Wang 2005.
Methods | Parallel randomised controlled clinical trial, randomisation ratio 1 : 1 | |
Participants |
Inclusion criteria: postmenopausal women (≥ 6 months since their last menstrual cycle) with perimenopausal symptoms, dyslipidaemia and abnormal endocrine function, aged 45‐55 years Exclusion criteria: use of steroid drugs Diagnostic criteria: not specified |
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Interventions |
Number of study centres: 1 Treatment before study: no Titration period: 3 month |
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Outcomes | Outcomes reported in abstract of publication: serum TC, HDL‐C, LDL‐C and triacylglycerol | |
Study details |
Run‐in period: no Study terminated before regular end (for benefit/because of adverse events): no |
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Publication details |
Language of publication: Chinese Commercial/non‐commercial/other funding: not reported Publication status: peer‐reviewed journal |
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Stated aim of study | Quote from publication: "To study the effects of soybean isoflavones on lipids metabolism in the perimenopausal female" | |
Notes | Baseline serum HDL‐C concentrations were very low | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Subjects were randomised to 3 groups" Comment: no information about sequence generation |
Allocation concealment (selection bias) | Unclear risk | Comment: no information about concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from publication:"The placebo group consumed the placebo capsules that looked like the isoflavones capsules" Comment: participants and personnel were potentially masked |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information about blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: number of participants analyzed was equal to the number of participants randomized |
Selective reporting (reporting bias) | Low risk | Comment: none detected |
Other bias | Low risk | Comment: no other sources of bias were found in this study |