Rehman 2015.
Methods | RCT | |
Participants | Included: 45 unmarried participants (primary dysmenorrhoea) between the ages of 15 to 25 years with regular menstrual cycles that lasted from 21 to 35 days with 2 to 6 days of flow, with moderate to severe dysmenorrhoea Excluded: women with pelvic pathology, irregular cycles, systemic illness, married women, allergic to NSAIDs and mild dysmenorrhoea, with a thyroid profile (to exclude systemic illnesses), taking any drug that could influence the study outcomes (such as NSAIDs and oral contraceptive pills) Age: mean rhubarb group = 18.87 years, mefenamic acid group = 17.73 years Source: women with primary dysmenorrhoea Location: India |
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Interventions | Group 1: rhubarb was finely powdered and filled in 500 mg capsules (N = 30); each capsule contained ˜420 mg of the powdered drug. Participants took 3 capsules of rhubarb twice a day, began treatment 2 days before the menstruation, and continued until the first 3 days of menstruation for 3 consecutive cycles Group 2: mefenamic acid (250 mg) (N = 15) was powdered and filled in capsules similar to the test drug Control group patients took capsules of mefenamic acid 3 times a day after meals for the same protocol |
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Outcomes |
Primary
Secondary
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Patients were randomised into 2:1 ration by simple randomizations (lottery method) to receive either rhubarb (i.e. experimental group, n=30) or mefenamic acid (control group, n=15).” |
Allocation concealment (selection bias) | High risk | “Investigator assigned the participants to interventions but the participants were not aware about the treatment.” “the participants were blinded to the treatment allocation.” Comment: the investigator knew in advance what intervention a particular participant would have. |
Blinding (performance bias and detection bias) All outcomes | Low risk | “This was a single‐blind trial. The appearances of the experimental and control drug capsules were identical, and no aroma was detected from either”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “45 were randomised into experimental and control groups. Three patients in the control group did not come for last follow up; information regarding lost to follow up was not obtained. The final analysis was conducted on 45 patients” Comment: an intention to treat analysis was applied |
Selective reporting (reporting bias) | Unclear risk | “In the rhubarb group, six (20%) patients were given the history of side effects out of which two patients complained bloating and four patients diarrhoea for the last two days of last cycle. As diarrhoea and bloating were mild and were not so much troubling, so the trial continued. No other side effects such as heart burn, abdominal pain and vomiting were reported by patients.” Comment: it is unclear whether or not data on adverse effects was collected systematically in both groups. |
Other bias | Low risk | Comment: we did not identify any other potential sources of bias. |