Nayeban 2014.
Methods | RCT | |
Participants | 90 participants randomised Included: participants within the age range of 18 to 26 years, single, with regular menstruation, no urogenital and coagulation disorders, and no previous history of abdominal or pelvic surgery Excluded: participants whose mean score of pain severity was < 40 (based on VAS) Age: mean = 29.7 years Source: students in the dormitories of Ferdowsi University of Mashhad Location: Iran |
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Interventions | Group 1: vitamin B1 100 mg/day (since the 15th day of the menstrual cycle until the beginning of the next cycle) Group 2: vitamin E 400 units/day (5 days in a month, from 2 days before the menstruation until the first 3 days) The treatment course continued for 3 menstrual cycles, and then the study authors collected all forms |
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Outcomes |
The study authors asked participants to record their most severe pain and its duration in the first 3 days, based on VAS and CMSS, respectively. They also asked participants if they had taken any analgesics for their pain; if so, the name and dosage of the medication was recorded in the treatment form. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “The participants whose mean score of pain severity was less than 40 (based on VAS), were excluded from the study, and the rest were randomly assigned to two groups.” Comment: the study authors did not describe the methods of sequence generation. |
Allocation concealment (selection bias) | Unclear risk | “Each medication package was placed on a separate box, coded by letters A and B, and was given to each participant.” Comment: the study authors did not describe the method of allocation concealment in sufficient detail. |
Blinding (performance bias and detection bias) All outcomes | High risk | “Each medication package was placed on a separate box, coded by letters A and B, and was given to each participant.” Comment: it is unclear whether or not the medication appearance in both groups was the same in all aspects, and also whether there was a difference of administrator. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: the study authors did not state how many participants they included in the analyses. |
Selective reporting (reporting bias) | Unclear risk | Comment: the study authors did not prespecify adverse events as an outcome. |
Other bias | Low risk | Comment: we did not identify any other potential sources of bias. |