Medical Forum / Diseases and Disorders / Sinusitis / December 2007
New Study: Antibiotics, Steroids No Better Than Placebo for Acute Sinusitis
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Steven L. - 05 Dec 2007 03:57 GMT Sinusitis Treatments Found Ineffective British study reports antibiotics and nasal steroids don't lessen symptoms By Amanda Gardner Posted 12/4/07
TUESDAY, Dec. 4 (HealthDay News) -- Antibiotics and nasal steroids work no better than a placebo in combating sinus infections, a new British study shows.
"Antibiotics are probably not as effective as have been previously believed, particularly for the majority of cases of acute sinusitis," said study author Dr. Ian Williamson, a senior lecturer in primary medical care at the University of Southampton. "Patients should turn more to symptomatic remedies like analgesics while the body heals itself, usually over a period of three days to three weeks. Topical steroids have little overall effect, but may be beneficial, particularly in milder cases of acute sinusitis."
"For sinusitis, however it is being diagnosed in the primary-care setting, many of these cases do not require treatment, and a more cautious and conservative approach would seem to be warranted," added Dr. Reginald F. Baugh, vice chairman of Texas A&M Health Science Center College of Medicine and director of the division of otolaryngology at Scott & White, in Temple, Texas.
But other experts say the study, published in the Dec. 5 issue of the Journal of the American Medical Association, is no reason to scrap antibiotics altogether in this scenario.
"This is a helpful and useful study, and we shouldn't condemn antibiotics in those people who need them," said Dr. Michael Stewart, chairman of the department of otolaryngology at New York Presbyterian-Weill Cornell Medical Center, in New York City.
But, he added, only a minority of sinus infections are bacterial and will respond to antibiotics. The majority are viral infections, which won't respond to antibiotics.
According to an accompanying editorial, sinus problems account for 25 million doctor's office visits in the United States each year. Antibiotics are used to treat sinus infections 85 percent to 98 percent of the time in the United States.
Overuse of antibiotics not only won't help a patient with a viral infection get better, it will contribute to the growing problem of antibiotic resistance, experts have noted.
"Antibiotic resistance is rising dramatically, and there is no question about that," Baugh said.
For this study, 240 adults with sinus infections were randomized to one of four treatment groups: 500 milligrams of the antibiotic amoxicillin three times a day for seven days plus 200 micrograms of the nasal steroid budesonide once a day for 10 days; a placebo in place of the antibiotic plus budesonide; amoxicillin plus a placebo in place of budesonide; or two placebos.
In the amoxicillin group, 29 percent of patients had symptoms lasting at least 10 days, and 33.6 percent of those not receiving amoxicillin had the same symptom length of time.
In both the budesonide and no-budesonide groups, exactly 31.4 percent of patients had symptoms lasting at least 10 days.
The nasal steroids seemed to be more effective in individuals who had less severe symptoms.
As the editorial pointed out, most patients with acute sinusitis will get better on their own. Unfortunately, there's no good way to determine who has viral sinusitis and who has bacterial sinusitis.
"It's difficult to make a distinction in a primary-care setting," Baugh said.
http://tinyurl.com/3269q7
[ Here's a link to the JAMA paper if you want to pay for it:
http://jama.ama-assn.org/cgi/content/full/298/21/2543
I disagree that there is no way to tell if the infection is viral or bacterial. There is an easy way to tell: Viral infections tend to be self-limiting. If you're still sick after 3 weeks, and the infection may even be getting worse, than it's probably not viral.
That's why I suggest that if you have acute sinusitis, resist the temptation to see your doctor right away. Wait a good 3 or 4 weeks and then see how it's doing. It may start to clear by then. ]
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Fred - 05 Dec 2007 06:18 GMT > Sinusitis Treatments Found Ineffective > British study reports antibiotics and nasal steroids don't lessen symptoms [quoted text clipped - 91 lines] > Email: �sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me. I just think that you need to keep the nasal membranes from excreting excessive mucus. This excessive mucus is the breeding ground for both bacteria and viruses. If you can keep the mucus flow to a minimum, you will have healthier sinuses. This means getting control of nasal inflammations.
Fred - 06 Dec 2007 18:57 GMT > Sinusitis Treatments Found Ineffective > British study reports antibiotics and nasal steroids don't lessen symptoms [quoted text clipped - 91 lines] > Email: �sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me. To get control of my sinus problems I used both a steroid and a drying agent. It makes sense. If you have a minor inflammation, use a steroid to help heal the interior of your nose. Then, concurrently, use a drying agent like Ipratropium Bromide to dry up the running nose. You are affecting the smooth muscle on the inside of your nose. I also used a nasal lavage to keep the insides of my nose clean. I still have minor drainage. If the nose runs too much, I just take a little more Ipratropium Bromide to dry up the unwanted mucus.
judy.n - 09 Dec 2007 18:54 GMT Steven, All the clinical guidelines talk about treating severe symptoms: so for many of us with deranged anatomy, thanks to surgery, we get very ill, very quickly. When I get a bad sinusitis, there is simply no way I could wait 3 weeks. So, clinical judgement is important. For the average, healthy person, waiting will usually work. I like the fact that the editorial admitted that no clear clinical indications will determine whether sinusitis is viral or bacterial-- and it's usually multifactoral, as the virus causes initial inflammation and destruction of cilia, and then the bacteria move in: hence the "double sickening". And, patients with immunodeficiencies, prior or recent surgery, or severe disease should be treated. To quote your editorial: "This is a helpful and useful study, and we shouldn't condemn antibiotics in those people who need them," said Dr. Michael Stewart, chairman of the department of otolaryngology at New York Presbyterian-Weill Cornell ..." Judy
> Sinusitis Treatments Found Ineffective > British study reports antibiotics and nasal steroids don't lessen symptoms [quoted text clipped - 91 lines] > Email: sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me. neil0502@yahoo.com - 10 Dec 2007 19:52 GMT > Steven, > All the clinical guidelines talk about treating severe symptoms: so [quoted text clipped - 15 lines] > Presbyterian-Weill Cornell ..." > Judy Another possible approach ... one that /I/ had to raise with Mayo's ENT (he reacted as though I'd just invented the notion):
Culture early. Treat late.
He thought it was a swell idea. I've /never/ had a culture to see what bug was making my sinuses sick. Have any of you?
From my paltry knowledge, they've figured out ways to figure out what bug is ailing you, particularly whether it's bacterial, fungal, or viral.
From my paltry knowledge, they've decided that each merits distinctly different treatment methods.
From my paltry knowledge, some don't particularly respond to treatment at all, but resolve with time.
From my paltry knowledge, there are NARROW-spectrum ABX that can be used to treat particular strains of particular bacteria, possibly more quickly, more cheaply, and with less resistance and deleterious effects on overall health.
So, I asked, any downside to /culturing/ immediately, but then Rx'ing NOTHING until the results were back?
Swell idea, he thought.
Did I just invent the wheel, or something???? Not to my way of thinking ... or ... hoping.
rpautrey2 - 15 Dec 2007 13:57 GMT If they aren't effective for acute sinusitis they certainly couldn't be effective for chronic sinusitis. See my "Sinus Drainage Methods" post in this group. My solution is probably the only solution. Paul
> Sinusitis Treatments Found Ineffective > British study reports antibiotics and nasal steroids don't lessen symptoms [quoted text clipped - 90 lines] > Steven L. > Email: sdlit...@earthlinkNOSPAM.net judy.n - 16 Dec 2007 21:38 GMT I just read the study and editorial: lousy study: done over 4 years( 2001-2005) with an average of one patient per practice recruited, with lousy clinical guidelines, only a 65% chance at best that the patients had bacterial sinusitis. So, if almost half, or more of the patients had viral illness, of course antibiotics made no difference. The editorial cited poor methods and selection bias, and concluded that judicious prescribing of antibiotics was indicated in acute sinusitis. They were looking at methods to predict who is really sick and one study looked at HS-CRP and improved symptoms with penicillin. So, this study is garbage: read it--even the abstract--not the news coverage. Judy
> If they aren't effective for acute sinusitis they certainly couldn't > be effective for chronic sinusitis. See my "Sinus Drainage Methods" [quoted text clipped - 94 lines] > > Steven L. > > Email: sdlit...@earthlinkNOSPAM.net Steven L. - 16 Dec 2007 22:44 GMT > I just read the study and editorial: lousy study: done over 4 > years( 2001-2005) with an average of one patient per practice > recruited, with lousy clinical guidelines, only a 65% chance at best > that the patients had bacterial sinusitis. But that is typical of what primary-care physicians deal with. That is the realistic situation.
Primary-care physicians are not set up to do cultures and determine if there is a bacterial infection. They usually just prescribe antibiotics for a patient based on symptoms. Patients are not referred to an ENT until they start getting recurrent or chronic sinus infections.
So this study is suggesting that primary-care physicians should not continue to throw antibiotics at the problem as they have been doing up to now.
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judy.n - 16 Dec 2007 23:02 GMT You reached a false conclusion: the study used CLINICAL guidelines that were flawed, and no one realistically only treats endoscopically obtained cultures, they treat patients clinically. All the Otolaryngology guidelines are based on clincial symptoms. So, as a clinician, if you use your judgement, listen carefully to the history, judge the severity of the illness, and understand how to apply clinical guidelines, you should prescribe antibiotics "judicicously": more and more, we use delayed prescriptions--and the article quoted that in England, where this is widely utilized, only 30% of patients picked up their antibiotics. You give the patient a prescription, and tell them that if things are getting worse: focal pain, fever, systemic symptoms, fill the script. Amazing how most patients are pretty accurate judges of the course and severity of their illness. Sinusitis is a clinical diagnosis: all imaginig is imperfect and endoscopically obtained cultures are rarely even utilized by ENT's who have the technology--only in resistant and/or persistant cases. In this study, the patients had to present with a single episode of non-recurrent "sinusitis". One episode. And the guidelines were one sided nasal discharge, and a few other symptoms that have been shown to have low predicitive value. I'll post the abstract. Judy
> > I just read the study and editorial: lousy study: done over 4 > > years( 2001-2005) with an average of one patient per practice [quoted text clipped - 17 lines] > Email: sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me. judy.n - 16 Dec 2007 23:09 GMT Here's the pubmed link to the abstract: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSear ch=18056902&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel. Pubmed_RVDocSum Comment in: JAMA. 2007 Dec 5;298(21):2543-4. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial.
Williamson IG, Rumsby K, Benge S, Moore M, Smith PW, Cross M, Little P. Department of Medicine, University of Southampton, Southampton, England. igw@soton.ac.uk CONTEXT: Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched. OBJECTIVE: To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis. DESIGN, SETTING, AND PATIENTS: A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged > or =16 years) with acute nonrecurrent sinusitis (had > or =2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid. INTERVENTION: A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days. MAIN OUTCOME MEASURES: Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms. RESULTS: The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline. CONCLUSION: Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN60825437. PMID: 18056902 [PubMed - indexed for MEDLINE]
Again, you should read the editorial: this is a flawed study, but it sure got a lot of press: 240 patients divided into 4 groups: that's 60/ group, over the course of 4 years. Underpowered, and the clinical criteria have a low predictive value.
But the press is all over it, and no one takes the time to actually look at the study. Judy
> You reached a false conclusion: the study used CLINICAL guidelines > that were flawed, and no one realistically only treats endoscopically [quoted text clipped - 40 lines] > > Email: sdlit...@earthlinkNOSPAM.net > > Remove the NOSPAM before replying to me. Steven L. - 17 Dec 2007 00:22 GMT > You reached a false conclusion: the study used CLINICAL guidelines > that were flawed, and no one realistically only treats endoscopically [quoted text clipped - 9 lines] > systemic symptoms, fill the script. Amazing how most patients are > pretty accurate judges of the course and severity of their illness. That's fine, but that's NOT how it's typically done in America. That's my point.
In America, a patient will go to the primary-care doctor and demand to be cured immediately because he or she has an important job and can't afford to call in sick. The family physician will prescribe the antibiotic "just in case" the infection might be bacterial, and the patient will start on it immediately. Another common scenario: A desperate mom will demand immediate antibiotic treatment for her asthmatic child, to try to prevent that midnight trip to the ER when the child gets an infection-triggered asthma attack.
(In fact, when I was a kid, antibiotics were even commonly prescribed for the *common cold*, ostensibly to try to prevent secondary bacterial infection. That's not done much anymore, fortunately.)
In America, antibiotics are majorly over-prescribed by primary-care physicians and taken by patients for many illnesses without waiting a couple of weeks to see if improvement is spontaneous. There will be a subgroup of patients who, for whatever reason, will worsen with time. But they should be examined again in that case, to rule out the onset of bronchitis, pneumonia, meningitis, etc.
> In this study, the patients had to present with a single episode of > non-recurrent "sinusitis". One episode. But again, that's typical. And the recommendation is correct: If this is the patient's first bout with a condition whose symptoms resemble sinusitis, the best treatment is *symptomatic* in the vast majority of cases. In that sense, it's no different from how you treat a common cold--because in fact, they're often two sides of the same coin.
As for the study symptomatology having low predictive value, the real issue for this study is not its predictive value but its *relevance*--is this the way the majority of primary-care physicians in America have attempted to diagnose sinusitis? The answer is yes, it is, as I can attest from personal experience. If you want to suggest that primary-care physicians should diagnose sinusitis with other more reliable criteria, that's a whole other study you could cite them.
This study really does seem to capture the *essence* of how acute nonrecurrent sinusitis is treated (or mistreated) by primary-care physicians here in America. And if they continue to do things that way, then the conclusion from this study is that they are better off doing nothing at all than throwing antibiotics at what they have diagnosed (or misdiagnosed) to be the problem. A conclusion with which I heartily agree.
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rpautrey2 - 18 Dec 2007 00:46 GMT PA!!!
> This study really does seem to capture the *essence* of how acute > nonrecurrent sinusitis is treated (or mistreated) by primary-care > physicians here in America. And if they continue to do things that way, > then the conclusion from this study is that they are better off doing > nothing at all than throwing antibiotics at what they have diagnosed (or > misdiagnosed) to be the problem. A conclusion with which I heartily agree.
> -- > Steven L. > Email: sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me.
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