Sinus infections: what we do and don't know

Aug 22 2010 Published by under Medicine, [Medicine&Pharma]

Acute sinusitis---a "sinus infection"---is one of the most common problems seen by primary care physicians.  The current preferred terminology is "acute rhinosinusitis", a term which is more descriptive of how the disease works (its "etiology").  In most cases, a patient will first develop cold or allergy symptoms including a runny, congested nose ("rhinitis").  The swelling in the nose will block off the holes ("ostia") that drain the sinuses.   Both cold viruses and allergies can cause inflammation in the nose and sinuses which will increase the flow of mucus.  As the mucus builds up in the sinuses with nowhere to go, the pressure increases causing pain in the face, forehead, and teeth.

Paranasal Sinuses

As the cold or allergies improve, the swelling decreases, allowing the mucus to flow back out of the sinuses.  But the longer the mucus pools in the sinuses without draining, the higher the chance that this nutritious fluid will become colonized and then infected with bacteria.  But most cases of sinusitis are primarily viral, and go away on their own without specific intervention, and only about 2% of colds go on to become bacterial sinusitis.

Deciding which sinus infections are viral and which bacterial is quite simple: we can puncture a sinus with a large needle, withdraw its contents, and send it to the lab for analysis.  Not surprisingly, most patients and physicians are resistant to such an approach.   Sinus X rays are abnormal in many patients with viral infections, so X rays don't help us much either, and are not recommended.  Patients who have had one-sided facial pain or tenderness, tooth pain, and thick green or yellow nasal discharge for more than a week are more likely to have bacterial sinusitis.  All of these folks should be given antibiotics immediately, right?

Not so much. Most of these patients can be treated with tylenol, decongestants, or anti-inflammatories such motrin, and they will get better on their own.  Patients who have significant symptoms that will not go away are the ones who should be treated with antibiotics.  Since most cases of acute sinusitis are caused by Streptococcus pneumoniae or Haemophilus influenzae, these can be targeted with narrow spectrum antibiotics to help prevent antibiotic resistance.

That's what the best science currently tells us.  But what is the worst science currently telling us?

Stores are stocked with all sorts of "sinus remedies", many of which are labelled "homeopathic".  My pharmacist colleague Scott Gavura was given a number of studies supposedly backing up the use of homeopathic remedies in sinusitis.  Among them was the paper cited below about a nostrum called "Sinfrontal".

The great thing about offering fake remedies for a disease like sinusitis is that since these diseases nearly always get better on their own, all you have to do is avoid injuring the patient and you can then claim credit for a cure that rightly belongs to nature herself.  Offering up fake evidence is simply icing on the cake.

This paper fails from the very start.  Here is the justification for the study from the abstract:

There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the
treatment of acute maxillary sinusitis (AMS).

And from the introduction itself:

The present trial was designed to demonstrate the efficacy and safety of Sinfrontal compared with placebo in patients with AMS confirmed by sinus radiography. As well as measuring the clinical efficacy of this homeopathic medication, the study also investigated the ability of subjects to work and/or to follow their usual activities of daily living—both during and following treatment with active medication compared with placebo—to assess the treatment success of this homeopathic medication as an integrated symptomatic therapy for AMS.

This is bad---very bad.  Clinical trials are supposed to test hypotheses.  We are not supposed to take sides.  If you design a study with the express purpose of "demonstrating efficacy" then that is very likely exactly what you will do.  Demonstrating efficacy is easy.  Proving that it is due to the specific intervention rather than to chance alone or to bias is the hard part, something that this study is not apparently designed to do.  They also fail to understand the background evidence: they rely on sinus X rays as a "gold standard" for the diagnosis of sinus infection.  As we have already seen, sinus X rays do not give very specific information about sinus infections.  Improvement was also gauged in part by improvement in sinus X rays.

So from the start, we have a study whose authors state clearly that they intend to prove their potion works, and who rely on an invalid gold standard for the definition of sinusitis.  This may lead to a study population who doesn't clearly have the disease of interest.  While the stated goals do not guarantee an invalid result, they must make us very wary of bias skewing the results.

Finally, there is the question of plausibility.  What is SinFrontal?  The study lists a set of ingredients and dilution strength, but the description certainly raises a few questions: what are these Latin-named ingredients?  They are not diluted as much as most homeopathic remedies.  Could there be measurable amounts of active ingredient, which by definition renders them non-homeopathic?

If they are as dilute as most homeopathic medications, then we must weigh the strengths of our conclusions carefully.  It is possible, by the statistics presented, that SinFrontal improved sinusitis symptoms more than placebo did.  If so, how?  Since no satisfactory explanation exists for the purported function of homeopathic remedies, and since accepting this hypothesis would cause us to suspect the very foundations of modern chemistry, this seems a less likely explanation for the results.  Given the significant biases and design flaws in the study, this would need to be replicated in order to even begin to draw a conclusion that the results were due to something other than chance or bias.

The modern treatment of sinusitis is remarkably effective and inexpensive.  We recognize that the overwhelming majority of cases resolve on their own in less than two weeks, and in the few cases where antibiotics may be needed, inexpensive and relatively benign antibiotics are effective.

References

Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA, American Academy of Family Physicians, American College of Physicians-American Society of Internal Mediciine, Centers for Disease Control, & Infectious Diseases Society of America (2001). Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Annals of internal medicine, 134 (6), 498-505 PMID: 11255528

Snow V, Mottur-Pilson C, Hickner JM, American Academy of Family Physicians, American College of Physicians-American Society of Internal Medicine, Centers for Disease Control, & Infectious Diseases Society of America (2001). Principles of appropriate antibiotic use for acute sinusitis in adults. Annals of internal medicine, 134 (6), 495-7 PMID: 11255527

ZABOLOTNYI, D., KNEIS, K., RICHARDSON, A., RETTENBERGER, R., HEGER, M., KASZKINBETTAG, M., & HEGER, P. (2007). Efficacy of a Complex Homeopathic Medication (Sinfrontal) in Patients with Acute Maxillary Sinusitis: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial EXPLORE: The Journal of Science and Healing, 3 (2), 98-109 DOI: 10.1016/j.explore.2006.12.007

20 responses so far

  • palmom says:

    Thanks for all the information but it's still a nuisance.
    pm

  • JJM says:

    Pal wrote "Could there be measurable amounts of active ingredient, which by definition renders them non-homeopathic?"

    I believe that is a mistaken concept; but homeopaths make stuff up and it is hard to be sure what anything means. I have a colleague (we have written two papers on homeopathy) who is quite the authority on the subject. I once asked her about the dilution need for something to be called homeopathic and she replied "How long is a piece of string?" That was several years ago and I am still measuring string.

    More recently (Skeptical Inquirer Sept.-Oct. 2010 34(5) pp. 8-9) Edzard Ernst noted that a homeopathic mother liquor (which I take to mean the initial, saturated solution) qualifies as a homeopathic prep.

    There are further problems with the claim according to classical homeopathy. As promulgated, homeopathy entails a single remedy (not a blend). Also, it requires individualized prescription. That is, two people that science tells us have the same condition would get different homeopathic remedies based on interviews with questions about whether we prefer warm or cold rooms, our favorite food, etc. One can be certain that if this study were negative, homeopaths would denigrate it on those two criteria.

    This article brings up the question of what we can do with a result that seems too good to be true? I truly hate to say it, but one must consider incompetence or cheating. Honesty and competence are critically important in science, much as US judge Learned Hand said that the most serious threat to justice was perjury.

  • PAS says:

    Why is it that homeopathy studies always seem to get the basic science they're using for measurements wrong? Wether it's using a 'gold standard' test that is no such thing, interpreting background noise in spectroscopy as meaningful, or just doing basic cell culture and assays wrong this sort of thing seems remarkably consistent.

    Of course then these 'studies' are held up as validation of homeopathy without the slightest examination. (Dullman in 3... 2... 1...)

  • palmd says:

    The above comment made me think...I looked back at the results section, and the data really do appear to be kinda miraculous.

  • bardiac says:

    So is the saline flush thing (as in with a neti pot) actually helpful or not?

  • palmd says:

    It's thought to be helpful. Evidence isn't that strong, but it's inexpensive, there is no evidence of harm, there is high plausibility, and some evidence point to its utility.

  • Tsu Dho Nimh says:

    OMG!!! Here's the ingredients list, and it has MERCURY! Give this to your kids and your grandkids will be autistic!

    Chininum arsenicosum D6 (Arseniate of Quinine)
    Ferrum phosphoricum D6
    Mercurius solubilis D6
    Mercurius sulphuratus ruber (Cinnabaris) D6

    ***************
    There is nothing in there that might even have a real effect on sinus infections. (Except the water you swallow the pill with)

  • Tsu Dho Nimh says:

    Bardiac ... Neti pots help with occasional use on an as-needed basis, but those who use them frequently reported more sinus problems.

    I don't remember where AI saw the study, but if your have greater than homeopathic google-fu you can find it.

  • CyberLizard says:

    As a chronic sinus sufferer, I'm ready to just take a damn hand drill and relieve the farking pressure myself. Would that qualify as homeopathic? :-P

  • palmd says:

    I suppose if you could find a 1/100000000000000000 bit

  • Nathan Myers says:

    Whose definition says a homeopathic remedy has to have nothing in it? Not the US FDA's. The zinc gluconate sold with a "homeopathic" label has a clinically effective amount of zinc in it, enough both to affect the progress of a viral infection, and, if you snort it (against instructions on the label) to cause permanent anosmia.

    Acute rhinosinusitis is all very well, but what's it called when a sinus bleeds?

  • palmd says:

    "clinically effective amounts of zinc" can have various meanings. what might be more accurate would be "physiologically active amounts of zinc" which have been shown to produce permanent anosmia.

  • Epinephrine says:

    I'm always cautious (once bitten, twice shy ) with sinusitis, since I had a case that developed into a pretty nasty orbital cellulitis and osteomyelitis. But I sure as heck wouldn't have recovered with homeopathy.

  • Nathan Myers says:

    Tsu Dho Nimh: Of course people who use neti pots frequently report more sinus problems. People who spend more time in casts report more broken bones, too. This is not to say that the pots can't cause problems, but rather just that your second statement doesn't seem to mean anything. Is there a more precise statement it stood in for that does mean something?

  • Tsu Dho Nimh says:

    Nathan:
    http://www.webmd.com/allergies/news/20091109/long-term-neti-pot-use-may-backfire

    Researchers say nasal mucus acts as a first line of defense against infections, and long-term nasal saline irrigation may interfere with this natural immune function.

  • nightsongfire says:

    As someone who has frequent and/or severe sinus/ear infections, I find the treatment guidelines suck. (I've also been sucked into the homeopathic stuff before out of desperation). A stronger statement on when NOT to use antibiotics is needed as is better explanation to the patient why not. On the flip side, more research is needed on when antibiotics should be used. I go to the doctor and get a prescription when my symptoms start, because of past history, but is this the right decision? My doctor agrees it is, but there doesn't seem to be any research/evidence to back that up.

  • Nathan Myers says:

    Thank you, that is what I was looking for.

  • James Sweet says:

    The way this stuff is marketed on supermarket shelves makes it even worse.

    I had not realized that the minimum age for most (real) cough medications had been raised to 4. I was in the supermarket trying to find a cough medicine I could give to my then-15-month-old son. Scanning the shelves, more than once I found one that was marketed as being safe for infants. "Oh phew, I found the kid's stuff!" I said to myself. Of course, being the skeptic I am, I turned it over to read the back.

    And a few years ago, even being a skeptic then too, I would have walked out with some nice expensive water to give to my son. Since then, I have learned all about homeopathy, so when I saw that "10X" listed after the "active ingredient", I immediately put it right back on the shelf.

    But damn, there was no indication it was homeopathic other than that. You just had to know. And it wasn't in the special homeopathic section (even though this supermarket has one), it was right there along with the "real" cough medicines.

    Pretty crappy.

  • human says:

    They say that most sinus infections are viral and not bacterial. I have asthma so when I go in with one, I get prescribed antibiotics as a matter of course. Now, I've tried sucking it up for days and hoping I get better, or just going in right away. Every single time I start to get better right after I start the antibiotics. So either I'm just special and weird, or else they're full of it about most sinus infections not being bacterial.

  • Salk says:

    Interesting and (for me!) topical article.

    I'm just recently recovered from a bacterial sinus infection. It started off with a bad headache, then developed into a fever three days later, and only then I started to get the pressure on my upper teeth and behind my eyeballs, accompanied by plugged ears. No post-nasal, drip, my nose didn't run and I didn't really have other "cold" symptoms (and I've had sinus infections so bad that there was a permanent, slimy, green line of post-nasal drip at the back of my throat for three days...vile). It cleared up within two days of some pretty strong antibiotics that absolutely killed my stomach- although they worked great, by the end of the 10-day dosage, the side effects were a pain. My mom also has a history of sinus infections.....are there certain things that make some individuals more susceptible than others?