Table 2.

Randomized, Controlled Trials of Red Clover for Lipids in postmenopausal women

Author, year	Design	Subjects	Intervention type, dose, and duration	Outcome
Campbell, 2004 41	RCT with crossover. 2 interventions were placebo and Promensil®.	Pre and postmenopausal women Mean age=57 (postmenopausal women) n=7 (postmenopausal women)	Women took two tablets each day of Promensil. Duration: 1 month	postmenopausal women only Total cholesterol and triglycerides not affected by treatment. HDL concentrations were significantly elevated over placebo.
Clifton-Bligh, 2001 42	RCT with 3 groups. One month of placebo period followed by 6 months of treatment and 1 month of placebo washout. Placebo periods were single blinded.	Postmenopausal women Mean age range 55–59 n=46	The three doses of Rimostil were: 28 mg/d, 57 mg/d, and 85.5 mg/d of isoflavones. Duration: 6 months	Serum HDL rose significantly with all three doses, but no dose-response effect. Safety: endometrial thickness did not change significantly during treatment.
Schult, 2004 43	RCT with 3 groups: Promensil®, Rimostil®, and placebo	Perimenopausal women Ages 45–60 n=250	Promensil: Red clover extract with 41 mg isoflavones per tablet Rimostil: Red clover extract with 28.6 mg isoflavones per tablet. Two tablets per day of each treatment. Duration: 12 weeks	Both extracts showed a significant decrease in triglyceride levels compared to placebo--decrease mainly among women with elevated triglycerides at baseline. Both extracts showed higher increases in HDL cholesterol compared placebo--increase of small magnitude and not significant.
Nestel, 1999 44	RCT with 2 groups: placebo or increasing does of isoflavone	Postmeneopausal women Ages 41–71 N=17	Promensil containing 40g of isoflavone was used. Active therapy group took 1 tablet Promensil for 5 weeks, then 2 tablets for another 5 weeks. Duration: 10 weeks total	No significant differences in plasma lipids with treatment. Over time a downward trend in LDL and an upward trend in HDL, reducing the LDL/HDL ratio by 10% in treatment vs. control (not statistically significant).
Atkinson, 2004 45	RCT with 2 groups: Placebo or isoflavone tablet	Pre, peri, and postmenopausal women Ages 49–65 N=205	Promensil tablet was uses as treatment. One tablet per day in intervention group. Duration: 12 months	No significant differences overall in total cholesterol, LDL, triglycerides, or HDL between treatments. Significant interaction between treatment and menopausal status for triglycerides only. Perimenopausal women taking isoflavone experienced a significant decrease in plasma triglycerides.
Howes, 2000 46	RCT with 2 groups placebo or increasing doses of isoflavone. Active: control group ratio of 6:1	Postmenopausal women Hypercholesterolemic Mean age=58.3 N=75	One isoflavone tablet contained 26 mg biochanin A, 16 mg formononetin, 0.5 mg daidzein, and 1mg genistein. Isoflavones were extracted from red clover. Active therapy group took 1 tablet for 5 weeks, then 2 tablets for an additional 5 weeks Duration: 10 weeks total	In both the active and control groups, no significant changes in total cholesterol, triglycerides, HDL, or LDL cholesterol.

^*Abbreviations: RCT=Randomized Controlled Trial