Evidence map›Paper›PMID 31953723›Full record

SynthesisClinical drug investigation2020

Factors Influencing Placebo Responses in Rheumatoid Arthritis Clinical Trials: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Studies.

Kota Nagai, Keisuke Matsubayashi, Kazuki Ide, Kahori Seto, Yohei Kawasaki, Koji Kawakami

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 24% 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

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. 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

6 authors at 2 institutions in 1 country.

Kota NagaiDepartment of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.
Keisuke MatsubayashiDepartment of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.
Kazuki IdeDepartment of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.
Kahori SetoDepartment of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.
Yohei KawasakiBiostatistics Section, Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677, Japan.
Koji KawakamiDepartment of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. kawakami.koji.4e@kyoto-u.ac.jp.ORCID http://orcid.org/0000-0002-7477-4071
Kyoto University · JPChiba University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveA better understanding of placebo responses and the specific factors influencing these outcomes is important for clinical trial design. We investigated the magnitude of placebo responses at 3 months and the potential factors influencing these outcomes in rheumatoid arthritis (RA) clinical trials.

methodsWe conducted a systematic review of randomized placebo-controlled trials of pharmacological agents for RA identified from PubMed, Embase, and Cochrane Central Register of Controlled Trials databases. The primary placebo outcome was American College of Rheumatology 20% response rate (ACR20). Data were pooled with a random-effects model. Factors influencing placebo response were assessed by meta-regression analyses. Subgroup analyses were performed for studies conducted in non-Western countries only versus in Western countries (North America and/or Europe) only or both.

resultsThe meta-analysis included 88 studies comprising 8406 patients receiving a placebo. The pooled estimate of placebo ACR20 was 29.0% (range 10.0-46.2; 95% confidence interval 27.2-30.9). Placebo ACR20 was negatively associated with trials in non-Western (Asian) countries and patient populations showing an inadequate response to biological disease-modifying antirheumatic drugs (DMARDs) in the multivariable analysis, whereas it was positively associated with the year of publication. No background DMARD treatment was also a negative predictor (albeit statistically non-significant). In subgroup analyses of Western and multiregional studies, study population and publication year were significant factors.

conclusionsOur meta-analysis suggests that study location, patient population, and a background DMARD treatment influence placebo ACR20. These along with placebo response temporal profiles have important implications for designing and interpreting RA clinical trials.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidHumansMalePlacebo EffectRandomized Controlled Trials as TopicTreatment OutcomeAntirheumatic Agents

Identifiers

PMID31953723
OpenAlexW2998866950

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.