Evidence map›Paper›PMID 23529787›Full record

SynthesisClinical drug investigation2013

Investigation of influencing factors on higher placebo response in East Asian versus Western clinical trials for partial epilepsy: a meta-analysis.

Yosuke Tachibana, Mamoru Narukawa

Abstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Clinical drug investigation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 46% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

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

2 authors at 1 institution in 1 country.

Yosuke TachibanaDepartment of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Shirokane-5-9-1, Minato-ku, Tokyo, Japan. ytachibana3@gmail.com
Mamoru Narukawa
Kitasato University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlacebo response in clinical trials for anti-epileptic drugs (AEDs) has been examined and a recent meta-analysis revealed that East Asian trials showed unexpectedly higher placebo response. As multi-national trials have become common, it is important to understand placebo response in different settings, including regions/countries for future clinical trials.

objectiveThe present meta-analysis aims to investigate the potential factors that contribute to higher placebo response in clinical trials for add-on therapy to adult patients with refractory partial epilepsy in East Asian and Western populations.

methodsA database was established based on published clinical trials conducted in East Asian and Western countries. The relationship between the degree of placebo response and potential influencing factors was examined by logistic regression analyses.

resultsThe database included 33 trials from five AEDs: gabapentin, topiramate, levetiracetam, pregabalin, and zonisamide. Placebo response was associated with patient characteristics such as disease duration, percentage of patients with complex partial seizure (CPS) at baseline, percentage of patients treated with two AEDs, protocol-required seizure frequency at baseline, and year of publication. Logistic regression analysis demonstrated that the placebo response in East Asian trials was statistically higher than that in Western trials.

conclusionPatient characteristics such as longer disease duration and CPS at baseline contribute to a reduction in placebo response in clinical trials of AEDs for partial epilepsy. While the reasons for the geographical difference in placebo response are not clear, these and other patient characteristics contributing to placebo response should be carefully considered in the design of future clinical trials of AEDs for partial epilepsy.

Indexed as

Asian PeoplePlacebo EffectResearch DesignAnticonvulsantsAsiaControlled Clinical Trials as TopicEpilepsies, PartialHumansLogistic ModelsOdds RatioTreatment OutcomeWestern WorldAnticonvulsants

Identifiers

PMID23529787
OpenAlexW1981412091

What OpenQuestion holds

Textmetadata
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Registered trials

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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.