Evidence map›Paper›PMID 36800940›Full record

ArticleBMC geriatrics2023

Protocol for a randomised, placebo-controlled, double-blinded clinical trial on the effect of oestrogen replacement on physical performance to muscle resistance exercise for older women with osteoarthritis of knee joint: the EPOK trial.

Tomohiro Mitoma, Jota Maki, Hikaru Ooba, Eriko Eto, Kasumi Takahashi, Tsunemasa Kondo, Tomohiro Ikeda, Yoko Sakamoto, Toshiharu Mitsuhashi, Hisashi Masuyama

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC geriatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 17β-Estradiol Effects in Skeletal Muscle: ADiagnostics (Basel, Switzerland) · 2024
    Article
  5. Review
  6. 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

10 authors at 2 institutions in 1 country.

Tomohiro MitomaDepartment of Obstetrics and Gynecology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Jota MakiDepartment of Obstetrics and Gynecology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Hikaru OobaDepartment of Obstetrics and Gynecology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Eriko EtoDepartment of Obstetrics and Gynecology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Kasumi TakahashiDepartment of Obstetrics and Gynecology, Ochiai Hospital, Okayama, Japan.
Tsunemasa KondoDepartment of Obstetrics and Gynecology, Ochiai Hospital, Okayama, Japan.
Tomohiro IkedaDepartment of Rehabilitation Medicine, Okayama University, Okayama, Japan.
Yoko SakamotoCenter for Innovative Clinical Medicine, Okayama University, Okayama, Japan.
Toshiharu MitsuhashiCenter for Innovative Clinical Medicine, Okayama University, Okayama, Japan.
Hisashi MasuyamaDepartment of Obstetrics and Gynecology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan. epoktrial@gmail.com.
Okayama University · JPOkayama Rosai Hospital · JP

Funding

Japan Society for the Promotion of Science 22K1777604
6 · The paper itself

Abstract

backgroundKnee osteoarthritis (KOA) is highly prevalent in older women, and previous studies suggest the involvement of hormonal factors play a role in the pathogenesis of osteoarthritis. KOA causes musculoskeletal impairment, resulting in decreased physical activity, muscle mass, and strength, which leads to sarcopenia and further increases the burden on healthcare systems. Oestrogen replacement therapy (ERT) improves joint pain and muscle performance in early menopausal women. Muscle resistance exercise (MRE) is a non-pharmacological method that preserves the physical functions of patients with KOA. However, data on short-term oestrogen administration combined with MRE in postmenopausal women, especially in those aged > 65 years, are limited. Therefore, this study presents a protocol of a trial aimed to examine the synergistic effect of ERT and MRE on lower-limb physical performance in older women with KOA.

methodsWe will conduct a double-blinded, randomised placebo-controlled trial in 80 Japanese women aged > 65 years living independently with knee pain. The participants will be randomly categorised into two groups: (1) 12-week MRE programme with transdermal oestrogen gel containing 0.54 mg oestradiol per push and (2) 12-week MRE programme with placebo gel. The primary outcome measured using the 30-s chair stand test, and secondary outcomes (body composition, lower-limb muscle strength, physical performance, self-reported measure of knee pain, and quality of life) will be measured at baseline, 3 months, and 12 months, and these outcomes will be analysed based on the intention-to-treat. DISCUSSION: The EPOK trial is the first study to focus on the efficacy of ERT on MRE among women aged > 65 years with KOA. This trial will provide an effective MRE to prevent KOA-induced lower-limb muscle weakness, confirming the benefit of short-term oestrogen administration.

trial registrationJapan Registry of Clinical Trials: jRCTs061210062. Registered 17th December 2021, https://jrct.niph.go.jp/en-latest-detail/jRCTs061210062 .

Indexed as

Osteoarthritis, KneeResistance TrainingAgedEstrogen Replacement TherapyEstrogensExercise TherapyFemaleHumansMusclesPainPhysical Functional PerformanceQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeEstrogensKnee osteoarthritisMuscle resistance exerciseOestrogen replacement therapyPhysical performanceSarcopenia

Identifiers

PMID36800940
PMCPMC9938988
OpenAlexW4321328472

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.