Nappi 2006a.

Methods	Randomised controlled trial
Participants	40 women with menopausal symptoms and primary headache (migraine without aura [MwA] and ETTH) of premenopausal onset (history ≥ 10 years), spontaneous menopausal status ≥ 12 months (mean 18 months) with follicle‐stimulating hormone levels > 30 IU/L, age between 51 and 55 years (mean age 53 years), body mass index > 19 and < 30 kg/m2
Interventions	Tibolone 2.5 mg/d 1 mg 17β‐oestradiol + 0.5 mg norethisterone acetate Administered for 6 months
Outcomes	Vaginal bleeding/spotting, vasomotor symptoms, vaginal dryness
Notes	Women had been using symptomatic medications and headache drug prophylaxis ≥ 3 months before entering the study Results on vasomotor symptoms and vaginal dryness (evaluated using Greene scale) available only as a graph Timing: unclear Location: Italy Multi‐centre: no information provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list of numbers
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It is stated that outcome measures were evaluated by a blind study author, although it is not clear whether this referred to the database level or to the clinical assessment of outcomes, which was not likely to be conducted in a blind fashion
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study authors state that all women completed the study following appropriate evaluation
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	Low risk	Supported by a grant from the Italian Ministry of Health. No conflicts of interest reported