Study Breakdown · Women’s Midlife
How did Aso’s 2012 trial test an S-equol preparation?
In a 12-week randomized trial, Aso and colleagues compared a fermented soy germ preparation called SE5-OH with placebo in postmenopausal Japanese women classified as equol nonproducers. Among the women included in the analysis, those who received SE5-OH reported a larger drop in daily hot flashes. The result applies to the preparation and population studied.
Key points
- The trial randomized 160 women. The researchers analyzed symptom outcomes for the 126 who completed the study.
- SE5-OH supplied 10 mg of S-equol per day in two doses and also contained other soy isoflavones.
- Both groups reported fewer hot flashes at week 12, with a larger average decrease in the SE5-OH group.
Scientific background
Some gut bacteria convert daidzein, a soy isoflavone, into S-equol. Aso’s team assessed this conversion with a standardized soy challenge followed by a urine test. The researchers repeated the test after a four-week placebo run-in. In this paper, “nonproducer” describes the result of that screening procedure. It does not predict an individual’s response to supplementation.
What the researchers examined
This multicentre, double-blind trial enrolled postmenopausal Japanese women who had at least one hot flash per day and met the screening criteria. The researchers assigned 77 to SE5-OH and 83 to placebo. Participants took one tablet with breakfast and one with dinner for 12 weeks. Each active tablet contained 5 mg of S-equol. The placebo used lactose in place of SE5-OH. Participants recorded hot-flash frequency in diaries, and the researchers followed them for six more weeks after treatment ended.
What the study found
By week 12, daily hot flashes had fallen by an average of 1.9 in the SE5-OH group and 1.0 in the placebo group among completers (between-group p = 0.009). These are changes from each group’s starting frequency. The study did not find a statistically significant difference in the combined frequency of daytime and nighttime sweating.
What the study does not establish
The trial compared the whole SE5-OH preparation with placebo, so it cannot isolate the effect of S-equol from that of other constituents. It did not compare SE5-OH with hormone therapy or establish long-term safety or benefit.
Limitations
The symptom analysis included 66 of the 77 women assigned to SE5-OH and 60 of the 83 assigned to placebo. The unequal exclusions can affect how well the final groups represent the people originally randomized. The study also excluded women with severe symptoms requiring treatment. Otsuka Pharmaceutical supplied SE5-OH and provided financial support. Takeshi Aso and Hiroaki Ohta disclosed consulting fees from Otsuka.
Evidence context
Branded Ingredient Evidence. This is a human randomized trial of the external SE5-OH preparation. Product identity and the screening criteria matter when considering how far the findings apply.
Relationship to DR.MORGAN
This study was not conducted on the finished DR.MORGAN product. S-EQUOL PLUS (NPN 80143622) is a separate formula. See its Product Reference for the authorized use, directions and full risk information.
Reference
Aso T, Uchiyama S, Matsumura Y, Taguchi M, Nozaki M, Takamatsu K, Ishizuka B, Kubota T, Mizunuma H, Ohta H. A natural S-equol supplement alleviates hot flushes and other menopausal symptoms in equol nonproducing postmenopausal Japanese women. Journal of Women’s Health. 2012;21(1):92–100. DOI 10.1089/jwh.2011.2753 · PubMed 21992596 · Publisher full text.