A VIEW FROM THE OFFICE

 

 

WHAT FORMS OF PREVENTION ARE OUR NATIONAL EXPERTS RECOMMENDING NOW?

 

 

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THE CRAZINESS OF THE US PREVENTIVE SERVICES TASK FORCE

    While the USPSTF is the best source of a summary of the evidence relating to the most common important health interventions, they are far less competent at marshaling the evidence to make a sound recommendation. They sometimes miss the forest for the trees. I have recently discussed at length the major problem with their recently updated guideline of counseling for physical activity. Well, they have done it again--this time regarding counseling for improved nutritional behaviors in primary care. To make really clear the folly of their position on these two important issues I will contract these new guidelines with their recent guideline on counseling for behavioral changes to prevent skin cancer.

BEHAVIORAL COUNSELING TO PREVENT SKIN CANCER: The USPSTF is concerned because more than 2 million cases of skin cancer are diagnosed annually in the United States. Most of these (two-thirds) are basal cell skin cancer, which is not associated with significant mortality. Basal cell carcinoma accounts for less than 0.1% of patient deaths due to cancer. The USPSTF expresses specific concern about the rising incidence of melanoma without acknowledging that most of this is due to overdiagnosis [See Dr. Gil Welch, "Overdiagnosed", previously reviewed here this year: Chapter 5.] Increased screening and biopsy has led to an increase in diagnosed cases, but there has, as yet, been no accompanying reduction in mortality, which overall suggest much ado about nothing. The patient behaviors that are the focus of this guideline are the use of sunscreen and avoidance of indoor tanning.

    "Sunprotective counseling in primary care varies in frequency and content, despite data suggesting that these behaviors need to be improved." (This is based on the observation than not many people consistently engage in such behaviors, not on any evidence that such behaviors actually work.) Against this would be the observation that "most existing studies did not suggest a strong association between total or chronic sun exposure and squamous cell carcinoma or basal cell carcinoma." So how is counseling to avoid sun exposure expected to do any good? As to the existing evidence of the effectiveness of counseling to avoid sun exposure, the USPSTF notes: "Evidence in adults and parents of newborns suggests that behavioral interventions can minimally increase composite scores measuring sunprotective behaviors. It is unclear, however, whether the small differences in composite scores of self-reported sunprotective behaviors translate into clinically meaningful behavior change to prevent skin cancer or sunburns."  This last statement would seem to indicate that as yet no routine counseling for sunprotective behaviors is as yet ready for prime time.

    Nonetheless the USPSTF recommends counseling children, adolescents, and young adults aged 10 to 24 years who have fair skin about minimizing their exposure to ultraviolet radiation to reduce risk for skin cancer. They do not recommend such counseling for those older than 24 years (insufficient evidence).

    Thus in this recommendation statement the USPSTF seems willing to suggest that all physicians treating persons aged 0-24 years should modify their practices to include counseling in order to avoid a small risk with an intervention that has small evidence of a small effect. They find no evidence of harms from the recommended intervention, not even "the lost opportunity to provide other services that have a greater health effect."

BEHAVIORAL COUNSELING INTERVENTIONS TO PROMOTE A HEALTHFUL DIET AND PHYSICAL ACTIVITY FOR CARDIOVASCULAR DISEASE PREVENTION IN ADULTS:  On the subject of counseling interventions to promote a healthful diet and physical activity for cardiovascular prevention (an admittedly far more important health priority), the USPSTF is not so tolerant of an incomplete database even though 49.7% of US adults older than 20 years have at least one of the following CVD risk factors: uncontrolled hypertension, uncontrolled elevated LDL cholesterol levels, or current smoking. "Although the correlation among healthful diet, physical activity, and the incidence of CVD is strong, existing evidence indicates that the health benefit of initiating behavioral counseling in the primary care setting to promote a healthful diet and physical activity is small." Do they mean smaller than the benefit of recommending sunprotective behaviors? "All persons, regardless of risk status for CVD, can benefit from improved nutrition, healthy eating behaviors, and increased physical activity," but they are not going to recommend any interventions to promote such behaviors. It is certainly non-intuitive that the USPSTF believes that spending our time to try to reduce the limited risk of skin cancers is worthwhile, but routine counseling to prevent heart disease is not.

    The USPSTF acknowledges that "in adult patients without known hypertension, diabetes, hyperlipidemia, or CVD, there is adequate evidence that the benefits of medium- to high-intensity behavioral counseling interventions to improve diet and increase physical activity are small to moderate...The USPSTF concludes with moderate certainty that medium- or high-intensity behavioral counseling interventions in the primary care setting to promote a healthful diet and physical activity have a small net benefit in adult patients without CVD, hypertension, hyperlipidemia, or diabetes."  The intensity of the intervention was categorized by total patient contact time as low (1 to 30 minutes), medium (31 to 360 minutes), or high (> 360 minutes). For some reason they did not analyze their recommendation to counsel persons aged 0 to 24 by the required intensity of intervention required to have an effect.

    The USPSTF does recommend intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. In order to address patient risk factor status, they implicitly recommend routine screening or assessment for cardiovascular risk using such risk calculators as the Framingham-based Adult Treatment Panel III calculator (available at http://hp2010.nhlbihin.net/atpiii/calculator.asp) along with routine lipid screening and screening for obesity. An important point that the USPSTF appears to miss completely is that these latter activities require time. For the first 15 years of my practice I was ardent in performing routine cardiac risk assessment. I found it time consuming even without an intervention. I finally made the decision, based purely on efficiency concerns, to skip the risk assessment component and to proceed directly to routine universal counseling for nutrition, exercise, and a healthy lifestyle for all patients, aged 4 to 100 years. This latter approach requires no more time than routine cardiac risk assessment yet includes the relevant intervention.

    The USPSTF declares that their lack of enthusiasm for nutrition, exercise, or lifestyle counseling is based not on the merits of the health benefits of physical activity, but on lack of clear evidence of the effectiveness of the counseling. This aspect of their recommendation reveals a major flaw in their analysis. They pay no attention to the now abundance evidence of the effectiveness of brief motivational interviewing. The evidence of the effectiveness as well as the details on the "how to" are well summarized in Rollnick. [http://search.barnesandnoble.com/Motivational-Interviewing-in-Health-Care-Stephen-Rollnick/e/9781593856120?r=1&cm_mmc=GooglePLA-_-Textbook-_-Q000000633-_-9781593856120&cm_mmca2=pla]  A handy 34 page guide to the technique is available free at http://www.psychmap.org/uploads/Motivational%20Interviewing%20brief%20guide.pdf. While a brief motivational interviewing is a relatively new technology [for which the majority of practicing physicians received no training at all] the evidence of effectiveness or just a 2-3 minute intervention on a repeated basis is compelling. It is currently that standard of care for changing behavior in health settings. The USPSTF needs to perform an evidence-review and recommendation of this technique and then reconsider their complete dismissal of low intensity interventions for diet and exercise counseling. Moreover, they need to explicitly consider that fact that regularly repeated brief motivational interviewing cumulatively constitutes a high-intensity counseling intervention.

    One final USPSTF point against routine counseling for diet and exercise derives from a potential harm of such counseling--"Harms may include the lost opportunity to provide other services that have greater health effect." This is a criterion that was not applied to their endorsement of counseling to promote sunprotective behavior between ages 0 and 24 years. Do they really believe that counseling for sunprotective behaviors has a greater effect than counseling for diet, exercise, or lifestyle? Once again I would like to remind readers of the benefits of a 5-element healthy lifestyle (based on 16 observational studies):

COMMENT: How on earth does the USPSTF reach the conclusion that these health benefits are not compelling or that appropriately performed brief motivational interviewing is not effective in leading to the related behavior changes? In part this is because they have broken down their analysis by individual components rather than by a simple global definition of a health lifestyle. This is important because such healthy behaviors have dramatic synergistic effects. The approach taken by the USPSTF suffers from a failure to prioritize recommendations based on the magnitude of health benefits and from the failure, where the evidence-base is still limited, to make recommendations based on relevant but lower quality studies such as the 16 observational studies that support the list of benefits above. To some extent Pascal's wager should apply to medicine. I would phrase it this way. If there is any possibility that the above benefits are real, then physicians should routinely recommend the 5 lifestyle behaviors to everyone just because the harms are nil.

SCREENING FOR AND MANAGEMENT OF OBESITY IN ADULTS: According to the USPSTF, while we should do no routine counseling for diet, exercise, or a healthy lifestyle, we should routinely screen adults for obesity. "The USPSTF recommends screening all adults for obesity. Clinicians should offer or refer patients with a body mass index (BMI) of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions...The USPSTF concludes with moderate certainty that screening for obesity in adults has a moderate net benefit."  This recommendation is ultimately based primarily on the fact that "intensive, multicomponent behavioral interventions for obese adults can lead to an average weight loss of 4 to 7 kg...[and] also improve glucose tolerance and other physiologic risk factors for cardiovascular disease."

    The USPSTF does not explain why it believes it is more important to screen for obesity than to prevent it (i.e., with diet, exercise, and lifestyle interventions). We have no data on the efficacy of obesity prevention because it has never been tried. One of the reasons that it has never been tried is that expert organizations like the USPSTF don't recommend it. They say they don't recommend it because there is insufficient evidence, and this leaves us in a 'Catch 22' situation.

    Nor has it adequately answered the compelling critique of its last obesity recommendation in 2004. At that time an editor for Journal Watch commented: "Despite good evidence these recommendations will be difficult to implement. First BMI calculation requires measurement of height, which is not obtained routinely in adults. Second, and more important, medication and surgery are effective, but their use is limited to the severely obese, and surgery is not without risk. In addition, pharmacologic therapies should be given in the context of counseling; however high-intensity counseling (for which there is the best evidence) generally is available only by referral, is of limited availability, and requires substantial patient commitment."(4)

    Finally, we're missing the point that the obese know who they are. In a practice-based study in 1998 among 755 consecutive patients of a single practice, all obese patients (BMI > 30) were aware that they were overweight. Physician estimate of BMI (without actual measurement) turned out to be reasonably sensitive (70%), specific (99%), and predictive of measured BMI (93% PPV).(5) Why would physicians need to spend their time screening for a condition that is obvious and certainly known to patients? The futility of screening is highlighted by the fact that there are no proven treatments for obesity in the primary care setting. Either high-intensity counseling outside of the physician's office or a referral for a surgical-based approach are required.

COMMENT: The USPSTF has missed the boat. Somehow their principles or internal guidelines don't allow them to probe beyond the highest quality studies or to base their guidelines on heuristic principles. The fact that they endorse counseling for sunprotective behaviors and screening for obesity over what they know to be the sound principle of leading a healthy lifestyle is deeply disturbing. Everyone makes a mistake sometime. That is ordinary, and human, and very forgivable. But to make the same mistake year after year. That's not. That's extraordinary.

SCREENING FOR ALCOHOL MISUSE: THE NEW USPSTF RECOMMENDATION:  The Task Force has been very busy. In this updated recommendation they confirm their previous 2004 recommendation: "The USPSTF recommends that clinicians screen adults, including young adults and pregnant women, for alcohol misuse and provide persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce alcohol misuse." In the related systematic review in Annals of Internal Medicine the Task Force summarizes the evidence for this recommendation as follows:

        "The 23 included trials generally excluded persons with alcohol dependence. The best evidence was for brief (10- to 15-minute) multicontact interventions. ['Very brief single contact (e.g., < 5 minutes) has limited impact.'] Among adults receiving behavioral interventions, consumption decreased by 3.6 drinks per week from baseline; 12% fewer adults reported heavy drinking episodes; and 11% more adults reported drinking less than the recommended limits. Evidence was insufficient to draw conclusions about accidents, injuries, or alcohol-related liver problems. Trials enrolling young adults or college students showed reduced consumptions and fewer heavy drinking episodes."

COMMENT: While we can all agree that moderate alcohol use is important to a healthy lifestyle, it is difficult to see why it is rated as more important than nutrition [actually an alcohol intervention ought to be considered a component of a global nutritional intervention] or exercise counseling. The reason for the difference in recommendations appears to be that the USPSTF considers alcohol counseling to be worth a more intense intervention (brief multicontact [each contact is 6-15 minutes) whereas it concludes that nutrition and exercise counseling only merit brief intervention counseling, which is ineffective according to their data, just as it is ineffective for alcohol counseling. Why the USPSTF is now willing to endorse 'brief multicontact interventions of 6-15 minutes for nutrition and exercise counseling is a mystery. Furthermore, the results cited in their evidence summary for the alcohol intervention involves only intermediate outcomes (i.e., the amount of alcohol consumed); the evidence is not adequate to demonstrate improved outcomes that matter--reduced accidents, lost time from work, less cirrhosis, etc. Certainly the poster above for lifestyle counseling shows far more significant improvements in outcomes that matter (incidence of major chronic diseases, cancer, and overall mortality).

        The USPSTF appears to have some kind of bias against nutrition and exercise counseling that is not explained by the evidence. Go figure.

OTHER FACTORS YOU MIGHT WANT TO CONSIDER:

    1. Sunscreen is expensive: These investigators performed a cost analysis study of sunscreen needs in two scenarios: a family of four on a 1-week beach vacation (4 hours/day in the sun), females in bikinis, males in swim trunks, reapplying sunscreen twice for adults and 3 times for children, and no other sun-protective measures taken), and a transplant patients using sunscreen year round. They also evaluated costs of 607 sunscreens from 17 Internet drugstores in 7 countries. Median sunscreen price was $1.70 per 10 g. Assuming that standard sunscreen application recommendations (2 mg/cm2) were followed, the median cost to the family varied from 4178.20 per week (if children were 2-year olds) to $238.40 per week (if children were 10-year-olds). The cost decreased by 33% if the family wore UV-protective T-shirts and by 41% if large-volume bottles were used--both strategies combined reduced the costs by 58%. The median cost to a transplant patients vai3ed from $245 to 292 per year.(6)

    2. Lifestyle changes could prevent 50% of common cancers: A research presenting at the Union for International Cancer Control (UICC) World Cancer Congress 2012 states: "More than 50% of cancer could be prevented if people simply implemented what is already known about cancer prevention." Most of this derives from lifestyle interventions. While the 'biggest buy' from lifestyle intervention is smoking cessation. It is also estimated that being overweight or obese causes approximately 20% of cancer. If people could maintain a healthy body mass index, the incidence of cancer could be reduced by approximately 50% in 2 to 20 years. (A healthy BMI for cancer prevention is from 21 to 23 kg/m2. Poor diet and lack of exercise are each associated with about 5% of all cancers. Improvement in diet could reduce cancer incidence by 50% and increases in physical activity could reduce cancer incidence by as much as 85% in 5 to 20 years.(7) COMMENT: Nonetheless the USPSTF remains far more interested in expensive and inconvenient screening strategies like mammography, occult blood stool testing, and colonoscopy to reduce breast cancer and colon cancer, respectively, by a mere 15%. The evidence is good, the impact and cost:benefit ratios, however, are disappointing.

    3. An alternative approach to obesity--prevention: The Institute of Medicine (supported by he Robert Wood Johnson Foundation) has issued a report on the prevention of obesity.(8) "Obesity has become so pervasive and severe that it 'constitutes a startling setback to major improvements achieved in other areas of health during the past century.'...What the country needs now is a set of obesity prevention action that, both individually and together, can accelerate meaningful change on a societal level." The Committee's recommendations include aggressive promotion of physical activity [Take note, USPSTF!], creation of environments conducive to healthy eating, and expanding the role of health care providers, employers, and schools in obesity prevention. The report identified 5 critical areas, or 'environments,' from which to attack the problem: physical activity, food and beverage, message (or marketing), health care and work, and schools. The 5 major goals for these environments are:

1. To make physical activity an integral and routine part of daily life.
2. To create food and beverage 'environments' that ensure that healthy options are routine and easy choices.
3. To transform messages about physical activity and nutrition.
4. To expand the role of health care providers, insurers, and employers in obesity prevention.
5. To make schools a national focal point for the prevention of obesity.

Specifically, with respect to health care providers, they recommend:

• Health care providers' standards of practice should include routine body mass index screening, counseling, and behavioral interventions for children, adolescents, and adults to improve physical activity behaviors and dietary choices.
• Medical, nursing, and physician assistants schools, and other relevant health care professional training programs and continuing education should include instruction in prevention, screening, diagnosis, and treatment of overweight and obesity in children, adolescents, and adults.
• Health care providers should serve as role models for their patients.

 

 

 

   350

parts per million of atmospheric carbon compatible with a familiar, sustainable planet Earth

REFERENCES:

 

1.  Lin JS, Eder M, Weinmann S. Behavioral counseling to prevent skin cancer: A systematic review for the US Preventive Services Task Force. Ann Intern Med 2011; 154: 190-201. Guideline: http://www.uspreventiveservicestaskforce.org/uspstf11/skincancouns/skincancounsrs.htm

2.  Moyer VA. Behavioral counseling interventions to promote a healthful diet and physical activity for cardiovascular disease prevention in adults: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2012; 157: 367-72.

3. Moyer VA. Screening for and management of obesity in adults: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2012; 157: 373-8.

4. Journal Watch 2004; 24 No 2: 18; cited in Action Advisor for Primary Care 2004; Vol 6 No 1: 3.

5. Little P. GP documentation of obesity: What does it achieve? Br J Gen Pract 1998; 48: 890-4; abstracted in The Family Practice Newsletter 1998; Vol 13 No 6: 24.

6. Mahe E et al. Are sunscreens luxury products? J Am Acad Dermatol 2011 Jul 11; [e-pub ahead of print]; http://dx.doi.org/10.1016/j.jaad.2010.06.043; abstracted in Journal Watch 2011.

7. Harrison P. Lifestyle changes could prevent 50% of common cancers. September 5, 2012 (Montreal, Quebec). Union of International Cancer Control (UICC) World Cancer Congress 2012. Presented August 29, 2012; reported in Medscape Medical News 2012: http://www.medscape.com/viewarticle/770357

8. Institute of Medicine. Accelerating progress in obesity prevention: Solving the weight of the nation. http://www.medscape.org/viewarticle/763753

MORE SUPPORT FOR A HEALTHY LIFESTYLE (DID WE NEED ANY?)

A VIEW FROM THE OFFI CE

MORE SUPPORT FOR A HEALTHY LIFESTYLE

(DID WE NEED ANY?)

 

 

LIFESTYLE RISK FACTORS PREDICT DISABILITY AND DEATH IN HEALTHY AGING ADULTS [THE 15TH MAJOR LIFESTYLE STUDY]: For the development of my "Formula for Health" I had collected 13 major observational studies and 1 RCT to support the synthesis of lifestyle essentials into just 5 lifestyle factors. These were cited in my Editorial in American Family Physician in 2010. Now it is time to add a new observational study to the list.(1)

        "[The] [p]ositive health effects of maintenance of normal weight, routine exercise, and nonsmoking are known for the short and intermediate term." These investigators studied the effects of these risk factors into advanced age. They collected data from 2,327 college alumnae aged 60 years of more who were followed annually (1986-2005) by questionnaires addressing health risk factors, history, and Health Assessment Questionnaire disability. Mortality data were ascertained from the National Death Index. Low-, medium-, and high-risk groups were created on the basis of the number (0, 1, > 2) of health risk factors (overweight, smoking, inactivity) at baseline. The medium- and high-risk groups had higher disability than the low-risk group throughout the study (P , 0.001). Low-risk subjects had onset of moderate disability delayed 8.3 years compared with high-risk subjects. Mortality rates were higher in the high-risk group (384 vs 247 per 10,000 person-years). The authors conclude: "Seniors with fewer behavioral risk factors during middle age have lower disability and improved survival. These data document that the associations of lifestyle risk factors on health continue into the ninth decade."

COMMENT: We already knew this, at least for elderly Europeans (aged 70-95 years) from the HALE Study which looked at 4 factors (not smoking, Mediterranean diet, exercise, and some consumption of alcohol. The benefits observed in the HALE study were truly dramatic-- 61-64% reductions in coronary and peripheral vascular mortality, 36% reductions in cancer (of all causes), and a 60% reduction in all-cause mortality. [It's OK to gasp.]

        So how much more data will it take before something like the "Formula for Health" becomes the cornerstone of all primary care--from cradle to grave? (Of course, it is NOT a data problem. Those who could be persuaded by data WERE persuaded a long time ago. For the rest, the data are irrelevant. It will probably take until ALL of the MONEY runs out to pay for procedures, tests, and medications before we give primary prevention a chance.

REVIEWING THE "FORMULA FOR HEALTH": DOES ADVICE TO EXERCISE WORK?  Of course, it does, but it's hard to prove. For this reason the USPSTF has dismissed physician counseling for exercise to the trash bin of "insufficient evidence," which I have always considered unfair. "The USPSTF found insufficient evidence to determine whether counseling patients in primary care settings to promote physical activity leads to sustained increases in physical activity among adult patients. Controlled trials of physical activity counseling in adult primary care patients were of variable quality and had mixed results. There were no completed trials with children or adolescents that compared counseling with usual care practices." [Not updated since 2002]  While we have to make concessions to the fact that the studies are few, small, often uncontrolled, and generally use suspicious "self-reported" amounts of exercise as outcomes, the remarkable thing is that a few minutes of physician or practice time, whether face-to-face or by phone or by class, makes a difference; the trend among studies is phenomenal. And, all of the lifestyle studies with their more global perspective identify exercise as a key component of a healthy lifestyle that is associated with the dramatic improvements in outcomes as mentioned above.

        The British are far more pragmatic and ultimately more fair, and with good reason. The BMJ has just published a systematic review of physical activity promotion based in primary care and found that it significantly increases physical activity levels at 12 months.(2) A prior meta-analysis of cohort studies found that self reported achievement of the official UK exercise goal (150 minutes of moderate intensity activity each week) was associated with a 19% reduction in the rate of all cause mortality, compared with sedentary behavior.(3) In the UK only 39% of men and 29% of women achieve this goal (2008).  A Cochrane review of interventions to promote physical activity in community dwelling adults showed a moderate effect on self reported physical activity and cardiorespiratory fitness at a minimum of 6 months of follow-up.  In addition, similar brief interventions have previously been shown to reduce smoking and alcohol use. One of the major problems with previous studies on exercise are that reviews included non-randomized trials and trials with short follow-up duration. Since the USPSTF recommendation (2002), however, there have been several large trials of physical activity promotion based in primary care with outcomes data after at least 12 months. It is time to take a fresh look. [Shame on you, USPSTF!]

        These investigators found a total of 15 relevant randomized controlled trials with 8745 subjects. Most interventions took place in primary care, included health professionals in delivery, and involved advice or counseling given fact to face or by phone (or both) on multiple occasions. In the 13 trials presenting self-reported physical activity, there were small to medium positive intervention effects as 12 months (OR, 1.42). The number-needed-to treat for one additional sedentary adult to meet internationally recommended levels of activity as only 12 (7-33). These are very positive results.

        Here are some other noteworthy aspects of the data to consider:

1. The authors could find no unpublished studies on brief interventions to promote exercise. Funnel plots of their pooled data did not suggest any publication bias.
2. A planned subgroup analysis showed significantly larger intervention effects on self reported activity in studies where control participants received no intervention than where they received a lesser comparator intervention. This analysis suggests that the observed positive effect on exercise levels may be underestimated as it appears that the comparator interventions themselves had positive effects. "The additional percentage of participants who reported meeting international activity recommendations at 12 months, compared with baseline, was 11-47% in participants allocated to receive an intervention, and 8-47% in those allocated to receive a comparator intervention. The corresponding range for those allocated to receive no intervention was from -2% to +19%. These findings suggest that briefer interventions, as used in the comparator groups, might achieve effects that are similar to those of more intensive interventions." 
3. Only one study reported an objective measure of physical activity level as an outcome, and in this study it was not significantly different. The authors call for more studies with an objective measure of outcome.
4. Only one study found a significant intervention effect on adverse events, reporting a relative 11% increase in falls and a 6% increase in injuries among intervention participants.
5. Since follow-up was limited to only 12 months in most trials, the effect of the exercise intervention of diabetes, cardiovascular events, or mortality could not be assessed.   

COMMENT: The USPSTF has been way too timid. They are missing the forest for the trees. Promoting exercise should be consider one of the absolute core activities of primary care practice. It's not. The USPSTF could be helping. It is not.

WALKING TO SAVE YOUR MIND: The Japanese have conducted a trial to evaluate the efficacy of a municipality-led walking program under the Japanese public Long-Term Care Insurance Act to prevent mental decline.(4) These data are from the program in the city of Takasaki. One hundred fifty community members aged 72.0 =/- 4 were randomly divided into intervention and control groups. A walking program was conducted once a week for 90 minutes for 3 months. The program encouraged participants to walk on a regular basis and to increase their steps per day gradually. The intervention was conducted in small groups of approximately six in order to obtain possible benefits in both exercise and social interaction. Cognitive function was measured using 9 tests in 5 domains: memory, executive function, word fluency, visuospatial abilities, and sustained attention. Quality of life, depressive state, functional capacity, range of activities, and social network were also assessed as well as motor function. There were significant differences between the intervention and control group in word fluency related to frontal lobe function (P=0.01), quality of life (P=0.002), functional capacity including social interaction (P < 0.001), and motor function (Timed Up and Go Test; P=0.002). COMMENT: As opposed to the "do nothing" attitude of the USPSTF, this is the kind of program we should be starting in our practices. Get every staff member (including a stint for yourself!) to lead a group at different hours during the day. I had a resident a few years ago (my esteemed Chief Resident at Santa Rosa, Dr. Serena Brewer, Touro graduate) who designed a project to do just this in a residency clinic setting. It would even reimburse well (if a provider spent some face-to-face time with each patient). You know what doomed it in this setting? The supporting hospital's fears of potential legal liability in the case that a patient might slip and fall. Sigh. We have to do better than this.

HOW OFTEN SHOULD I EXERCISE, DOC? The answer from Joseph Alpert, MD [Editor-in-Chief of American Journal of Medicine] is "Only on the days you eat."(8) His full answer is: "Our DNA heritage with its highly complex biochemical and physicological processes is appropriate to a very active lifestyle, not a modern 21st centruy couch potato, fast-food existence. Consdequently, we should make every effort to include elements that resemble the Paleolithic lifestyle [of our ancestors] in our modern daily existence. My lifestyle includes daily exercise, lots of fruits and vegetables in the diet, and avoidance of heavily engineered snack food. Of course, I also do not smoke tobacco nor do I consume large quantities of alcohol. I recommend these liefstyle elements to all my patients. When friends or family ask, 'How often should I exercise?' my answer is always 'Only on the days you eat.' That seems to get the message across." COMMENT: It's a shame that he didn't mention relaxation or stress reduction. But perhaps that is not an option for the Editor in Chief of American Journal of Medicine. 

ANOTHER ASIAN STUDY: AS LITTLE AS 15 MINUTES OF EXERCISE EACH DAY MAY PROLONG LIFE: A prospective cohort study from Taiwan examined the association between physical activity and mortality.(5) In this study, people who did as little as 90 minutes of exercise each week (who would ordinarily be considered physically inactive) were analyzed as a separate group. Around 12.5% (28,311 of 226,493 subjects) of those who exercised at all did so for about 15 minutes of 6 days a week. The study followed up for an average of 8 years more than 400,000 people who underwent regular health check-ups. Compared with people who exercised very little, those who did not exercise at all had a 17% higher risk of dying from any causes, and an 11% higher risk of dying from cancer. Each extra 15 minutes of daily exercise was linked with a 4% reduction in the risk of dying from any cause, and a 1% lower risk of cancer related death. The results held in both sexes, regardless of age, smoking and drinking habits, and overall risk of cardiovascular disease. The authors conclude that, at age 30, men who exercised for 15 minutes each day on average could expect to live 2.6 years longer than their peers who did not exercise at all; women could expect 3.1 years of extra life. Among 30 year olds who met the recommendations for physical activity--30 minutes exercise on 5 days a week--men could expect to live 4.2 years longer and women 3.7 years longer, compared with their physically inactive peers.

1.  Chakravarty EF et al. Lifestyle risk factors predict disability and death in healthy aging adults. Am J Med 2012; 125: 190-197.

2. Orrow G. et al. Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ 2012; 344:e1389 doi: 10.1136/bmj.e1389 (March 26, 2012).

3. Woodcock J et al. Non-vigorous physical activity and all-cause mortality: systematic review and meta-analysis of cohort studies. Int J Epidemiol 2011; 40: 121-38.

4. Maki Y et al. Effects of an intervention using a community-based walking program for prevention of mental decline: a randomized controlled trial. J Am Geriatr Soc 2012 Mar; 60(3): 505-10. doi: 10.1111/j.15

5. Wen CP et al. Minimum amount of physical activity for reduced mortality and extended life expectancy: a prospective cohort study. Lancet 2011; 378: 1244-53.

A COCKTAIL FOR LONGEVITY & HEALTH

A VIEW FROM THE OFFICE

DIET & LONGEVITY: A NEW APPROACH

GLASSES UP! A COCKTAIL TO ROUND UP YOUR LIFE:  As you know (perhaps ad nauseam) my approach to maximizing the lifespan (i.e., reducing all-cause mortality) is to follow The Formula for Health: 0 cigarettes, 5 servings of fruits & vegetables a day, 10 minutes of relaxation a day, maintaining a BMI < 30, and getting 150 minutes of exercise each week. Now these researchers have done me one better. They offer a cocktail of 30 ingredients to delay aging and extend the life span.(1) The data are preliminary but very positive (i.e., in mice). The thesis makes perfect sense. We have learned that health is always multifactorial and never attributable to a single factor. The reason that the Okinawans live so long is that there diet has little meat but contains more than 15 different kinds of fruits and vegetables each day. These investigators have further refined the nutrition essentials to go beyond a simple one-a-day multivitamin (which, prior to this I enthusiastically supported).

        This nutrient cocktail was developed by Dr. C. David Rollo and colleagues at the McMaster University in Canada. It was not a simple ad hoc formulation, but was strategically selected to address the five key mechanisms of aging. 

THE 5 KEY MECHANISMS OF AGING

oxidative stress

inflammation

mitochondrial dysfunction

insulin resistance

loss of membrane integrity

  

"No single mechanism alone accounts for any one specific disease process. Instead, all five mechanisms interact with one another to produce both general aging and specific conditions that limit activity, cognitive function, and ultimately lifespan...All animals, from worms to insects to humans, change in very similar fashions as they succumb to the five key mechanisms of aging."  Dr. Rollo and colleagues studied the impact of these nutrients on laboratory mice because of their short normal life span." (A mouse is considered 'old' by age 2 years.) They sought to study measures that would apply equally to mice and humans. They chose to focus on how much the aging animals moved and how their cognitive function changed with time. 

        "As they grow older, all animal species move about less and less each day, spending more and more time at rest or in sleep. Reduced mobility is an excellent marker of aging, because it is closely linked to overall metabolic rate, feeding, fat storage, brain neurotransmitter levels, mitochondrial function, and cardiovascular and skeletal muscle systems...[L]loss of mobility in humans is associated with muscle wasting, bone thinning, and other changes that increase the risk of other negative outcomes such as fractures, pneumonia, and skin infections. Cognitive function also declines with age in all animal populations. Younger animals typically learn faster, requiring fewer repetitions to master a task. They can also bring up important memories faster and more accurately, allowing them to find food, escape threats, and protect other members of their species. Studies show that preserving cognitive function into older ages is associated with longer life spans."

       In the study, the 30-ingredient cocktail was soaked into small pieces of bagel. For the longevity study they used both normal mice and a special strain that demonstrates accelerated aging as a result of excessive sensitivity to all five aging mechanisms. Compared with control animals, the supplemented mice of the accelerated aging strain lived 28% longer. Supplemented normal mice survived 11% longer than controls. For the mobility component of the study the investigators placed the mice in a system of transparent chambers, where they were given food, water, and an exercise wheel; they recorded the amount of time each animal spent moving about the enclosure over a 24-hour period. "Normal, unsupplemented mice showed a progressive decline in activity; by 24 months their mobility was roughly half that of younger normal animals. By 24 months of age, supplemented normal mice were moving roughly three hours more per day than were unsupplemented animals. No other treatment has ever been found that ameliorates declining mobility to this extent."

        Dr. Rollo's group also measured biochemical markers that might explain the difference in mobility. Supplemented older mice had increased activity of the neurotransmitter dopamine (decreased dopamine levels are associated with loss of movement in aging humans and in Parkinson's disease). They also had increased measures of mitochondrial activity, "suggesting that supplemented animals simply had more energy as they aged." Finally, they measured decreased levels of protein corbonyls--altered molecules that reflect the impact of glycation and oxidation on cells and tissues.

        To assess cognitive outcomes they  tested the mice on a water maze that required the animals to find and remember the location of a platform submerged just below the surface of a pool filled with waters. This test is an indicator of both learning skills and memory. They repeated this test each day for 5 days. At first all of the animals had difficulty finding the platform taking an average of 81 seconds. By day 5 young mice had learned and remembered enough to find the platform 43% faster than on day 1. "Older unsupplemented mice, however, showed no significant improvement in the time it took them to find the platform, indicating age-related impairments in learning and memory. But with supplementation, old mice showed a level of learning almost identical to that of young mice; in fact on day 5 they took an average of 46% less time to find the platform than they did on day 1. In other words, supplemented old mice showed the same ability to learn and remember new tasks as did young animals." In the related biochemical observations they noted that brain mitochondrial activity fell steadily with age in the untreated mice, while supplemented animals showed a steady increase in this measure of brain energy supply; mice with higher brain mitochondrial activity proved to be significantly better learners than those with lower mitochondrial activity; and brain weights, which normal decrease with age, were higher in supplemented male mice by 7%, and in females by 11%, compared with brain weights of control animals.

        The editors of Life Extension Magazine (free 3 month trial subscription available at this link:  http://www.lef.org/magazine/mag2012/may2012_Nutrient-Cocktail-Delays-Aging-Extends-Life-Span_01.htm) summarize the article as follows:

1. "Aging is a complex, multifactorial process, but five major mechanisms are now known to account entirely or in part for most human age-related diseases.
2. Dr. Rollo and colleagues have developed and tested successfully in mice a 30-nutrient supplement mixture designed to attack all 5 mechanisms of aging.
3. Tested in mice, the supplement mix extends life span by up to 28% while improving the aging animals' mobility and cognitive function.
4. All 30 ingredients are known to be safe and effective in human beings.If this mixture, or one like it, has similar effectiveness in humans, one could expect an 80-year-old to add nearly 9 years of life with youthful levels of activity and cognition."

Anyone interested?

And, of course, here is the prize. The 30 ingredients of the cocktail are:

TABLE OF NUTRIENT COCKTAIL INGREDIENTS
NUTRIENT	MECHANISM OF AGING AFFECTED
	Oxidant stress	Inflammation	Mitochondrial function	Insulin resistance	membrane integrity
B vitamins (B1, B3 (niacin), B6, B12,and folate.	x		x	x
Vitamin C	x
Vitamin D		x		x
Acetyl-L-carnitine	x		x
Alpha-lipoic acid	x	x	x	x
Aspirin		x
Beta-carotene				x	x
Bioflavonoids	x	x
Chromium picolinate				x
Garlic	x	x	x	x	x
Ginger root extract	x	x	x	x	x
Ginkgo biloba	x
Ginseng	x	x	x	x	x
Green tea extract	x	x		x
L-glutathione	x
Magnesium	x			x
Manganese	x			x
Melatonin	x	x
N-acetyl cysteine	x
Potassium	x			x
Rutin	x	x
Selenium	x	x	x	x	x
Vitamin E	x
Cod liver oil (omega-3)		x			x
Coenzyme Q10	x	x	x
Flax seed oil		x			x

COMMENT:  In my opinion this list makes complete sense. Over the years in my newsletters I have reviewed favorably 28 of the 30 ingredients as having important preventive benefits; the only ones that are new to me are rutin and manganese. The table above suggests particularly potent health benefits from garlic, ginger, selenium, and ginseng. 

        One of the important trends in medicine is the evolution of the 'polypill' principal. The original 'polypill' published by Wald & Law in the British Medical Journal 2004 consisted of a recommendation for universal consumption, starting at age 50, of an aspirin, folic acid, a statin, and 3 antihypertensive agents (regardless of baseline blood pressure) in half their usual starting doses. The imputed benefits were a greater than 80% reduction in heart disease and stroke. Then came the healthy lifestyle literature starting with the Hale Study focusing on a recipe of no smoking, regular exercise, a Mediterranean diet (which contains a lot of the ingredients above), and any intake of alcohol; the reported benefits for these elderly subjects over 10 years were a 60% reduction in mortality over, a 64% reduction in coronary heart disease, a 61% reduction in cardiovascular disease, and a 60% reduction in cancer. On the lifestyle front, I further refined a healthy lifestyle to my "Formula for Health" with the imputed benefits listed below:

This article takes the evolution of this concept yet one more step farther. Expect to see much more of this in the future.

WHAT IS THE BEST WAY TO DISPOSE OF OLD MEDICATIONS?  This is an important and very practical concern. The 'experts' have previously led us to believe that to dispose of medications with minimal damage to health and the environment, they should all be dropped off somewhere (like your local pharmacy) to be incinerated. The exception to this was a previous FDA recommendation that the following medications could be flushed down the toilet:

Abstral, tablets (sublingual)	Fentanyl
Actiq, oral transmucosal lozenge *	Fentanyl Citrate
Avinza, capsules (extended release)	Morphine Sulfate
Daytrana, transdermal patch system	Methylphenidate
Demerol, tablets *	Meperidine Hydrochloride
Demerol, oral solution *	Meperidine Hydrochloride
Diastat/Diastat AcuDial, rectal gel	Diazepam
Dilaudid, tablets *	Hydromorphone Hydrochloride
Dilaudid, oral liquid *	Hydromorphone Hydrochloride
Dolophine Hydrochloride, tablets *	Methadone Hydrochloride
Duragesic, patch (extended release) *	Fentanyl
Embeda, capsules (extended release)	Morphine Sulfate; Naltrexone Hydrochloride
Exalgo, tablets (extended release)	Hydromorphone Hydrochloride
Fentora, tablets (buccal)	Fentanyl Citrate
Kadian, capsules (extended release)	Morphine Sulfate
Methadone Hydrochloride, oral solution *	Methadone Hydrochloride
Methadose, tablets *	Methadone Hydrochloride
Morphine Sulfate, tablets (immediate release) *	Morphine Sulfate
Morphine Sulfate, oral solution *	Morphine Sulfate
MS Contin, tablets (extended release) *	Morphine Sulfate
Nucynta ER, tablets (extended release)	Tapentadol
Onsolis, soluble film (buccal)	Fentanyl Citrate
Opana, tablets (immediate release)	Oxymorphone Hydrochloride
Opana ER, tablets (extended release)	Oxymorphone Hydrochloride
Oramorph SR, tablets (sustained release)	Morphine Sulfate
Oxecta, tablets (immediate release)	Oxycodone Hydrochloride
Oxycodone Hydrochloride, capsules	Oxycodone Hydrochloride
Oxycodone Hydrochloride, oral solution	Oxycodone Hydrochloride
Oxycontin, tablets (extended release) *	Oxycodone Hydrochloride
Percocet, tablets *	Acetaminophen; Oxycodone Hydrochloride
Percodan, tablets *	Aspirin; Oxycodone Hydrochloride
Xyrem, oral solution	Sodium Oxybate

        By this time, fortunately, we have the benefit of a little experience with such guidelines and thoughtful review.(2)  The problem remains that American homes are filled with unused prescription drugs. "Each year we squirrel away 200 million pounds of pharmaceuticals we don't need anymore." Flushing or trashing drugs was the traditional means of disposal for decades, but in recent years take-back programs have been encouraged. The DEA has organized four nationwide take-back events since 2010. The most recent, in late April, collected more than 500,000 pounds of unwanted medications.        Flushing has fallen out of favor for all but a handful of drugs (see above) because of concerns about water contamination. Also we have data from Sweden that participation in take-back programs tends to stagnate at around 40%. New research, however, from the University of Michigan concludes that trashing drugs may be the most environmentally-friendly option. The researchers looked at the overall environmental impact of 3 disposal methods--flushing, trashing, and incineration. They analyzed how much of the drugs would enter the environment, emissions impacts from transportation, water treatment, and burning of waste materials. Their results show that flushing allows the highest levels of drugs to enter the environment by far, and creates more pollution than trashing. Drugs collected by take-back programs are incinerated, which means that none of the medicines themselves enter the environment, but these programs produce much greater emissions of green house gases and other pollutants than either flushing or trashing. This is mostly because consumers have to travel to a drop-off point and then the collected drugs are shipped somewhere else for incineration. The investigators suggest that home disposal is beneficial because we already have an infrastructure for collecting household trash. If our take-back programs are no more efficient than the Swedish programs, then our take-back program produces three times as much pollution while allowing about the same amount of drugs ultimately to reach the environment as home disposal in the trash. COMMENT: This suggestion makes a lot of sense. While the intention of take-back programs was to spare the environment, unless you take a more global perspective, you may be doing more harm than good. I, for one, appreciate being able to put my drugs back in the trash.

REFERENCES:

1.  Life Extension Magazine. May 2012. Nutrient 'Cocktail' Delays Aging and Extends Life Span.

 This article was brought to my attention by reader Phawda Moore.

2. NPR.org/blogs/health. Trash can may be greenest option for unused drugs. accessed 9:53 am, May 18, 2012.