Oscillococcinum: What a Pharmacist Should Know During Flu Season

An earlier version of this article stated that the manufacturer received a warning letter from the FDA about off-label claims. The statement referred to a warning letter sent to one Internet marketer who made off-label claims for many products during the influenza pandemic. The manufacturer requested the marketer to cease and desist making such claims, and ultimately stopped sales to this retailer.

Want to learn more about how you can help your patients this flu season? Check out this upcoming CE webinar on what makes this flu season different.

Influenza season is in full swing, and social media and the internet are full of "remedies" that promise to help restore a patient's full health in a seemingly quick and "natural" way.

One such product that has been gaining a lot of attention lately is oscillococcinum, which markets itself like a natural oseltamivir. The product has been around for decades and has enjoyed its share of both popularity and criticism. Social media buzz is active with people attesting to its efficacy.

Oscillococcinum's active ingredient is Anas barbariae hepatis et cordis extractum 200CK, made from the heart and liver of wild duck and is diluted repeatedly until essentially no molecules of duck heart or liver are found in the actual pill. It is thought that because wildfowl are a natural resorvoir for influenza and nucleic and phosphoric compounds in the pill resemble influenza, that the combination contribute to antiviral activity, but the exact mechansim of action is not well described. The product's website cites 2 clinical studies indicating that it decreases the severity and duration of influenza-related symptoms. Both were placebo-controlled studies, whose primary outcome included resolution of fever and other symptoms by or at 48 hours of treatment, and each study did show a statistical advantage over placebo. Other studies, including multiple Cochrane systemic reviews (most recently in 2015), have been published.² The 2015 Cochrane review evaluated 6 studies, including 2 on influenza prophylaxis and 4 for the treatment of influenza. The review specifically commented on notable flaws and bias within the studies' methods. It concluded that there was no significant benefit of the product in preventing influenza and, based on 2 low-quality rated studies, that there was an absolute risk reduction of 7.7% in flu-like symptoms compared with placebo after 2 days of oscillococinum use (P=0.001) but that a significant difference was no longer seen by day 4 of treatment (P=0.1). The authors ultimately concluded that oscillococcinum may work, but the evidence was not strong or sufficent enough to definitively say one way or the other, particularly given the poor quality of the studies available.

Another review by Marrari et al. published in 2012 looked at 3 studies, all published between 1988 and 1998.⁵ Two of the 3 studies were the sources cited on the product's webpage for proof of clinical efficacy. The authors' conclusion was in direct support of oscillococcinum's efficacy. However, the conflict of interest section at the very end of the article indicates that all the authors were employees of the product's maker, and therefore, the strong potential for a biased conclusion and recomendation should be considered. Interestingly, there are not readily retrievable studies looking at the active ingredient, Anas barbariae, outside of oscillococcinum.

Overall, oscillococcinum is relatively safe. The inactive ingredients include sucrose and the most common adverse effects seen in published studies were headache, rash, itching, and myalgia. Each dose is approximately $1.10, which is cheaper than the approximate $5 to $7 per dose of the now generic oseltamivir but still not inexpensive. It is interesting that given the potential oscillococcinum showed in early studies, that subsequent large, well-designed studies were never conducted to definitively determine its efficacy.

The product is still being marketed based off of 2 older studies. Such studies would provide valuable answers to the role oscillococcinum has in influenza mangement, but like with so many homeopathic products, it seems questions regarding that role will remain unanswered for the foreseeable future. In the age of evidence-based medicine, what recommendation should be made when the evidence is inconclusive? The old adage "it probably won't help, but it won't hurt either" seems applicable.

References

1. Boiron. Oscillococcinum. Newtown Square, PA.

2. Mathie RT, Frye J, Fisher P. Homeopathic oscillococciunum for preventing and treating influenza and influenza-like illness. Cochrane Database Syst Rev. 2015 Jan 28;1:CD001957. doi: 10.1002/14651858.CD001957.pub6.

3. Ulbricht C, Chao W, Clark A, et al. Oscillococcinum (Anas barbariae hepatis et cordis extractum 200CK HPUS): An Evidence-Based Systematic Review by the Natural Standard Research Collaboration. Alternative and Complimentary Therapies. 2011;17:41-49

4. Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled, double-blind evaluation. Br Homeopath J. 1998;87:69-76.

5. Marrari LA, Terzan L, Chauferren G. Oscillococcinum for influenza treatment. Ann Ist Super Sanita.2012;48:105-109

6. Https://www.walgreens.com

7. https://www.lowestmed.com

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