一项评估一水合氧化镁治疗夜间腿部痉挛的疗效的随机、双盲、安慰剂对照、多中心研究。
A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps.
机构信息
Department of General Practice (Family Medicine), Bogomolets National Medical University, Kyiv, Ukraine.
Day Hospital Department, "Artem" Clinic, Kiev, Ukraine.
出版信息
Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.
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.
背景
镁补充剂被广泛用于预防和治疗夜间腿部痉挛（NLC）。然而，支持其有效性的证据很少。主要障碍源于缺乏细胞吸收的评估。在目前的研究中，我们测试了镁补充剂 - 氧化镁一水合物（MOMH）的功效和安全性，在体外环境中证明了其细胞吸收率的提高。
方法
2018 年 2 月至 8 月，在乌克兰的医院和门诊诊所进行了一项随机、双盲、安慰剂对照的多中心研究。合格的受试者每天睡前服用 MOMH 226mg 胶囊或安慰剂，持续 60 天。评估的参数包括 NLC 发作的频率和持续时间、睡眠质量、NLC 引起的疼痛和生活质量子评分。使用 Fisher 确切检验比较组间分类变量。使用学生检验或曼-惠特尼检验比较不同时间点组间的差异。在研究结束时使用协方差分析（ANCOVA）进行组间比较。
结果
最初筛选的 216 名受试者中有 175 名（81%）完成了研究。与基线相比，两组在研究结束时 NLC 发作次数均显著减少（p < 0.001）。两组之间 NLC 发作次数减少的幅度存在显著差异（p = 0.01），表明 MOMH 组的减少幅度明显高于安慰剂组（分别为-3.4 和-2.6）。此外，与安慰剂相比，MOMH 治疗可显著减少 NLC 持续时间（p < 0.007）和改善睡眠质量（p < 0.001）。
结论
MOMH 被证明对 NLC 的治疗有效且安全耐受良好。
试验注册
NCT03807219，于 2019 年 1 月 16 日回顾性注册。
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