Evidence map›Paper›PMID 26927501›Full record

Trial reportJournal of pediatric and adolescent gynecology2017

The Effects of Gonadotropin-Releasing Hormone Agonist Combined with Add-Back Therapy on Quality of Life for Adolescents with Endometriosis: A Randomized Controlled Trial.

Jenny Sadler Gallagher, Henry A Feldman, Natalie A Stokes, Marc R Laufer, Mark D Hornstein, Catherine M Gordon, Amy D DiVasta

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric and adolescent gynecology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 4% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Endometriosis During Adolescence: A Narrative Review.Journal of clinical medicine · 2025
    Review
  4. Observational
  5. Review
  6. Review
  7. Article
  8. Dysmenorrhea, Endometriosis and Chronic Pelvic Pain in AdolescentsJournal of clinical research in pediatric endocrinology · 2020
    Article
  9. Article
  10. 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

7 authors at 4 institutions in 1 country.

Jenny Sadler GallagherDivision of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts. Electronic address: jenny.sadler@childrens.harvard.edu.
Henry A FeldmanClinical Research Program, Boston Children's Hospital, Boston, Massachusetts.
Natalie A StokesUniversity of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Marc R LauferBoston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.
Mark D HornsteinBoston Center for Endometriosis, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.
Catherine M GordonDivision of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
Amy D DiVastaDivision of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts.
Boston Children's Hospital · USBrigham and Women's Hospital · USUniversity of Cincinnati · USUniversity of Pennsylvania · US

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
Pediatrician-Scientist Training ProgramT32HD043034 · NICHD · CHILDREN'S HOSPITAL BOSTON · PI FLEISHER, GARY ROBERT · 2003 to 2007
$1.1M
Biomechanical Stimulation & Skeletal Health in Adolescents with Anorexia NervosaK23HD060066 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI DIVASTA, AMY D · 2009 to 2013
$656k
NCRR NIH HHS UL1 RR025758NICHD NIH HHS K23 HD060066NICHD NIH HHS T32 HD043034
6 · The paper itself

Abstract

STUDY

objectiveUse of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis.

designTwelve-month double-blind, placebo-controlled trial.

settingPediatric Gynecology clinic in Boston, Massachusetts.

participantsFifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa.

interventionsSubjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months.

main outcome measuresThe Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals.

resultsAt baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (P

conclusionFemale adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHa combined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL.

Indexed as

Quality of LifeAdolescentBostonContraceptives, Oral, SyntheticDouble-Blind MethodDrug Therapy, CombinationEndometriosisEstrogensEstrogens, Conjugated (USP)FemaleGonadotropin-Releasing HormoneHumansLeuprolideNorethindroneNorethindrone AcetatePainContraceptives, Oral, SyntheticEstrogensEstrogens, Conjugated (USP)Gonadotropin-Releasing HormoneLeuprolideNorethindroneNorethindrone AcetateAdd-back therapyAdolescenceEndometriosisGonadotropin releasing hormone agonistQuality of life

Identifiers

PMID26927501
PMCPMC5001926
OpenAlexW2284702379

What OpenQuestion holds

Textmetadata
LicenceTDM
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.