Lindelof 1990.
Methods | Within‐patient, randomised trial One centre in Stockholm Period of inclusion not stated |
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Participants |
Inclusion criteria Not stated Exclusion criteria
Baseline data: active treatment of lesions on 1 side of the body vs control on the other side (17 participants)
Withdrawal: 2 dropouts (1 because of flare‐up at other parts of the body, and 1 elderly participant because of illness) |
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Interventions |
Intervention 1 A: Grenz ray therapy (4 Gy) once per week Intervention 2 B: placebo Co‐interventions: none Duration of treatment: 6 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The nurse treating the patient gave the active radiation or placebo treatment according to a randomised predetermined code" Comment: no precision on how the code was generated |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind placebo‐controlled. Neither the patient nor the evaluating doctor knew which side had received active Grenz ray therapy" Comment: probably done, but nurse treating the patient was not blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind placebo‐controlled. Neither the patient nor the evaluating doctor knew which side had received active Grenz ray therapy" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Of the 17 patients who started the trial, 2 patients failed to participate throughout the study" Comment: no clear mention of how study authors deals with dropouts |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |