Smith 1995.
Methods | Randomized active controlled parallel trial | |
Participants | Women diagnosed with PMS and who showed a statistically significant PMS trend in 3 or more symptoms on a daily symptoms rating scale (PDQ) kept prospectively for a 4 to 8 week period of time | |
Interventions | 100 µg versus 200 µg transdermal oestradiol patches 56 women were allocated to treatment with estraderm TTS 100 µg twice weekly continuously (El00 group), 56 women to treatment with Estraderm TTS 200 µg twice weekly continuously (E200 group). In both the El00 and E200 groups half of the women were allocated to take dydrogesterone 10 mg daily from day 17 to 26 of the cycle and half to take medroxyprogesterone acetate 5 mg daily from day 17 to 26 Duration: follow‐up visits were scheduled at the end of the 4th and 8th months of treatment. |
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Outcomes |
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Notes | Trial conducted in the UK, funding source unknown. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided on implementation of envelope method |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelope |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Non‐blinded trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Non‐blinded trial |
Incomplete outcome data (attrition bias) All outcomes | High risk | 21% dropout and 8% lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | No specific reasons to suspect other bias |