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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Prophylactic antibiotics reduce pancreatic necrosis in acute necrotizing pancreatitis: a meta-analysis of randomized trials

L Yao, X Huang, Y Li, R Shi, and G Zhang.

Review published: 2010.

Link to full article: [Journal publisher]

CRD summary

The review concluded that prophylactic antibiotic treatment reduced the occurrence of infected pancreatic necrosis but did not affect mortality, non-pancreatic necrosis or surgical intervention in patients with acute necrotic pancreatitis. The small and variable quality evidence base and potential for biases limit the reliability of the pooled results. The authors’ call for further research appears warranted.

Authors' objectives

To compare prophylactic antibiotic treatment with placebo for acute necrotising pancreatitis.

Searching

PubMed, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from January 1990 to March 2010 for articles published in any language. Search terms were reported. Symposia proceedings, abstracts and poster presentations from major gastrointestinal meetings were searched.

Study selection

Randomised controlled trials (RCTs) of prophylactic antibiotic treatment (beta-lactams, quinolones or cephalosporins) versus placebo/no treatment (control) in patients with acute necrotising pancreatitis with computer tomography-proven necrosis were eligible for inclusion. Trials had to provide outcome data on infected pancreatic necrosis, mortality, non-pancreatic infection or need for surgical intervention. It appeared that trials that studied oral antibiotics were excluded.

The included trials studied prophylaxis with imipenem, cefuroxime, ofloxacin, metronidazole, imipenem-cilastatin or meropenem (various doses and regimens) versus placebo or no treatment. Four trials were multicentre and five trials were single centre. Trials were published between 1993 and 2009. Acute necrotising pancreatitis was mainly due to gallstones and alcohol.

The authors did not state how many reviewers undertook study selection.

Assessment of study quality

Quality assessment was undertaken using the Jadad scale of randomisation, blinding and follow-up to give a score up to a maximum 5. Studies that scored 3 or more were deemed higher quality and those that scored less than 3 were judged lower quality.

Two reviewers independently performed quality assessment. Disagreements were resolved by discussion.

Data extraction

Data were extracted on infected pancreatic necrosis, mortality, non-pancreatic infection and need for surgical intervention and used to calculate odds ratios (ORs) and relative risks (RRs), together with 95% confidence intervals (CIs).

Two reviewers independently extracted data. Disagreements were resolved by discussion.

Methods of synthesis

A fixed-effect meta-analysis was used to calculate pooled odds ratios and relative risks, together with 95% CIs. A random-effects model was used where significant statistical heterogeneity was detected. Statistical heterogeneity was assessed using the Ι² and Χ² statistics (Ι²>50% and p<0.1 denoted significance). Subgroup analysis was done for quality criteria and type of antibiotic.

Results of the review

Nine trials were included (564 patients as reported in text). Trial sample size ranged from 26 to 100 patients. Seven trials were deemed higher quality (scores ranged from 3 to 5) and two trials were deemed lower quality (scores ranged from 1 to 2). Where reported, three trials were double-blind and four trials were single-blind.

Compared with control, antibiotic prophylaxis was associated with statistically significantly lower risk of infected pancreatic necrosis (RR 0.73, 95% CI 0.54 to 0.98; nine RCTs; Ι²=14%). There was no significant difference for mortality (nine RCTs), non-pancreatic necrosis (eight RCTs) and need for surgical intervention (eight RCTs). Subgroup analysis indicated differences in results between single-blinded and double-blinded trials; full results were presented in the review. Results for individual antibiotic agents were generally not significant for any outcomes except beta-lactams. Beta-lactams were associated with a statistically significantly lower risk of non-pancreatic necrosis (RR 0.66, 95% CI 0.49 to 0.89; five RCTs; Ι²=74%).

Authors' conclusions

Prophylactic antibiotic treatment reduced the occurrence of infected pancreatic necrosis but did not affect mortality, non-pancreatic necrosis or surgical intervention in patients with acute necrotic pancreatitis.

CRD commentary

Inclusion criteria for the review were appropriately defined and several relevant databases were searched. It appeared that articles in any language were included but in the abstract the authors stated that the searches were restricted to English. Publication bias was not assessed (which was appropriate as there were only nine studies) and could not be ruled out. Attempts were made to reduce reviewer error and bias during data extraction and quality assessment; whether the same methods were used for study selection was unclear. Quality assessment indicated that some of the evidence was low quality. Most trials had sample sizes of fewer than 100 patients. The authors also noted that use of enteral nutrition was not reported in all trials.

Data were pooled and statistical heterogeneity was reported. There was evidence of statistical heterogeneity and few patient details were reported so assessing clinical heterogeneity was difficult and it was not possible to determine how appropriate the data were for pooling. Subgroup analysis was conducted but the small numbers mean that these analyses may not be reliable. There were some discrepancies between the reporting of numbers across the review.

The small and variable quality evidence base together with potential for biases limit the reliability of the pooled results. The authors’ call for further research appears warranted.

Implications of the review for practice and research

Practice: The authors stated that prophylactic antibiotics plus enteral nutrition should be used in acute necrotic pancreatitis.

Research: The authors stated that more high quality trials were needed. The effects of enteral nutrition should be reported in future RCTs as nutrition plays an important role in infections.

Funding

Not stated.

Bibliographic details

Yao L, Huang X, Li Y, Shi R, Zhang G. Prophylactic antibiotics reduce pancreatic necrosis in acute necrotizing pancreatitis: a meta-analysis of randomized trials. Digestive Surgery 2010; 27(6): 442-449. [PubMed: 21071945]

Indexing Status

Subject indexing assigned by NLM

MeSH

Anti-Bacterial Agents /therapeutic use; Humans; Necrosis; Pancreatitis, Acute Necrotizing /drug therapy /pathology; Randomized Controlled Trials as Topic

AccessionNumber

12011003387

Database entry date

06/11/2012

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 21071945

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