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. 2016 Jun 3;2016(6):CD009873. doi: 10.1002/14651858.CD009873.pub3

Wilkinson 2007.

Methods Study design: RCT
Country: UK
Total: 288 randomised (aromatherapy with massage group n = 144, no‐massage group n = 144)
Participants Population: people with cancer, referred to complementary therapy services with clinical anxiety or depression, or both
Setting: recruited from 4 cancer centres and 1 hospice in England between September 1998 and May 2002
Mean age: 52.1 years
Interventions Intervention: 4‐week course of weekly, 1‐hour sessions of aromatherapy massage
Comparison: psychological support services as part of cancer care (usual supportive care)
Country of training: not reported
Years in practice: not reported
Outcomes Outcome measures at randomisation, 6 weeks, and 10 weeks post‐randomisation
Primary outcome
  • Clinical anxiety or depression, or both (%)


Secondary outcomes
  • State Anxiety Inventory (SAI)

  • Center for Epidemiological Studies Depression (CES‐D)

  • European Organization of Research and Treatment of Cancer QoL questionnaire (EORTC QLQ‐C30)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned using random number sequence, and balanced in randomly sized blocks"
Allocation concealment (selection bias) Low risk Used numbered sealed opaque envelopes
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessed 6 same outcomes (SAI, CES‐D, EORTC‐pain, fatigue, nausea/vomiting, global QoL) at 6 weeks and 10 weeks post‐randomisation in both groups
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 67/288 lost to follow‐up
Quote: "the data available at 6 and 10 weeks post randomisation were not representative of the complete sample of randomly assigned patients"
Selective reporting (reporting bias) Unclear risk Quote: "along with missing questionnaires, the continuous secondary outcome measures were considered missing if fewer than half of the items of a factor were completed"
Size Low risk n = 288
Other bias Low risk No other significant bias found

BMT: bone marrow transplantation; DBP: diastolic blood pressure; ms: millisecond; n: number of participants; QoL: quality of life;

RCT: randomised controlled trial; SBP: systolic blood pressure.