Evidence map›Paper›PMID 29310653›Full record

Trial reportNutrition journal2018

Effect of soy lecithin on fatigue and menopausal symptoms in middle-aged women: a randomized, double-blind, placebo-controlled study.

Asuka Hirose, Masakazu Terauchi, Yurika Osaka, Mihoko Akiyoshi, Kiyoko Kato, Naoyuki Miyasaka

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

Trial report in Nutrition journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 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.ORCID 0000-0001-5577-0094
Yurika OsakaDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Mihoko AkiyoshiDepartment of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Kiyoko KatoDepartment of Women's Health, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
Naoyuki MiyasakaDepartment 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

backgroundLecithin is a complex mixture of phospholipids which compose lipid bilayer cell membranes. Lipid replacement therapy, or administration of phospholipids for the purpose of repairing the dmaged cell membranes, had been shown to alleviate fatigue. The present study aimed to investigate the effect of soy lecithin on fatigue in middle-aged women, as well as other menopausal symptoms and various health parameters.

methodsThis randomized, double-blind, placebo-controlled study included 96 women aged 40 to 60 years who complained of fatigue. The participants were randomized to receive active tablets containing high-dose (1200 mg/day; n = 32) or low-dose (600 mg/day; n = 32) soy lecithin, or placebo (n = 32), for 8 weeks. The following parameters were evaluated: age, menopausal status, lifestyle factors, physical and psychological symptoms of menopause, subjective symptoms of insomnia and fatigue, body composition, cardiovascular parameters, and physical activities and objective sleep states obtained from actigraphy before and 4 and 8 weeks after treatment. Fatigue was evaluated using the Profile of Mood States (POMS)-brief, Menopausal Health-Related Quality of Life questionnaire, Chalder Fatigue Scale, and Brief Fatigue Inventory.

resultsEighty-nine women completed the study. There were no significant differences in the changes in Chalder Fatigue Scale score (placebo vs low-dose vs high-dose groups: -2.9 ± 1.1, -3.2 ± 1.1, and -3.5 ± 1.0; P = 0.79). On the other hand, the improvements were greater in the high-dose group compared with the placebo group concerning vigor scores in the POMS-brief (1.9 ± 0.7 vs 0.2 ± 0.6; P = 0.02), diastolic blood pressure (-4.1 ± 1.8 vs 1.2 ± 1.9; P = 0.05), and cardio-ankle vascular index (-0.4 ± 0.2 vs 0.07 ± 0.1; P = 0.03) after 8 weeks of treatment.

conclusionsHigh-dose (1200 mg/day) soy lecithin not only increases vigor, but also lowers the diastolic blood pressure and cardio-ankle vascular index in middle-aged women who present with fatigue.

trial registrationUMIN-CTR UMIN000017127 .

Indexed as

MenopauseAnxietyDepressionDose-Response Relationship, DrugDouble-Blind MethodFatigueFemaleGlycine maxHot FlashesHumansJapanLecithinsMental DisordersMiddle AgedSleep Initiation and Maintenance DisordersLecithinsAtherosclerosisCardiovascular risksFatigueLipid replacement therapyMenopausal symptomsPsychological symptomsSoy

Identifiers

PMID29310653
PMCPMC5757297
OpenAlexW2783469595

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.