Shahraki 2006.
Study characteristics | ||
Methods | Open‐label, parallel‐group RCT | |
Participants | 120 pregnant, multiparous women aged 25 to 35 years (mean age 29.2 years old) who suffered from muscular cramps and were in the 25th to 28th week of pregnancy when referred to a gynaecology clinic in Shahrekord, Iran | |
Interventions | Randomized to 3 groups: Group 1: 100 mg Vitamin E oral pill once a day (n = 40) Group 2: 8 cc of a 8% milk of magnesium suspension (267.2 mg elemental magnesium) 3 times a day, before meals (n = 40) Group 3: 500 mg calcium carbonate oral pill once a day (n = 40) All treatments administered for 45 days |
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Outcomes | Number of cramps over the last 24 hours Duration of cramps in seconds Cramp intensity (measured on a 1 to 10 points VAS) Frequency of low and high pain (1 to 5 = low pain rate and 6 to 10 = high pain) Each outcome measured on day 0, 45, and 90 |
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Conflicts of interest | Funding and conflicts of interest not reported | |
Funding | Funding and conflicts of interest not reported | |
Notes | Published in English but likely translated from a different language, with the result that some information is incomprehensible. Conducted from September 2004 to July 2005 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No information available on the method of randomization. Quote: “Each group was included 40 persons which were divided randomizly and turn of coming.” No table with baseline characteristics |
Allocation concealment (selection bias) | High risk | No information available |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label |
Incomplete outcome data (attrition bias) All outcomes | High risk | 120 initially included but results only presented for 90 participants. Paper only describes 20 participants quitting the study. Type of analysis unclear, likely to be per protocol |
Selective reporting (reporting bias) | Low risk | All planned outcomes are addressed in the results |
Cramp diary (recall bias) | Unclear risk | Unclear but given reporting was recall of the last 24 hours; unlikely that a diary was used |
Other bias | Low risk | No obvious other bias |