Evidence mapPaperPMID 41719376Full record

SynthesisPLoS neglected tropical diseases2026

Design and analysis of randomized clinical trials for onchocerciasis, loiasis and mansonellosis: A systematic review.

Fabrice Lotola Mougeni, Marta Bofill Roig, Marc P Hübner, Ute Klarmann-Schulz, Benjamin Lenz, Sabine Specht, Martin Posch, Sonja Zehetmayer

Abstract readSystematic Review
In one paragraph

Synthesis in PLoS neglected tropical diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
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.

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

8 authors.

Fabrice Lotola MougeniCenter for Medical Data Science, Medical University of Vienna, Vienna, Austria.
Marta Bofill RoigDepartment of Statistics and Operations Research and Institute for Research and Innovation in Health (IRIS), Universitat Politècnica de Catalunya - BarcelonaTech (UPC), Barcelona, Spain.
Marc P HübnerUniversity of Bonn, University Hospital Bonn, Institute for Medical Microbiology, Immunology and Parasitology, Bonn, Germany.
Ute Klarmann-SchulzUniversity of Bonn, University Hospital Bonn, Institute for Medical Microbiology, Immunology and Parasitology, Bonn, Germany.
Benjamin LenzUniversity of Bonn, University Hospital Bonn, Institute for Medical Microbiology, Immunology and Parasitology, Bonn, Germany.
Sabine SpechtFilarial Disease, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Martin PoschCenter for Medical Data Science, Medical University of Vienna, Vienna, Austria.
Sonja ZehetmayerCenter for Medical Data Science, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0001-6863-7997

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe design and analysis of randomized clinical trials (RCTs) in filarial diseases such as onchocerciasis, loiasis, and mansonellosis pose unique statistical challenges, including skewed endpoints and limited sample sizes. This systematic review summarizes design and analysis approaches of RCTs conducted in these diseases with a focus on the statistical methodology. METHODS AND

findingsA systematic search was conducted in PubMed and four trial registries to identify RCTs investigating treatments for onchocerciasis, loiasis, and mansonellosis published or registered between 2000 and 2024. We excluded studies focusing on new methods or pharmacokinetics, short reports, and Phase I trials. Forty-four studies met the inclusion/exclusion criteria (23 for onchocerciasis, 16 for loiasis, and 5 for mansonellosis), information was retrieved from the registries, the manuscripts and/or the study protocol. As primary efficacy endpoints, for onchocerciasis studies qualitative endpoints dominated, while quantitative endpoints were more frequently observed for loiasis and mansonellosis. The most frequently reported hypothesis tests for the primary endpoint were the Mann-Whitney U and the chi-squared tests. We found considerable heterogeneity between trials - not only in study-specific parameters such as the number of arms, type of blinding or control group - but also in design parameters or attributes that could be standardized within each disease across studies with similar objectives, such as the primary endpoint, length of follow-up, the analysis method and the primary analysis population.

conclusionsSeveral trials were well-planned with detailed information provided in either the manuscript or the registry. However, for some trials, information was sparse or incomplete, indicating a need for more structured and transparent reporting. Adopting established frameworks such as CONSORT and ICH E9 (R1) estimand approach would enhance transparency and better align trial objectives, analyses, and reported conclusions.

Indexed as

LoiasisMansonelliasisOnchocerciasisRandomized Controlled Trials as TopicAnimalsHumansResearch Design

Identifiers

PMID41719376
PMCPMC12952602

What Socratic holds

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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 Socratic graph.