Jansen 1997.
Methods | Double‐blind, parallel group RCT, set in the Netherlands | |
Participants | 106 adult participants from general population who suffered at least 3 muscle cramps per week | |
Interventions | Hydroquinine hydrobromide dihydrate 300 mg daily (200 mg at supper, 100 mg at bedtime) or placebo for 2 weeks | |
Outcomes | Cramp number, cramp days, cramp intensity (graded 1 = mild to 10 = severe), cramp duration, cramp location, adverse events | |
Notes | Adult volunteers were recruited via a notice in a regional newspaper, and posters in pharmacies and libraries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent investigator used the random‐number generator of the SAS program to create the randomisation schedule." |
Allocation concealment (selection bias) | Low risk | Quote: "All investigators involved in the study and all participants were unaware of the treatment allocation." |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "The only side‐effect definitely related to hydroquinine was a bitter taste or dry mouth (ten participants)..." Comment: inadequate blinding with high risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants who failed to complete the trial were accounted for |
Selective reporting (reporting bias) | Unclear risk | Data were collected with respect to cramp duration, severity and location, in addition to the primary outcome of frequency. However little actual data are presented to justify the "insignificant differences between drug and placebo" reported, and no mention of results for cramp location is made |
Other bias | Unclear risk | Quote: "We recruited volunteers through notices in regional newspapers and posters in libraries and pharmacies." |