Evidence map›Paper›PMID 32114477›Full record

ArticleBMJ open2020

Medroxyprogesterone acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and endometrial carcinoma: trial protocol for a prospective, randomised, open, blinded-endpoint design, dose-response trial (FELICIA trial).

Akira Mitsuhashi, Yohei Kawasaki, Makoto Hori, Tadami Fujiwara, Hideki Hanaoka, Makio Shozu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 7% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Metformin for endometrial hyperplasia.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
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  5. Review
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  7. Cancers · 2024
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  9. Article
  10. Article
  11. Review
  12. Metformin and Cancer, an Ambiguanidous Relationship.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
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  17. Article
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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 2 institutions in 1 country.

Akira MitsuhashiDepartment of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan antira@faculty.chiba-u.jp.ORCID 0000-0003-3948-9256
Yohei KawasakiBiostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.
Makoto HoriClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Tadami FujiwaraClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Hideki HanaokaClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Makio ShozuDepartment of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan.
Chiba University Hospital · JPChiba University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionProgestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC). However, the results of three meta-analyses revealed a high remission rate, as well as an association with a high rate of relapse. We previously conducted a phase II of medroxyprogesterone acetate (MPA) plus metformin as a fertility-sparing treatment for AEH and EC patients, and reported that metformin inhibited disease relapse after remission. METHODS AND ANALYSIS: A randomised, open, blinded-endpoint design phase IIb dose response trial was planned to commence in July 2019. The trial aims to identify the appropriate dose of metformin to be combined with MPA therapy for fertility ETHICS AND DISSEMINATION: The protocol was approved by the institutional review board at Chiba University Hospital and boards at 14 other institutions. The trial will be conducted according to the principles of the World Medical Association's Declaration of Helsinki and in accordance with Good Clinical Practice (GCP) standards. The trial findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT2031190065).

Indexed as

Antineoplastic Agents, HormonalEndometrial HyperplasiaEndometrial NeoplasmsFertility PreservationHypoglycemic AgentsMedroxyprogesterone AcetateMetforminAdultDisease-Free SurvivalDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesHumansProportional Hazards ModelsProspective StudiesAntineoplastic Agents, HormonalHypoglycemic AgentsMedroxyprogesterone AcetateMetforminadult oncologygynaecological oncology

Identifiers

PMID32114477
PMCPMC7050341
OpenAlexW3008446873

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.