Abstract
BackgroundMagnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting.MethodsA randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018. Eligible subjects received a capsule with MOMH 226 mg or placebo, once daily, at bedtime, for a 60-day period. The assessed parameters included frequency and duration of NLC episodes, quality of sleep, NLC-induced pain and quality of life sub-scores. The Fisher’s Exact Test for comparison of groups by categorical variables was used. The Student’s test or Mann-Whitney test were used for between-group comparison at different timepoints. ANCOVA followed by contrast analysis was used for comparison of groups at the end of the study.Results175 (81%) out of 216 initially screened subjects completed the study. The number of NLC episodes has significantly decreased by the end of the study period as compared to baseline in both groups (p < 0.001 for both). There was a significant between-group difference in the magnitude of reduction in NLC episodes (p = 0.01), indicating a higher decrease in the MOMH group as compared to the placebo group (− 3.4 vs − 2.6, respectively). In addition, MOMH treatment resulted in a greater reduction in NLC duration (p < 0.007) and greater improvement in sleep quality (p < 0.001) as compared to placebo.ConclusionsMOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated.Trial registrationNCT03807219, retrospectively registered on January 16, 2019.
Highlights
Nocturnal leg cramps (NLC) are a common lowerextremity condition reported by about 50% of adults and ~ 7% of children [1, 2]
We report the results of a randomized controlled trial testing the hypothesis that magnesium oxide monohydrate (MOMH) may be effectively and safely used in treating nocturnal leg cramps (NLC), following 60-day administration
216 subjects who have been diagnosed with NLC, were recruited from hospital wards and outpatient clinics and entered the screening period of the trial. 28 subjects were subsequently excluded due to having less than 4 NLC episodes during the 2-week screening period. 2 additional subjects were excluded due to meeting other exclusion criteria and 2 subjects withdrew their consent. 184 were randomized into the placebo (N = 89) and MOMH (N = 95) groups
Summary
Nocturnal leg cramps (NLC) are a common lowerextremity condition reported by about 50% of adults and ~ 7% of children [1, 2]. Magnesium supplements are commonly used in the treatment of NLC, despite the lack of conclusive evidence for their efficacy [10]. Their effectiveness was demonstrated in a double-blind, randomized, placebocontrolled study of pregnant women [11]. Other trials [12,13,14] did not show significant benefits This could stem from treatment-unrelated effects, such as period-bias, or from a failure to obtain adequate cellular accumulation [15,16,17]. Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). We tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting
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