The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding), by indirectness (all participants were postmenopausal women and most of the participants were recruited from non-Asian populations), and by imprecise results (few patients).
A Cochrane review [Abstract] 1 included 5 studies with a total of 208 subjects. The participants in the included trials were postmenopausal women, and the interventions ranged from 3 to 6 months. Three studies used isoflavones interventions and placebo controls, and 2 studies used soy protein-containing isoflavones and compared this with soy isolated protein plus less than 4 mg isoflavones/day. Isoflavones are plant-based chemicals related to phyto-oestrogen, which are found in soy and red clover. Asian people consume more isoflavones from their regular diet than Western people. Four studies reported results in non-Asian populations published in English and one study reported results in Chinese people published in Chinese. The Chinese study was excluded from meta-analysis due to substantial differences in clinical characteristics of participants. There were no outcome data on death from any cause, morbidity, complications, health-related quality of life and costs.
Compared with placebo, there was a statistically significant effect of isoflavones alone on triglycerides (MD -0.46 mmol/L, 95% CI -0.84 to -0.09; 2 studies, n=52) and no statistically significant effect on total cholesterol, LDL-cholesterol or HDL-cholesterol. There was no statistically significant effect of soy protein containing isoflavones on hypercholesterolaemia. Combined results for isoflavones versus placebo or soy protein + isoflavones versus soy protein are shown in table T1.
Outcome | Participants (studies) | Mean difference (95% CI) |
---|---|---|
Total cholesterol | 166 (4) | -0.08 (-0.34 to 0.19) |
LDL-cholesterol | 132 (3) | -0.16 (-0.39 to 0.07) |
HDL-cholesterol | 132 (3) | -0.03 (-0.22 to 0.16) |
Triglycerides | 165 (4) | -0.15 (-0.43 to 0.13) |
Two studies reported adverse effects, including gastrointestinal discomfort (bloating and constipation) and an increased number of hot flushes. None of the trials found serious adverse events.
Date of latest search:
Primary/Secondary Keywords