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Ear Infections: To Treat or Not to Treat

Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.

Current Medical Guidelines

In 2004, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) collaborated to issue evidence-based guidelines based on a review of the published evidence

Something was lost in the transmission: the guidelines have been over-simplified and misrepresented, so it’s useful to look at what they actually said. There were six parts:

1. Criteria were specified for accurate diagnosis.

  • History of acute onset of signs and symptoms
  • Presence of middle ear effusion (ear drum bulging, lack of mobility, air-fluid level)
  • Signs and symptoms of middle ear inflammation: Either red ear drum or ear pain interfering with normal activity or sleep

They stressed that AOM must be distinguished from otitis media with effusion (OME). OME is more common, occurs with the common cold, can be a precursor or a consequence of AOM, and is not an indication for antibiotic treatment.

2. Pain should be treated regardless of whether antibiotics are used.

3A. Observation without antibiotics is an option for a child with uncomplicated AOM.

  • Limited to otherwise healthy children and stratified by age
    • 6 mo to 2 years with non-severe illness and uncertain diagnosis
    • 2 and older without severe symptoms or with uncertain diagnosis.
    • All children under 6 mo should be treated.
  • Parents must have ready means of communicating with clinician.
  • A system must be in place to re-evaluate the child. Strategies include a parent-initiated visit and/or phone contact for worsening condition or no improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net antibiotic prescription to be filled if illness does not improve in 48 to 72 hours.

3B. Amoxicillin is the treatment of choice

4. Reassess in 48-72 hours.

  • If AOM is confirmed in a patient being observed, start antibiotics.
  • If patient is already on an antibiotic and symptoms persist, change it.

5. Encourage prevention

  • Modify the modifiable risk factors: limit attendance at child care centers, breastfeed for 6 months, avoid supine bottle feeding and bottle propping, and avoid exposure to passive tobacco smoke.
  • Influenza vaccine is 30% effective in reducing the incidence of AOM.
  • Pneumococcal vaccine provides a 6% reduction.

6. No recommendations for CAM. They reviewed alternative medicine treatments and found no evidence to support them.

Alternative Medicine

Alternative medicine often misrepresents the facts: for instance, one homeopathic website says

Recent medical studies have shown that giving antibiotics does not effect [sic] the course of ear infections at all.

CAM offers a smorgasbord of options for treating ear infections, but none of them are supported by any credible scientific evidence. Here are a few examples:

  • Jay Gordon, MD recommends herbal and homeopathic remedies.
  • Joseph Mercola, DO warns that antibiotics are harmful, ineffective, and unnecessary. He recommends garlic ear drops, putting breast milk in the ear canal, and onion poultices.
  • Natural News recommends chiropractic; essential oils; herbal remedies including Echinacea, goldenseal, olive leaf and St. John’s wort; and eliminating dairy.
  • Andrew Weil, MD recommends cranial osteopathy and eliminating dairy products.
  • Many chiropractors claim to treat ear infections with upper cervical adjustments to promote drainage of the ear and support immune function. Ear-related claims are particularly common in that profession because D.D. Palmer, founder of chiropractic, claimed to have been originally inspired by a case of curing deafness with a neck “adjustment.”
  • An acupuncture website recommends needling TH 5, GB 41, GB 20, TH 17 and GB 2.
  • A homeopathic website offers to treat the whole child instead of just treating ear infections. They consider the child’s personality, likes and dislikes, and other factors; then choose the right homeopathic remedy to strengthen the health of the child. They claim that their treatment will make everything in the patient’s life get better.

Difficulty of diagnosis

Parents suspect their child has an ear infection when they notice irritability, pulling at the ear, and fever. These symptoms may be due to other causes, some of them serious, so a diagnosis by a doctor is essential. Anyone who has attempted to examine the ears of a struggling 2-year-old realizes that diagnosis is not a straightforward, black-and-white procedure. Many clinicians are not skilled in pneumatic otoscopy and tympanometry and they may have to rely on the appearance of the tympanic membrane (TM) through a simple otoscope. The ear canal is narrow and the view often obstructed by wax. The TM can be red because the child is crying. It can be a difficult judgment call to say whether the TM is bulging or dull, especially when you can only see part of it. When a doctor sees a sick child with an unexplained fever, it is tempting to call it AOM and have an answer and an excuse to “do something” (give antibiotics) when the diagnosis is not really so clear.

New Studies

Critics have suggested that the studies the recommendations were based on had limitations such as biases in patient selection, varying diagnostic criteria, and suboptimal antibiotic regimens. Two new studies have re-assessed antibiotic treatment using strict diagnostic criteria and optimum antibiotic regimens.

On January 13, 2011 The New England Journal of Medicine published two very similar high-quality studies done in Pittsburgh and Finland. Neither was funded by Big Pharma or any other commercial entities. Both addressed acute otitis media in very young children (6-23 months and 6-35 months respectively). Both were randomized double-blind studies. Both used stringent diagnostic criteria, with examiners who were skilled otoscopists. Both used amoxicillin/clavulanate rather than amoxicillin alone, since the evidence now indicates it is the most effective treatment.

Both studies found that antibiotics were clearly superior to placebo. The Finnish study calculated an NNT of 3.8 (the number of children that must be treated for one to benefit). It found that the benefit was the same regardless of the severity of the illness. Diarrhea and diaper rash were more common in those getting antibiotics. One patient in the placebo group developed mastoiditis. No increase in colonization by antibiotic-resistant bacteria was found.

An accompanying editorial stresses that the key to the optimal management of acute otitis media remains the accuracy of the diagnosis.

Conclusion

It is now clear that young children with a certain diagnosis of AOM recover more quickly with antibiotic treatment. The benefits of antibiotic treatment must be balanced against the development of resistant strains and the recognized side effects of antibiotics. Watchful waiting is only appropriate for patients over 6 months old when the diagnosis is uncertain. The new studies suggest that severity of illness should not be a criterion for deciding which children to treat, but that the emphasis should be on accurate diagnosis. I’m guessing that these two new studies will lead to revised guidelines.

Posted in: Clinical Trials, Pharmaceuticals

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42 thoughts on “Ear Infections: To Treat or Not to Treat

  1. threelittlepigs says:

    Very interesting. Thank you for this article.

    What is the story on ear tubes? I thought they were a mostly safe way to reduce ear infections and oral antibiotic use. However, some seemingly science-based websites say they are not based in evidence and are controversial. I really like our ENT and he never mentioned any reason not to get them-just the small risk of the anesthesia.

  2. Adam_Y says:

    Actually searching for information about ear tubes seems to point back to the recommendations Dr. Hall writes about here. It looks like the original reason to get ear tubes was completely wrong. The fluid buildup inside of the ear does not actually result in permament hearing loss and is only temporary.

  3. Since seeing a child with a runny ear, I would be completely happy to go with ear tubes evidence be dammed. It’s just so gross.

  4. windriven says:

    What is the deal with Joseph Mercola, DOh? His website includes this bon mot:

    “The existing medical establishment is responsible for killing and permanently injuring millions of Americans…”

    He has been published in JAMA and BMJ but, as Dr. Hall notes, he
    “warns that antibiotics are harmful, ineffective, and unnecessary. He recommends garlic ear drops, putting breast milk in the ear canal, and onion poultices.”

    Onion poultices??? Did he get his degree from the Count Chocula Secret Decoder Ring School of Osteopathy?

    Is Mercola a dangerous quack or does he just play one on the internet?

  5. LovleAnjel says:

    Treatment is complex and multi-optioned. So it must be wrong and contradictory! Here, my simple remedy will fix you, no matter what your symptoms or disease course. Boot to the head.

    I hope ear tubes get phased out, if the evidence is not for them. Parents can get really stressed out trying to keep water from getting into those tubes all the time.

  6. LovleAnjel says:

    @windriven

    How the hell will breast milk fix an ear infection?! He’s really gone off the “breast milk contains antibodies” deep end.

    I have seen forums where posters say it’s okay to have a neonate around sick people because “breast milk contains antibodies”. It’s not magic, people!

  7. Paul says:

    @threelittlepigs and @Adam_Y,

    There are two reasons we recommend kids get ear tubes.
    The primary reason these days is for recurrent bacterial infections (or a persistent infection that is not going away). There is decent evidence for that.

    The other reason – persistent non-infected middle ear fluid has fallen out of favor. Good studies have shown no difference in short or long term language development in kids with chronic ear fluid whether they had tubes placed or not. (As I recall, the primary risk factor for poor language development was lower maternal education)

    so, we rarely send kids to get tubes just for chronic fluid . Every now and then – we may consider it in a child with obvious developmental problems who has chronic ear fluid AND has been shown to have hearing loss. That’s probably 1 kid a year for me.
    But, I send several a month to get tubes, because they have chronic bacterial infections. In most kids, they get a significant reduction in infections.

  8. windriven says:

    @Paul

    Would you mind saying in which region of country you practice? I grew up in the midwest and never knew anyone who got tubes. I later lived for a number of years in New Orleans where tube insertion is (or at least was then) nearly as common as hair-cutting. Now I live in the Pacific Northwest and, so far as I can tell, tubes are rare here.

    Is there any evidence to support regional differences in the incidence of otitis media?

  9. windriven says:

    @LovleAngel

    It really disturbs me when I encounter physicians who peddle nonsense. It is easy enough to dismiss garden variety quacks but licensed physicians enjoy a level of (usually) well-earned credibility. When they trade on that credibility to peddle nonsense it seems to me a monstrous ethical lapse. It diminishes the profession and erodes the line between medical practice and witchcraft in the public mind.

  10. Paul says:

    @windriven-

    I’m in NJ. All of my training has been Mid-Atlantic or in the Northeast. I’m not aware of any regional differences in infection or diagnosis. But, I’m sure there are differences in management.

  11. roblindeman says:

    Excellent post, few quibbles:

    Dr. Hall opens the post with the quotation regarding the percentage of admissions for AOM to Bellevue in 1932. She may be quoting Jerome Klein’s editorial accompanying the NEJM articles. I can find NO EVIDENCE TO SUPPORT THIS CLAIM. The only reference Dr. Klein gives is to a paper in the journal Laryngoscope from 1935. The article cited makes no mention whatsoever to AOM admissions at Bellevue in any year. If anyone can locate references that support this claim, PLEASE PRODUCE THEM.

    As for the NEJM articles themselves, they confirm what is already known about antibiotic therapy of AOM: you need to treat lots of kids to get improvement from one of them. For example, in the Pittsburgh study, the number needed to treat (NNT) to get improvement at day 7 is 7 (seven). That is, six out of seven will not benefit.

    This result is all the more remarkable because the study adhered to strict inclusion criteria for AOM, AND YET the treatment effect was small. For us common folk in the community, especially ED physicians, I seriously doubt that strict diagnostic criteria are considered. I am willing to be corrected if I am wrong on this.

    As for harms, both studies demonstrate that the treatment group was significantly more likely to be harmed (although diarrhea is not a serious complication, I will stipulate).

    Finally, if there is solid evidence that we should all be using Amox-Clavulanate instead of Amox first-line in AOM, I would like to see it. I haven’t as of yet.

  12. LovleAnjel says:

    @windriven

    I totally agree. I had a friend almost go to crazyland after reading Mercola’s page. She was amenable to Quackwatch information, luckily.

  13. Harriet Hall, thanks for the article. Chiroprators and other untrained individuals treating ear infections makes me say grrr. Perhaps more on that later.

    Regarding ear tubes – gosh, what’s up with folks today. They are all going off and doing online research, coming back with opinions based on their research, without sharing the links of their sources.

    Inquiring minds want to know. :)

    Since my son is on his 4th set of ear tubes, I should proclaim an ear tube bias. Also that I’m a laymen, so what do I know?

    But here’s my take on ear tubes, via info from our ENT and a bit of online research months ago, which I won’t provide links for either :), cause I can’t remember.

    If the child’s Eustachian tubes are not draining properly and the are experiencing Otis media with effusion (OME) then they are at risk for more ear infections, perforation of the ear drum and temporary conductive hearing loss that is a result of the effusion. Perforation of the ear drum carries the risk of permanent hearing loss. Depending upon the age, the conductive hearing loss (from the effusion itself) can cause speech delays, behavior problems or school problems, since even mild hearing loss hampers our ability to understand speech. Those issues typical correct themselves (over some time) once the OME is corrected.

    There are a number of reason that Eustachian tubes may not drain properly; temporary congestion/inflammation from a cold or sinus infection; longer term congestion from allergic rhinitis or sinusitis; the Eustachian tubes temporarily too horizontal to drain properly or there may be a permanent structural abnormality.

    For a child with typical anatomy, the rule of thumb for OEM is watchful waiting for four months to see if the effusion is self correcting. (the child grows, creating a better slant in the Eustachian tubes, the congestion or inflammation clears up, etc).

    If, after four months, the effusion remains (diagnoses through t-pan) then the child may be candidate for temporary ear tubes, particularly if there are other concerns such as speech delay or repeat ear infections.

    Usually a smaller temporary ear tube will be used. These fall out in 6 to 12 months. At that point a trial of several months observation is suggested, since the child’s growth (or other factors) may have corrected the Eustachian tube drainage issue.
    The temporary tubes have a small risk of causing permanent hearing loss, that must be balanced with the small risk of permanent hearing loss might be caused by a infection related perforation.

    If repeat tubes are needed, longer lasting T-tubes may be recommended. T-tube usually last at least one year and can last several. They carry a higher risk of permanent mild hearing loss, but lower the risks of permanent hearing loss that could be caused by repeat ear tube insertion or infection related perforation.

    Also,

    If a child has typical anatomy and yet long term problems with OME (past age 5), it may be wise to investigate the cause. Allergies, structural abnormality, what’s up?

    Silicone ear plugs work quite well for swimming.

    Oh and the child with ear tubes can still get an ear infection with the yucky drainage. :( In my anecdotal experience, it’s been much less likely.

    Here’s an article on the over use of ear tubes and when they are appropriate. http://www.nytimes.com/2006/08/15/health/15brody.html

  14. Adam_Y says:

    There are two reasons we recommend kids get ear tubes.
    The primary reason these days is for recurrent bacterial infections (or a persistent infection that is not going away). There is decent evidence for that.

    No no there isn’t.

  15. roblindeman says:

    Oops. Found the Ref Klein referred to. And I’m glad I did! Because the article in question argues, pace Dr. Klein, that even in the pre-antibiotic era, AOM was over-treated (i.e., with myringotomy).

    The authors Journal of Pediatrics article, Bakwin and Jacobziner, document a spontaneous and precipitous decline in admissions for AOM over a four-year period. The explanation appears to be that docs stopped doing so many myringotomies.

    Plus ca change…

  16. Mhops says:

    For otherwise normal/healthy kids, watchful waiting is just fine for OME. The research supporting this excludes children with other health/developmental conditions, however.

    For kids with recurrent AOM, ear tubes are a very reasonable choice, but a choice it is (in most cases). When advising parents on making this decision, I ask them to consider their child’s suffering and side effects/intolerances that may have been experienced with the antibiotics (these can be quite troublesome). Ear tubes can reduce the number of infections and amount of oral antibiotics the child is being prescribed. Most parents are very happy with tubes.

    A frequent dilemma, however, is assuming that the history is indeed accurate — that the child wasn’t misdiagnosed (had OME, or even had teething problems and no ear diagnosis at all).

    I only advise ear plugging if they are going to be exposed to dirty water, otherwise there isn’t evidence that this is needed for baths and chlorinated pools.

  17. Adam_Y

    You’ll find here the AAP recommendation on ear tubes. You’ll find the review of the evidence there too. It’s a free download.

    http://www.ncbi.nlm.nih.gov/pubmed?term=%22AAP%2C%20AAFP%2C%20AAO-HNS%20Subcommittee%20on%20Otitis%20Media%20with%20Effusion%22Corporate%20Author

  18. Sorry for that dreadfully non-functional link. This should be better

    http://www.ncbi.nlm.nih.gov/pubmed/15222643

  19. Angora Rabbit says:

    I’m curious. Has the incidence of inner ear infections increased in children? Or is it a case of increased diagnosis and treatment? I ask because I don’t recall this growing up (in the 60s), and now it’s all I hear parents complaining about. I don’t recall any of us kids getting these, though we certainly got mumps, chicken pox and measles. Am I suffering from Selective Memory Syndrome or is this a real change?

  20. windriven says:

    @Paul

    My speculation was that there may be a higher incidence in the southeast owing to higher humidity and average temperatures, longer summers, or some other environmental factor or combination of factors. Or it may be that my small (and totally unscientific) sample size simply overstates the incidence in the southeast.

  21. Probably confirmation bias, but it’s always reassuring when SBM echos my pediatrician’s methods.

  22. Angora Rabbit,

    I suspect it might be daycare. Young kids with tiny horizontal eustachian tubes and repeated URIs. Kids go to daycare even when they’re sick, so they share whatever they have.

  23. moderation says:

    I would have to agree with roblindeman the NNT seems quite high when considering the stringent inclusion criteria.

    After reading the articles I am not sure I understand why the choice to use Augmentin, first line … it is not the current recommendation and therefore clouds the results as to how they would apply to the current guidelines.

    As to questions about variation in frequency of antibiotic treatment … you will often see variation due to several reasons. Having worked in the ER and in a pediatric clinic, I found I was much more likely to prescibe antibiotics in the ER, where my patient was more likely to be lost to follow up. Often choice to treat or observe is related to experience and comfort level examining and managing pediatric diseases … I remember some time ago reading that Rx rates for OM pediatrics<family practice<ER. Also, resistance rates vary from state to state. As I remember SoCal had a particularly high resistance rate … some speculate due to the OTC availability of abx in Tiajuana.

  24. MOI says:

    Regarding breastmilk – Many moms swear that BM helps with pink eye, so why not infections in the ear? Really, I’m asking.

    Here is a table of the components in BM and what those components are effective treating, in vitro.

    http://www.latrobe.edu.au/microbiology/table1.html

    I do not know the common bacteria that infects those with AOM but perhaps it’s possible that BM could help with AOM. It IS free and unless you are ignoring your child’s worsening symptoms, I don’t see much of a downside.

  25. windriven says:

    @MOI

    I would be skeptical about using breast milk to treat anything unless one finds oneself unable to access regular medical care (ie desert island). The table you linked indeed listed a variety of antibacterial factors known to appear in human breast milk. But tables 4 and 5 in the same series showed bacterial and viral contaminants also known to appear in human breast milk.

    Further, your statement: “It IS free and unless you are ignoring your child’s worsening symptoms, I don’t see much of a downside,” is a bit shortsighted. Cat urine is also free and has the additional benefit, absent UTI, of being sterile. But I wouldn’t use that to treat my child either.

    High quality medical care delivered by well-trained personnel is widely available in the industrialized world. Why gamble with a child’s hearing, sight or general health with folk remedies when such care is available?

  26. MOI says:

    Windriven –

    I never stated to not take your child to the doctor. Why not discuss with your doctor treating the ear infection with BM? Diarrhea and diaper rash may not sound like a big deal but when the diarrhea turns into bloody diarrhea and your doctor is concerned on the off chance that a bug took advantage of the compromised gut flora due to antibiotics and to stop treatment and watch your child closely for worsening symptoms…you want to be damn sure next time that antibiotic treatment is the prudent course of action.

    And is there is a reason why you compared BM to cat urine?? Unless cat urine has anti-microbial properties (not to mention that urine is a waste-product while BM is not), I do not see how that analogy is appropriate here.

  27. moderation says:

    MOI: you should probably look into the anatomy of OM, also known as an “internal ear infection”. The infection occurs behind the tympanic membrane, which unless ruptured, is impenetrable to liquid (such as breast milk) dripped into the ear canal. This does not even take into the account the fact that BM would contain inadequate concentrations of antimicrobial factor to be effective in vitro.

  28. moderation says:

    Whoops, should be in vivo.

  29. MOI “Diarrhea and diaper rash may not sound like a big deal but when the diarrhea turns into bloody diarrhea and your doctor is concerned on the off chance that a bug took advantage of the compromised gut flora due to antibiotics and to stop treatment and watch your child closely for worsening symptoms”

    I agree on the diarrhea issue. When my son was little he had that reaction to amoxillion, and it wasn’t just a little loose stool. He would flood his diaper several times a day with full out liquid stool. That is the point when you start risking dehydration. He didn’t have as bad a reaction to the alternative that the doctor prescribed after that, but maybe some might not be so lucky.

    On the other hand, due to the fact that the breast milk can’t reach the infection and I’m very leery of putting anything in the ears, I wouldn’t be inclined to try breast milk. I have no idea what the yeast population in ears is, but my daughter was inclined to yeast rashes, which I was warned to keep sugary substances away from (she would get them in her neck fold…sweet pudgy baby.) Also, since breast milk was never free to me, it would have been a complicated endeavor, regardless.

  30. roblindeman says:

    “Ear infections used to be a devastating problem.”

    “In the 1980s, [w]e realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days.”

    Neither statement is entirely true. OM never was a devastating problem. The frequency of hospital admissions, it turns out, was because myringotomy, the only therapy available, apparently required admission to hospital. While it’s true that mastoiditis occurred, it was rare, as it is today.

    Pace Dr. Hall, we already knew in the 19th century that 80% of AOM resolved without therapy.

    AOM was overtreated prior to the advent of chemotherapy, and it continues to be overtreated, in a large and serious way, today.

  31. MOI says:

    Moderation – I had considered that. By giving antibiotics you are treating the infection systemically with a medication that is designed specifically to kill off a wide range of bacterial whatnots. I just remember when I was a child that ear drops were used when I had ear infections.

    Michigan – I hadn’t considered that. But what exactly causes yeast infections? The only one my son had (thank goodness, I have heard horror stories about thrush) was on his bum. Some Lotrimin cleared it up.
    Oh and if BM was a reliable alternative, it would only be convenient for those currently breastfeeding. =)

  32. “But what exactly causes yeast infections? The only one my son had (thank goodness, I have heard horror stories about thrush) was on his bum. Some Lotrimin cleared it up.
    Oh and if BM was a reliable alternative, it would only be convenient for those currently breastfeeding. =)”

    On yeast infections*. I’ve been told by pediatricians (and a couple of vets) that yeast is a natural organism that lives on most people. It likes moist environments like under a diaper, the mouth, etc. Thrush, yeast infections and yeast rashes are caused by an over population of yeast. This can be because beneficial bacterial are killed off (as a yeast infection caused by taking antibiotics) or an environment that is just more friendly to yeast than bacteria or too friendly to both (one can get a yeast and bacterial infection). Yeast likes sugar. (don’t we all). The sugar connection is not usually important with a yeast rash in the diaper area, I don’t think…, but can be relevant when the rash is in an area that juice or other sugary substance might sit in, such as a neck crease. I’m not sure about the mouth, I’ve never had to deal with thrush (luckily).

    My thought is that an ear, particularly an infected one, might be a moist enough place for yeast to reside in and adding a sugary substance might possibly cause an over population. My daughter’s yeast rashes were rather difficult to clear up when she was young (needed prescription salve) and I wouldn’t want to have to deal with it in the ears, particularly on top of an ear infection.

    This in entirely speculation, though.

    Also as a side note, if the child has ear tubes, one doesn’t need oral antibiotics, they can use drops that go through the tubes and can work locally on the infection.

    *once again, I’m not a medical person or even a science person.

  33. moderation says:

    MOI: What you were treated for as a child was probably otitis externa, also known as “swimmer’s ear” … an infection of the skin that lines the ear canal and is treated with topical abx drops. OM can be treated with abx drops, but only in the presence of PE tubes (or a ruptured TM) which allow the abx drops access to the middle ear.

  34. Werdna says:

    “As for harms, both studies demonstrate that the treatment group was significantly more likely to be harmed (although diarrhea is not a serious complication, I will stipulate).”

    …and probably has far, far more variability per child than say perforation of the tympanic membrane.

  35. roblindeman says:

    “…and probably has far, far more variability per child than say perforation of the tympanic membrane.”

    … a complication that occurred in both groups, with no statistically-significance, at least according to the authors; Pittsburgh study 1/144 vs. 6/147

  36. Werdna says:

    “a complication that occurred in both groups, with no statistically-significance”

    Can you cite the portion of the article that specifically indicates no statistical significance? I don’t see it.

  37. roblindeman says:

    Table 3

  38. Werdna says:

    Where does is say “not significant”?

  39. roblindeman says:

    Two of the outcomes, protocol-defined diarrhea and diaper area dermatitis are flagged and the p-values for statistical significance are given below. Are you suggesting that the absence of a flag and a p-value implies that there is statistical significance but the authors chose not to highlight it? Why are we even arguing about this?

  40. Werdna says:

    Well I’m not sure why *you’re* arguing about anything.

    However yes, there’s a lot of reasons why someone might not flag a figure. Considering that P-Values are far better tools for ruling something out than ruling it in. It’s IMHO not such a good way to annotate. I suppose my implied question is why something that obviously has a rather large variability like “diarrhea” (even given their clinical definition) gets seemingly huge significance in your eyes.

  41. MOI says:

    michigan & moderation – Thank you for the information!

  42. Sid Offit says:

    Nice article Harriet

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