Lehmann‐Willenbrock 1988.
| Methods | Design: randomised, controlled, single‐centre trial Randomisation ratio: not stated Study duration: not stated |
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| Participants | Participant characteristics: 60 women were randomised (oestriol = 15, oestrogen = 15, oestradiol/norethisterone = 15, black cohosh = 15), and 5 (8.3%) dropped out. Mean age not stated. Duration of menopause not stated Inclusion criteria: female, hysterectomised, aged under 40 years, has at least 1 intact ovary, complaining of climacteric symptoms Exclusion criteria: type I diabetes mellitus, chronic hepatitis, deep vein thrombosis, breast cancer, contraindication to HT Diagnostic criteria: not stated Co‐morbidities: not stated Co‐medications: not stated |
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| Interventions | Number of study centres: 1 Country/location: Kiel, Germany Setting: university gynaecological hospital Intervention (route, total, dose/day, frequency): oral isopropanolic extract of Cimicifuga racemosa (Remifemin, 2 mg) 2 tablets, twice daily Control (route, total, dose/day, frequency): oral oestriol (Ovestin, 1 mg) 1 tablet daily; oral conjugated oestrogen (Presomen, 1.25 mg) 1 tablet daily; oral oestradiol/norethisterone acetate (Trisequens) 1 tablet, daily Duration of intervention: not stated Duration of follow‐up: 24 weeks Run‐in period: not stated Treatment before study: not stated Titration period: not applicable |
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| Outcomes | Primary outcomes: KI, serum FSH, serum LH Secondary outcomes: not stated Additional outcomes: not stated |
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| Notes | This study reported final value scores | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised" (method not described) Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | There is no mention of blinding Comment: probably not done |
| Incomplete outcome data (attrition bias) All outcomes | High risk | ITT was not mentioned 5 women withdrew from the study; however, the number and reasons for withdrawal were not given for each group separately |
| Selective reporting (reporting bias) | Unclear risk | Data for all primary outcomes were reported, although no study protocol was published or lodged |
| Other bias | Unclear risk | Participant characteristics at baseline were not reported |