Evidence map›Paper›PMID 26294070›Full record

Trial reportArchives of gynecology and obstetrics2016

Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study.

Asuka Hirose, Masakazu Terauchi, Mihoko Akiyoshi, Yoko Owa, Kiyoko Kato, Toshiro Kubota

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Asuka HiroseDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Masakazu TerauchiDepartment of Women's Health, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan. teragyne@tmd.ac.jp.
Mihoko AkiyoshiDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Yoko OwaDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Kiyoko KatoDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Toshiro KubotaDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Tokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMany studies have demonstrated the effectiveness of isoflavones on menopausal symptoms; however, these mostly used high dosages. Because high-dose isoflavone may result in endometrial hyperplasia, we investigated whether low-dose isoflavone aglycone alleviates menopausal symptoms similarly to high dosages.

methodsWe conducted a randomized, double-blind, placebo-controlled study in 90 healthy women aged 40-60 years who had at least one menopausal symptom on the Menopausal Symptom Scale (MSS). The participants were randomized to receive active tablets containing ultralow-dose (12.5 mg/day; n = 30) or low-dose (25 mg/day; n = 30) isoflavone aglycone, or placebo (n = 30) tablets, for 8 weeks. Their menopausal symptoms were evaluated using MSS, Hospital Anxiety and Depression Scale (HADS), and Athens Insomnia Scale (AIS) before, and 4 and 8 weeks after treatment.

resultsEighty-seven women (97 %) completed the 8-week treatment. In the low-dose group, significant improvement was observed from baseline, in the following parameters: (1) HADS-depression subscale score, (2) AIS score, (3) MSS-somatic symptom score after 4 and 8 weeks of treatment, and (4) MSS-vasomotor symptom score after 8 weeks of treatment. The changes in scores on HADS-depression subscale and AIS from baseline to 8 weeks were significantly higher in the low-dose group than in the placebo group.

conclusionsLow-dose (25 mg/day) isoflavone aglycone significantly alleviated symptoms of depression and insomnia in Japanese middle-aged women. Clinical Trial Registration UMIN-CTR UMIN000011876.

Indexed as

AdultAnxietyDepressionDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansIsoflavonesJapanMenopauseMiddle AgedSleep Initiation and Maintenance DisordersTreatment OutcomeIsoflavonesDepressionFlavonoidsInsomniaMoodSleep

Identifiers

PMID26294070
PMCPMC4757620
OpenAlexW1847568498

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.