Evidence map›Paper›PMID 38100463›Full record

ArticlePloS one2023

A phase I study of intra-anal artesunate (suppositories) to treat anal high-grade squamous intraepithelial lesions.

Sandy Hwang Fang, Mihaela Plesa, Evie H Carchman, Nicole A Cowell, Emily Staudt, Kyleigh Ann Twaroski, Ulrike K Buchwald, Cornelia L Trimble

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in PloS one, 2023. 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
2.1field-weighted citation impact, top 11% 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, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Anti-tumor mechanism of artesunate.Frontiers in pharmacology · 2024
    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

8 authors at 3 institutions in 1 country.

Sandy Hwang FangDepartment of Surgery, Oregon Health & Science University, Portland, Oregon, United States of America.ORCID 0000-0002-9097-6968
Mihaela PlesaFrantz Medical Development, Ltd, Mentor, Ohio, United States of America.
Evie H CarchmanDepartment of Surgery, University of Wisconsin School of Medicine, Madison, Wisconsin, United States of America.
Nicole A CowellDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Emily StaudtDepartment of Surgery, University of Wisconsin School of Medicine, Madison, Wisconsin, United States of America.
Kyleigh Ann TwaroskiDepartment of Surgery, University of Wisconsin School of Medicine, Madison, Wisconsin, United States of America.
Ulrike K BuchwaldDepartment of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.ORCID 0000-0002-6671-0115
Cornelia L TrimbleDepartment of Obstetrics and Gynecology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Johns Hopkins University · USUniversity of Wisconsin–Madison · USOregon Health & Science University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAblation or surgical excision is the typical treatment of anal high-grade squamous intraepithelial lesions (HSIL). Recurrences are common due to the persistence of underlying human papillomavirus (HPV) infection. Additional well-tolerated and effective non-surgical options for HPV-associated anal disease are needed.

methodsThis 3+3 dose escalation Phase I clinical trial evaluated the safety and tolerability of artesunate suppositories in the treatment of patients with biopsy-proven HSIL.

resultsThe maximal tolerated dose was 400 mg, administered in 3 cycles. All adverse events associated with the use 200- and 400-mg artesunate suppositories were Grade 1. At the 600-mg dose, patients experienced clinically significant nausea.

conclusionArtesunate suppositories are a safe treatment option for anal HSIL.

Indexed as

Anus NeoplasmsHIV InfectionsPapillomavirus InfectionsSquamous Intraepithelial LesionsAnal CanalArtesunateHomosexuality, MaleHumansMaleSuppositoriesArtesunateSuppositories

Identifiers

PMID38100463
PMCPMC10723659
OpenAlexW4389778908

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.