N-of-1 is the term used to describe one person as the sole participant in a clinical trial. Clinical trials are used to test new pharmaceuticals, medical devices, and innovative health-related techniques. The practice of yoga with a trained yoga professional can be akin to an N-of-1 clinical trial. The proof of efficacy is measured by how yoga makes the individual feel.
Yoga treats the person, not the disease. Large clinical trials are looking at the macrocosm of a disease or illness, which is great. It is important to know how large groups of people respond within a clinical trial. If an individual gets the placebo or the treatment and doesn’t respond positively however, they become a segment of a statistic. Yoga approaches health at the N-of-1 level. Yoga can address the microcosm (and super microcosm) of dis-ease in a person.
The N-of-1 idea is gaining some traction in a world where clinical trials may involve hundreds or thousands of participants. Large trials are designed to learn how groups of people will respond to certain treatments. New drugs and medical techniques are developed using the scientific method in these case studies. Clinical trials also inform the direction of the next generation of study and research. And big data in clinical trial research has become another technology tool for analyzing all kinds of detailed bits of information. Gathering huge amounts of data on individuals is the N-of-all method.
The N-of-1 experience is something we all do when we practice body awareness in yoga. We are trying to figure out how we feel and what makes us feel better. Body awareness is being aided by technology, biofeedback, and groups like The Quantified Self. Check out their podcasts and read about their conferences where they put out a call for N-of-1 papers.
For individualized medicine, the greatest measure of success is STILL how people feel after receiving the trial drug or treatment. Enter the N-of-1 experience. When you go to a doctor you’d like her to “practice medicine” in the N-of-1 model. That is, tailored to your particular sex, weight, age, anatomy, family history, medical history, etc. N of 1 = you, the real person.
One or a thousand, what the diff in a clinical trial? Clinical trials are typically designed to select participants based on specific criteria. For example, a clinical trial involving the effects of a treatment on people with COPD (Chronic Obstructive Pulmonary Disease) might begin with selecting an even mix of men and women, smokers and non-smokers, people diagnosed with COPD or limited respiratory capacity, and individuals with no breathing problems. There might be a control group and the trial might be designed as a double blind study. The larger the sample size, the more compelling the results . . . sort of.
What if you’re not in the P < 0.05 club? That’s the golden line of 5%, the true test of statistical significance. In yoga we look for a wider golden line in our practice. Yoga is a “clinical trial” where the focus is an N-of-1 study where the true passing grade is closer to 100%.
Methods and resources for N-of-1 and N-of-All:
Design and Implementation of N-of-1 Trials: A User’s Guide. https://effectivehealthcare.ahrq.gov/topics/n-1-trials/research-2014-5/. Published February 12, 2014.
Gibson B. An N of One and an N of All: Personalized Medicine and Personalized Yoga. Yoga for Healthy Aging. https://yogaforhealthyaging.blogspot.com/2014/05/an-n-of-one-and-n-of-all-personalized.html. Published May 27, 2014.
Cirone M. How Glenn Sabin’s Book – n of 1 – is Helping to Change the Face of Cancer Care. Integrative Cancer Review. http://integrativecancer.org/why-glenn-sabins-book-n-of-1-is-changing-the-face-of-cancer-care-a-book-review/. Published February 6, 2017.
