Influenza Research in 2008-2009
The next step was to conduct a proper prospective trial examining the homeopathic treatment of influenza in a controlled study design. To do so, we had to apply for and receive IRB (Institutional Review Board) approval, and design the trial in such a way as to test several aspects simultaneously. Primarily, these aspects are the remedy selection process, the ability of a questionnaire/predictive tool to allow non-homeopaths to accurately identify patients needing the remedy, and the actual comparison of efficacy between a homeopathic remedy and placebo. In some respects it would be easier to test one of those parameters at a time, but given limitations on resources and time, this approach was adopted.
I pulled a team together consisting of Liz Kaltman, Janet Monnier, Ryan Kirkby, and myself, and began in earnest to design the pilot trial. The specific goals for the trial were as follows:
- To test the tools that would be used in a full scale trial in the future.
- To show that homeopathic trials can be designed with scientific rigor.
- To allow for the possibility that in a full, well-designed trial, homeopathic treatment would be more effective than placebo.
- To show that once a remedy (or the genus epidemicus) is decided upon, no homeopath need be involved.
- To generate a proof of concept for a treatment model that could work within the general healthcare system.
With these goals in mind, we then developed rigorous inclusion criteria for trial patients, matching orthodox drug trials and CDC criteria, and chose a hospital site for the trial. The hospital was a Portland Adventist hospital Urgent Care center in Gresham, Oregon, under the leadership of Janet Monnier.
We then developed forms, documentation, and testing methodology and then contacted and entered into a relationship with the National College of Naturopathic Medicine (NCNM) and passed through their IRB process. Carlo Calabrese, employed there was chosen as the Primary Investigator.
In the meantime, I had been seeing patients with ILI (Influenza like illness) but no clear picture had emerged until my sentinel case arrived from western Pennsylvania. A medical doctor in family medicine, a long standing patient of mine in her mid 50s, called with a clear new set of influenza-like symptoms. Realizing that what I was seeing might be the first of many, I spent a great deal of time interviewing her, essentially retaking her full case history along with the specific symptoms of her current illness. After arriving at a remedy, I continued asking many questions related to the remedy to see which were present and which were not. The same day a patient in her late 20s called me from outside Bloomington, Indiana. I again spent considerable time to understand the detailed picture of her disease presentation, finding the same remedy as in the first patient. The next day a 60 year old psychotherapist from Amherst, Massachusetts saw me for ILI with essentially the same set of symptoms. That was the original onslaught of patients that cemented my initial impression that a consistent symptom picture was emerging for a then current genus epidemicus.
My next step was to confirm the remedy in the next set of patients, and see which symptoms are most characteristic to that epidemic. It took another 9 patients to do so, and was eventually continually reconfirmed looking at a total pool of 53 patients with ILI. Now I knew the remedy and had a set of symptoms characteristic of the genus epidemicus picture. Of these patients, one was tested with a quick flu testing kit, which was positive for influenza infection.
The final step in the process, after generating the list of characteristic symptoms, was more difficult. I needed to develop a tool that would effectively remove all other remedies that were also presenting during that flu season, leaving behind only the genus epidemicus remedy. The process which generates this tool requires a multistep approach, where in each iteration the questionnaire is modified and then tested for accuracy against patients for which the remedy is known. I am leaving out the description of this lengthy process of creating accuracy in this article.
At this point, the genus epidemicus remedy had been chosen, the predictive tool and tracking documents developed, the study site located, and IRB approval obtained. The medicines for the study were provided both the indicated remedy and the placebo by Washington Homeopathics, under the leadership of Joe Lillard. We then appointed a non-homeopath to administer the questionnaire and pick people for inclusion using the influenza inclusion criteria we previously developed. This study coordinator was Amber Howard of Portland, Oregon, who also helped translate all of our documents into Spanish to accommodate the many Spanish speaking immigrants coming through the chosen site.
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