Jones 1983.
Methods | Double‐blind RCT of cross‐over design, UK | |
Participants | 9 elderly participants seeking treatment from GP for at least 2 cramp nights per week | |
Interventions | Quinine sulphate 300 mg or placebo daily for a 2‐week treatment period, followed by a 2‐week washout period before cross‐over to a second 2‐week treatment period. A 2‐week run‐in period (of placebo) preceded the first phase of treatment | |
Outcomes | Improvement in sleep induction (graded 1 = difficult to 10 = easy), sleep quality (graded 1 = poor to 10 = good), cramp severity (graded 1 = mild to 10 =severe), cramp timing (before or after 2 am), cramp duration and adverse events | |
Notes | Table of results for cramp duration contradicts commentary in Results section | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The study was double‐blind and crossed over within patients, and randomised..." Comment: details of randomisation not provided |
Allocation concealment (selection bias) | Low risk | Quote: "...the study was... randomised and balanced by an independent observer." Comment: probably adequate concealment |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "The study was double‐blind.... the two weeks between treatments were single‐blind with patients taking placebo." Comment: no explicit mention of how blinding was achieved |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 9 participants completed the trial |
Selective reporting (reporting bias) | Low risk | All outcome measures commented upon in analysis, including adverse events |
Other bias | Low risk | Adequate washout periods. Trial ended at designated time period |