Ornidazole for prophylaxis of postoperative Crohn’s disease recurrence: A randomized, double-blind, placebo-controlled trial

Rutgeerts, Paul; Assche, Gert Van; Vermeire, Séverine; D’Haens, Geert R.; Baert, Filip; Noman, Maja; Aerden, Isolde; Hertogh, Gert De; Geboes, Karel; Hiele, Martin; D’Hoore, André; Penninckx, Freddy

doi:10.1053/j.gastro.2005.01.010

Cited by 390 publications

(241 citation statements)

References 17 publications

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“…The authors demonstrated that, as soon as 8 d after the reinfusion of intestinal fluids, focal infiltration of mononuclear cells, eosinophils, and polymorphonuclear cells in the lamina propria, small vessels, and epithelium appeared in the previously normal excluded neoterminal ileum. Furthermore and considering this hypothesis, the same group showed some years later that nitroimidazolic antibiotics are efficient in preventing POR, as will be later discussed [11,12] . The onset of disease recurrence begins by the appearance of new mucosal lesions (morphologic recurrence) that can be assessed by means of radiological or endoscopic techniques and the evolution of these lesions mimics the previous phenotypic pattern in every particular patient, as shown when the indication for reoperation is evaluated [13] .…”

Section: Recurrencementioning

confidence: 97%

Postoperative Crohn’s disease recurrence: A practical approach

Nos¹,

Domènech²

2008

WJG

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risk patients. Nitroimidazolic antibiotics, although efficient, are associated with a high rate of intolerance and might induce irreversible side effects when used for a long-term. Thiopurines are not widely used after ileocecal resection, maybe because some concerns in giving immunomodulators in asymptomatic patients still remain. In the era of biological agents and genetic testing, a well-established preventive strategy for POR is still lacking, and larger studies to identify good clinical, serological, and genetic predictors of early POR as well as more effective drugs (or drug combinations) are needed.

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Section: Recurrencementioning

confidence: 97%

Postoperative Crohn’s disease recurrence: A practical approach

Nos¹,

Domènech²

2008

WJG

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“…Overall, the ECCO consensus and a North American Pediatric Workshop support a modest overall bene t of approximately 1 in 10 patients (NNT = 10) for mesalamine at delaying / preventing postoperative recurrence (77,238) . Short-term administration of high-dose metronidazole, 20 mg / kg, and a 1-year course of ornidazole, 1 g / day, also reduce the likelihood of recurrence for up to 1 year (243,244) . However, both agents have been poorly tolerated due to an increased risk of peripheral neuropathy such that additional studies of alternative antibiotics or additional dosing studies are required to identify a safe and e ective regimen.…”

Section: Maintenance Therapymentioning

confidence: 99%

Management of Crohn's Disease in Adults

2009

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Guidelines for clinical practice are intended to suggest preferable approaches to particular medical problems as established by interpretation and collation of scientifi cally valid research, derived from extensive review of published literature. When data that will withstand objective scrutiny are not available, a recommendation may be made based on a consensus of experts. Guidelines are intended to apply to the clinical situation for all physicians without regard to specialty. Guidelines are intended to be fl exible, not necessarily indicating the only acceptable approach, and should be distinguished from standards of care that are infl exible and rarely violated. Given the wide range of choices in any health-care problem, the physician should select the course best suited to the individual patient and the clinical situation presented. These guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee. Expert opinion is solicited from the outset for the document. The quality of evidence upon which a specifi c recommendation is based is as follows: Grade A: Homogeneous evidence from multiple well-designed randomized (therapeutic) or cohort (descriptive) controlled trials, each involving a number of participants to be of suffi cient statistical power. Grade B: Evidence from at least one large well-designed clinical trial with or without randomization, from cohort or case -control analytic studies, or well-designed meta-analysis. Grade C: Evidence based on clinical experience, descriptive studies, or reports of expert committees. The Committee reviews guidelines in depth, with participation from experienced clinicians and others in related fi elds. The fi nal recommendations are based on the data available at the time of the production of the document and may be updated with pertinent scientifi c developments at a later time.

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“…However, significantly more patients in the ornidazole group dropped out of the study because of side effects. In summary, these data indicate that ornidazole might offer a therapeutic alternative in preventing postoperative recurrence [70] .…”

Section: Postoperative CD (Surgically-induced Remission)mentioning

confidence: 68%

Conventional therapy for Crohn’s disease

Büning

Lochs²

2006

WJG

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Crohn's disease (CD) is a multifactorial disorder of unknown cause. Outstanding progress regarding the pathophysiology of CD has led to the development of innovative therapeutic concepts. Numerous controlled trials have been performed in CD over the last years. However, many drugs have not been approved by regulatory authorities due to lack of efficacy or severe side effects. Therefore, well-known drugs, including 5-ASA, systemic or topical corticosteroids, and immunosuppressants such as azathioprine, are still the mainstay of CD therapy. Importantly, biologicals such as infliximab have shown to be efficacious in problematic settings such as fistulizing or steroid-dependent CD. This review is intended to give practical guidelines to clinicians for the conventional treatment of CD. We concentrated on the results of randomized, placebo-controlled trials and meta-analyses, when available, that provide the highest degree of evidence. We provide evidence-based treatment algorithms whenever possible. However, many clinical situations have not been answered by controlled clinical trials and it is important to fill these gaps through expert opinions. We hope that this review offers a useful tool for clinicians in the challenging treatment of CD.

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Ornidazole for prophylaxis of postoperative Crohn’s disease recurrence: A randomized, double-blind, placebo-controlled trial

Cited by 390 publications

References 17 publications

Postoperative Crohn’s disease recurrence: A practical approach

Postoperative Crohn’s disease recurrence: A practical approach

Management of Crohn's Disease in Adults

Conventional therapy for Crohn’s disease

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