Effect of a combination of isoflavones and Actaea racemosa Linnaeus on climacteric symptoms in healthy symptomatic perimenopausal women: a 12-week randomized, placebo-controlled, double-blind study.
OBJECTIVE
To investigate the effects of a novel dietary supplement containing soy isoflavones and Actaea racemosa Linnaeus (formerly called Cimicifuga racemosa L.) on climacteric symptoms in healthy perimenopausal women.


METHODS
In a multicenter, randomized, placebo-controlled, double-blind study, 124 women experiencing at least five vasomotor symptoms every 24 hours were randomized to receive daily either a phytoestrogen-containing supplement (n = 60) or placebo (n = 64) for 12 weeks. The modified Kupperman Index and Greene Climacteric Scale, a visual analogue scale designed to measure quality of life and the daily number and severity of hot flushes, was used in the screening period and in weeks 6 and 12. Changes in these scores from baseline were calculated.


RESULTS
At weeks 6 and 12, all scores in both groups had improved compared with baseline, though the overall difference in scores between the groups was not statistically significant.


CONCLUSIONS
The supplement containing soy isoflavones and A racemosa L. had no statistically significant effect on climacteric symptoms in perimenopausal women experiencing at least five vasomotor symptoms per day.
Verhoeven
Marieke O
MO
Project Ageing Women, Department of Obstetrics & Gynecology, VU University Medical Center, Amsterdam, The Netherlands.
van der Mooren
Marius J
MJ
van de Weijer
Peter H M
PH
Verdegem
Peter J E
PJ
van der Burgt
Leontine M J
LM
Kenemans
Peter
P
D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use; D031885:Cimicifuga; D002979:Climacteric; D019587:Dietary Supplements; D004311:Double-Blind Method; D005228:Fatty Acids, Essential / Q000627:therapeutic use; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007529:Isoflavones / Q000097:blood / Q000627:therapeutic use*; D008041:Linoleic Acids; D008875:Middle Aged; D031665:Oenothera biennis; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use; D010938:Plant Oils; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D017965:gamma-Linolenic Acid
D000975:Antioxidants; D005228:Fatty Acids, Essential; D007529:Isoflavones; D008041:Linoleic Acids; D010936:Plant Extracts; D010938:Plant Oils; C028498:evening primrose oil; D017965:gamma-Linolenic Acid