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. 2013 Dec 10;2013(12):CD001395. doi: 10.1002/14651858.CD001395.pub4

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
Interventions
  • Phytoestrogen: isoflavones

    • Formulation: Promensil 40‐mg tablets (daidzein, genistein, biochanin, formononetin)

  • Placebo tablets

    • Dose, duration and timing of administration: two tablets each morning for 12 weeks


Participants given list of foods to avoid, including legumes and isoflavone supplements
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