Kashanian 2013.
Methods | RCT | |
Participants | Included: single women from 18 to 25 years of age, whose dysmenorrhoea started at menarche, without any increase over time, regular menstrual cycles, and normal pelvic examination Excluded: women that had any pelvic and abdominal surgeries, prior genital infection or pelvic pain, used other sedatives during the cycle, history of psychological problems or drug use, abnormal or heavy bleeding, smoking or alcohol consumption, digestive problems, prolonged stress in family or job, known pelvic or uterine anomaly, abnormal ultrasound of uterus and ovaries, and vitamin E allergy Age: vitamin E group = 22.8 years, placebo = 23.5 years Source: randomised 120 women aged 18 to 25 with primary dysmenorrhoea, of whom only 94 finished the study and were analysed. One woman had mild pain (VAS < 3), 44 had moderate pain (VAS 3 to 7) and 49 had severe pain (VAS 7 to 10) Location: Iran |
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Interventions | Group 1: vitamin E 400 IU/day for 2 days before and 3 days after menses (total 5 days), for 2 cycles (N = 60, 42 analysed) Group 2: placebo (N = 60, 52 analysed) |
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Outcomes |
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Notes | One woman had only mild dysmenorrhoea (and it is unclear which group she was in) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: participants chose an envelope. |
Allocation concealment (selection bias) | Unclear risk | Comment: the study used sealed sequentially distributed envelopes labelled A, B, C, or D. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: outcome assessors and treating physicians were blinded. Vitamin E and placebo were identical in shape, colour, taste, and smell. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: only 42/60 participants in the intervention group and 52/60 of the control group completed the study. The dropout rate was 21.7% (26/120). |
Selective reporting (reporting bias) | Unclear risk | Comment: adverse effects were not reported. |
Other bias | Low risk | Comment: we did not identify any other potential sources of bias. |