Evidence map›Paper›PMID 32595770›Full record

ArticleEuropean endocrinology2020

Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial.

Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko, Kee-Hyoung Lee, Dong-Kyu Jin, Han-Wook Yoo, Jin Soon Hwang, Woo Yeong Chung, Heon-Seok Han, Vinay Prusty and 1 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in European endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01778023 (A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT01778023 phase3completednot on this map

A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone (hGH) (Norditropin® Nordilet®) Therapy on Height Velocity (Ht-V) in Patients With Idiopathic Short Stature in Korea

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2014Enrolled54ConditionsGrowth Disorder, Idiopathic Short StatureArmssomatropin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

11 authors at 10 institutions in 1 country.

Min Ho JungThe Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, South Korea.
Byung-Kyu SuhThe Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
Cheol Woo KoKyungpook National University Hospital, Daegu, South Korea.
Kee-Hyoung LeeKorea University Anam Hospital, Seoul, South Korea.
Dong-Kyu JinSamsung Medical Center, Sung Kyun Kwan University, Seoul, South Korea.
Han-Wook YooAsan Medical Center, Seoul, South Korea.
Jin Soon HwangAjou University Hospital, Suwon, South Korea.
Woo Yeong ChungInje University Busan Paik Hospital, Busan, South Korea.
Heon-Seok HanChungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Vinay PrustyNovo Nordisk Pharma Gulf FZ-LLC, Dubai, United Arab Emirates.
Ho-Seong KimSeverance Hospital, Yonsei University Health System, Seoul, South Korea.
Ajou University Hospital · KRAsan Medical Center · KRCatholic University of Korea · KRChungbuk National University Hospital · KRInje University Busan Paik Hospital · KRKorea University Medical Center · KRKyungpook National University Hospital · KRSamsung Medical Center · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRYonsei University Health System · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis trial evaluated the efficacy and safety of growth hormone (GH) therapy (Norditropin®; Novo Nordisk, Bagsværd, Denmark) in paediatric patients with idiopathic short stature (ISS) in Korea.

methodsThis was an open-label, parallel-group, multicentre, interventional trial (ClinicalTrials.gov identifier: NCT01778023). Pre-pubertal patients (mean age 6.2 years; height, 107.1 cm) were randomised 2:1 to 12 months' GH treatment (0.469 mg/kg/week; group A, n=36) or 6 months untreated followed by 6 months' GH treatment (group B, n=18). Safety analysis was based on adverse events (AEs) in all GH-treated patients.

resultsAfter 6 months, height velocity (Ht-V), change in both height standard deviation score (Ht-SDS) and insulin-like growth factor 1 (mean difference [95% confidence interval {CI}]: 5.15 cm/year [4.09, 6.21]; 0.57 [0.43, 0.71]; 164.56 ng/mL [112.04, 217.08], respectively; all p<0.0001) were greater in group A than in group B. Mean difference in Ht-V for 0-6 months versus 6-12 months was 2.80 cm/year (95% CI 1.55, 4.04) for group A and -4.60 cm/year (95% CI -6.12, -3.09; both p<0.0001) for group B. No unexpected AEs were reported.

conclusionsDuring the first 6 months, height was significantly increased in GH-treated patients versus untreated patients with ISS. Safety of GH was consistent with the known safety profile.

Indexed as

clinical trialHuman growth hormoneidiopathicshort stature

Identifiers

PMID32595770
PMCPMC7308103
OpenAlexW3020013392

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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.