Warburton 1987.
Methods | Double‐blind RCT of cross‐over design | |
Participants | 22 elderly outpatients (mean age 74 years), seeking treatment for leg cramps | |
Interventions | Quinine bisulphate 300 mg or placebo daily for a 3‐week treatment period, followed by immediate cross‐over onto another 3‐week treatment period (i.e. no washout period inbetween). A 2‐week run‐in period before the trial involved quinine abstention | |
Outcomes | Cramp number, "cramp index" (the product of intensity score 1 = mild to 3 = severe and duration < 1 min = 1, 1 to 10 min = 2, 11 to 20 min = 3, 21 to 60 min = 4, or > 60 min = 5), adverse events | |
Notes | Cramp duration and intensity could not be separated from the "cramp index". Individual patient data were available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the remainder were allocated, using a table of random numbers..." Comment: probably adequate |
Allocation concealment (selection bias) | Unclear risk | No details given regarding allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Treatments were quinine, 300 mg, at night, or an identical, sugar coated placebo tablet..." Comment: satisfactory blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 1 participant dropped out during the placebo stage for an unspecified reason and was not included in the final analysis |
Selective reporting (reporting bias) | Low risk | All outcome measures mentioned in the protocol were addressed in the analysis |
Other bias | High risk | Quote: "followed by two, sequential, 3‐week treatment periods." Comment: no washout period between each treatment phase raises the possibility of significant carry‐over effect |