Roca 1992.
Methods | Double‐blind, parallel group RCT, set in Ohio, USA | |
Participants | 30 participants on dialysis, with a history of leg cramps | |
Interventions | 2‐month placebo run‐in period, then active phase of either daily quinine 325 mg at bedtime with a vitamin E placebo, or vitamin E 400 IU at bedtime with a quinine placebo, for 2 months | |
Outcomes | Cramp number, cramp intensity (graded 1 = no pain to 6 = excruciating), adverse events | |
Notes | 29 participants (aged 21 to 73 years) from a community‐based academic hospital in Ohio, USA, completed the study. Study compares quinine to vitamin E as well as vitamin E and quinine to placebo. Although researchers state adverse effects of interventions will be investigated, no mention is made of these in the Results or Discussion | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were then randomized into two groups..." Comments: no description of randomisation protocol |
Allocation concealment (selection bias) | Unclear risk | No details regarding how allocation may have been concealed is given |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "quinine 325 mg at bedtime with a vitamin E placebo or 2) vitamin E 400 IU at bedtime with a quinine placebo." Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 11 of 40 participants did not complete the trial, all of whom were accounted for. However, 1 participant died after randomisation but no details were given about which treatment was received or whether the death was related to the medication given |
Selective reporting (reporting bias) | High risk | Adverse events were an outcome but no results given. Also results are given only for first month of treatment, despite treatment duration being 60 days |
Other bias | Low risk |