Effects and safety of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women.

2008-05
Menopause (New York, N.Y.) 15(3)
- Jittima Manonai
- Apichart Chittacharoen
- Umaporn Udomsubpayakul
- Hathai Theppisai
- Urusa Theppisai

PubMed: 18202589
DOI: 10.1097/gme.0b013e31815c5fd8

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 71
Population: healthy postmenopausal women aged 45 to 60 years old
Methods: randomized, double-blind, placebo-controlled study; received 20, 30, or 50 mg Pueraria mirifica in capsules or identical placebo once daily for 24 weeks
Blinding: Double-blind
Duration: 24 weeks

Objective

To evaluate the effect of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women and to evaluate the safety of Pueraria mirifica on endometrium; breast tissue; and hematologic, hepatic, and renal systems.

Design

This was a randomized, double-blind, placebo-controlled study in a university hospital of healthy postmenopausal women aged 45 to 60 years old. Women were enrolled voluntarily and randomly received 20, 30, or 50 mg Pueraria mirifica in capsules or identical placebo once daily for 24 weeks. Outcome measures were lipid profiles, bone-specific alkaline phosphatase level, endometrial thickness, endometrial histology, breast ultrasonography, complete blood count, liver function test, and renal function test.

Results

After 24 weeks of treatment, 71 women were evaluated. Of the 71 women, 51 randomly received varying doses of Pueraria mirifica and 20 received placebo. Pueraria mirifica and placebo significantly increased triglyceride levels by 15% from baseline levels (P<0.05). The Pueraria mirifica group showed a significant decrease in bone-specific alkaline phosphatase levels after 24 weeks of treatment compared with the placebo group; from 0.22+/-0.18 U/L to 0.13+/-0.01 U/L in the Pueraria mirifica group and from 0.20+/-0.10 U/L to 0.20+/-0.14 U/L in the placebo group. Endometrial thickness did not change after treatment in both groups (P>0.05). No endometrial proliferation or hyperplasia was reported after 24 weeks of treatment in both groups. There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.

Conclusion

Pueraria mirifica at a dose of 20, 30, and 50 mg/d for a 24-week period demonstrated an estrogen-like effect on bone turnover rate. Pueraria mirifica did not demonstrate an estrogen-like effect on endometrial thickness and endometrial histology. Mild adverse effects occurred after Pueraria mirifica and placebo treatment.

Research Insights

Pueraria Mirifica→Improved Breast Tissue Structure
There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.
Effect
Neutral
Effect size
Small
Dose
20, 30, or 50 mg/day
Pueraria Mirifica→Increased Endometrial Thickness
Endometrial thickness did not change after treatment in both groups (P>0.05).
Effect
Neutral
Effect size
Small
Dose
20, 30, or 50 mg/day
Pueraria Mirifica→Increased Triglyceride Level
Pueraria mirifica and placebo significantly increased triglyceride levels by 15% from baseline levels (P<0.05).
Effect
Neutral
Effect size
Small
Dose
20, 30, or 50 mg/day
Pueraria Mirifica→Reduced Bone-Specific Alkaline Phosphatase Level
The Pueraria mirifica group showed a significant decrease in bone-specific alkaline phosphatase levels after 24 weeks of treatment compared with the placebo group; from 0.22+/-0.18 U/L to 0.13+/-0.01 U/L in the Pueraria mirifica group and from 0.20+/-0.10 U/L to 0.20+/-0.14 U/L in the placebo group.
Effect
Beneficial
Effect size
Moderate
Dose
20, 30, or 50 mg/day

Adverse Events Reported

Pueraria Mirifica→triglyceride levels
Pueraria mirifica and placebo significantly increased triglyceride levels by 15% from baseline levels (P<0.05).
Finding
Increased risk
Magnitude
15% increase from baseline levels
Significant
Yes
Pueraria Mirifica→adverse effects on breast tissue
There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.
Finding
No significant difference
Significant
No
Pueraria Mirifica→complete blood count abnormalities
There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.
Finding
No significant difference
Significant
No
Pueraria Mirifica→endometrial proliferation or hyperplasia
No endometrial proliferation or hyperplasia was reported after 24 weeks of treatment in both groups.
Finding
No significant difference
Pueraria Mirifica→endometrial thickness
Endometrial thickness did not change after treatment in both groups (P>0.05).
Finding
No significant difference
Significant
No
Pueraria Mirifica→liver function test abnormalities
There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.
Finding
No significant difference
Significant
No
Pueraria Mirifica→renal function test abnormalities
There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study.
Finding
No significant difference
Significant
No
Pueraria Mirifica→Overall tolerability
Mild adverse effects occurred after Pueraria mirifica and placebo treatment.
Finding
Reported
Grade
mild