Melis 1997 L.

Methods	Treatment assigned in random fashion; duration of study 3/12
Participants	50 post‐menopausal women Inclusion criteria: physiological menopause of at least 1 year Exclusion criteria: hormone treatment less than 6/12 ago, illness or malignancy that contraindicated oestrogen treatment, BP>140/80, positive MSU
Interventions	Group A (n=25): oestriol vaginally 0.5 mg / day for 14/7, then alternate days for 3/12 in total Group B (n=25): oestriol vaginally 0.5 mg / day for 14/7, then alternate days for 3/12 in total + benzidamine 140 mg daily
Outcomes	Biochemical markers: azotamine, glucose, GPT, GOT, g‐GT, bilirubin, total cholesterol, triglycerides, HDL‐cholesterol, FSH, oestriol levels Clinical evaluation of genital symptoms: pruritus, leucorrhoea, sensation of vaginal dryness, dyspareunia) Evaluation of general climacteric symptoms: psychological, insomnia, headaches, irritability, depression, neurovegetative: hot flushes Colposcopy Vaginal cytology, karyopycnotic index Every 15 days women were asked about side effects of treatment and filled in diary with intensity of symptoms
Notes	No adverse events, no losses to follow up; study designed to look at vaginal changes rather than at incontinence, incontinence forms part of menopausal symptoms
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	no description
Allocation concealment (selection bias)	Unclear risk	no description
Blinding (performance bias and detection bias) All outcomes	Unclear risk	no description
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	no description