Evidence map›Paper›PMID 34016111›Full record

Trial reportBMC women's health2021

Anastrozole and levonorgrestrel-releasing intrauterine device in the treatment of endometriosis: a randomized clinical trial.

Pedro Acién, Irene Velasco, Maribel Acién

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC women's health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 21% 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, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Review
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

3 authors at 2 institutions in 1 country.

Pedro AciénDepartment/Division of Gynecology, Miguel Hernández University, San Juan Campus, 03550, San Juan, Alicante, Spain. acien@umh.es.ORCID 0000-0002-5773-1862
Irene VelascoObstetrics and Gynecology Service, San Juan University Hospital, 03550, San Juan, Alicante, Spain.
Maribel AciénDepartment/Division of Gynecology, Miguel Hernández University, San Juan Campus, 03550, San Juan, Alicante, Spain.
Universitat de Miguel Hernández d'Elx · ESHospital Universitari Sant Joan D'Alacant · ES

Funding

FIS PI07/0417 y PI10/01815
6 · The paper itself

Abstract

backgroundTo study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.

methodsProspective, randomized clinical trial.

settingUniversity Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms. PATIENTS: Thirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7).

interventionsAnastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment.

main outcome measuresVisual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.

resultsA significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57-4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019).

conclusionsDosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

trial registrationEudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

Indexed as

Contraceptive Agents, FemaleEndometriosisIntrauterine DevicesIntrauterine Devices, MedicatedAnastrozoleFemaleHumansLevonorgestrelLondonProspective StudiesAnastrozoleContraceptive Agents, FemaleLevonorgestrelAnastrozoleAromatase inhibitorsClinical trialEndometriomasEndometriosisLevonorgestrel-IUD

Identifiers

PMID34016111
PMCPMC8138989
OpenAlexW2988425880

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.