Evidence map›Paper›PMID 23511031›Full record

Trial reportInflammatory bowel diseases2013

Ciprofloxacin for the prevention of postoperative recurrence in patients with Crohn's disease: a randomized, double-blind, placebo-controlled pilot study.

Hans H Herfarth, Jeffry A Katz, Stephen B Hanauer, William J Sandborn, Edward V Loftus, Bruce E Sands, Joseph A Galanko, Dolly Walkup, Kim L Isaacs, Christopher F Martin and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 6 pooled it
3.7field-weighted citation impact, top 7% 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

22 citing papers in PubMed, 6 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
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  5. Anti-tuberculous therapy for maintenance of remission in Crohn's disease.The Cochrane database of systematic reviews · 2016
    Pooled it
  6. Pooled it
  7. Review
  8. Article
  9. Review
  10. Review
  11. A review of the therapeutic management of Crohn's disease.Therapeutic advances in gastroenterology · 2022
    Review
  12. Medical therapies for postoperative Crohn's disease.Therapeutic advances in gastroenterology · 2021
    Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. 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

12 authors at 6 institutions in 1 country.

Hans H HerfarthDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina 27599, USA. hherf@med.unc.edu
Jeffry A Katz
Stephen B Hanauer
William J Sandborn
Edward V Loftus
Bruce E Sands
Joseph A Galanko
Dolly Walkup
Kim L Isaacs
Christopher F Martin
Robert S Sandler
Ryan B Sartor
University of North Carolina at Chapel Hill · USMassachusetts General Hospital · USMayo Clinic · USUniversity Hospitals Case Medical Center · USUniversity of Chicago · USWinnMed · US

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1985 to 2026
$30.5M
Pilot study on the safety and efficacy of ciprofloxacin for prophylactic preventiR21DK080408 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HERFARTH, HANS H. · 2007 to 2008
$397k
NIDDK NIH HHS 1R21DK080408-01NIDDK NIH HHS P30 DK034987NIDDK NIH HHS R21 DK080408
6 · The paper itself

Abstract

backgroundThe commensal bacterial flora plays a critical role in the postoperative recurrence of Crohn's disease (CD). We conducted a randomized, double-blind, placebo-controlled 6-month pilot trial of ciprofloxacin for the prevention of endoscopic recurrence in patients with CD who underwent surgery.

methodsThirty-three patients with CD, who had undergone surgery with ileocolonic anastomosis within the previous 2 weeks, were randomized to treatment with ciprofloxacin (500 mg twice daily) or placebo tablets for 6 months. Endpoints were endoscopic recurrence at 6 months and safety and tolerability of long-term ciprofloxacin therapy.

resultsThirty-three patients were randomized; 14 patients discontinued the study early. Significant endoscopic recurrence was observed in 3 of 9 patients (33%) in the ciprofloxacin group and 5 of 10 patients (50%) in the placebo group at 6 months after surgery (P < 0.578). The intention-to-treat analysis demonstrated endoscopic recurrence in 11 of 17 patients (65%) in the ciprofloxacin group and 11 of 16 patients (69%) in the placebo group at month 6 (P < 0.805). Thirty-six adverse events occurred in 19 of 33 patients (58%). Possible drug-associated adverse events occurred significantly more often in the ciprofloxacin group (P < 0.043), leading to study drug discontinuation in 24% (4 of 17) and 6% of patients (1 of 16) in the ciprofloxacin and placebo groups, respectively (P < 0.166).

conclusionsIn this pilot study, ciprofloxacin was not more effective than placebo for the prevention of postoperative recurrence in patients with CD. Long-term ciprofloxacin therapy is limited by drug-associated side effects. Future studies in postoperative prevention of CD should evaluate antibiotic approaches with a more favorable safety profile.

Indexed as

Secondary PreventionAdolescentAdultAnastomosis, SurgicalAnti-Infective AgentsCiprofloxacinCrohn DiseaseDouble-Blind MethodEndoscopyFemaleFollow-Up StudiesHumansMaleMaximum Tolerated DoseMiddle AgedPilot ProjectsAnti-Infective AgentsCiprofloxacin

Identifiers

PMID23511031
PMCPMC4596532
OpenAlexW2332160220

What OpenQuestion holds

Textmetadata
LicenceTDM
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.