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 |
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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 |
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Interventions |
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Outcomes | Kupperman Menopausal Index Karyopyknotic Index Maturation value Endometrial thickness Laboratory investigations Bone mineral density Acceptability of treatment |
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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 |