Evidence map›Paper›PMID 19794937›Full record

Trial reportKorean journal of ophthalmology : KJO2009

Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm.

Jin Sook Yoon, Jae Chan Kim, Sang Yeul Lee

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Korean journal of ophthalmology : KJO, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01180348 (Randomized Study of Clinical Non-inferiority of Medicine Botulift), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 16% 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.

NCT01180348 phase3completednot on this mapstarted 2011, after this paper: background citation

Randomized Study of Clinical Non-inferiority of Medicine Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) Compared to Botox ® (Allergan Inc.) in the Improvement of Wrinkles in the Facial Region.

TypeinterventionalSponsorAzidus BrasilRan2011 to 2012Enrolled192ConditionsWrinklesArmsBotulift, Botox
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. The efficacy and safety of neubotulinumtoxinA for the treatment of forehead horizontal lines in Asians - A clinical, prospective, interventional, split-face study.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2024
    Article
  5. Article
  6. [New botulinum toxins for aesthetic dermatology : A comprehensive review].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021
    Review
  7. Review
  8. Article
  9. Article
  10. Impact of Neu-botulinumtoxinA on the Severity and Quality of Life of Cervical Dystonia Patients.Tremor and other hyperkinetic movements (New York, N.Y.) · 2016
    Article
  11. Botulinum toxin for the treatment of movement disorders.Current neurology and neuroscience reports · 2012
    Review
  12. Article
  13. Review
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

3 authors at 2 institutions in 1 country.

Jin Sook YoonDepartment of Ophthalmology, Institute of Vision Research, University of Yonsei, Seoul, Korea.
Jae Chan Kim
Sang Yeul Lee
Yonsei University · KRChung-Ang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacies and safeties of Meditoxin (Medy-Tox, Korea) and Botox in the treatment of essential blepharospasm.

methodsWe performed a double-blind, randomized, comparative trial comparing Meditoxin and Botox for treatment of blepharospasm in 60 patients from the intention-to-treat (ITT) population and 52 patients from the per-protocol (PP) population. We analyzed the improvements in severity of spasm (SS) at four weeks post-injection as a primary efficacy outcome. Changes in eyelid closing force (CF) and functional visual status (FVS) after injection were analyzed for secondary efficacy outcomes, and adverse effects were demonstrated for the safety evaluation.

resultsImprovement in SS was noted in 90.3% of the Meditoxin group and 86.2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS post-injection (p>0.05). Since the lower limit of the 95% confidence interval (-1.76% for ITT, -1.64% for PP) was over the -15% threshold, we determined that Meditoxin was not inferior to Botox in either the ITT or PP populations. Adverse effects developed in 16.1% of the Meditoxin group and 27.6% of the Botox group, but no serious adverse events were found in either group.

conclusionsMeditoxin and Botox were comparable in efficacy and safety in the treatment of essential blepharospasm.

Indexed as

AgedBlepharospasmBotulinum Toxins, Type ADouble-Blind MethodFemaleHumansInjectionsMaleMiddle AgedNeuromuscular AgentsTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsBotox®Essential blepharospasmMeditoxin®

Identifiers

PMID19794937
PMCPMC2739960
OpenAlexW2112259295

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.