Abstract:
Magnesium 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.
Methods: A 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.
Results: 175 (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.
Conclusions: MOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated.
