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ARTICLES: Ellen R. Wald, David Nash, and Jens Eickhoff Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children Pediatrics 2009; 124: 9-15 [Abstract] [Full text] [PDF]

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Treating acute bacterial sinusitis in children: some questions remain

Jon M Farber   (6 July 2009)

Pediatricians do not always treat clinically defined sinusitis with antibiotics

Carlos E Armengol   (17 August 2009)

Inadequate evidence to support high dose amoxicillin/clavulanate for acute sinusitis

Jane M. Garbutt, MD, Benjamin Littenberg, MD   (14 September 2009)

Response to Treating acute bacterial sinusitis in children: some questions remain

Ellen R Wald   (14 October 2009)

Response to "Pediatricians do not always treat clinically defined sinusitis with antibiotics

Ellen R Wald   (14 October 2009)

In response to inadequate evidence to support igh dose amoxicillin clavulanate for acute sinusitis

Ellen R Wald   (15 October 2009)

Treating acute bacterial sinusitis in children: some questions remain 6 July 2009
Jon M Farber, Pediatrician ALL Pediatrics Send letter to journal: Re: Treating acute bacterial sinusitis in children: some questions remain JMFPEDS{at}msn.com Jon M Farber	The article by Wald et al is a useful initial approach to the problem of treating sinusitis, but still leaves me with a practical dilemma when I encounter such a child in the office. The majority of children I see with sinusitis are those in the 'persistent' group, with relatively unimpressive symptoms which have, however, lasted for ten or more days. Anecdotally, I have not been impressed that these children do better with antibiotics, and certainly not that 10 days of treatment are necessary. Can the authors use their data to compare antibiotic/placebo usage and responses for only children in the persistent category, or are the numbers of patients too small to have sufficient power? Also, if I read the article correctly, the treatment group was given the antibiotic in two divided doses (see the first paragraph under 'recruitment and randomization'). This one day's worth of treatment would certainly be a major reduction in antibiotic use, compared to the more standard course of 10 days (as with their back up medicine for treatment failures). Is this indeed how the medicine was given? Conflict of Interest: None declared
Pediatricians do not always treat clinically defined sinusitis with antibiotics 17 August 2009
Carlos E Armengol, pediatrician Pediatric Associates of Charlottesville, VA Send letter to journal: Re: Pediatricians do not always treat clinically defined sinusitis with antibiotics cea{at}charlottesvillepeds.com Carlos E Armengol	Dear Editor, In a recent study on the treatment of acute sinusitis1, Dr Wald and her colleagues demonstrated a significant benefit to patients given amoxicillin/clavulanic acid over those given placebo. I applaud them for the effort to undertake an evidenced based approach to the treatment of a common complication of viral respiratory disease. However, I do have concerns regarding the clinical criteria used in the protocol to arrive at the diagnosis of bacterial sinusitis. The study defined one of three clinical presentations as evidence of sinusitis: persistent symptoms, children with acutely worsening symptoms, and children with severe symptoms. As a practicing pediatrician in a private office, I often see patients with presentations that meet these criteria, particularly persistent symptoms in young children attending daycare or preschool. I sense that these children have prolonged or recurrent viral respiratory illnesses affecting the sinuses, and if all these children received antibiotics, few would actually benefit. In an effort to determine the frequency with which the physicians in our office make a diagnosis of acute sinusitis, I searched our practice management software for instances of an International Classification of Disease, edition 9 (ICD-9) diagnosis of acute sinusitis (461.9) and compared that to the total number of sick visits during the first 6 months of 2009. Our office billing sheet allows only this code for sinusitis diagnoses. As the results (Table) indicate, some pediatricians in our office diagnose acute sinusitis as rarely as 0.5 episodes per 1000 sick office encounters while others do so at rates over 40 per 1000. A similar search of the database in our community hospital produced one admission of a patient from our practice with ethmoid sinusitis and orbital cellulitis that fit the severe clinical criteria in the study. Certainly it is difficult to draw any conclusions from this data. However, it does demonstrate that general pediatricians that see similar patient populations might diagnose and manage respiratory diseases differently with few if any complications from watchful waiting. Hence, it is possible to manage viral respiratory disease without treating patients for bacterial sinusitis except seldomly. Therefore, until we have developed better diagnostic criteria for bacterial sinusitis, I recommend that we steer away from prescribing antibiotics to treat most cases of clinically-defined sinusitis. Sincerely, Carlos E. Armengol, MD Charlottesville, VA Table. The Rates of Acute Sinusitis Diagnoses (ICD-9 469.1) per 1000 Sick Patient Encounters For Each Physician in One Private PediatriAc Practice During the First Six Months of 2009. 1. Ellen R. Wald, David Nash, and Jens Eickhoff. Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children. Pediatrics, Jul 2009; 124: 9 - 15. Conflict of Interest: None declared Physician Episodes of Sinusitis Office Encounters Rate/1000 Encounters A 1 1899 0.5 B 4 1654 2.4 C 15 1806 8.3 D 15 1508 9.9 E 10 863 11.6 F 26 1890 13.8 G 29 1629 17.8 H 40 1995 20.1 I 39 1708 22.8 J 26 997 26.1 K 24 829 29.0 L 15 506 29.6 M 45 1141 39.4 N 54 1285 42.0 O 93 2058 45.2 Inadequate evidence to support high dose amoxicillin/clavulanate for acute sinusitis 14 September 2009 Jane M. Garbutt, MD, Research Associate Professor of Medicine and Pediatrics Washington University School of Medicine, Benjamin Littenberg, MD Send letter to journal: Re: Inadequate evidence to support high dose amoxicillin/clavulanate for acute sinusitis jgarbutt{at}dom.wustl.edu Jane M. Garbutt, MD, et al. To the Editor, Dr Wald concludes that her recent study of high-dose amoxicillin/clavulanate potassium in children with clinically diagnosed acute bacterial sinusitis (ABS) supports antimicrobial treatment for most children with this diagnosis.(1) We disagree with this conclusion and are concerned that it may contribute to inappropriate use of antibiotics. Important methodologic flaws are described below. Key study outcomes were assessed using an unvalidated symptom score. The score’s ability to assess a clinically significant change in symptoms over time has not been evaluated, and the researcher’s acknowledge that “arbitrary” changes in the score are used to define important endpoints.(2) It would be helpful to know if parents agreed with these arbitrary assessments, particularly if parents of children with “treatment failure” (a key outcome for this study) would have requested an alternative treatment. The primary outcome, the proportion of children who were cured on day 14, was not assessed in 41% of subjects (4 antibiotic recipients and 19 placebo subjects), violating the intention-to-treat principle. Many of these children may well have been “cured” at 14 days without additional therapy. This may explain why the spontaneous resolution rate observed in this study (14%) is much lower that observed in other studies (~80%).(3) It would be helpful to know which symptoms persisted in those who were not “cured” and the level of impairment that resulted. It is reported that antibiotic therapy resulted in “a clinical cure more quickly.” Yet, time to cure is not reported and time to improvement was the same for both groups. It would be useful to confirm the distribution of children with potentially confounding factors (such as use of non-study medications, asthma and allergies) was similar in both groups. Dr Wald suggests that an earlier study enrolled mainly children with a URI rather than ABS and that antibiotic dosing was sub-therapeutic. (4) Actually, all subjects had a physician’s diagnosis of acute sinusitis, > 10 days of symptoms that were not improving, and a score > 1 on a validated sinus symptom severity score (range 0 to 3).5, 6) As local prevalence of amoxicillin-resistant Streptococcus pneumoniae at the time of the study was 3%, the dose (40mg/kg of amoxicillin) was adequate.(7) Because of flaws in design and reporting, Dr Wald’s study does not provide convincing evidence of a clinically important benefit. We believe the evidence from other studies in adults and children that suggest no clinical benefit for most patients is more compelling.(3,4, 8,9) Jane M. Garbutt, MB, ChB, FRCP Benjamin Littenberg, MD REFERENCES 1. Wald E. R., Nash D., Eickhoff J. Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. Pediatrics. 2009;124(1):9-15. 2. Wald E. R., Chiponis D., Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial. Pediatrics. 1986;77(6):795-800. 3. Ahovuo-Saloranta A., Borisenko O. V., Kovanen N., Varonen H., Rautakorpi U. M., Williams J. W., Jr., et al. Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev. 2008(2):CD000243. 4. Garbutt J. M., Goldstein M., Gellman E., Shannon W., Littenberg B. A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis. Pediatrics. 2001;107(4):619- 625. 5. Harris S. J., Wald E. R., Senior B. A., Shores C., Garbutt J. M., Littenberg B., et al. The sinusitis debate. Pediatrics. 2002;109(1):166-167. 6. Garbutt J. M., Gellman E. F., Littenberg B. The development and validation of an instrument to assess acute sinus disease in children. Qual Life Res. 1999;8(3):225-233. 7. Garbutt J., St Geme J. W., 3rd, May A., Storch G. A., Shackelford P. G. Developing community-specific recommendations for first-line treatment of acute otitis media: is high-dose amoxicillin necessary? Pediatrics. 2004;114(2):342-347. 8. Williamson I. G., Rumsby K., Benge S., Moore M., Smith P. W., Cross M., et al. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. JAMA. 2007;298(21):2487-2496. 9. Young J., De Sutter A., Merenstein D., van Essen G. A., Kaiser L., Varonen H., et al. Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. Lancet. 2008;371(9616):908-914. Conflict of Interest: None declared Response to Treating acute bacterial sinusitis in children: some questions remain 14 October 2009 Ellen R Wald, physician University of Wisconsin School of Medicine and Public Health Send letter to journal: Re: Response to Treating acute bacterial sinusitis in children: some questions remain erwald{at}wisc.edu Ellen R Wald I appreciate the comments by Dr. Farber. Almost all of the children(89%) within each group of patients (intervention and control) had persistent symptoms. Accordingly, I am confident that the results can be extrapolated to that group of youngsters. I apologize that the duration of therapy, which was 10 days, was not clear. In patients to whom these criteria are stringently applied, ie, respiratory symptoms (nasal congestion/discharge or cough or both) lasting more than 10 days without evidence of improvement, the response to antibiotics is most often dramatic with a rapid diminution of signs and symptoms. The caveat that the symptoms are not already improving, as would be the case in most uncomplicated cases of viral upper respiratory infection, is very important. If symptoms are already improving, there is no need to and we wouldn't recommend antibiotic treatment. Conflict of Interest: None declared Response to "Pediatricians do not always treat clinically defined sinusitis with antibiotics 14 October 2009 Ellen R Wald, physician University of Wisconsin School of Medicine and Public Health Send letter to journal: Re: Response to "Pediatricians do not always treat clinically defined sinusitis with antibiotics erwald{at}wisc.edu Ellen R Wald We appreciate the comments of Dr. Armengol. It is difficult to do a direct comparison of the data which he presents and that which is found in our article. One of the most important observations made in the context of our study was the infrequency with which children presenting to their primary care pediatrician were diagnosed to have acute bacterial sinusitis when these criteria were stringently applied. Of 2135 children presenting to their physician with respiratory complaints, only 139 (6.5%) fit criteria for acute bacterial sinusitis. The number per thousand visits would surely be lower as many children visit their pediatrician for well child visits and non-respiratory complaints. Furthermore, many children with respiratory complaints never visit their primary care provider. This number is reproduced in the work of several other investigators and I believe is surprisingly low (Ueda D, Pediatric Infect Dis 1996;Aitken M, Arch Pediatric Adolesc Med 1998, Kakish KS, Pediatr Infect Dis, 2000). The impact of antimicrobial treatment of children fitting criteria for acute bacterial sinusitis is a more rapid resolution of respiratory symptoms by parental report. Conflict of Interest: None declared In response to inadequate evidence to support igh dose amoxicillin clavulanate for acute sinusitis 15 October 2009 Ellen R Wald, physician University of Wisconsin School of Medicine and Public Health Send letter to journal: Re: In response to inadequate evidence to support igh dose amoxicillin clavulanate for acute sinusitis erwald{at}wisc.edu Ellen R Wald Garbutt et al disagree with our conclusion regarding the benefit of antibiotic therapy in children with acute bacterial sinusitis. They question the validity of the scoring system which we have used for the past 25 years. While it is true that we have not published a formal study of its validity, it has performed extremely well over time and correlates nearly perfectly with parental report of outcomes. In other words, in general when children worsen as judged by an increasing score, parents have requested that the clinical course be deemed a "failure" and that cefpodoxime be started. Of 23 children who failed therapy, 19 actively made this request as their respiratory symptoms (nasal discharge or cough or both)were unchanged or worsened. The 14 day outcome was not reported in the 23 children who failed therapy as all were now known to be receiving cefpodoxime. The time to clinical improvement was the same in each arm of the study as all of the children who failed treatment were removed from the placebo category as they were now on active drug. We reiterate that children with acute bacterial sinusitis identified by stringent clinical criteria benefit from antimicrobial therapy as evidenced by a more rapid clincical cure than those children receiving placebo. Conflict of Interest: None declared