N of 1 Study
The ultimate individual test. What happens when SierraSil President Michael Bentley agrees to be the sole test subject of a clinical trial of his own product?
It was over a Thai food lunch on August 24, 2015 that Dr. James McCormack challenged me to consider an N of 1 study of a passionate SierraSil customer. James is a Professor in the Faculty of Pharmaceutical Sciences at UBC who has received awards for his education and research in two hemispheres. He has presented 100's of seminars on drug therapy over the last 25 years, focusing on shared-informed decision-making using evidence based information and rational therapeutic principles. In addition, he has published over 100 articles, mainly in the area of rational drug therapy, and served as an editor for two internationally recognized textbooks on rational drug therapy.
James had reviewed the research to date on SierraSil, our natural mineral ingredient, but did not find the clinical trial results to be persuasive enough to suggest SierraSil had an important benefit over placebo. James understands we are a small company and that research can be expensive, so he proposed an N of 1 trial that he would supervise without compensation as a favour and out of curiosity. An N of 1 trial is a study with a single patient, who receives, on a randomized basis, either a placebo or treatment in various cycles over a defined time frame. This type of trial can help figure out if a treatment is effective for an individual participant. James, based on the evidence he had seen was willing to bet a dinner that the avid SierraSil fan who participates in the trial would not notice a discernible difference.
As an avid SierraSil user, I offered to be the candidate. By October, we had outlined a scoring system and Caroline Eve, Director of Quality Control and Regulatory for SierraSil, had arranged for sets of placebo and treatment bottles simply marked A or B. It should be noted that I didn’t know which was treatment or placebo, nor did James. James then randomized the A and B products and provided them to me simply marked with hand written numbers from 1 to 8. Each contained 42 capsules of either placebo or treatment suitable for a 14 day supply. On Sunday, October 4th, I started on bottle one and finished bottled 8 on Saturday January 23, 2016. On a daily basis, I recorded my physical activity and my level of soreness on a scale from 1 to 7:
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No soreness;
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Minimal soreness (can be easily ignored without effort);
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Mild soreness (can be ignored with effort);
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Moderate soreness (cannot be ignored but does not influence my daily activities);
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Moderately severe soreness (cannot be ignored and occasionally limits my daily activities);
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Severe soreness (cannot be ignored and often limits my concentration on daily activities);
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Very severe soreness (cannot be ignored and markedly limits my daily activities and often requires
rest).
Scores were recorded at a consistent time of day, between 7 and 8 AM. There were no surprises that soreness was generally higher on a day following intense exercise. On Monday, January 25, I emailed James my final activity and scoring log, and I speculated on which bottles were placebo and treatment based on ‘how I felt’ and as reflected in the scores.
Caroline Eve notified James which products were placebo and treatment. James called me shortly afterward and noted the following: One, he was impressed that I was able to guess correctly whether each bottle was SierraSil or placebo. He said the odds of doing so by chance were extremely low. Two, my four lowest average (per bottle/2 week blocks) soreness scores all linked with treatment, while the
four highest soreness scores all matched with placebo. My average soreness score (range 1-7) was 2.13 on placebo and 1.29 on SierraSil a difference of 0.84. Based on these results he concluded that for me it certainly looked like it was having a noticeable effect.
The conclusion that can be scientifically drawn from this trial is that SierraSil works for me! Given the results, James did wonder why SierraSil didn’t fair better in some of the earlier clinical trials. In my opinion it's likely due to protocols being inconsistent with our suggested guidelines both by the patient’s weight or by timing of the dose. That said, this N of 1 study was interesting for me to participate in. It proved that SierraSil reduced activity related soreness for me, and I’m looking forward to a relaxing follow-up lunch or dinner with James as bets are settled!
-Michael Bentley