van de Weijer 2002.
Methods | Design: parallel‐group Number screened for inclusion: 42 (six ineligible, 24 did not return to clinic, tqo recorded inadequate data in diary during screening phase) Number randomly assigned: 30 Number dropped out: six (three in each group, mainly because of lack of efficacy) Number lost to follow‐up: nil Number analysed: 26 Intention‐to‐treat analysis: no Power calculation: not stated Duration: 12 weeks Timing: not stated Location: university clinic, The Netherlands Funding: industry funded (Novogen Ltd, Australia) | |
Participants | Inclusion criteria: postmenopausal women 49 to 65 years of age with at least 12 months' amenorrhoea, average of > five hot flushes daily
Exclusion criteria: HT or antibiotics within 12 weeks of study entry, undiagnosed vaginal bleeding, active liver or renal disease, history of allergy to foodstuffs, cardiovascular disease or thromboembolism
Age, years: active arm 52.5 (SD 5.2), placebo 54.2 (SD 7.4) Recruitment method: not stated |
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Interventions |
Participants given list of foods to avoid, including legumes and isoflavone supplements |
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Outcomes | Menopausal symptoms: daily diary for number of hot flushes, list of 21 symptoms to score on 4‐point scale Measures of change in quality of life | |
Notes | Baseline hot flush count = average count of last seven days from four‐week screening phase | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blank envelopes containing allocation shuffled, numbered consecutively, then given consecutively to participants |
Allocation concealment (selection bias) | Low risk | Participants took envelope to pharmacy, where number in envelope was matched with batch number of medication |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and researchers blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both participants and researchers blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition > 10% and unbalanced between groups |
Selective reporting (reporting bias) | High risk | Adverse events not reported |