Nygaard 2008.
Study characteristics | ||
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") (n = 23), or a matched placebo tablet (n = 22), 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‐hour urinary magnesium on days 1 and 15 |
|
Conflicts of interest | 1 author contributed in developing the magnesium tablet in 1985, and he received a compensation from Nycomed for this effort. The rest of the authors have no conflict of interest. | |
Funding | Source of funding not provided | |
Notes | Published. Conducted from August 2000 to January 2003 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “The randomization program was provided by Medstat Research AS.” Comment: probably adequate; however, the frequency of cramping at baseline was not assessed, making it impossible to tell if the group was imbalanced in this important baseline characteristic |
Allocation concealment (selection bias) | Unclear risk | No description of any method of allocation concealment |
Blinding of participants and personnel (performance 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 |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes measured from forms completed by blinded participants |
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 dropouts 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 | Low risk | No other obvious bias |