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Question:
Is there any evidence that the homeopathic medicine, Oscillococcinum (Anas barbariae hepatis et cordis extractum 200CK HPUS) is effective at preventing or treating swine-origin influenza A (H1N1) viral infections?

Answer:
Part 1.  The recent emergence and global impact of the swine-origin influenza A (H1N1) virus along with the knowledge that available methods for prevention and treatment are limited has raised concerns about how we will be able to offer preventative therapies and/or treatment to those in need should the situation worsen.  While the Centers for Disease Control and Prevention (CDC) recommend oseltamivir (Tamiflu®) and zanamivir (Relenza®) as effective therapies, worldwide supply is not sufficient to offer prophylaxis or treatment to everyone.(1,2)  In addition, there are a number of people that will not take treatments that are not "natural" or that are known to be synthetic/prescription medications.  As such, the use of natural, herbal or homeopathic treatments thought to be active against swine-origin influenza A (H1N1) viral infections are likely to increase and are now being advocated by a number of non-medical sources found on the internet.  One such homeopathic medicine being recommended is Oscillococcinum (Anas barbariae hepatis et cordis extractum 200CK HPUS).(3) 

Oscillococcinum is a patented homeopathic medicine that is in the form of granules and is manufactured primarily by Boiron Laboratories.(3)  Prior to the emergence of the swine-origin influenza A (H1N1) or avian influenza A (H5N1) viruses, Oscillococcinum was reported to be used by over 1,000 United Kingdom physicians, and 10,000 French and German homeopathic physicians for influenza infections (flu).(4)  Are there any efficacy data regarding the use of Oscillococcinum for the prevention or treatment of the flu?

Two separate systematic reviews have been done and will help answer this question.  One was done by the Cochrane Collaboration specifically on Oscillococcinum and another by a group from the United Kingdom that included Oscillococcinum in its systematic analysis.(4,5)  Both groups came to similar findings.  The Cochrane Collaboration included a total of 7 trials in their review of which 3 were prevention trials representing 2,265 participants and 4 were treatment trials representing 1,194 participants.  Of these trials only 2 studies had sufficient information to complete the full data extraction.  They found that there was no evidence that Oscillococcinum can prevent influenza (relative risk, 0.64; 95% confidence interval (CI), 0.28 - 1.43).(4)  As it related to the treatment of the flu, Oscillococcinum reduced the length of the influenza illness by 0.28 days (95% CI, 0.5 - 0.06).(4)  This translates into participants taking Oscillococcinum experiencing an average reduction in duration of illness by only 6 hours, with a range of 1 hour to 12 hours of benefit.(4)  This conclusion was consistent among both systematic analyses and while it is statistically significant, this is of debatable clinical significance.(4,5)  This is especially true given the poor standards used by these trials in reporting data.(4)  In fact, several of the studies never made it to full publication and one was published in a general medical magazine versus a scientific journal.(4)  Fortunately, there are no known major side effects associated with its use. 
 
Is Oscillococcinum regulated by the U.S. Food and Drug Administration?  Yes.  Homeopathic medicines meeting certain criteria are regulated by the FDA.(6)  However, it is important to note that the trials used in these systematic reviews and data published to date do not include any scientific evidence for use of Oscillococcinum for the prophylaxis or treatment of the current swine-origin influenza A (H1N1) flu.  In addition, the current CDC recommendations for prevention and treatment against the current strains of the H1N1 virus do not include Oscillococcinum as a recommended option.  As such, its use for the prevention or treatment of the current H1N1 strain cannot be recommended and should not be used in place of other standard treatments that have supporting scientific information. 
 
What is the mechanism by which Oscillococcinum may offer this potential small benefit in the treatment of the flu and what is important for clinicians to know?  The process of how Oscillococcinum is made and its mechanism action will be addressed in part 2 of this series. 
 
(PW Nat Med Newsl 2009;1(17):1-4.) ©2009 Pharmacology Weekly, Inc. 
 
Take Home Points:
 
1. The use of natural, herbal or homeopathic treatments thought to be active against swine-origin influenza A (H1N1) viral infections is likely to increase and are now being advocated by a number of non-medical sources found on the internet.  One such homeopathic medicine being recommended by some non-medical authorities is Oscillococcinum (Anas barbariae hepatis et cordis extractum 200CK HPUS). 
2. A systematic review of 7 trials by the Cochrane Collaboration concluded that there is no evidence that Oscillococcinum prevents influenza illness.  In addition, the Cochran Collaboration and a group out of the United Kingdom concluded that participants who took Oscillococcinum experienced a reduction in duration of illness of 6 hours, with a range of 1 hour to 12 hours of benefit.
3. It is important to note that the trials used in these systematic reviews and data published to date, do not include any scientific evidence for use of Oscillococcinum for the prophylaxis or treatment of the current swine-origin influenza A (H1N1) flu.
 
Considerations for Clinicians Based on Setting:
 
Outpatient Setting:
Since Oscillococcinum can be purchased over the counter and on the internet, it would be important for all clinicians to know that this homeopathic treatment is not only being advocated by some non-medical or non-scientific authorities, but patients may inquire about its safety and efficacy should the current or future influenza infections get worse.  It would also be important for clinicians to assess the personal beliefs and desires regarding various treatment options so that treatment plans can be adjusted accordingly. 
 
Inpatient Setting:
The above information from the outpatient setting is also applicable, especially if a patient is discharged from the hospital on standard treatment which is known to be effective and recommended by medical authorities for the prophylaxis and/or treatment of the swine-origin influenza A (H1N1) virus.  Adherence to this regimen could be influenced by the patients underlying knowledge of various treatment options and/or personal beliefs regarding the use of prescription medications. 
 
Important Counseling Bullet Point(s):
 
It would be most important for clinicians to counsel their patients about the lack of objective and well designed clinical trials evaluating the safety and efficacy of Oscillococcinum for regular influenza illness as well as the prevention or treatment of swine-origin influenza A (H1N1) viral infections.  In addition, patients should be advised to immediately begin and complete treatment regimens prescribed to them not only for their own health but for the health of those in their communities.  
 
Medical/Legal Consideration(s):
 
There were no cases identified in the 2008 edition of LexisNexis' Drugs in Litigation regarding Oscillococcinum or products liability claims against the drug manufacturer, and Pharmacology Weekly's legal counsel has not identified any such cases to date.(7)  Nevertheless, several peer-reviewed scientific publications have shown that there is no definitive evidence for the use of Oscillococcinum in the prevention and/or treatment of influenza illness (and more specifically the swine-origin influenza A (H1N1) viral infection) it would be prudent to document in the medical chart that an inquiring patient has been advised that the use of this homeopathic treatment is not currently recommended as a substitute to currently recommended options such as oseltamivir and zanamivir.
 
Test Questions for CE:
 
Which of the following is the active ingredient of Oscillococcinum?
a. Sambucus nigra
b. Anas barbariae hepatis et cordis extractum 200CK HPUS
c. Panax quinquefolium
d. Andrographis paniculata 

Which of the following best represents the average reduction in duration of influenza illness experienced by patients taking Oscillococcinum?
a. 6 hours
b. 24 hours
c. 36 hours
d. 48 hours
  
True or False:  Oscillococcinum has not been studied in patients with the current swine-origin influenza A (H1N1) viral infection.
a. True
b. False
 
Pharmacology Weekly, Inc. is an accredited provider for continuing medical education (CME) by the American Academy of Continuing Medical Education (AACME) and this newsletter is worth 0.25 hours of category 1 CME for those subscribers with access to CE. 
 
Medical Director: Gregory C. McKeever, MD
Editor-in-Chief:  Anthony J. Busti, PharmD, BCPS, FNLA, FAHA
Board Members & Reviewers:  Donald S. Nuzum, PharmD; Brooke J. Daves, JD
Disclosures of Conflict of Interest:  None
 
Issue Citation:
Busti AJ, Nuzum DS, Daves BJ, McKeever GC.  Is there any evidence that the homeopathic medicine, Oscillococcinum (Anas barbariae hepatis et cordis extractum 200CK HPUS) is effective at preventing or treating swine-origin influenza A (H1N1) viral infections?   PW Nat Med Newsl 2009;1(17):1-4.
 
References:
1. Busti AJ, Margolis DM, Herrington J, Nuzum DS, Daves BJ, McKeever GC.  How can the antiviral, oseltamivir (Tamiflu®) work to treat swine-origin influenza A strain (H1N1) viral infection?  PW Pharmacother Newsl  2009;1(16):1-4.  Pharmacology Weekly
2. Center for Disease Control and Prevention.  H1N1 Flu (Swine Flu) and You.  Accessed: May 12, 2009 at: http://www.cdc.gov/h1n1flu/qa.htm
3. Boiron. Oscillococcinum.  Newtown Square, PA.   Accessed on May 12, 2009 at: Click here
4. Vickers AJ, Smith C.  Homeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes.  Cochrane Database Syst Rev  2006;3:CD001957.  PubMed
5. Guo R, Pittler MH, Ernst E.  Complementary medicine for treating or preventing influenza or influenza-like illness.  Am J Med  2007;120:923-929.e3.  PubMed
6. U.S. Food and Drug Administration. Sec 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15). Accessed on 5/12/09.  Available at: http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html
7. Patterson RM, Hoyle PC, Editorial Staff of the Publishers of Lawyers' Medical Cyclopedia eds.  Drugs in Litigation: Damage Awards Involving Prescription and Nonprescription Drugs.  2008 Edition.  LexisNexis.  San Francisco, CA.
 
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