Sohrabvand 2006.
| Methods | Open label RCT with 4 parallel treatment groups | |
| Participants | 84 pregnant women. Recruitment method (Iranian women) not provided. | |
| Interventions | Group 1: 500 mg calcium carbonate tablet once daily Group 2: 7.5 mmol magnesium aspartate (182 mg elemental magnesium) twice daily Group 3: 100 mg of thiamine (vitamin B1) plus 40 mg of pyridoxine (vitamin B6) once daily Group 4: No treatment |
|
| Outcomes | "Change in muscle spasms" on a 3‐point ordinal scale (no change, "relative improvement", or "absolute improvement") | |
| Notes | Unusual design. Each treatment was given over two weeks but efficacy was assessed at 4 weeks. Published as a "brief communication" (letter) only. Funding source not provided. No definition of relative and absolute improvement was given in the manuscript but this was confirmed with the author to mean partial and complete resolution of the overall cramp burden (which presumably takes into account both intensity and frequency). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description |
| Allocation concealment (selection bias) | Unclear risk | No description |
| Blinding (performance bias and detection bias) All outcomes | High risk | Open label trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No details regarding flow of patients in the manuscript but author communication suggests no dropouts. |
| Selective reporting (reporting bias) | Unclear risk | Primary outcome not identified (though only one outcome reported). Table 2 showed statistical significance in total improvement for groups 2 and 3 compared to group 4 but in the text it stated groups 1 and 3 (which is supported by the CI results). |
| Cramp diary (recall bias) | High risk | Specifics were not given but there appeared to have only been a qualitative assessment of the change in cramps upon study completion |
| Other bias | High risk | Baseline characteristics were said to be not significantly different but they were not provided. Unclear who rated the degree of improvement (patient or physician).Trial was very under reported. Outcomes were grouped in an impractical way |
CI: confidence interval IV: intravenous RCT: randomized controlled trial