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

Radhakrishnan 2009.

Methods Design: parallel‐group
Number randomly assigned: 100
Number dropped out: 15 (six in soy group and nine in control group)
Number analysed: 85
Intention‐to‐treat analysis: no
Power calculation: yes, 7% decrease in cholesterol with 80% power and 20% withdrawal rate
Duration: six months
Timing: not stated
Location: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India
Funding: Dupont Protein Technology International–manufactured soy and protein supplements
Participants Inclusion: last menstruation at least 12 months previous or six weeks since bilateral oophorectomy; FSH level 40 mlU/mL; unwillingness to take or intolerance to HT; not currently taking lipid‐lowering drugs, antidiabetic medications or herbal supplements; discontinued HT more than three months previously
Exclusion: unexplained vaginal bleeding, hypertension, diabetes, liver dysfunction, renal or cardiac disease, active thromboembolic disease, deep vein thrombosis, coronary artery disease, cerebrovascular accident or past history of thromboembolic disease associated with oestrogen use; present or past oestrogen‐dependent malignancy such as breast or endometrial carcinomas, known peanut/legume allergy
Mean age, years: 48.07 ± 5.44 in the soy group; 49.71 ± 7.27 in the placebo group
Recruitment method: from outpatient clinic
Interventions
  • Soy group (n = 50): sachets containing 25 g of isoflavone‐rich soy protein isolate with 75 mg of isoflavones in powder form, sweetened with aspartase with mild vanilla flavour

  • Placebo group (n = 50): sachets containing 25 mg of milk protein, which looked and tasted identical to the soy supplement

    • Both sachets contained equal amounts of elemental calcium (900 mg) and other trace elements and vitamins

    • Followed up at baseline and at three and six months

Outcomes Kupperman Menopausal Index
Karyopyknotic Index
Maturation value
Endometrial thickness
Laboratory investigations
Bone mineral density
Acceptability of treatment
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned using computer‐generated randomised numbers in blocks of 10
Allocation concealment (selection bias) Low risk Precoded sachets were provided by DUPONT Protein Technology International
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Stated as double‐blind
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Stated as double‐blind
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 15 stopped the trial prematurely during the initial two months: six in the study group and nine in the control group. Main reasons were gastrointestinal side effects and food intolerance. Three cases in each group were lost to follow‐up
Selective reporting (reporting bias) Low risk Original protocol not viewed. Outcomes listed in the methods sections were reported in the results