Akbari 2012.
Methods | Randomised controlled trial (RCT) | |
Participants | Included: students, being unmarried; with moderate or severe dysmenorrhoea according to the McGill pain rating scale; not known to have chronic diseases; had regular intervals of 21 to 35 days for menstrual periods; no history of myoma, pelvic tumour, endometriosis, and PID; no symptoms such as burning, itching, and abnormal discharge during the study; no use of special drugs; no history of allergy to fenugreek or other plants, and not taking herbal medicines during 3 months before intervention. Excluded: allergic to fenugreek seed during intervention; incorrectly taking the capsules; taking any other herbal medicine during intervention and taking less than 4 capsules daily. Students who had irregular menstrual cycles, endometriosis, history of medication usage, experienced acute stress, and/or had vaginal symptoms (burning, irritation, itching, or discharge) Age: mean age of fenugreek group = 19.86 years; mean age of placebo group = 20.0 years Source: Shahid Beheshty University of Medical Sciences Location: Iran |
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Interventions | Group 1: fenugreek seeds capsule content of 900 mg seed powder prescribed (N = 53, 51 analysed) Group 2: placebo starch (similar capsule with same recipe content starch; 500 mg) (N = 53, 50 analysed) The intervention group took 2 to 3 capsules 3 times per day, for the first 3 days of their menstruation for two consecutive menstrual cycles (a daily dose of 5400 mg to 8100 mg). |
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Outcomes |
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Notes | There were 2 sources information for this study: a conference abstract (poster presentation) and the full‐text article published in 2014 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Computer generated random numbers were used to divide participants into two groups for receiving fenugreek or placebo.” |
Allocation concealment (selection bias) | Unclear risk | “Participants and researchers were kept blinded to treatment allocation” Comment: there were insufficient details on how to keep participants and researchers blinded to treatment allocation. |
Blinding (performance bias and detection bias) All outcomes | Low risk | “Fenugreek seed's capsule content of 900 mg seed powder prescribed 3 times a day and 2‐ 3 capsules duration first three days of menstrual period and for persons in control group prescribed placebo (similar capsule with same recipe content starch) in two cycles.” “The capsules were similar with respect to shape, colour, and packaging.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “Unmarried Students were randomly assigned to two groups who received fenugreek (n=51) or placebo (n=50).” “106 individuals were enrolled in the study. The final analysis involved 101 students, 51 of whom received fenugreek and 50 received placebo.” |
Selective reporting (reporting bias) | Unclear risk | “Systemic symptoms of dysmenorrhoea (fatigue, headache, nausea, vomiting, lack of energy, syncope) decreased in the fenugreek seed group (p<0.05). No side effects were reported in the fenugreek group.” Comment: it is unclear whether or not the study authors collected data on adverse effects systematically in both groups. |
Other bias | Low risk | Comment: we did not identify any other potential sources of bias. |