2‐1‐1 |
Selection bias possible: considerable inhomogeneities of baseline QoL data
Participant/observer bias possible: local reactions deblinded partly for mistletoe treatment. |
| Semiglasov 2006 |
Computer‐generated random lists |
Unclear |
Inhomogeneities among baseline QoL data stated (no data reported) |
In‐/exclusion criteria reported |
Patient: designed as double‐blind, but intervention unblinded due to local reactions
Care provider: unclear (see above)
Outcome assessor: unclear |
15 dropouts during chemotherapy (reasons not reported). 6 dropouts during 2‐months follow‐up after chemotherapy (MT 2 pats, PT 4 pats.) |
Delphi List:
1‐1‐0‐1‐0‐0‐0‐1‐0
Jadad List:
2‐1‐1 |
Selection bias possible: inhomogeneities of baseline QoL data
Participant/observer bias possible: local reactions deblinded partly for mistletoe treatment.
Attrition bias possible: 15 dropouts (balance between groups unclear)
Statistics: no intention‐to‐treat analysis |
| Steuer‐Vogt 2001 |
Balanced randomisation lists; block randomisation within both strata |
Central allocation |
No significant differences among groups regarding important prognostic factors |
In‐/exclusion criteria reported |
Patient: no
Care provider: no
Outcome assessor: unclear |
45 dropouts/withdrawal, balanced between the groups; reasons stated in CONSORT figure |
Delphi List:
1‐1‐1‐1‐0‐0‐0‐1‐1
Jadad List:
2‐0‐1 |
Performance bias possible: Intervention not blinded,
Contamination possible: No measurement of ML‐I antibodies in the control group, therefore provision of unintended treatment with mistletoe extracts not controllable.
Participant/observer bias possible: unblinded investigation of quality of life |
