The Effect of Magnesium Therapy on Nocturnal Leg Cramps: A Systematic Review and Meta-Analysis

Nocturnal Leg Cramps (NLC) are sudden, painful, involuntary contractions of the lower limb muscles, predominantly affecting the calves, that occur during periods of rest or sleep. This condition is particularly prevalent in older adults and pregnant women, with studies estimating that up to 54% of individuals over 80 years and 33% over 50 years’ experience NLC, with 6% reporting nightly episodes [1,2]. Clinically, NLC is diagnosed based on characteristic features including abrupt onset, localized pain in the calf or foot, occurrence during nocturnal rest and relief with muscle stretching by International Classification of Sleep Disorders (ICSD-3) [2,3]. Differential diagnosis includes restless legs syndrome, periodic limb movement disorder, peripheral neuropathy, and vascular claudication, all of which require careful history and neurologic assessment to distinguish [4,5]. The pathophysiology remains multifactorial, involving neuromuscular hyperexcitability, electrolyte imbalances, vascular insufficiency and pharmacologic side effects. While quinine was historically used for treatment, it is no longer recommended due to significant adverse effects including thrombocytopenia, QT prolongation, and hypersensitivity reactions [6,7]. Current non-pharmacologic interventions such as passive stretching, hydration optimization, and sleep hygiene are considered first-line approaches, but evidence for their efficacy is mixed [8,9]. Magnesium is an essential intracellular cation that serves as a cofactor in over 300 enzymatic reactions, particularly in neuromuscular transmission and muscle physiology [10]. It functions as a physiological calcium antagonist, regulating voltagegated calcium channels and modulating the excitability of neuronal membranes [11]. In skeletal muscle, magnesium inhibits excessive acetylcholine release at neuromuscular junctions and enhances calcium reuptake into the sarcoplasmic reticulum, thereby promoting relaxation [12,13].

Deficiency in magnesium has been associated with increased nerve conduction, hyperexcitability, and spontaneous muscle activity-conditions conducive to cramp development. Hypomagnesemia is frequently observed in the elderly, individuals with malnutrition, renal loss, gastrointestinal disorders and those on chronic diuretics [14,15]. Evidence regarding magnesium’s therapeutic role in NLC has been inconsistent. Earlier systematic reviews and RCTs yielded mixed results, with some reporting reduced cramp frequency, particularly in pregnancy-associated cases, while others found no significant difference compared to placebo [16-18]. For instance, a meta-analysis by Sebo et al. [16] concluded that oral magnesium did not significantly reduce NLC frequency in the general population, though benefit was suggested in subgroups such as pregnant women [16]. Since then, several RCTs with improved methodology and diverse magnesium formulations have been published, warranting an updated synthesis of the available evidence. This study aims to conduct a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy of magnesium supplementation in reducing the frequency of nocturnal leg cramps in adults, addressing methodological limitations of previous reviews and incorporating the most recent clinical data.

Protocol and registration

This systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [19]. The study protocol was prospectively registered in PROSPERO (International Prospective Register of Systematic Reviews) under the registration number CRD420251020341.

Search strategy

A comprehensive literature search was performed across five electronic databases: PubMed, Scopus, Ovid, the Cochrane Library and Google Scholar. The search covered studies published from database inception through March 2025. The strategy employed both Medical Subject Headings (MeSH) and relevant free-text terms, including: “magnesium,” “leg cramps,” “night leg cramps” and “nocturnal leg cramps.” Boolean operators (AND, OR) were used to optimize sensitivity and specificity. Search queries were tailored to the indexing system of each database. In addition, the reference lists of all included studies and relevant systematic reviews were manually screened to identify any eligible trials not captured in the initial search. No language restrictions were applied during the search process. All records were independently screened by two reviewers (S.W. and C.S.), and discrepancies were resolved through discussion or adjudication by a third reviewer.

Eligibility criteria and study selection

The study included only Randomized Controlled Trials (RCTs) published in English that met the following eligibility criteria:
A. Population/participants: adults aged 20 years or older.
B. Intervention: Magnesium with no restrictions on type, formulation, dose, frequency, or duration of therapy.
C. Comparison/control group: Participants who did not engage in Magnesium therapy. They may have performed usual care.
D. Outcomes: all nocturnal leg cramp symptoms assessment: frequency, intense pain, duration, sleep disruption, distress.

Data extraction

Data were independently extracted by two reviewers (S.W. and C.S.) using a predesigned standardized data extraction form. Extracted data included: study characteristics (author, year and country), participant demographics (age, sex and sample size), intervention details (form, dose, route and duration of magnesium administration), comparator characteristics and outcome measures (frequency of nocturnal leg cramps).

Discrepancies between reviewers were resolved through discussion and a third reviewer was consulted if consensus could not be reached. When data were missing or unclear, corresponding authors were contacted for clarification. If no response was received, only available data from the publication were used in the analysis.

Quality assessment

The risk of bias for each included randomized controlled trial was independently assessed by two reviewers (S.W. and C.S.) using the Cochrane Risk of Bias 2.0 tool [20]. This tool evaluates five domains:
A. Bias arising from the randomization process.
B. Bias due to deviations from intended interventions.
C. Bias due to missing outcome data.
D. Bias in measurement of the outcome.
E. Bias in selection of the reported result. Each domain was judged as “low risk,” “some concerns,” or “high risk” based on the signaling questions and algorithm provided in the RoB 2.0 guidelines.

Data analysis

All statistical analyses were performed using Review Manager (RevMan) version 5.4.1. For continuous outcomes, pooled Mean Differences (MDs) and 95% Confidence Intervals (CIs) were calculated. A random-effects model was applied to account for potential heterogeneity among studies. Statistical heterogeneity was assessed using the I² statistic. The degree of heterogeneity was categorized into three levels: low (I²< 25%), moderate (I²=25%- 75%), and high (I²>75%). Subgroup analyses were conducted according to duration of intervention (< 4 weeks vs. ≥ 4 weeks) and daily magnesium dosage (<1,000mg/day vs. ≥1,000mg/day). Funnel plots were planned to assess potential publication bias.

All statistical tests were two-tailed, and a p-value < 0.05 was considered statistically significant.

Search results

A total of 810 records were identified from five databases, namely PubMed (n=55), Scopus (n=468), Ovid (n=6), the Cochrane Library (n=34), and Google Scholar (n=247). After removing 124 duplicate records, 686 titles and abstracts were screened. Of these, 629 were excluded due to non-English language (n=12), irrelevance to nocturnal leg cramps (n=395), or lack of magnesium-related interventions (n=222). Fifty-seven full-text reports were retrieved and assessed for eligibility. Of these, 48 were excluded for the following reasons: non-randomized study design (n=36) and lack of NLC-related outcomes (n=12). Ultimately, nine randomized controlled trials [17,18,21-27] met the inclusion criteria and were included in the qualitative synthesis. Of these, five studies [17,22- 25] provided sufficient data for quantitative meta-analysis. The study selection process is summarized in the PRISMA 2020 flow diagram (Figure 1).

Figure 1:PRISMA flow diagram of literature search and study selection.

Study characteristics

A total of nine Randomized Controlled Trials (RCTs), published between 1995 and 2024, were included in this systematic review. The studies were conducted in diverse settings including Sweden, Argentina, the United Kingdom, Norway, Canada, Thailand, Israel, Ukraine and Indonesia. Sample sizes ranged from 30 to 184 participants, with a combined total of 626 individuals enrolled across all nine trials. The studied populations included both healthy pregnant women and older adults (age range 20–77 years), with varying eligibility criteria such as experiencing ≥ 2 to ≥ 8 Nocturnal Leg Cramps (NLCs) over defined periods. All studies compared magnesium to placebo and the primary outcomes included frequency, severity and duration of nocturnal leg cramps. Most studies used daily diary records to document NLC events, while four studies employed validated pain intensity scales such as the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS). Additionally, three studies assessed sleep-related outcomes using instruments such as the Pittsburgh Sleep Quality Index (PSQI), a 0-5 VAS sleep scale, or diary-based sleep disturbance logs. Two studies included quality-of-life assessments using the SF-36 Health (Table 1).

Table 1:Characteristics of included studies.

(NLC: Nocturnal Leg Cramps, VAS: Visual Analog Scale, NS: Not Significant, CRF: Case Record Form, NCSD: The Nocturnal Cramps Sleep Diary, NRS: Numeric Rating Scale)

Intervention protocols varied in terms of magnesium formulation, dosage, route of administration and treatment duration. Eight studies used oral administration, while one employed intravenous magnesium sulfate. Daily magnesium doses ranged from 100mg to 1,800mg and treatment duration varied between 5 and 60 days. Magnesium citrate was the most frequently used form, followed by magnesium oxide and magnesium lactate combinations (Table 2).

Table 2:Characteristics of Magnesium in included studies.

Quality assessment of included studies

The methodological quality of the nine included studies was assessed using the Cochrane Risk of Bias 2.0 tool across five domains: Randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome and selection of the reported result. The results are summarized in Figure 2. Overall, 33.3% of the studies were rated as having low risk of bias, 44.4% had some concerns, and 22.2% were judged to be at high risk. In the domain assessing the randomization process, 77.8% of the studies were considered to have low risk, reflecting adequate methods for sequence generation and baseline comparability. However, one study demonstrated high risk due to imbalances in age and sex at baseline without sufficient explanation. Low risk of bias was identified in 88.9% of studies for deviations from intended interventions, missing outcome data and measurement of the outcome. Most studies reported consistent adherence to intervention protocols and had minimal attrition. Furthermore, outcome measurement was generally robust, with most trials employing daily diary records or validated pain rating scales, which are widely accepted for self-reported symptomatology such as nocturnal leg cramps. The domain related to the selection of the reported result raised concerns in 66.7% of studies. This was largely attributed to the absence of pre-registered analysis plans or incomplete reporting across multiple outcome timepoints. While self-reported tools such as symptom diaries, VAS and sleep disturbance logs are appropriate for capturing patient-experienced symptoms, their reliance without protocol-specified statistical hierarchy may have contributed to selective reporting risk (Figures 2 & 3).

Figure 2:Quality assessment showing risk of bias in each included study.

Figure 3:Quality assessment summary showing risk of bias of all included studies.

Meta-analysis

A total of five randomized controlled trials [17,22-25] comprising 266 participants, were included in the meta-analysis. All studies employed patient-reported daily diaries as the primary tool for capturing the weekly frequency of NLC.

Pooled effect of magnesium on weekly frequency of nocturnal leg cramps: The meta-analysis of five randomized controlled trials [17,22-25] evaluating the weekly frequency of Nocturnal Leg Cramps (NLC) using total scores from daily record questionnaires demonstrated no statistically significant difference between the magnesium and control groups. The pooled mean difference was -0.94 (95% CI: -3.09 to 1.20; p=0.39), indicating that magnesium supplementation did not significantly reduce NLC episodes compared to placebo. However, the heterogeneity test was statistically significant (p=0.02), with moderate heterogeneity observed across studies (I²=65%), suggesting variability in study outcomes and populations (Figure 4).

Figure 4:Forest plot showing a meta-analysis of the mean difference in total weekly frequency NLC between the magnesium group and the control group. Green squares represent individual studies (size reflects weight); horizontal lines show 95% CI; black diamond indicates overall effect.

Subgroup analysis of weekly frequency of nocturnal leg cramps: Subgroup analysis by duration of magnesium administration throughout the intervention period (Figure 5).

Figure 5:Forest plot of the subgroup meta-analysis showing the mean difference in total weekly frequency NLC between the magnesium group and the control group, categorized by duration at least 4 weeks and less than 4 weeks. Green squares represent individual studies (size reflects weight); horizontal lines show 95% CI; black diamond indicates overall effect.

Participants who received magnesium continuously for at least 4 weeks across three eligible studies [17,22,23] (total n=182) were included in this subgroup analysis. The pooled results showed no statistically significant difference in the reduction of weekly nocturnal leg cramp frequency between the magnesium and control groups (mean difference, -1.88; 95% CI (-4.47 to 0.72); p=0.16). However, the test for subgroup differences revealed no statistically significant difference (p=0.06), and the degree of heterogeneity was moderate (I²=65%). For participants who received magnesium for less than 4 weeks, two studies [24,25] (n=84) were included. The meta-analysis showed no statistically significant difference in weekly cramp frequency between the magnesium and control groups (mean difference, 0.61; 95% CI (-1.84 to 3.06); p= 0.63). Likewise, the test for subgroup differences was not statistically significant (p=0.28) and heterogeneity was low (I² = 14%). Based on this subgroup analysis, although magnesium administration for ≥4 weeks did not yield statistically significant results, the reduction in cramp frequency was more favorable compared to the < 4-week group, suggesting a possible benefit from longer treatment duration.

Subgroup analysis by daily magnesium dosage (Figure 6): For participants who received a daily magnesium dosage of ≥ 1,000mg, two studies [22,25] with a combined total of 88 participants were included in the meta-analysis. The pooled results showed no statistically significant difference in the weekly frequency of nocturnal leg cramps between the magnesium and control groups (mean difference, -0.21; 95% CI (-2.87 to 2.45); p=0.88). The test for subgroup differences was also not statistically significant (p=0.62) and the degree of heterogeneity was low (I²=0%).

Figure 6:Forest plot of the subgroup meta-analysis showing the mean difference in total weekly frequency NLC between the magnesium group and the control group, categorized by daily dose ≥1000mg and <1000mg. green squares represent individual studies (size reflects weight); horizontal lines show 95% CI; black diamond indicates overall effect.

For participants who received a daily magnesium dosage of < 1,000mg, three studies [17,23,24] with 178 participants were included. The meta-analysis showed no statistically significant difference between groups (mean difference, -1.26; 95% CI (-4.35 to 1.84); p=0.43). However, a significant degree of heterogeneity was observed across these studies (p=0.006; I²= 80%), indicating considerable inconsistency in the outcomes. When comparing both subgroups, there appeared to be a trend suggesting that participants who received < 1,000mg/day of magnesium experienced a greater reduction in weekly NLC frequency than those receiving ≥ 1,000mg/ day, though the difference did not reach statistical significance.

Publication bias

Publication bias was assessed using funnel plots. The plots appeared symmetrical and showed an even distribution of effect sizes around the mean difference, indicating a low likelihood of publication bias. The assessment was performed separately for the meta-analyses examining the effects of magnesium on Nocturnal Leg Cramp (NLC) frequency based on treatment duration and daily magnesium dosage.

This study aimed to evaluate the effectiveness of magnesium in alleviating the frequency of Nocturnal Leg Cramps (NLC) in adults through a systematic review and meta-analysis of randomized controlled trials. Magnesium has long been proposed as a nonpharmacological treatment option due to its biological role in muscle contraction and neuronal excitability [28]. Magnesium is known to contribute to physiological muscle relaxation by reducing nerve excitability and inhibiting calcium influx at the neuromuscular junction. Its deficiency has been associated with increased muscle spasms and cramps. Therefore, magnesium supplementation has been hypothesized to reduce the frequency and severity of nocturnal leg cramps [29]. The findings of this study, however, did not demonstrate a statistically significant reduction in the frequency of NLC episodes among individuals receiving magnesium compared to placebo. A moderate degree of heterogeneity was observed among the included studies (I²=65%, p for heterogeneity=0.02), suggesting variability in the therapeutic response to magnesium supplementation across different populations. This inconsistency may be partially explained by principles of human physiology and pharmacology. Magnesium plays a critical role in neuromuscular function and requires time to re-establish intracellular equilibrium, particularly within muscle tissue [12]. As a result, its therapeutic effects may not become evident in the short term, especially during the initial phase of administration. The onset of action may therefore be delayed, leading to a diminished or inconsistent response during early treatment periods. Additionally, the studies included in this review utilized a range of magnesium dosages, potentially resulting in variable serum concentrations and inconsistent pharmacodynamic effects [13]. Such dosage discrepancies may have influenced the degree of muscular responsiveness observed, thereby contributing further to the inter-study heterogeneity. This aligns with findings from previous reviews such as Sebo et al. [16], which also failed to detect a meaningful therapeutic effect in the general population. Nonetheless, subgroup analyses in this study revealed a possible trend toward reduced cramp frequency in those receiving magnesium for ≥ 4 weeks or in doses < 1,000mg/day. Although not statistically significant, these trends suggest that treatment duration and dosing may influence therapeutic response, which is consistent with prior research indicating that baseline magnesium status and individual physiological variability may be key moderators. From a physiological standpoint, the body may require time to restore magnesium levels within skeletal muscle tissue [30]. Sustained magnesium supplementation over a longer duration may enhance muscle relaxation efficiency and reduce peripheral nerve hyperexcitability, which are key contributors to Nocturnal Leg Cramp (NLC) pathophysiology [12,30]. This delayed onset of action aligns with the biological mechanism by which magnesium modulates calcium influx, inhibits excessive acetylcholine release at the neuromuscular junction and stabilizes excitable membranes, thereby potentially alleviating neuromuscular irritability over time [31].

Heterogeneity among studies may reflect variations in study design, dosage, treatment duration, participant characteristics and outcome measurement tools. Most studies used self-report diaries to assess cramp frequency, which-while reflective of reallife symptoms-may introduce reporting bias or lack sensitivity in detecting subtle clinical changes. The variation in magnesium formulations (e.g., citrate, oxide, sulfate), routes of administration (oral vs. IV), and differences in outcome definitions (e.g., frequency per week, intensity, duration) may also contribute to the inconsistencies observed. Although this meta-analysis did not demonstrate a statistically significant effect of magnesium supplementation in reducing the frequency of Nocturnal Leg Cramps (NLC) compared to placebo, trends observed in subgroup analyses-particularly among individuals receiving treatment for four weeks or longer and those receiving less than 1,000mg/daysuggest potential clinical benefits. These findings should serve as a foundation for the design of future clinical trials aimed at evaluating the role of magnesium in NLC management more conclusively. It is recommended that future randomized controlled trials clearly define the study population, particularly with respect to age, comorbidities, and baseline magnesium status, which may influence responsiveness to supplementation. Interventions should employ standardized magnesium preparations and dosages to facilitate comparison across studies. Furthermore, treatment duration should be adequate, preferably extending beyond four weeks, to assess the sustained therapeutic effect. Outcome measures should not be limited to cramp frequency but should also capture pain severity, cramp duration, and impacts on sleep and quality of life. To improve methodological rigor, future studies should adopt proper randomization techniques, allocation concealment and blinding protocols to reduce the risk of bias.

This systematic review and meta-analysis evaluated the efficacy of magnesium in reducing the frequency of Nocturnal Leg Cramps (NLC) in adults. Pooled results from five randomized controlled trials showed no statistically significant difference between magnesium and placebo groups. However, subgroup analyses indicated a trend toward reduced cramp frequency in those receiving magnesium for at least four weeks or at daily doses below 1,000mg. Despite the lack of statistical significance, these findings suggest potential clinical relevance under specific conditions. In conclusion, magnesium supplementation may offer some benefit in the management of NLC, but current evidence remains inconclusive. Additional welldesigned randomized controlled trials are warranted to determine its role in targeted populations.

The authors gratefully acknowledge the support and assistance provided by Choltira Tangkeeratichai, MD, during the entire process of this study.

The authors declare no conflicts of interest.

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