Evidence map›Paper›PMID 30110706›Full record

Trial reportHormone research in paediatrics2018

Effect of Growth Hormone Therapy on Height Velocity in Korean Children with Idiopathic Short Stature: A Phase III Randomised Controlled Trial.

Woo Yeong Chung, Han-Wook Yoo, Jin Soon Hwang, Cheol Woo Ko, Ho-Seong Kim, Dong-Kyu Jin, Kee-Hyoung Lee, Heon-Seok Han, Premila Paranchothy, Byung-Kyu Suh

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hormone research in paediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01746862 (A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01746862 phase3completednot on this map

A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2012 to 2015Enrolled90ConditionsIdiopathic Short StatureArmsSaizen®
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
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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

10 authors.

Woo Yeong ChungDepartment of Pediatrics, Inje University Busan Paik Hospital, Busan, Republic of Korea.
Han-Wook YooDepartment of Pediatrics, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Jin Soon HwangDepartment of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of Korea.
Cheol Woo KoDepartment of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Ho-Seong KimDepartment of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Dong-Kyu JinDepartment of Pediatrics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Kee-Hyoung LeeDepartment of Pediatrics, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Heon-Seok HanDepartment of Pediatrics, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Premila ParanchothyMerck Ltd, Korea, Seoul, Republic of Korea.
Byung-Kyu SuhDepartment of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe SYNERGY (Saizen® for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea.

methodsThe SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms.

results97 children were screened; 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p < 0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78; p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH.

conclusionTreatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months.

Indexed as

Growth DisordersBody HeightChildChild DevelopmentChild, PreschoolFemaleHuman Growth HormoneHumansMaleHuman Growth HormoneEfficacyHeight velocityIdiopathic short statureRecombinant human growth hormoneSafety

Identifiers

PMID30110706
PMCPMC6214610

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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.