Evidence map›Paper›PMID 35204805›Full record

SynthesisBiomolecules2022

Placebo-Related Adverse Events in Rheumatoid Arthritis.

Ratna Shree Sharma, Johannes Pallua, Michael Schirmer

Open access · goldAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in Biomolecules, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 53% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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.

Ratna Shree SharmaRheumatology Research Group, Department of Internal Medicine, Clinic II, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.
Johannes PalluaUniversity Hospital for Orthopedics and Traumatology, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.ORCID 0000-0003-0203-213X
Michael SchirmerRheumatology Research Group, Department of Internal Medicine, Clinic II, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.ORCID 0000-0001-9208-7809
Innsbruck Medical University · ATUniversität Innsbruck · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prospective, double-blind, randomized, placebo-controlled studies are considered to provide the highest quality of interventional evidence. This meta-analysis summarizes the frequencies of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA) in the placebo arms of 101 such studies in rheumatoid arthritis, including a total of 17,150 patients in the placebo arms and 37,819 patients in the verum arms. Placebo-treated patients reported more than one adverse event in a median of 55.0%, 65.5%, and 72.5% (compared to 72.3% in the verum arms), and a serious adverse event in 2.5%, 5.8%, and 8.6% (compared to 5.9% in the verum arms), with stable doses of corticosteroids, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biological DMARDs as background therapies, respectively. Odds ratios were comparable between placebo and verum arms for nausea (1.00 with 95% confidence interval (CI) 0.86-1.17), for hepatobiliary disorders (1.08 with CI 0.85-1.36), for abnormal hepatic functions (1.09 with CI 0.83-1.44), and general disorders and administration site conditions (1.39 with CI 0.95-2.03). A publication bias has to be assumed for nausea (

Indexed as

Antirheumatic AgentsArthritis, RheumatoidHumansNauseaProspective StudiesRandomized Controlled Trials as TopicAntirheumatic Agentsadverse effectscomplementary medicinemusculoskeletal diseasesnocebo effectplacebo-controlled trialrheumatologyshared decision-making

Identifiers

PMID35204805
PMCPMC8869088
OpenAlexW4212830572

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.