Evidence map›Paper›PMID 34689288›Full record

ArticleJapanese journal of ophthalmology2022

Comparison of combination therapy of prednisolone and cyclosporine with corticosteroid pulse therapy in Vogt-Koyanagi-Harada disease.

Takashi Ono, Hiroshi Goto, Tsutomu Sakai, Fumihiko Nitta, Nobuhisa Mizuki, Hiroshi Takase, Yutaka Kaneko, Junko Hori, Satoko Nakano, Nobuhisa Nao-I and 5 more

Abstract readEquivalence TrialMulticenter Study
PubMed Publisher
In one paragraph

Article in Japanese journal of ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
2.2field-weighted citation impact, top 12% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
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  9. 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

15 authors at 11 institutions in 1 country.

Takashi OnoMiyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan.
Hiroshi GotoDepartment of Ophthalmology, Tokyo Medical University, Tokyo, Japan.
Tsutomu SakaiDepartment of Ophthalmology, Jikei University School of Medicine, Tokyo, Japan.
Fumihiko NittaDepartment of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine, Sendai, Japan.
Nobuhisa MizukiDepartment of Ophthalmology, Yokohama City University School of Medicine, Yokohama, Japan.
Hiroshi TakaseDepartment of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
Yutaka KanekoDepartment of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine, Yamagata, Japan.
Junko HoriDepartment of Ophthalmology, Nippon Medical School, Tokyo, Japan.
Satoko NakanoDepartment of Ophthalmology, Oita University, Faculty of Medicine, Oita, Japan.
Nobuhisa Nao-IDepartment of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Nobuyuki OhguroDepartment of Ophthalmology, Japan Community Healthcare Organization Osaka Hospital, Osaka, Japan.
Kazunori MiyataMiyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan.
Makoto TomitaSchool of Data Science, Yokohama City University, Yokohama, Japan.
Manabu MochizukiMiyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan. m.manabu.oph@tmd.ac.jp.ORCID http://orcid.org/0000-0002-8240-4134
Japan VKH Disease Treatment Study Group
Tokyo Medical and Dental University · JPYokohama City University · JPMiyata Eye Hospital · JPJikei University School of Medicine · JPTohoku University · JPTokyo Medical University · JPUniversity of Miyazaki · JPYamagata University · JPNippon Medical School · JPOita University · JPOsaka Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacy and safety of a combination therapy of prednisolone and cyclosporine and corticosteroid pulse therapy in Vogt-Koyanagi-Harada (VKH) disease. STUDY

designA prospective, multicenter, randomized, non-inferiority trial.

methodsPatients of new-onset acute VKH disease at 11 centers in Japan between 2014 and 2018 were randomized to a combination (oral prednisolone 60 mg daily with gradual taper-off to 35 mg/day and cyclosporine 3 mg/kg/day) and corticosteroid (methylprednisolone 1000 mg for 3 days followed by oral prednisolone) groups, and were followed for 1 year.

resultsThirty-four were assigned to the combination and thirty-six patients to the corticosteroid group. Recurrence/worsening risk was 0.15 (95% confidence-interval [CI] 0.03-0.27) in the combination group and 0.25 (95% CI 0.11-0.39) in the corticosteroid group, with a risk difference of - 0.10 (90% CI - 0.27 to 0.06), demonstrating non-inferiority of the combination group with a non-inferiority margin of 0.20 (P = 0.0013). Serious adverse events occurred in three patients (two with hyponatremia and one with severe headaches) in the combination group and none in the corticosteroid group. Sunset glow fundus grades and cataract rates at 1 year were 0.57 (95% CI 0.42-71) and 4.3% in the combination group and 0.91 (95% CI 0.78-1.04) and 34.0% in the corticosteroid group, respectively.

conclusionsCombination therapy was noninferior to corticosteroid therapy with respect to recurrence/worsening risk. Notably, the recurrence/worsening risk, sunset glow fundus grade, and cataract rate were lower in the combination group than in the corticosteroid group.

Indexed as

Uveomeningoencephalitic SyndromeCyclosporineHumansMethylprednisoloneProspective StudiesCyclosporineMethylprednisoloneCorticosteroid pulse therapyCyclosporineRecurrence or worsening riskSunset-glow fundusVogt–Koyanagi–Harada disease

Identifiers

PMID34689288
OpenAlexW3211291193

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.