Evidence map›Paper›PMID 34719399›Full record

Trial reportNutrition journal2021

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

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03807219 (A Randomized, Multicenter, Prospective, Double-blind, Placebo-controlled, Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03807219 nacompletednot on this map

A Randomized, Multicenter, Prospective, Double-blind, Placebo-controlled, Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC

TypeinterventionalSponsorNaveh Pharma LTDRan2018 to 2018Enrolled216ConditionsNocturnal Leg CrampsArmsMagnox Comfort, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Olha BarnaDepartment of General Practice (Family Medicine), Bogomolets National Medical University, Kyiv, Ukraine.
Pavlo LohoidaDay Hospital Department, "Artem" Clinic, Kiev, Ukraine.
Yurii HolovchenkoNeurology Department, Clinical Hospital No.3, Kyiv, Ukraine.
Andrii BazylevychNeurology Department, Clinical Hospital No.3, Kyiv, Ukraine.
Valentyna VelychkoFamily Medicine Department, Railway Clinical Hospital, Odessa, Ukraine.
Iryna HovbakhNeurology Department, Clinical Hospital No.9, Kharkiv, Ukraine.
Larysa Bula"Desna" Clinic, Ternopil, Ukraine.
Michael ShechterLeviev Heart Center, Chaim Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel. shechtes@netvision.net.il.ORCID 0000-0002-4193-9917
Kyiv City Clinical Oncology Center · UABogomolets National Medical University · UAKharkiv Regional Clinical Psychiatric Hospital No 3 · UATel Aviv University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Magnesium OxideSleep-Wake Transition DisordersDouble-Blind MethodHumansMuscle CrampQuality of LifeTreatment OutcomeMagnesium OxideFood supplementMagnesiumNLCNocturnal leg cramps

Identifiers

PMID34719399
PMCPMC8559389
OpenAlexW3154052593

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.