Kouides 2009.
Methods | A randomised cross‐over study. | |
Participants | 116 recruited. Inclusion criteria: women having a lab detectable bleeding disorder, a MBL amounting to more than 100 mL per bleed, a negative pelvic examination (though women with fibroids with the uterus was < 12 weeks gestational size were included), a negative PAP smear within the last 12 months, having regular periods and not on any medications that might affect coagulation. Participants gave written consent. Exclusion criteria: women having a blood loss of < 100 mL per cycle. Women having no laboratory detectable bleeding disorder. |
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Interventions | One group received IN‐DDAVP first for 2 menstrual cycles and subsequently received tranexamic acid for 2 menstrual cycles, and the other group received tranexamic acid first followed by IN‐DDAVP. There was no washout period in between washout. Intranasal DDAVP 300 lg, was administered on days 2 and 3 of menstrual bleeding (1 puff in each nostril each day) Trenaxamic acid was administered in tablet form at a dosage of 1 g 4 times each day for the first 5 days of menstrual bleeding. |
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Outcomes | 1. Menstraul blood loss PBAC was the method used 2. QoL 3. Adverse effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no information on the method used. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding not carried out but as the primary outcome is objective, this does not cause bias. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding not carried out but as the primary outcome is objective, this does not cause bias. |
Incomplete outcome data (attrition bias) All outcomes | High risk | A high dropout rate (43% for the IN‐DDAVP to tranexamic acid sequence and 33% for the tranexamic acid to IN‐DDAVP sequence). Paper did state "However, comparisons by sequence of the demographic characteristics, race and diagnosis, by attrition, sequence and treatment yielded minimal differences". |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Unclear risk | No mention of pharmaceutical funding or other potential sources of bias. |
IN‐DDAVP: intranasal desmopressin INR:international normalised ratio MBL: menstrual blood loss PAP: Papanikolaou smear PBAC: pictorial blood assessment chart QoL: quality of life