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. 2016 Mar 22;2016(3):CD002124. doi: 10.1002/14651858.CD002124.pub2

Abdelmaeboud 2014.

Methods Cross‐over trial (a pilot phase III)
Participants Included: women aged between 18 and 28 years, regular cycles (21 to 35 days) with duration of 3 to 7 days, a history of at least 6 consecutive months of moderate to severe primary dysmenorrhoea as determined by the verbal rating scale (VRS, a 4‐point self‐rated verbal score: 0, none; 1, mild; 2, moderate; and 3, severe menstrual pain), with the pain lasting for at least 2 days and who required analgesia in each of the last 3 consecutive cycles, preceding study participation.
Excluded: women who were planning to get married during the study; known or suspected secondary dysmenorrhoea and other causes of chronic pelvic pain, other use of drugs, other medical conditions (listed in publication)
Age: median = 23 years; range: 25.5 to 24 years
Source: Faculty of Medicine, Ain Shams University
Location: Egypt 2011 to 2012
Interventions Group 1: 40 mg uzara tablets (roots of the South‐African uzara plant,Xysmalobium undulatum), 2 tablets per 8 hours, then 1 tablet per 8 hours beginning 2 days before the expected start of menstruation (N = 30)
Group 2: 400 ibuprofen tablets, 1 tablet per 6 hours beginning 2 days before the expected start of menstruation (N = 30)
Both groups continued for 5 days, and stopped treatment when there was mild or no pain 6 to 8 hours from the last dose.
Outcomes Primary
  • Pain intensity (visual analogue scale (VAS) scale 10 cm) recorded by patients;

  • participants’ global evaluation of the study medication (recorded by patient as effective or non‐effective);

  • absence from school;

  • use of a rescue medication;

  • in those who continued the treatment, the pain intensity difference (PID) at certain points after start of medication and its sum (SPID).


Secondary
  • Adverse reactions;

  • drug tolerability.

Notes No first phase data were available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “The randomisation sequence was computer generated and kept concealed by the first author who played no role in patients’ recruitment.”
Allocation concealment (selection bias) Low risk "The randomisation sequence was computer generated and kept concealed by the first author who played no role in patients’ recruitment."
“Other co‐authors ‐indulged in patients’ recruitment and consenting to the study‐ were continuously updated regarding number of participants with assigned sequence. They collaborated together to allocate the next available number to each participant in order of her enrolment in the study. Subsequently, the first author was contacted and asked to release the sequence (order of drug intake, uzara/ibuprofen or vice versa).”
Blinding (performance bias and detection bias) 
 All outcomes High risk Comment: the study authors did not mention blinding. In addition, blinding might not be accomplished as the difference of dose (2 tablets versus 1 tablets) and administrator.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no losses to follow‐up.
Selective reporting (reporting bias) Low risk Comment: the study protocol was available. Adverse effects were reported in both groups.
Other bias Low risk Comment: we did not identify any other potential sources of bias.