Evidence map›Paper›PMID 37118716›Full record

Trial reportBMC complementary medicine and therapies2023

Effect of γ-tocopherol supplementation on premenstrual symptoms and natriuresis: a randomized, double-blind, placebo-controlled study.

Tomoko Higuchi, Tomomi Ueno, Shigeto Uchiyama, Shunji Matsuki, Mariko Ogawa, Kiyoshi Takamatsu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary medicine and therapies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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 3 institutions in 1 country.

Tomoko HiguchiSaga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., 5006-5 Yoshinogari, Kanzaki-Gun, Saga, 842-01, Japan. Higuchi.Tomoko@otsuka.jp.
Tomomi UenoSaga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., 5006-5 Yoshinogari, Kanzaki-Gun, Saga, 842-01, Japan.
Shigeto UchiyamaSaga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., 5006-5 Yoshinogari, Kanzaki-Gun, Saga, 842-01, Japan.
Shunji MatsukiSouseikai Sugioka Memorial Hospital (Currently Souseikai Fukuoka Mirai Hospital) Clinical Research Center, Fukuoka, Japan.
Mariko OgawaDepartment of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan.
Kiyoshi TakamatsuDepartment of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan.
Otsuka (Japan) · JPTokyo Dental College Ichikawa General Hospital · JPSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomized, double-blind, placebo-controlled study aimed to investigate the effects of γ-tocopherol (Toc) supplementation on premenstrual symptoms and natriuresis.

methodsWe enrolled 51 Japanese women with premenstrual symptoms, particularly those who showed increased symptoms induced by water retention during the luteal phase compared with the follicular phase. Premenstrual symptoms were recorded in the first cycle's postmenstrual follicular phase; physical measurements and urine collection were conducted during the 48-h run-in period. The test supplement, which contained 180 mg of γ-Toc or placebo, was orally administered twice a day for 7 days during the luteal phase of the first and second cycles in a crossover manner. The same evaluation was conducted during the luteal phase, beginning in the morning of the sixth day of supplement administration.

resultsCompared with placebo intake, γ-Toc intake significantly reduced "fatigue" and "irritability/anger" symptoms. Furthermore, compared with placebo intake, γ-Toc intake significantly reduced the thigh circumference. Regarding the "swelling of the legs" and "heavy legs" symptoms and the thigh circumference, the biphasic trend of increasing and decreasing values in the daytime and morning, respectively, during the follicular phase was not observed at the luteal phase with placebo intake. Contrastingly, γ-Toc intake resulted in significantly lower values in the morning than placebo intake. The mean difference in 24-h urinary sodium excretion between γ-Toc and placebo intake was 10.6 mEq (95% confidence interval (CI): -0.1, 21.4, p = 0.05, power 55%). Plasma γ-Toc and its metabolite γ-carboxyethyl hydroxychroman (CEHC) levels were significantly higher with γ-Toc intake than with placebo intake. There were no significant between-supplement differences in serum electrolyte levels or cumulative urinary potassium excretion.

conclusionγ-Toc intake could effectively alleviate certain premenstrual syndrome symptoms, particularly those related to water retention during the luteal phase. Furthermore, the underlying mechanism may involve the diuretic effect of γ-CEHC, which is a γ-Toc metabolite.

trial registrationUMIN000047989; registration date: 10/06/2022, retrospectively registered.

Indexed as

gamma-TocopherolPremenstrual SyndromeDietary SupplementsFemaleHumansNatriuresisWatergamma-TocopherolWaterPremenstrual symptomsWater retentionγ-carboxyethyl hydroxychromanγ-tocopherol

Identifiers

PMID37118716
PMCPMC10148532
OpenAlexW4367312872

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.