Table.
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.