Maule 1990.
Methods | RCT of cross‐over design | |
Participants | 16 participants from general practice (mean age 76 years) who experienced at least 2 leg cramps per week | |
Interventions | 2‐week washout then 4 blocks of 3‐week treatment periods consisting of quinine bisulphate (300 mg) or placebo or cork or wood in woollen bags | |
Outcomes | Cramp number, adverse events | |
Notes | Quinine compared against placebo and folklore. Only data provided is that for adverse events, but how many participants suffered these is not clear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "were allocated to receive the three treatments and placebo in random order." Comment: details of randomisation not provided |
Allocation concealment (selection bias) | Unclear risk | No mention of how allocation was concealed |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "the two tablets (quinine & placebo) should have been physically identical, but owing to lack of funds this criterion was not met." Comment: treatments were clearly distinguishable |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were 6 withdrawals from the trial; it is not clear from which treatment group they withdrew from, and the precise causes of the withdrawals are not given |
Selective reporting (reporting bias) | Low risk | Quote: "During analysis of the data only average cramp number was considered because the duration section of the form was inadequately filled in by the majority of patients." Commment: suggests authors would have, as planned, analysed such data if they were available |
Other bias | High risk | Treatments were sequential with no dedicated washout period between each phase, raising the possibility of significant carry‐over/withdrawal effects |