Lee 1991.
Methods | Single‐blind, parallel group RCT, set in Taiwan | |
Participants | 31 cirrhotic participants with an average of over 3 muscle cramps per week | |
Interventions | 4‐week run‐in period, followed by a 4‐week treatment period of either quinidine sulphate 200 mg twice‐daily or placebo twice‐daily | |
Outcomes | Cramp number, adverse events | |
Notes | Study conducted on an outpatient basis in Taiwan. 31 participants (mean age 62 years) completed the study. 84% participants were men | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...were allocated, using a table of random numbers." Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | No mention of how allocation was conveyed to the investigators, though as this was a single‐blinded study, concealment may not have been attempted at all |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Patients were not aware of which drug was being prescribed, but physicians were." Comment: single‐blinded study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 31 out of 43 participants completed the study and withdrawals are accounted for (excluded due to low cramp frequency or poor record keeping) and were excluded before randomisation |
Selective reporting (reporting bias) | Low risk | All intended outcome measures are addressed in the results |
Other bias | Low risk | Except for the lack of double‐blinding counted above, nil else significant |