Hays 1986.
Methods | Double‐blind RCT of cross‐over design, set in Florida USA | |
Participants | 62 participants (mean age 47 years) who experienced at least 2 leg cramps per week | |
Interventions | 2‐week baseline then 2 weeks of quinine sulphate (325 mg) or placebo, then 2‐week washout, then 2 weeks of cross‐over treatment, then 2‐week washout | |
Outcomes | Cramp number, cramp intensity, cramp days, adverse events | |
Notes | Second trial by Scholl pharmaceuticals submitted to FDA, but with higher quinine dose of 325 mg. Unpublished. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...medications will be assigned according to a predetermined randomization schedule" Comment: no details of the "randomization schedule" are provided |
Allocation concealment (selection bias) | Low risk | Quote: "Each subject's medications will be provided by the Sponsor and distributed by the Invesitgator" Comment: appears that allocation was concealed |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Placebo capsules...will be identical in appearance" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All withdrawals were accounted for |
Selective reporting (reporting bias) | Low risk | All outcomes reported on |
Other bias | Unclear risk | Conducted by manufacturer of quinine tablets |