Leo Winter 1986.
Methods | Double‐blind RCT of cross‐over design, set in New York and California, USA | |
Participants | 205 participants (mean age 44 years) who experienced at least 2 leg cramps per week | |
Interventions | 1‐week washout then 4 blocks of 5‐day treatment periods separated by 2‐day washouts. Treatments consisted of 129.6 mg quinine sulphate twice daily, or a quinine‐vitamin E combination (129.6 mg quinine sulphate plus 800 Units vitamin E) twice daily, or 800 units vitamin E twice daily | |
Outcomes | Cramp number, cramp intensity, cramp days, sleep disturbance, adverse events. | |
Notes | The second largest trial. 2‐centre trial (New York & California). NB short treatment periods. Unpublished | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...patients were assigned at random to 24 treatment sequences according to a randomisation schedule" Comment: no details of how the "randomisation schedule" was generated |
Allocation concealment (selection bias) | Low risk | Quote: "...according to a randomisation schedule prepared by an independent person who did not participate in the study" Comment: appears adequate |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "...under the double‐blind condition for identically appearing study medications" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All withdrawals and those lost to follow‐up were fully accounted for |
Selective reporting (reporting bias) | Low risk | All outcomes are reported in the results |
Other bias | High risk | High risk of bias caused by very short washout periods between treatments. Also, trial conducted by manufacturer of quinine tablets |