This peer-reviewed study was directed by lifestyle medicine pioneer Dean Ornish, M.D., founder and president of the nonprofit Preventive Medicine Research Institute and clinical professor of medicine at the University of California, San Francisco, in collaboration with other renowned scientists and neurologists from leading academic medical centers. These include:

• Harvard Medical School / Massachusetts General Hospital (Rudolph E. Tanzi, Ph.D.; Steven E. Arnold, M.D.; Dorene Rentz, Psy.D.)
• Karolinska Institute (Miia Kivipelto, M.D., Ph.D.)
• Preventive Medicine Research Institute (Dean Ornish, M.D.; Catherine Madison, M.D.; Colleen Kemp, R.N.; Anne Ornish, B.A.; Sarah Tranter, R.N.; Nancy DeLamarter, M.S.W.; Noel Wingers, M.S.; Carra Richling, R.D.)
• University of California, San Francisco (Dean Ornish, M.D.; Charles E. McCulloch, Ph.D.; Jue Lin, Ph.D.; Kim Norman, M.D.)
• Renown Health Institute of Neurosciences (Jon Artz, M.D.)
• University of California, San Diego (Douglas Galasko, M.D.; Rob Knight, Ph.D.; Daniel McDonald, Ph.D.; Lucas Patel, B.S.)
• Duke University Medical Center (Rima Kaddurah-Daouk, Ph.D.)
• Buck Institute for Research on Aging (Eric Verdin, M.D.)

“I’m cautiously optimistic and very encouraged by these findings, which may empower many people with new hope and new choices,” said Dr. Ornish. “We do not yet have a cure for Alzheimer’s, but as the scientific community continues to pursue all avenues to identify potential treatments, we are now able to offer an improved quality of life to many people suffering from this terrible disease.”

The research team recruited 51 participants with a diagnosis of mild cognitive impairment or early dementia due to Alzheimer’s disease and randomly assigned them to either an intensive lifestyle intervention group (no drugs added) or a usual-care control (comparison) group. Members of the control group were instructed not to make any lifestyle changes during the 20-week trial.

The intervention group participated in an intensive lifestyle program with four components: (1) a whole-foods, minimally processed plant-based diet low in harmful fats, refined carbohydrates, alcohol and sweeteners — predominantly fruits, vegetables, whole grains and legumes, plus selected supplements — with all meals sent to each patient’s home to maximize adherence; (2) moderate aerobic exercise and strength training for at least 30 minutes per day; (3) stress management, including meditation, stretching, breathing and imagery, for one hour per day; and (4) support groups for patients and their spouses or study partners, for one hour three times per week.

Improvements in patients with early Alzheimer’s disease

To measure pre- and post-trial cognitive function, the researchers utilized four standard tests used in Food and Drug Administration drug trials: the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog), Clinical Global Impression of Change (CGIC), Clinical Dementia Rating–Sum of Boxes (CDR-SB) and Clinical Dementia Rating Global (CDR-G).

Results after 20 weeks showed overall statistically significant differences between the intervention group and the randomized control group in cognition and function in three of these measures (CGIC, p = 0.001; CDR-SB, p = 0.032; CDR-G, p = 0.037), and differences of borderline significance in the fourth test (ADAS-Cog, p = 0.053). When a mathematical outlier was excluded, all four measures showed significant differences in cognition and function in the experimental group. Three of these measures showed improvement in cognition and function in the intervention group and one test showed significantly less disease progression. In contrast, the randomized control group worsened in all four of these measures.

Not all patients in the intervention group improved; in the CGIC test, 71% improved or were unchanged. In contrast, none of the patients in the control group improved, eight were unchanged and 17 (68%) worsened.

Many patients who experienced improvement reported regaining lost cognition and function. For example, several patients in the intervention group reported that they had been unable to read a book or watch a movie because they kept forgetting what they had just read or viewed and had to keep starting over, but now they were able to do so and retain most of this information. One individual reported that it used to take him weeks to finish reading a book, but after participating in the study he was able to do so in only three or four days and was able to remember most of what he read.

A former business executive reported regaining the ability to manage his own finances and investments. “It was so much a part of my life — who I am, and who I was — it was hard saying that part of me was just gone,” he said. “I’m back to reconciling our finances monthly; I keep up to date on our investments. A lot of self-worth comes back.”

A woman said that for five years she had been unable to prepare their family business financial reports, but now she is able to do so accurately. “A deep sense of identity is returning. It’s given me a new lease on life, and yet it’s a familiarity and something I’ve always prided myself on. I’m coming back like I was prior to the disease being diagnosed. I feel like I’m me again — an older but better version of me.”

There was a statistically significant dose-response correlation between the degree of lifestyle changes in both groups and the degree of change in most measures of cognition and function testing. In short, the more these patients changed their lifestyle in the prescribed ways, the greater was the beneficial impact on their cognition and function.

This dose-response correlation adds to the biological plausibility of these findings and may help to explain, in part, why some patients in the intervention group improved and others did not (although other mechanisms may also play a role). Other studies have shown that more moderate lifestyle changes such as adopting the Mediterranean diet may slow the rate of progression (worsening) of Alzheimer’s disease but may not go far enough to improve cognition and function.

In addition to improvements in cognition and function, the intervention group also demonstrated significant improvements in several key blood-based biomarkers. One of the most clinically relevant biomarkers is called the Aβ42/40 ratio, which is a measure of amyloid, thought to be an important mechanism in Alzheimer’s disease. This measure improved in the lifestyle intervention group (with the presumption that this improvement reflected amyloid moving out of the brain and into the blood), but it worsened in the randomized control group, and these differences were statistically significant (p = 0.003).

There was also a statistically significant dose-response correlation between the degree of lifestyle change and the degree of improvement in this amyloid ratio (p = 0.035). This direction of change in amyloid was also a major finding with lecanemab, a drug approved for treating Alzheimer’s disease last year.

Also, the gut microbiome in the intervention group showed a significant decrease in organisms that raise the risk of Alzheimer’s disease and an increase in organisms that are protective against Alzheimer’s disease. These biomarker and gut microbiome results also add to the biological plausibility of the overall findings.

According to renowned Alzheimer’s scientist Miia Kivipelto, M.D., Ph.D., “These findings add to the growing body of evidence that moderate multimodal lifestyle changes may help prevent Alzheimer’s disease or slow its progression, and also suggest that more intensive multimodal lifestyle changes may have additional benefits for improving cognition in patients with early Alzheimer’s disease.”

New hope in tackling a devastating and costly disease

Alzheimer’s disease, the fifth-leading cause of death among Americans aged 65 and older, is not only physically and emotionally devastating; it’s also extremely costly. The disease currently affects more than six million people in the U.S., at an annual cost of more than $345 billion. By 2050, the number affected is expected to reach 13 million, with costs projected to skyrocket to $1.1 trillion annually.

“There’s a desperate need for Alzheimer’s treatments,” said study co-author Rudolph E. Tanzi, Ph.D., an acclaimed professor of neurology at Harvard Medical School and director of the McCance Center for Brain Health at Massachusetts General Hospital, one of the study’s clinical sites. “Biopharma companies have invested billions of dollars in the effort to find medications to treat the disease, but only two Alzheimer’s drugs have been approved in the past 20 years — one of which was recently taken off the market, and the other is minimally effective and extremely expensive and often has serious side effects such as brain swelling or bleeding into the brain. In contrast, the intensive lifestyle changes implemented in this study have been shown here to improve cognition and function, at a fraction of the cost — and the only side effects are positive ones.”

“I am delighted and honored to be a part of this groundbreaking study showing for the first time in a controlled clinical trial what the epidemiology has told us all along: Lifestyle factors are critically important in our efforts to address Alzheimer’s. While efforts to develop drugs to treat this disease will continue, this study provides a blueprint for practical, easily implemented steps that can significantly alter the progression to full Alzheimer’s disease,” said study co-author Eric Verdin, M.D., president and CEO of the Buck Institute for Research on Aging.

This study has implications for preventing Alzheimer’s disease as well. New technologies such as artificial intelligence now make it possible to predict an individual’s likelihood of developing this disease years before it becomes clinically apparent, but many people ask, “Why would I want to know if I’m likely to get Alzheimer’s disease if I can’t do anything about it? It will just make me worry.” Although further research is needed, it is reasonable to believe that the same intensive lifestyle changes that often improve cognition and function in those with mild cognitive impairment or early dementia due to Alzheimer’s may help prevent the disease as well.

“This study finally gives us scientific data to support what many of us in this field have believed instinctively for years, that lifestyle interventions may determine the trajectory of people’s Alzheimer’s journeys,” said Maria Shriver, founder of the Women’s Alzheimer’s Movement (WAM) at Cleveland Clinic, which provided early seed funding for this study. “We opened the WAM Prevention and Research Clinic at Lou Ruvo Center for Brain Health in Las Vegas for women 30 to 60 years of age who are at higher risk than average for developing Alzheimer’s. The protocols we use involve adopting many of the lifestyle interventions employed in this study. So, showing success in improving the health trajectories of those already diagnosed with Alzheimer’s clearly offers hope to those who want to delay or prevent developing the disease altogether. This is a study to give us hope.”

A growing body of lifestyle medicine research

Dr. Ornish has directed peer-reviewed research at the nonprofit Preventive Medicine Research Institute for over four decades. He is often referred to as “the father of lifestyle medicine.”

The Institute’s studies, published in leading peer-reviewed medical and scientific journals, focus on the power of lifestyle medicine to help prevent and often reverse the progression of many of the most common and costly chronic diseases. These include coronary heart disease, Type 2 diabetes, early-stage prostate cancer, hypertension, hypercholesterolemia, and now, early-stage Alzheimer’s disease.

Dr. Ornish’s most recent bestselling book, “Undo It!,” co-authored with Anne Ornish, puts forth his unifying theory: the reason that the same lifestyle changes may beneficially affect so many different chronic diseases is that these share common biological mechanisms that are directly affected by what people eat, how much they exercise, how they respond to stress, and how much love and support they enjoy. Alzheimer’s is the latest example of why “what’s good for your heart is also good for your brain.”

In 2010, the Centers for Medicare & Medicaid Services (CMS) began providing nationwide Medicare coverage for Dr. Ornish’s program, which has been shown to often reverse the progression of coronary heart disease, as “intensive cardiac rehabilitation.” This nine-week program is offered online, so individuals can join classes from the comfort of their own homes, enabling participation by those who cannot afford to take time off work, who live far from a hospital or who cannot afford childcare, thereby reducing health disparities and inequities. “I’m very grateful to CMS for providing Medicare coverage. Having seen what a powerful difference this program of lifestyle changes can make, I appreciate very much that it is now available to all eligible Medicare beneficiaries with heart disease who can benefit from it,” Dr. Ornish said.

About the Preventive Medicine Research Institute 

The Preventive Medicine Research Institute (PMRI), a 501(c)(3) nonprofit organization, was founded in 1984 by Dean Ornish, M.D., to conduct pioneering research evaluating the power of lifestyle medicine and to make healthy lifestyle changes more widely available to those who can benefit from them. PMRI’s research uses the latest in high-tech medical and scientific technologies to assess the benefits of these low-tech and low-cost lifestyle changes. For more information about PMRI’s four decades of peer-reviewed lifestyle medicine research, please visit https://pmri.org.

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Professional guidelines already advise against using common medications such as steroids or NSAIDs such as Ibuprofen as a first line treatment for acute or chronic back pain.

Now a new study has been published which associates early use of these medicines with development of chronic back pain.

Lower back pain is a leading driver of disability across the globe, so the idea that what people commonly reach for to get some relief may be leading to worse outcomes and increased misery for millions of people should be taken seriously.

Hopefully more studies will be done, including clinical trials, which can provide evidence for causation.

In the meantime, it is already the position of numerous professional organizations, including the American Academy of Family Physicians, that non-drug treatment options such as superficial heat, massage, spinal manipulation, and other non-drug treatments should be tried before medications.

Nonpharmacologic treatment, including superficial heat, massage, acupuncture, or spinal manipulation, should be used initially for most patients with acute or subacute low back pain.

Which begs the question, if a bunch of different treatments are all shown to be equally effective for the treatment of a common condition, which treatment do you choose?Chiropractic Care Versus Medication For Chronic Lower Back Pain In Elderly PatientsThe evidence increasingly favors spinal manipulation over prescription drugs when considering patient satisfaction and…medium.com

I’d propose you pick the treatments which are both cost effective and offer the least adverse side effects. While over the counter NSAIDs are certainly cost effective, this study provides some evidence that they may not be as benign in terms of side effects as many people assume.

The tendency to use nonsteroidal anti-inflammatories persists despite their unimpressive performance. An analysis of randomized clinical trials found that these drugs had almost no benefit over placeboes in reducing low back pain.

Chiropractic care often involves several modalities recommended as first line treatments in the care of acute and subacute back pain. Typically a visit to the chiropractor will involve some superficial heat, patient education, reassurance, soft tissue treatment such as massage, spinal manipulation (chiropractic adjustment), stretching, lifestyle modification advice, or home exercise recommendations.When Your Back Hurts, Sometimes It’s Better Not Knowing Exactly WhyYou want an answer, but there are hidden costs to finding out.medium.com

While usually not as inexpensive as a $7 bottle of Advil, chiropractic care is often given some of the highest marks for patient satisfaction and appears comparable in cost effectiveness to standard medical care.

It Can Be Overwhelming

There are so many options when trying to decide what to do about a case of acute back pain. It can feel like you’re in a supermarket with too many options. Not everyone is going to respond the same way to a treatment, further confusing things. Some people love a visit to the chiropractor, other people hate getting adjusted. My wife doesn’t like acupuncture, I find it helps.

What I recommend to my patients is what I understand to be effective, low-risk, and evidence based. It is not in my scope of practice to tell a patient what medications to take or not to take, but as an aspect of informed consent I do tell my patients what other options they have for their care.

If they are in my office I am going to be biased and recommend a trial of chiropractic care for most cases of acute back pain, but they have other options such as yoga, acupuncture, exercise, topical analgesics, medications, et cetera.

Does this recent study pointing out there may be more risk involved in taking common medications confirm my bias towards conservative non-pharmacological interventions for pain? Yes. Does it mean I will stop taking Ibuprofen when I have pain? Probably not, but I might think twice the next time I reach for when my shoulder or back feels cranky.

Works Consulted:

DOI: 10.1126/scitranslmed.abj9954Common Medications Can Prolong Back Pain, Study SaysA clinical trial will be needed to verify the research, which offered a warning about taking steroids or…www.nytimes.com

doi.org/10.7326/M16–2367

Haas, Mitchell et al. “Cost-effectiveness of medical and chiropractic care for acute and chronic low back pain.” Journal of manipulative and physiological therapeutics vol. 28,8 (2005): 555–63. doi:10.1016/j.jmpt.2005.08.006

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Lifestyle Changes May Be Better Than Rx Drugs

Let me be clear about this point — There’s a wealth of data that shows when specific healthy lifestyle interventions are performed correctly – with actionable recommendations – the effect can be just as good if not better than some prescription drugs. Take diabetes as an example.  The Diabetes Prevention Program (DPP) evaluated how intensive lifestyle changes might compare to medication in preventing the progression of prediabetes to diabetes. With more than 25 research sites around the country and thousands of participants, this study serves as a landmark trial should change how we think about lifestyle intervention!

Here’s what they did: They split participants into three groups – one received the drug metformin, one received no specific intervention, and the third receives intensive lifestyle coaching that consisted of a low-calorie, low-fat diet and at least 150 minutes per week of moderate intensity exercise. Participants received specific advice on what and how to eat, as well as what types of exercises to do.

The goal was to lose 7% of their baseline body weight.  For most people, that was 15-20 lbs.  Guess who got the most benefit? The lifestyle group did the best of all three groups—it even out-performed the one group that received medication.  As for the belief that older folks won’t make changes (“can’t teach an old dog new tricks”), lifestyle changes for people over 60 years of age resulted in 71% reduction in diabetes risk!  This wasn’t a one-time benefit where participants gained weight when the program was finished.  Even after 10 years, the risk reduction was 34%. 

If you combine social support with lifestyle changes, the results can be even more impressive! A recent study teaching lifestyle changes in a group support setting included patient-centered counseling techniques, motivation to change, social support and assistance with goal setting, action planning and self-monitoring.  Again, the goal was 7% weight loss, 150 minutes per week of moderate-intensity exercise including 2-3 sessions of muscle strengthening, as well as a program for healthy-eating.  All of this was not done in a vacuum – There were 12 hours of educational group sessions. The majority of participants were followed by 2 years.  No medications were prescribed.

Again, impressive results in reversing high blood sugars!  In fact, there was a 40-47% reduction in the risk of developing type 2 diabetes in those who participated in the study.

Lifestyle changes work! Of course, they have to be done properly.  We often like to quip “medications only work in people who take them” – well, lifestyle changes need to be prescriptive with specific advice and results measured consistently over time if you’re going to recommend them.  I find the biggest problem is that physicians don’t encourage patients in a meaningful way to eat healthy, be more active, and focus on quality sleep.  They don’t talk to patients about the benefits, so patients often don’t make a real effort.

Physicians Have Their Limits – Look at Varied Coaching Options

The argument from physicians will be “ I don’t have time” or “I don’t get paid to give that type of advice.”  That should not be a sufficient reason to not provide proven therapeutic interventions.  Yes, we must be practical – most physicians are not equipped right now to do this.

The remedy?  We use consultants all the time as part of our medical training, and now we need to start consulting for help with strategies to address lifestyle. Let’s partner with nutritionists and personal trainers to advise patients with specific information on how to eat healthy, as well as give detailed advice about different exercises.  We need to use digital tools that provide real-time feedback to help patients make healthy choices.  These include apps that can analyze food quality through pictures, continuous glucose monitors to assess blood sugar, as well as devices that tell you whether you are burning fat or carbs in the morning, at bedtime, and before exercise.  And we need insurance coverage to ensure everyone can benefit from it.

Lifestyle changes work!  Sure, there’s still a role for medications for many people – but let’s not jump to them all the time.

*****

[Editor’s Note: Dr. John Whyte is author of the bestselling health guide: “Take Control of Your Diabetes Risk.” From his newest work, you can learn more about ways to reduce your diabetes risk and change your mindset from “I hope I don’t get diabetes to I can prevent diabetes.“]

Perreault L, Kahn SE, Christoph CA, Knowler WC, Hamman RF; Diabetes Prevention Program Research Group. Regression from pre-diabetes to normal glucose regulation in the diabetes prevention program. Diabetes Care. 2009 Sep;32(9):1583-8. doi: 10.2337/dc09-0523. Epub 2009 Jul 8. PMID: 19587364; PMCID: PMC2732165.

Sampson M, Clark A, Bachmann M, et al. Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia: A Randomized Clinical Trial. JAMA Intern Med. 2021;181(2):168–178. doi:10.1001/jamainternmed.2020.5938

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