Garrison 2011a.
Study characteristics | ||
Methods | Double‐blind, parallel‐group RCT | |
Participants | 46 non‐pregnant rest cramp sufferers (mean age 69.3 yrs) with at least 8 cramps in a 30 day baseline diary. Recruitment from posters and pamphlets in 21 Canadian (Richmond, British Columbia) family practitioner offices and also by newspaper advertisement | |
Interventions | 5 days consecutive 4‐hour IV infusions of 250 ml 5% dextrose in water either with 20 mmol of magnesium sulphate (treatment group) (n = 24) or without magnesium sulphate (control group) (n = 22) (20 mmol magnesium sulphate = 486 mg elemental magnesium) |
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Outcomes | Primary: Change in the number of cramps per week from baseline at 30 days Secondary:
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Conflicts of interest | No mention of conflict of interest | |
Funding | Independent funding | |
Notes | Published. Conducted from January 2007 to October 2008 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization, using a computer generated random allocation sequence without any blocking or stratification was carried out by the hospital pharmacist dispensing the study drugs according to a series of opaque allocation envelopes kept in the pharmacy." Comment: satisfactory randomization |
Allocation concealment (selection bias) | Low risk | Quote: "All investigators, study nurses and subjects were blinded as to treatment allocation." Comment: satisfactory allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: 1) "Active and Placebo solutions were indistinguishably clear and colorless." 2) "Subjects had been told that IV site discomfort was possible with both placebo and Mg infusions. While generally it was considered that blinding was reasonable, the sensation of burning at the IV site, coupled with the additional saline dilution in some Mg participants, could have compromised the blind to some extent (presumably favouring the intervention)." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Diary completed by participants blinded to the intervention but blinding to the intervention was at an unclear risk of bias. To avoid compromising the blind, all participants underwent urine collection identically, and results of urine testing (along with baseline serum Mg) were sequestered from investigators until trial completion. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts or losses to follow‐up. ITT analysis |
Selective reporting (reporting bias) | Low risk | Did not process urine samples for magnesium of those getting placebo (although did a reasonable job collecting urine samples from all participants to make sure the blinding was not broken). Report described severity and duration of cramps only as not being different (i.e. no numbers given); however, trial authors made these data available. |
Cramp diary (recall bias) | Low risk | Diary used |
Other bias | Low risk | No obvious other bias |