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.
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.
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