title: Isoflavones for hypercholesterolaemia in adults.
abstract: BACKGROUND
  Hypercholesterolaemia is a significant risk factor for cardiovascular diseases. Isoflavones may be effective in improving hypercholesterolaemia.
  
  
  OBJECTIVE
  To assess the effects of isoflavones for hypercholesterolaemia.
  
  
  METHODS
  We searched the following databases: The Cochrane Library (Issue 9, 2012), MEDLINE, EMBASE, Chinese BioMedical Database and China National Knowledge Infrastructure (all to September 2012).
  
  
  METHODS
  We considered randomized controlled clinical trials in hypercholesterolaemic participants comparing isoflavones versus placebo, or soy isolated protein added with isoflavones versus soy isolated protein alone.
  
  
  METHODS
  Two review authors independently abstracted relevant population and intervention characteristics. We resolved any disagreements through discussion, or if required by a third party. We assessed the risk of bias of trials against key criteria: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other sources of bias.
  
  
  RESULTS
  We included five randomized trials (208 participants, 104 in the intervention group and 104 in the control group). Interventions ranged from three to six months. Four trials reported results in non-Asian populations published in English. One trial reported results in Chinese people published in Chinese. Overall, the risk of bias of included trials was high or unclear. There were no outcome data on death from any cause, morbidity, complications, health-related quality of life and costs. Two trials reported adverse effects, including gastrointestinal discomfort (bloating and constipation) and an increased number of hot flushes. None of the trials found serious adverse events. There was a slight significant effect on triglycerides in favour of isoflavones when compared with placebo (mean difference (MD) -0.46 mmol/L (95% confidence interval (CI) -0.84 to -0.09; P = 0.02; 52 participants; 2 trials). No statistically significant effects on total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol were shown in favour of isoflavones.
  
  
  CONCLUSIONS
  We found no evidence for effects of isoflavones on patient-important outcomes or lowering of cholesterol levels in people with hypercholesterolaemia. Our findings have to be interpreted with caution due to high or unclear risk of bias in several risk of bias domains, and low number of participants in trials.
authors.affiliation: Nutrition, Third Military Medical University, Chongqing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Qin
authors.forename: Kai
authors.initials: K
authors.lastname: Niu
authors.forename: Yuan
authors.initials: Y
authors.lastname: Zeng
authors.forename: Peng
authors.initials: P
authors.lastname: Liu
authors.forename: Long
authors.initials: L
authors.lastname: Yi
authors.forename: Ting
authors.initials: T
authors.lastname: Zhang
authors.forename: Qian Yong
authors.initials: QY
authors.lastname: Zhang
authors.forename: Jun Dong
authors.initials: JD
authors.lastname: Zhu
authors.forename: Man Tian
authors.initials: MT
authors.lastname: Mi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D007529:Isoflavones / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D030262:Soybean Proteins / Q000627:therapeutic use*
chemical_list: D007529:Isoflavones; D030262:Soybean Proteins