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

Colli 2012.

Methods Design: parallel‐group randomised placebo‐controlled trial
Number of women randomly assigned: 90
Number of women analysed: 75
Intention‐to‐treat analysis: no
Power calculation for sample size: no
Duration: six months
Timing: October 2009 to March 2010
Location: gynaecology service in Parana, Brazil
Funding: Conselho Nacional de Desenvolvimiento Cientifico e Tecnologico
Participants Inclusion criteria: women 46 to 68 years of age; FSH > 40 mIU/L, oestradiol < 30 pg/mL, amenorrhoea > 12 months; climacteric symptoms
Exclusion criteria: one or more contraindications to the use of synthetic HT, use of any synthetic HT in the past six months; use of antibiotics in past six months; signs of gastrointestinal malabsorption syndrome
Mean age of participants, years: 54 to 57
Recruitment: from gynaecology clinic
Interventions

  • Flaxseed extract (two 500‐mg capsules daily, with each capsule containing 50 mg of standardised lignan)

  • Flaxseed meal (two tbsp (45 g) of ground whole flaxseed corresponding to 270 mg lignan)

  • Placebo (two 500‐mg capsules of collagen daily)

    • Capsules taken in the morning before the first meal, and ground flaxseed mised with milk, yogurt or juice
Outcomes

  • Hot flash score (intensity)

  • Kupperman Index score

  • Vaginal epithelial maturation value

  • Endometrial thickness

  • Adverse events
Notes Group 2 was not blinded, as the women took a different product from placebo
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly distributed": method not described
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Group 1 blinded but group 2 not blinded (non‐identical placebo)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk Substantial dropouts with no reasons stated and uneven between groups
Selective reporting (reporting bias) Low risk All prespecified outcomes reported