Fung 1989.
Methods | Double‐blind RCT of cross‐over design, set in Utah, USA | |
Participants | 9 elderly outpatients with a history of night cramps of at least 1 year, with at least 2 cramps per week | |
Interventions | Quinine sulphate 200 mg or placebo at bedtime for a 4‐week treatment period, followed by a 1‐week washout period before cross‐over to a second 4‐week treatment period | |
Outcomes | Cramp number, cumulative duration of attacks (in minutes), cumulative score of cramp severity (graded 1 = mild to 3 = severe), adverse events | |
Notes | The cumulative duration of cramps was calculated as was the score for intensity. Duration or intensity per cramp was not calculated. However, these were calculated from individual patient data. Recruitment in June to December 1987 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...and patients were randomly assigned.." Comment: no details of the randomisation process are provided |
Allocation concealment (selection bias) | Unclear risk | No details provided on how allocation was concealed |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "in a double‐blind manner to begin receiving either quinine or a placebo." Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Explanation given for the one drop‐out, but was not included in analysis on an intention‐to‐treat basis |
Selective reporting (reporting bias) | Low risk | All intended outcome measures are addressed in the results |
Other bias | Unclear risk | 7 of the 8 volunteers who completed the trial were women |