BMJ  2004;328:957 (17 April), doi:10.1136/bmj.328.7445.957

Letter

Treatment of acute pyelonephritis in children

Conclusions should have been more cautious

EDITOR—The evidence supporting one of Craig and Hodson's major conclusions, that oral and intravenous antibiotics are equally safe and effective for acute pyelonephritis in children, has important caveats.¹

None of the two trials (one published, one ongoing) comparing oral and parenteral antibiotics have found significant differences in the frequency of renal scars after six months to one year of follow up.^{2 3} However, they were not specifically designed to assess whether the two treatments were equivalent. Rather, they aimed to determine whether there were differences between them. Failure to show differences in a randomised controlled trial does not mean that they are equivalent.^{4 5}

The largest study, conducted by Hoberman et al, illustrates the issue.² Renal scarring was found in 11 out of 140 and in 15 out of 132 children assessed six months after treatment with intravenous cefotaxime and oral cefixime, respectively. The absolute rate difference in the frequency of this outcome is -3.5%, but its 95% confidence interval (-10.9% to 3.6%) shows that the rate with oral treatment could be almost 11% higher than that observed with parenteral treatment. The evidence shows that the treatments could be equivalent but does not (yet) rule out clinically important differences.

Craig and Hodson should be more cautious in their conclusions. A well designed equivalence randomised trial needs to be conducted before recommending oral antibiotics as an alternative to parenteral treatment in children with acute pyelonephritis.

School of Medicine, Pontificia Universidad Javeriana. Carrera 7 No 40-62, Bogotá, Colombia jmlozano{at}javeriana.edu.co

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Competing interests: None declared.

References

1. Craig JC, Hodson EM. Treatment of acute pyelonephritis in children. BMJ 2004;328: 179-80. (24 January.)[Free Full Text]
2. Hoberman A, Wald ER, Hickey R, Baskin M, Charron M, Majd M, et al. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Pediatrics 1999;104: 79-86.[Abstract/Free Full Text]
3. Montini G, Murer L, Gobber D, Comacchio S, Toffolo A, Dall'Amico R, et al, on behalf of the IRIS Study Group. Oral vs initial intravenous antibiotic treatment of urinary tract infections in children: a multicentre trial. Nephrol Dial Transpl 2003;18(suppl 4): S816a.
4. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996;313: 36-9.[Free Full Text]
5. Makuch RW, Johnson MF. Some issues in the design and interpretation of "negative" studies. Arch Int Med 1986;146: 986-9.

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