Randomised trial, 1986
Does the progestin norethisterone cause premenstrual syndrome-like symptoms?
Yes, norethisterone caused dose-related adverse effects similar to PMS, particularly at the higher dose. This helps researchers understand what causes PMS.
What they did
58 postmenopausal women taking oestrogen replacement therapy were given norethisterone 2.5 or 5 mg daily for 7 days, and placebo for two separate 7-day periods, in a randomized, double-blind design. Symptoms were assessed using the Menstrual Distress Questionnaire.
What they found
Adverse effects were dose-related. At 5 mg/day, norethisterone caused significant changes in five out of eight symptom groups: pain, concentration problems, behavioural changes, water retention, and negative affect.
What it means for you
Adding the progestin norethisterone to oestrogen created PMS-like symptoms, which helps explain what may cause PMS. The study used postmenopausal women as a model rather than women with actual menstrual cycles, which limits how much we can apply the findings to real PMS.
58
postmenopausal women studied
5 of 8
symptom groups affected at 5 mg/day
5 mg/day
norethisterone dose causing symptoms
About the study
- Original title
- The effects of norethisterone in postmenopausal women on oestrogen replacement therapy: a model for the premenstrual syndrome
- Authors
- Magos AL, Brewster E, Singh R et al.
- Journal
- British journal of obstetrics and gynaecology
- Year
- 1986
- Study design
- Randomised trial
- Participants
- 58
- What was tested
- Norethisterone at 2.5 mg or 5 mg daily versus placebo for 7-day periods
- Read the paper
- doi.org/10.1111/j.1471-0528.1986.tb07868.x
Topics
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