A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps

Olha Barna, Pavlo Lohoida, Yurii Holovchenko, Andrii Bazylevych, Valentyna Velychko, Iryna Hovbakh, Larysa Bula, Michael Shechter, Olha Barna, Pavlo Lohoida, Yurii Holovchenko, Andrii Bazylevych, Valentyna Velychko, Iryna Hovbakh, Larysa Bula, Michael Shechter

Abstract

Background: 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.

Trial registration: NCT03807219 , retrospectively registered on January 16, 2019.

Keywords: Food supplement; Magnesium; NLC; Nocturnal leg cramps.

Conflict of interest statement

Authors declare of having no conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study Flow Diagram
Fig. 2
Fig. 2
The Change in the Number of NLC Episodes During the Study. Mean number of NLC episodes per week as calculated at each study visit is presented for each group (placebo (n = 87) – blue; MOMH (n = 86) – red)
Fig. 3
Fig. 3
Analysis of the Secondary Efficacy Parameters. Secondary efficacy parameters are presented as calculated at each study visit for each study group (Placebo (N = 87) – blue, MOMH (N = 86) – red). A. Mean NLC episode duration (left, MOMH N = 86), NLC-related pain (middle), Sleep quality (right). Reduction in these parameters indicates improvement. B. Quality of life parameters – Physical functioning (top left), Role limitation due to physical health (top middle), Role limitation due to emotional problems (top right), Vitality (middle left), Mental health (middle), Social functioning (middle right), Body pain (bottom left), General health (bottom right). Increased values indicate improvement

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