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. 2011 Sep 7;2011(9):CD002008. doi: 10.1002/14651858.CD002008.pub4

Arnold 1989.

Methods Randomised controlled trial. 
 Duration 6 months. Intervention to 10 weeks and follow‐up to 6 months for some outcomes.
Participants Adults (n = 50: 29 men and 21 women aged 34 ‐ 88 years) living at home, planned to receive radiotherapy for cancers of head and neck.
Mean weight in treatment and comparison groups was 1 ‐ 2 kg below usual weight at study entry.
3 deaths in the dietary counselling and supplement group.
Interventions Intensive dietary counselling (n = 27) versus intensive dietary counselling and the prescription of nutritional supplements to provide an additional 960 ‐ 1080 kcal/day (n = 23).
Outcomes Survival*, number having a complete response to therapy, radiation side‐effects, tumour status, body weight*, serum albumin, transferrin and change in dietary energy*, protein intake.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but no details of method.
Allocation concealment (selection bias) Unclear risk No details of method of allocation concealment.
Blinding (performance bias and detection bias) 
 Clinical outcomes Unclear risk Not discussed.
Blinding (performance bias and detection bias) 
 Functional outcomes Unclear risk Not discussed.
Blinding (performance bias and detection bias) 
 Nutritional outcomes Unclear risk Not discussed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals. 3 deaths in the dietary counselling and supplement group.
Selective reporting (reporting bias) Unclear risk All outcomes reported. Data on mortality obtained from the paper. Data on weight change obtained by extrapolation from Figure 3. Energy intake data presented in a figure with no standard deviations or standard error, therefore risk of bias. No response received from author to request for data.
Other bias Low risk Baseline variables stated, groups similar at baseline.