Sidorov 1993.
Methods | Double‐blind RCT of cross‐over design, set in USA | |
Participants | 19 adult participants from general medicine clinic who experienced at least 2 leg cramps per week | |
Interventions | 2‐week run‐in period, followed by either quinine bisulphate 200 mg at night or placebo daily for 3 weeks before cross‐over to a second 3‐week treatment period | |
Outcomes | Cramp number, cramp intensity (graded 1 = mild to 10 = severe), cramp duration (seconds), adverse events | |
Notes | Single centre. Conducted in USA | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was accomplished using a simple random numbers table..." Comment: probably adequate |
Allocation concealment (selection bias) | High risk | No evidence that allocations were concealed |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "Patients were blinded to all study periods. However, study personnel were aware that periods one and three used placebo." Comment: details of how investigators and participants were blinded not provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 6 participants who left the study were accounted for |
Selective reporting (reporting bias) | Low risk | All outcome measures mentioned in the methods were addressed in the analysis |
Other bias | Unclear risk | The study group who successfully completed the study consisted of 14 women and only 2 men |