Evidence map›Paper›PMID 21865352›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2011

A randomized pilot study of monthly cycled testosterone replacement or continuous testosterone replacement versus placebo in older men.

Melinda Sheffield-Moore, E Lichar Dillon, Shanon L Casperson, Charles R Gilkison, Douglas Paddon-Jones, William J Durham, James J Grady, Randall J Urban

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 9% 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

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Translational studies in older men using testosterone to treat sarcopenia.Transactions of the American Clinical and Climatological Association · 2014
    Trial
  11. Trial
  12. Article
  13. Article
  14. The Roles of Androgens in Humans: Biology, Metabolic Regulation and Health.International journal of molecular sciences · 2022
    Review
  15. The Role of Testosterone in the Elderly: What Do We Know?International journal of molecular sciences · 2022
    Review
  16. Article
  17. Article
  18. Article
  19. Review
  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

8 authors at 1 institution in 1 country.

Melinda Sheffield-MooreDepartment of Internal Medicine, The University of Texas Medical Branch at Galveston, Texas 77555, USA.
E Lichar Dillon
Shanon L Casperson
Charles R Gilkison
Douglas Paddon-Jones
William J Durham
James J Grady
Randall J Urban
The University of Texas Medical Branch at Galveston · US

Funding

ZOLLINGER-ELLISON SYNDROME AND DUODONAL ULCER DISEASEM01RR000073 · NCRR · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI ANDERSON, KARL ELMO · 1985 to 2009
$31.3M
UTMB OAIC Research Education Component (REC)P30AG024832 · NIA · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI JAMES S. GOODWIN, MD, MELISSA M. MORROW · 2005 to 2026
$26.7M
UTMB CLINICAL AND TRANSLATIONAL SCIENCE AWARD: NASA BED REST STUDIESUL1RR029876 · NCRR · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2009 to 2011
$17.7M
UTMB Clinical and Translational Science AwardUL1TR000071 · NCATS · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2012 to 2014
$14.4M
Cyclic Testosterone on muscle function in older menR01AG022023 · NIA · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI URBAN, RANDALL J · 2004 to 2009
$1.6M
NCATS NIH HHS UL1 TR000071NCRR NIH HHS M01 RR000073NCRR NIH HHS M01 RR 00073NCRR NIH HHS UL1 RR029876NIA NIH HHS P30 AG024832NIA NIH HHS R01 AG022023
6 · The paper itself

Abstract

contextCycling androgens has been reported by athletes to improve physical performance by enhancing muscle mass and strength, a paradigm that has not been studied, and may have clinical value in older men being treated with testosterone.

objectiveWe investigated the efficacy of a monthly cycled testosterone regimen that uses half the testosterone dose as the current standard of care continuous therapy on body composition and muscle strength in older men. DESIGN, SETTING, AND PATIENTS: Twenty-four community-dwelling older men 70 ± 2 yr of age with total testosterone levels below 500 ng/dl were randomized at the Institute for Translational Sciences-Clinical Research Center into a 5-month double-blind placebo-controlled trial.

interventionSubjects were dosed weekly for 5 months, receiving continuous testosterone (TE, n = 8; 100 mg testosterone enanthate, im injection), monthly cycled testosterone (MO, n = 8; alternating months of testosterone and placebo), or placebo (PL, n = 8).

main outcome measuresMain outcomes included body composition by dual-energy x-ray absorptiometry and upper and lower body muscle strength. Secondary outcomes included body weight, serum hormones, and mixed-muscle protein fractional synthesis rate (FSR).

resultsTotal lean body mass was increased and percent fat was reduced after 5 months in TE and MO (P < 0.05). Upper body muscle strength increased in TE, and lower body muscle strength increased in TE and MO (P < 0.05). FSR increased in TE and MO (P < 0.05) but not in PL.

conclusionsCycled testosterone improved body composition and increased muscle strength compared with placebo and increased FSR similarly to continuous testosterone.

Indexed as

AgedAndrogensBody CompositionBody WeightDrug Administration ScheduleHormone Replacement TherapyHumansMaleMuscle, SkeletalMuscle StrengthPilot ProjectsTestosteroneTreatment OutcomeAndrogensTestosterone

Identifiers

PMID21865352
PMCPMC3205888
OpenAlexW2058174948

What OpenQuestion holds

Textmetadata
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.