Dunn 1993.
Methods | Double‐blind RCT of cross‐over design, carried out in 2 centres in the UK | |
Participants | 28 participants (aged 51 to 82 years) selected from 2 general practices on the basis that they received regular repeat prescriptions for quinine | |
Interventions | Quinine sulphate 300 mg daily or placebo for a 30‐day treatment period, followed by a 3‐day washout period before cross‐over to a second 30‐day treatment period | |
Outcomes | Number of cramp nights, adverse events | |
Notes | Results were invalidated by a significant carry‐over effect due to a short washout period | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...a randomised double blind cross‐over trial..." Comment: details of randomisation not provided |
Allocation concealment (selection bias) | Unclear risk | No details regarding allocation concealment are provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details regarding methods of blinding are provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Of the 28 recruited, 25 completed the two parts of the trial and filled in diary cards successfully. Two of the three drop‐outs did so because of severe cramps during placebo period" Comment: 1 drop‐out not accounted for |
Selective reporting (reporting bias) | Low risk | Both the intended outcome measures were addressed in the results and analysis |
Other bias | High risk | Cross‐over trial with only 3 days allocated to washout period rendered a significant carry‐over effect of treatment |