Magnesium for skeletal muscle cramps

Scott R Garrison; G Michael Allan; Ravneet K Sekhon; Vijaya M Musini; Karim M Khan

doi:10.1002/14651858.CD009402.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison: 1 Idiopathic rest cramps, magnesium versus placebo, outcome: 1.1 % Change in cramp frequency from baseline at 4 weeks.

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Figure 4

Forest plot of comparison: 1 Idiopathic rest cramp efficacy, magnesium versus placebo, outcome: 1.3 Proportion of subjects with a ≥ 25% reduction in cramp frequency at 4 weeks.

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Figure 5

Forest plot of comparison: 1 Idiopathic rest cramps, magnesium versus placebo, outcome: 1.6 Number of cramps per week at 4 weeks.

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Figure 6

Forest plot of comparison: 1 Idiopathic rest cramp efficacy, magnesium versus placebo, outcome: 1.7 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 4 weeks.

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Analysis 1.1

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 1 % Change in cramp frequency from baseline at 4 weeks.

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Analysis 1.2

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 2 % Change in cramp frequency from baseline at 12 weeks.

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Analysis 1.3

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 3 Proportion of subjects with a ≥ 25% reduction in cramp frequency at 4 weeks.

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Analysis 1.4

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 4 Proportion of subjects with a ≥ 25% reduction in cramps at 12 weeks.

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Analysis 1.5

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 5 Number of cramps per week at 4 weeks.

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Analysis 1.6

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 6 Number of cramps per week at 12 weeks.

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Analysis 1.7

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 7 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 4 weeks.

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Analysis 1.8

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 8 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 12 weeks.

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Analysis 1.9

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 9 Proportion of subjects rating their cramps as moderate or severe (i.e. ≥ 2 on the 3 point intensity scale) at 4 weeks.

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Analysis 1.10

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 10 Proportion of subjects rating their cramps as moderate to severe (i.e. with mean cramp intensity ≥2 on the 3 point intensity scale) at 12 weeks.

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Analysis 1.11

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 11 Proportion of subjects with the majority of cramp durations ≥ 1 minute at 4 weeks.

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Analysis 1.12

Comparison 1 Idiopathic rest cramp efficacy, magnesium versus placebo, Outcome 12 Proportion of subjects with majority of cramp durations ≥ 1 minute at 12 weeks.

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Analysis 2.1

Comparison 2 Adverse effects of treatment, magnesium versus placebo, Outcome 1 Withdrawals due to adverse events.

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Analysis 2.2

Comparison 2 Adverse effects of treatment, magnesium versus placebo, Outcome 2 Number of subjects with major adverse events.

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Analysis 2.3

Comparison 2 Adverse effects of treatment, magnesium versus placebo, Outcome 3 Number of subjects with minor adverse events.

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Magnesium for skeletal muscle cramps
Patient or population: Nonpregnant patients with muscle cramps (largely older adults) Settings: Outpatients recruited through primary care clinics or community advertising Intervention: Magnesium supplements (oral or intravenous) Comparison: Placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Magnesium
Percentage change in cramp frequency from baseline at 4 weeks	The mean percentage change in cramp frequency in the control groups was ‐27.8% (i.e. a 27.8% reduction)	The mean percentage change in cramp frequency in the magnesium groups was 3.9% lower	‐3.9% (‐21.1 to 13.3)	83 (2 studies)	⊕⊕⊕⊝ moderate	This difference was neither clinically nor statistically significant. The 95% confidence interval excludes a 25% reduction beyond placebo
Percentage of participants with a ≥ 25% reduction in their cramp frequency at 4 weeks	The mean percentage of placebo recipients achieving a 25% or better reduction in the frequency of their cramps was 65.9%	The mean percentage of magnesium recipients achieving a 25% or better reduction in the frequency of their cramps was 8% lower	‐8% (‐28% to 12%)	83 (2 studies)	⊕⊕⊕⊝ moderate	This difference was neither clinically nor statistically significant
Number of cramps per week at 4 weeks	The mean number of cramps per week in the placebo groups while on treatment was 4.35	The mean number of cramps per week in the magnesium groups was 0.01 cramps per week higher	0.01 cramps per week (‐0.52 to 0.55)	213 (4 studies)	⊕⊕⊕⊝ moderate	This difference was neither clinically nor statistically significant. The 95% confidence interval excludes a 1 cramp per week reduction
Percentage of participants rating their cramps as moderate or severe (i.e. mean cramp intensity ≥ 2 on the 3 point intensity scale) at 4 weeks	The mean percentage of placebo recipients rating their cramps as moderate or severe was 30%	The mean percentage of magnesium recipients rating their cramps as moderate or severe was 9% greater	9% (‐7% to 25%)	91 (2 studies)	⊕⊕⊕⊝ moderate	This difference was neither clinically nor statistically significant
Percentage of participants with the majority of cramp durations ≥ 1 minute at 4 weeks	The mean percentage of placebo recipients with the majority of cramp durations ≥ 1 minute was 22.7%	The mean percentage of magnesium recipients with the majority of cramp durations ≥ 1 minute was 19% greater	19% (‐7% to 45%)	46 (1 study)	⊕⊕⊝⊝ low	This difference was neither clinically nor statistically significant
Number of participants with major adverse events	1 out of 22	0 out of 24	‐50 per 1000 (‐160 to 70)	46 (1 study)	⊕⊝⊝⊝ very low	This difference was neither clinically nor statistically significant
Number of participants with minor adverse events	Adverse events were not reported in a way that permitted the number of participants with minor adverse events to be determined. Each study of oral magnesium inferred that side effects were similar in frequency to placebo. Intravenous magnesium was associated with asymptomatic hypotension (3/24 magnesium versus 0/22 placebo recipients), transient light‐headedness (2/24 magnesium versus 0/22 placebo) and burning of the IV site (12/24 magnesium versus 0/22 placebo).
CI: Confidence interval;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
Downgrading of the quality of evidence is based largely on the number of studies and participants contributing to each estimate. The quality of evidence for the number of participants with major adverse events is considered very low because such events are rare.

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Table 1. Table 1. Study design of the seven included trials

Study	Number/design/clinical Setting	Mean age (years)	% Female	Magnesium dose and route of administration	Frequency of administration	Treatment and assessment periods (days)	Washout period (days)	Comparator
Dahle 1995	N = 73 Parallel Pregnancy	Not given (child‐ bearing years)	100%	5 mmol combination Mg lactate + Mg citrate (122 mg elemental Mg) taken orally	Once each morning and twice each evening	Treatment 21 Assessment 21	Not applicable	Matched placebo tablet
Frusso 1999	N = 45 Cross‐over Idiopathic	61.6	73.3%	Mg citrate 900 mg tablet (100 mg elemental Mg) taken orally	Twice daily	Treatment 28 Assessment 28	28	Matched placebo tablet
Garrison 2011	N = 46 Parallel Idiopathic	69.3	69.6%	20 mmol Mg sulfate (486 mg elemental Mg) given intravenously	Once daily over 4 hrs on 5 consecutive days	Treatment 5 Assessment 90	Not applicable	Matched placebo solution
Nygaard 2008	N = 45 Parallel Pregnancy	30.9	100%	Mg lactate and Mg citrate chewable tablets containing 122 mg elemental Mg taken orally	Once each morning and twice each evening	Treatment 14 Assessment 14	Not applicable	Matched placebo tablet
Roffe 2002	N = 73 Cross‐over Idiopathic	62.9	54.3%	1830 mg of tri‐magnesium dicitrate powder (300 mg elemental Mg) poured from a sachet into a glass of water taken orally	Once each evening	Treatment 42 Assessment during last 28 days of treatment	First 14 days of second treatment period considered as washout	Matched placebo powder
Rosenbaum 2011	N = 40 Parallel Idiopathic	66.6	57.5%	Slow release tablet of Mg lactate containing 84 mg of elemental Mg taken orally	Two tablets twice daily	Treatment 30 Assessment 30	Not applicable	Matched placebo tablet
Sohrabvand 2006	N = 84 Parallel Pregnancy	Not given (child‐ bearing years)	100%	7.5 mmol magnesium aspartate (182 mg elemental Mg) taken orally. Unclear if tablet or powder / solution	Twice daily	Treatment 14 Assessment 28	Not applicable	3 different comparators 1) No treatment 2) 500 mg calcium carbonate tablet once daily 3)100 mg of thiamine (vit B1) plus 40 mg of pyridoxine (vit B6) once daily
vit B1: vitamin B1

Table 1. Table 1. Study design of the seven included trials

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Comparison 1. Idiopathic rest cramp efficacy, magnesium versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 % Change in cramp frequency from baseline at 4 weeks Show forest plot	2	83	Mean Difference (IV, Fixed, 95% CI)	‐3.93 [‐21.12, 13.26]

2 % Change in cramp frequency from baseline at 12 weeks Show forest plot	1	43	Mean Difference (IV, Fixed, 95% CI)	‐12.09 [‐40.22, 16.04]

3 Proportion of subjects with a ≥ 25% reduction in cramp frequency at 4 weeks Show forest plot	2	83	Risk Difference (M‐H, Fixed, 95% CI)	‐0.08 [‐0.28, 0.12]

4 Proportion of subjects with a ≥ 25% reduction in cramps at 12 weeks Show forest plot	1	43	Risk Difference (M‐H, Fixed, 95% CI)	0.11 [‐0.19, 0.41]

5 Number of cramps per week at 4 weeks Show forest plot	4	213	Mean Difference (Fixed, 95% CI)	0.01 [‐0.52, 0.55]

6 Number of cramps per week at 12 weeks Show forest plot	1	43	Mean Difference (IV, Fixed, 95% CI)	‐0.84 [‐3.23, 1.55]

7 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 4 weeks Show forest plot	3	175	Mean Difference (Fixed, 95% CI)	‐0.04 [‐0.18, 0.11]

8 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 12 weeks Show forest plot	1	43	Mean Difference (IV, Fixed, 95% CI)	‐0.18 [‐0.55, 0.19]

9 Proportion of subjects rating their cramps as moderate or severe (i.e. ≥ 2 on the 3 point intensity scale) at 4 weeks Show forest plot	2	91	Risk Difference (M‐H, Fixed, 95% CI)	0.09 [‐0.07, 0.25]

10 Proportion of subjects rating their cramps as moderate to severe (i.e. with mean cramp intensity ≥2 on the 3 point intensity scale) at 12 weeks Show forest plot	1	43	Risk Difference (M‐H, Fixed, 95% CI)	‐0.06 [‐0.21, 0.10]

11 Proportion of subjects with the majority of cramp durations ≥ 1 minute at 4 weeks Show forest plot	1	46	Risk Difference (M‐H, Fixed, 95% CI)	0.19 [‐0.07, 0.45]

12 Proportion of subjects with majority of cramp durations ≥ 1 minute at 12 weeks Show forest plot	1	43	Risk Difference (M‐H, Fixed, 95% CI)	0.14 [‐0.13, 0.42]

Comparison 1. Idiopathic rest cramp efficacy, magnesium versus placebo

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Comparison 2. Adverse effects of treatment, magnesium versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Withdrawals due to adverse events Show forest plot	4	201	Risk Difference (M‐H, Fixed, 95% CI)	‐0.03 [‐0.10, 0.03]

1.1 Idiopathic cramps (largely older adults)	2	86	Risk Difference (M‐H, Fixed, 95% CI)	0.02 [‐0.06, 0.11]
1.2 Pregnancy‐associated leg cramps	2	115	Risk Difference (M‐H, Fixed, 95% CI)	‐0.07 [‐0.17, 0.02]
2 Number of subjects with major adverse events Show forest plot	2	91	Risk Difference (M‐H, Fixed, 95% CI)	‐0.02 [‐0.10, 0.05]

2.1 Idiopathic cramps (largely older adults)	1	46	Risk Difference (M‐H, Fixed, 95% CI)	‐0.05 [‐0.16, 0.07]
2.2 Pregnancy‐associated leg cramps	1	45	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.08, 0.08]
3 Number of subjects with minor adverse events Show forest plot	1	45	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.27, 0.25]

3.1 Idiopathic cramps (largely older adults)	0	0	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Pregnancy‐associated leg cramps	1	45	Risk Difference (M‐H, Fixed, 95% CI)	‐0.01 [‐0.27, 0.25]

Comparison 2. Adverse effects of treatment, magnesium versus placebo

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