Evidence map›Paper›PMID 21693037›Full record

Trial reportReproductive biology and endocrinology : RB&E2011

Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: a randomized controlled trial.

Simone Ferrero, Pier L Venturini, David J Gillott, Valentino Remorgida

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Reproductive biology and endocrinology : RB&E, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 8 pooled it
4.3field-weighted citation impact, top 6% 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, 8 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Gonadotropin-releasing hormone analogues for endometriosis.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Pooled it
  5. Clinical practice guidelines for endometriosis in Japan (The 3rd edition).The journal of obstetrics and gynaecology research · 2022
    Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Management Challenges of Deep Infiltrating Endometriosis.International journal of fertility & sterility · 2021
    Review
  18. Article
  19. New insights on the pathogenesis of endometriosis and novel non-surgical therapiesJournal of the Turkish German Gynecological Association · 2018
    Article
  20. 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

4 authors at 3 institutions in 3 countries.

Simone FerreroDepartment of Obstetrics and Gynaecology, San Martino Hospital and University of Genoa, Italy. dr@simoneferrero.com
Pier L Venturini
David J Gillott
Valentino Remorgida
Ospedale Policlinico San Martino · ITQueen Mary University of London · GBUniversity of Genoa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhen aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.

methodsWomen with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.

resultsA total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p=0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p=0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p=0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.

conclusionsAromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

Indexed as

AdultAromatase InhibitorsDrug Therapy, CombinationDyspareuniaEndometriosisFemaleHumansLetrozoleNitrilesNorethindroneNorethindrone AcetatePatient SatisfactionPelvic PainTriazolesTriptorelin PamoateUltrasonographyAromatase InhibitorsLetrozoleNitrilesNorethindroneNorethindrone AcetateTriazolesTriptorelin Pamoate

Identifiers

PMID21693037
PMCPMC3141645
OpenAlexW2153646713

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.