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ARTICLE: Jane M. Garbutt, Marion Goldstein, Elliot Gellman, William Shannon, and Benjamin Littenberg A Randomized, Placebo-Controlled Trial of Antimicrobial Treatment for Children With Clinically Diagnosed Acute Sinusitis Pediatrics 2001; 107: 619-625 [Abstract] [Full text] [PDF]

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eLetters published:

A parent's view of treatments for sinusitis

Freya J Schultz   (2 April 2001)

response to letter

jane garbutt   (4 April 2001)

Sterilizing abscesses used to be considered bad form. Why are we studying it as a treatment option?

Mary Fay   (9 April 2001)

14 days of symptoms: better place to start?

Marc Habert   (13 April 2001)

response to Dr Fay's letter

jane garbutt   (14 April 2001)

Re: 14 days of symptoms: better place to start?

Michael Buebel   (7 May 2001)

Response to Dr Habert and Dr Buebel

jane garbutt   (12 May 2001)

A parent's view of treatments for sinusitis 2 April 2001
Freya J Schultz, Multi-Agency CSHCN Staff Analyst N/A Send letter to journal: Re: A parent's view of treatments for sinusitis freya{at}co.santa-barbara.ca.us Freya J Schultz	As a parent of a child who suffered recurrent sinusitis and otitis media, I am wondering why the trial did not consider anti-fungal medication and was restricted only to conventional antibiotics? After the Mayo clinic study published last year on fungal sinusitis, I would think that the pediatrics community would consider evaluating the benefits of anti-fungal treatment for children. I am an adult who has suffered since early childhood with ear, nose and throat problems associated with sinusitis. I recently requested and received treatment along the Mayo Clinic lines from my internist and my son's pediatricians, and for the first time in my life and my son's (I am over 40) we have been completely free of congestion and discharge. While it is certainly interesting to note that amoxicillin and augmentin do not work (I knew that, having had multiple prescriptions in our family), I would think it would be more useful to know what DOES work. Nystatin seems to work just fine. Freya Schultz 5793 Encina Road, Apt. 102 Goleta, CA 93117
response to letter 4 April 2001
jane garbutt Send letter to journal: Re: response to letter jgarbutt{at}im.wustl.edu jane garbutt	From: Jane Garbutt [mailto:jgarbutt@im.wustl.edu] Sent: Monday, April 02, 2001 7:39 PM To: Pediatrics P3Rs Subject: Re: P3R regarding your article in Pediatrics Dear Sir Mr Schultz makes a good point that it would be very useful to identify a treatment that does work rather than ones that do not. I agree. The main objective of our study was to determine if antibiotics commonly used to treat clinically diagnosed acute sinusitis in children offer any benefit to patients. In the absence of benefit, we suggest their use be restricted to patients with prolonged symptoms for at least 3 weeks rather than the 10-14 days currently suggested. We believe this strategy will reduce unnecessary antibiotic use without adversely affecting patient outcomes. We are interested in evaluating other approaches for symptom relief, and different diagnostic methods to accurately identify children with acute bacterial sinusitis who will likely benefit from antibiotic treatment. There are two main reasons why our trial did not consider antifungal agents. First, the evidence of benefit from antifungal agents became available after our study was completed. Second, Mr Schultz's son suffers from recurrent sinusitis, not acute sinusitis as did our patient population. The causative agents for these diseases are thought to be different. I have not read the original literature on fungal sinusitis, but believe that antifungal medications have been found to be beneficial for recurrent and chronic sinusitis, not acute sinusitis. It would be interesting to evaluate the role of antifungal agents in acute sinusitis. I am not aware if any such studies are currently underway. Jane Garbutt MBChB >An electronic letter was submitted from Pediatrics Online's Post Publication >Peer Review for your article. It is our intention to post this letter on >the web site and we would like your feedback on the letter. > >Your article (citation): > > A Randomized, Placebo-Controlled Trial of Antimicrobial Treatment for >Children With Clinically Diagnosed Acute Sinusitis > Jane M. Garbutt, Marion Goldstein, Elliot Gellman, William Shannon, >and Benjamin Littenberg > Pediatrics 2001; 107: 619-625 (Articles) > http://www.pediatrics.org//cgi/content/abstract/107/4/619 > http://www.pediatrics.org//cgi/content/full/107/4/619
Sterilizing abscesses used to be considered bad form. Why are we studying it as a treatment option? 9 April 2001
Mary Fay, pediatrician Send letter to journal: Re: Sterilizing abscesses used to be considered bad form. Why are we studying it as a treatment option? mfay2{at}home.com Mary Fay	It comes as no surprise - at least to me - that antibiotics do not change the course of uncomplicated acute sinusitis. As a general pediatrician who has been dealing with this problem on an increasing basis over the last decade (the number of cases seeming to correlate to the increasing numbers of children with allergies), I feel signs and symptoms of uncomplicated acute sinusitis are those of inflammation, not infection, and antibiotics alone are not an effective or recommended treatment we should be investigating. You have to treat the problem to see improvement, not treat symptoms of the problem, and the problem is one of too much swelling and poor drainage of secretions. Retained secretions become secondarily infected with bacteria, fungi, or some other organism living nearby, but this is an expected complication of the real problem, which is inflammation, and treating infection alone is doomed to fail. To make the patient feel better you have to relieve the block and allow infected material to flow out of the sinuses, not sterilize what is essentially an abscess. You might be able to sterilize some infected sinuses, but if normal drainage isn’t reestablished, the minute the antibiotics are stopped, or some resistance is developed, you will be back in trouble. Ultimately, you will cause more problems because you will be faced with increasing resistance to the antibiotics used, and in children, you run the risk of permanent structural changes in the upper airways that will cause poor drainage all the time – inflammation being present or not. Maybe I am naive in my views, but when did sterilizing abscesses become the recommended way of dealing with infection, and when did we replace common sense with statistical analysis of data not worth considering in the first place?
14 days of symptoms: better place to start? 13 April 2001
Marc Habert, Pediatrician Sound Shore & Mount Sinai Medical Centers Send letter to journal: Re: 14 days of symptoms: better place to start? marcohaber{at}aol.com Marc Habert	This was a very interesting study and applicable to everyday general pediatric practice. It seems as if most of the improvement in symptoms occurred in the first 3 days of "treatment". I wonder if using 14 days of symptoms instead of only 10 would have changed the results in anyway? Were there a subgroup of children who had at least 14 days of symptoms?
response to Dr Fay's letter 14 April 2001
jane garbutt, physician Send letter to journal: Re: response to Dr Fay's letter jgarbutt{at}im.wustl.edu jane garbutt	Dear Dr Fay I agree with Dr Fay that use of antibiotics when the primary problem is not a bacterial infection will not benefit the patient will likely result in more harm than good. Our study sought to ascertain whether this was the case for children with acute uncomplicated sinusitis. The pathogenesis of sinusitis is incompletely understood, resulting in a variety of treatment regimens. Current treatment recommendations do suggest antibiotic treatment for children who meet the clinical diagnosis of acute sinusitis (non-specific upper respiratory symptoms that are not resolving and persist for at least 10 days), and antibiotics are commonly used to treat this condition. In fact acute sinusitis is the fifth most frequent diagnosis resulting in an antibiotic prescription in pediatric ambulatory care. Most other treatments have not been evaluated in a systematic way, and their benefit is uncertain. There is much work to do. We need to improve our diagnostic accuracy to enable us to identify children with bacterial sinusitis who will likely benefit from antibiotic treatment. We also need to evaluate symptomatic treatments (over the counter and prescription medications) to determine the most effective treatment for children with acute sinusitis. Jane Garbutt MBChB
Re: 14 days of symptoms: better place to start? 7 May 2001
Michael Buebel, Family Physician Western Pennsylvania Hospital Send letter to journal: Re: Re: 14 days of symptoms: better place to start? mbuebel{at}wpahs.org Michael Buebel	I agree with Dr. Habert's question, and I am hoping it will be answered soon. It is clear that the current "principles" say Rx with ABX 10-14 days after onset of symptoms. I assumed Dr, Garbutt had to choose the 10 day mark to get the study approved by their IRB (ie. more conservatve approach when considering placebo for possible acute bacterial rhinosinusitis). Concerning the other comment about improved response in 3 days: it does appear from the graph that there was a larger benefit from augmentin in the first 3 days, but the text says this was not clinically significant. Thank you Dr. Garbutt for doing this important study. It will surely change my practice. It really reaffirmed my belief that these kids with mild symptoms for 14 days don't need to be treated. Our daycare provider tells me "they all have snotty noses"--and it is true. I hope the other doctors in my area will follow suit so my child is no longer exposed to these resistant bugs.
Response to Dr Habert and Dr Buebel 12 May 2001
jane garbutt, physician Washington University, St Louis, MO Send letter to journal: Re: Response to Dr Habert and Dr Buebel jgarbutt{at}im.wustl.edu jane garbutt	Dear Dr Habert and Dr Buebel Thank you for your interesting question concerning the subgroup of patients with at least 14 days of symptoms. I apologize for the delay in my response. 117 of the 161 patients included in the analysis had symptoms for at least 14 days, 40 of whom received amoxicillin, 40 amoxicillin- clavulanate and 37 placebo. We have repeated our primary analyses to measure symptom change in this subgroup of patients to determine if they experience any treatment benefit. Once again, change in sinus symptoms was the same in all groups, regardless of outcome assessment method used (S5 score or Improvement rate). Using repeated measures analyses to compare outcomes at Days 3,7,10 and 14, there was no difference in symptom resolution among the 3 treatment groups (S5 score: n=117, P=0.49; Improvement rate: n=105, P=0.71). Similarly, we found no difference for the same outcome comparisons for patients treated with an antibiotic and those treated with placebo (S5 score: n=117, P=0.78; Improvement rate: n=105, P=0.77). All repeated measures analyses are controlled for age and gender differences at baseline. To address concerns about the apparent early difference in S5 scores seen in Figure 1, we repeated the analyses for symptom differences at Day 3 for this subgroup of patients. Comparing patients treated with an antibiotic with those treated with placebo and correcting for repeated comparisons, we found no significant difference between treatment groups at Day 3 using the S5 score (P=0.86) or improvement rate (P=0.14). Jane Garbutt MBChB