Evidence map›Paper›PMID 26181088›Full record

Trial reportObstetrics and gynecology2015

Hormonal Add-Back Therapy for Females Treated With Gonadotropin-Releasing Hormone Agonist for Endometriosis: A Randomized Controlled Trial.

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

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00474851 (The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis), which is not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
8.0field-weighted citation impact, top 3% 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.

NCT00474851 phase2completednot on this map

The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial

TypeinterventionalSponsorBoston Children's HospitalRan2007 to 2015Enrolled53ConditionsEndometriosisArmsNorethindrone acetate + estrogens, norethindrone acetate + placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. 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 1 institution in 1 country.

Amy D DiVastaDivision of Adolescent Medicine, the Division of Gynecology, and the Clinical Research Program, Children's Hospital Boston, the Boston Center for Endometriosis, and the Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts; the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; and the Divisions of Adolescent Medicine and Endocrinology, Hasbro Children's Hospital, Providence, Rhode Island.
Henry A Feldman
Jenny Sadler Gallagher
Natalie A Stokes
Marc R Laufer
Mark D Hornstein
Catherine M Gordon
Island Institute · 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 RR-025758NCRR NIH HHS UL1 RR025758NICHD NIH HHS K23 HD060066NICHD NIH HHS T32 HD043034
6 · The paper itself

Abstract

objectiveTo assess whether add-back therapy with norethindrone acetate or norethindrone acetate plus conjugated equine estrogens is superior to maintain bone health in adolescents and young women using gonadotropin-releasing hormone agonists for endometriosis. Gonadotropin-releasing hormone agonists are associated with deleterious effects on bone. Hormonal add-back may mitigate these effects.

methodsAdolescents and young women (n=51) received a random, double-blind assignment to add-back with norethindrone acetate (5 mg/day) plus conjugated equine estrogens (0.625 mg/day) or norethindrone acetate plus placebo for 12 months. Body composition, bone mineral content, and bone mineral density (BMD) were obtained by dual-energy X-ray absorptiometry every 6 months. Quality-of-life measures were collected every 3 months. Intention-to-treat comparison of outcomes was conducted by repeated-measures analysis of variance.

resultsThirty-four adolescents and young women completed the trial; dropouts did not differ from those who completed the trial. Bone mineral density was normal at baseline. At 12 months, total body bone mineral content and BMD had increased in the norethindrone acetate plus conjugated equine estrogens group (bone mineral content +37 g, P<.001 and BMD +0.012 g/cm, P=.05), but not in those receiving norethindrone acetate plus placebo (bone mineral content P=.19 and BMD P=.95). Lean mass increased only in those receiving conjugated equine estrogens (+1.4 kg, P=.001). Improvements in physical functioning domains of quality-of-life assessments were greater with norethindrone acetate plus conjugated equine estrogens (P=.005). No differences were seen at the hip or lumbar spine by dual-energy X-ray absorptiometry. No significant adverse events occurred.

conclusionHormonal add-back successfully preserved bone health and improved quality of life for adolescents and young women with endometriosis during 12 months of gonadotropin-releasing hormone agonist therapy. Combination norethindrone acetate plus conjugated equine estrogens add-back appears to be more effective for increasing total body bone mineral content, areal BMD, and lean mass than norethindrone acetate monotherapy. CLINICAL

trial registrationClinicalTrials.gov; www.clinicaltrials.gov, NCT00474851. LEVEL OF EVIDENCE: I.

Indexed as

Quality of LifeAbsorptiometry, PhotonAdolescentBone DensityBone ResorptionDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEndometriosisEstrogens, Conjugated (USP)FemaleFollow-Up StudiesGonadotropin-Releasing HormoneHumansNorethindroneEstrogens, Conjugated (USP)Gonadotropin-Releasing HormoneNorethindroneNorethindrone Acetate

Identifiers

PMID26181088
PMCPMC4545413
OpenAlexW951303760

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.