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. 2015 May 13;2015:1113.

Table.

GRADE Evaluation of interventions for Leg cramps.

Important outcomes Leg cramp symptoms
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of treatments for idiopathic leg cramps?
1 (12) Leg cramp symptoms Diltiazem versus placebo 4 –3 0 0 0 Very low Quality points deducted for weak methods, sparse data, and incomplete reporting.
4 (213) Leg cramp symptoms Magnesium salts versus placebo 4 –1 0 –1 0 Low Quality point deducted for weak methods; directness point deducted for uncertainty about included population (skeletal cramps)
14 (at least 982) Leg cramp symptoms Quinine versus placebo 4 –1 –1 0 0 Low Quality point deducted for weak methods; consistency point deducted for statistical heterogeneity
1 (94) Leg cramp symptoms Stretching exercises versus passive non-stretching exercises 4 –2 0 –2 0 Very low Quality points deducted for weak methods and sparse data; directness points deducted for choice given to participants of treatment at 6 weeks, and use of co-intervention (quinine)
1 (27) Leg cramp symptoms Vitamin E versus placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete reporting of results; directness point deducted for restricted population (inclusion only of men)
4 (at least 513) Leg cramp symptoms Vitamin E versus quinine 4 –1 –1 –1 0 Very low Quality point deducted for weak methods; consistency point deducted for statistical heterogeneity; directness point deducted for uncertainty about included population (skeletal cramps)
What are the effects of treatments for leg cramps in pregnancy?
2 (102) Leg cramp symptoms Calcium salts versus no treatment or vitamin C placebo 4 –2 –1 –1 0 Very low Quality points deducted for sparse data and weak methods; consistency point deducted for conflicting results; directness point deducted for uncertain benefits from control treatment
3 (202) Leg cramp symptoms Magnesium salts versus placebo or no treatment 4 –2 0 –1 0 Very low Quality points deducted for weak methods and incomplete reporting of results; directness point deducted for unclear outcomes in one RCT
1 (62) Leg cramp symptoms Multivitamin and mineral supplements versus placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and poor follow-up; directness point deducted as study not designed to assess treatment for cramps

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.