Osmers 2005.
| Methods | Design: randomised, placebo‐controlled, double‐blind, multicentre, parallel group trial Randomisation ratio: 1:1 Study duration: not stated |
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| Participants | Participant characteristics: 309 women enrolled, 304 were randomised (black cohosh = 153, placebo = 151), and 36 dropped out (11.8%). Mean age (black cohosh = 54.0 ± 6.0 years, placebo = 55.0 ± 6.0 years). Median duration of climacteric complaints (black cohosh = 4.4 years, placebo = 5.1 years) Inclusion criteria: female, postmenopausal (≥ 12 months since last regular menstruation or ≥ 6 months since last regular menstruation plus FSH ≥ 50 U/L), ≥ 45 years of age, MRS ≥ 0.4 in at least 3 items Exclusion criteria: BMI > 35 kg/m2, cancer, drug abuse, diseases interfering with the assessment of climacteric symptoms, participation in another clinical trial within the last 180 days Diagnostic criteria: not stated Co‐morbidities: not stated Co‐medications: not stated |
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| Interventions | Number of study centres: 24 Country/location: Germany Setting: Gynaecological and gynaecologically experienced private practices Intervention (route, total, dose/day, frequency): oral isopropanolic extract of Cimicifuga racemosa (Remifemin, equivalent to 2.5 mg extract or 20 mg root stock) 1 tablet, twice a day Control (route, total, dose/day, frequency): oral placebo (excipients only) 1 tablet, twice a day Duration of intervention: 12 weeks Duration of follow‐up: not applicable Run‐in period: not applicable Treatment before study: 1‐week washout period for those taking non‐hormonal climacteric drugs, supplements, antiepileptics, psycholeptics or psychoanaleptics. 4‐week washout period for those taking hormone replacement therapy Titration period: not applicable |
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| Outcomes | Primary outcomes: intensity of climacteric symptoms (MRS) Secondary outcomes: MRS subscales (hot flushes, atrophy, psyche and soma) Additional outcomes: adverse events, liver enzymes, BMI |
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| Notes | This study reported change‐from‐baseline scores; final value scores were not made available on request | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "each patient was randomly assigned to receive one blinded Remifemin tablet or matching placebo...medication was prenumbered using a 1:1 ‐ randomization block size of 4" (method of sequence generation 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 | Quote: "double‐blind", though there was no mention of who was blinded, or any assurance that interventions matched in appearance, taste or odour Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "The primary efficacy analysis used the Intention‐to‐treat population" Number and reasons for withdrawal were similar between groups |
| Selective reporting (reporting bias) | Unclear risk | All primary and secondary outcomes listed were reported, although no study protocol was published or lodged |
| Other bias | Low risk | There were no significant differences in participant characteristics between groups at baseline |