Nygaard 2008.
Methods | Double‐blind, parallel group RCT | |
Participants | 45 pregnant women with rest cramps and no previous cramp treatment. Recruitment by pamphlets provided to pregnant Norwegian women undergoing 18 week ultrasound | |
Interventions | Either a chewable tablet containing 122 mg elemental magnesium ("primarily as Mg lactate and Mg citrate"), or a matched placebo tablet, taken once each morning and twice each evening for 2 weeks | |
Outcomes | Number of days or nights in which cramps occurred over 2 weeks. Degree of cramp pain on a 5‐point ordinal scale. Side effects. Serum magnesium and calcium and 24‐h urinary magnesium on days 1 and 15 | |
Notes | Published. Source of funding not provided. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The randomization program was provided by Medstat Research AS.” Comment: Probably adequate |
Allocation concealment (selection bias) | Unclear risk | No description of allocation method given |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: “Both groups received a plastic container with the trial medication, 42 chewable tablets...”, containing either magnesium or placebo, both provided by the manufacturer Comment: Probably adequate |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 7/45 women (15.6%) dropped out (2 from the treatment arm and 5 from control). Reasons were given and most were unrelated to potential drug effects. None of the 7 were included in the analysis because of a lack of data. |
Selective reporting (reporting bias) | Low risk | Primary outcome assumed to be the number of days and nights with cramping but not explicitly stated. All outcomes reported. |
Cramp diary (recall bias) | Low risk | Diary used |
Other bias | Unclear risk | Frequency of cramping at baseline was not assessed, making it impossible to tell if the group was imbalanced in this important baseline characteristic |