Effect of Magnesium Oxide Supplementation on Nocturnal Leg Cramps: A Randomized Clinical Trial
Roguin Maor N, Alperin M, Shturman E, Khairaldeen H, Friedman M, Karkabi K, Milman U
JAMA internal medicine · 22 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2017-02-27 · JAMA Intern Med · vol. 177 · issue 5 · p. 617
- Publisher
- American Medical Association
- Cited
- 38 citations · more than 90% of similar papers · 2.9× the field average
- Impact
- Top 10% most cited in its field
- References
- 26 works
- Access
- Open access (repository copy)
- Research areas
- Diagnosis and Treatment of Venous Diseases · Dietary Effects on Health · Wound Healing and Treatments
- Keywords
- Medicine, Bedtime, Placebo, Volunteer, Randomized controlled trial, Magnesium, Regimen, Clinical trial, Internal medicine, Physical therapy, Anesthesia
- MeSH
- humans, sleep-wake transition disorders, magnesium oxide, treatment outcome, double-blind method, sleep, quality of life, dietary supplements, aged, middle aged, israel, female, male, early termination of clinical trials, surveys and questionnaires
7 authors
From IL
- Noga Roguin MaorTechnion – Israel Institute of Technology; Clalit Health Services
- Mordechai AlperinTechnion – Israel Institute of Technology; Clalit Health Services
- Elena ShturmanTechnion – Israel Institute of Technology; Clalit Health Services
- Hassan KhairaldeenTechnion – Israel Institute of Technology; Clalit Health Services
- Moran FriedmanTechnion – Israel Institute of Technology; Clalit Health Services
- Khaled KarkabiTechnion – Israel Institute of Technology; Clalit Health Services
Abstract
Importance
Magnesium supplements are widely marketed for prophylaxis of nocturnal leg cramps (NLC) despite no evidence of significant benefit.
Objective
To determine whether magnesium oxide is better than placebo for NLC prophylaxis.
Design, setting, and participants
A randomized, double-blind, placebo-controlled clinical trial of 2 weeks eligibility screening followed by 4 weeks of treatment was conducted in northern Israel, from February to October 2013. An intention-to-treat data analysis was performed from March 22, 2014, to April 17, 2016. We used a volunteer sample of community-dwelling individuals experiencing NLC, 21 years or older, with 4 or more documented episodes of NLC during 2 weeks of screening.
Interventions
Capsules containing either magnesium oxide or a similar-looking placebo to be taken orally, once daily at bedtime for a period of 4 weeks.
Main outcomes and measures
The primary outcome was the difference in the mean number of NLC per week between the screening and treatment phases. Secondary outcomes included severity and duration of NLC, quality of life, and quality of sleep.
Results
Of the 166 volunteers, 72 (43%) were excluded, of whom 15 declined to participate and 57 did not meet the inclusion criteria. Of the 94 individuals (39% male; mean [SD] age, 64.9 [11.1] years) randomly assigned to magnesium oxide (48) or placebo (46), 6 did not complete the study protocol (3 in each group). Mean (SD) change of NLC was -3.41 (4.05) (from 7.84 [5.68] to 4.44 [5.66]) and -3.03 (4.53) (from 8.51 [5.20] to 5.48 [4.93]) per week in the magnesium oxide and placebo groups, respectively, a difference between groups of 0.38 (0.48) NLC per week (P = .67 in an intention-to-treat analysis). There were no between-group differences in the severity and duration of NLC, quality of life, or quality of sleep.
Conclusions and relevance
Oral magnesium oxide was not superior to placebo for older adults experiencing NLC. The decrease in the mean number of NLC per week, from the screening to the treatment phase in both groups, is probably a placebo effect that may explain the wide use of magnesium for NLC.
Trial registration
clinicaltrials.gov Identifier: NCT01709968.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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