Friday, September 30, 2011

Two natural anti-inflammatory herbs show superiority to celecoxib in treating osteoarthritic pain while posing less risk to kidney/liver than NSAIDs.

Herbs Beat Pain Drug in Study

Published September 28, 2011
FoxNews.com


In a recent study presented at the World Congress on Osteoarthritis in San Diego, a combination remedy of two herbal extracts called Rhulief™, demonstrated superior efficacy compared with the prescription drug celecoxib (the generic of the brand name Celebrex®) for relieving osteoarthritis pain of the knee. The Rhulief product contains an extract of turmeric root (Curcuma longa) called BCM-95, and an extract of boswellia (Boswellia serrata) called BosPure. Both turmeric root and boswellia have long histories of traditional use for the treatment of arthritis pain.

Twenty-eight patients completed the comparative study, which was conducted by physicians at the Anugraha Medical Center in Kochin, India. In the study, subjects of both sexes aged 18 to 65 years were randomized into two groups and were treated for a period of 12 weeks. The subjects were medically stable with moderate form of osteoarthritis evidenced by narrowing of the medial joint space with swelling. One group received celecoxib, 100 mg, twice daily and the second group received a 500 mg blend of the Rhulief combination of the herbal extracts BCM-95 curcumin and BosPure boswellia twice daily.

At the conclusion of the study, 93 percent of the herbal treated subjects could walk more than 1000 meters vs. 86 percent in the drug group. Approximately 93 percent of the herbal group reported improvement in or elimination of pain vs. 79 percent of the drug group. There were no serious adverse events in the study, and no significant changes in kidney or liver function, vital signs, or hemogram (complete blood count) measures. The statistical difference in improvement between the two groups is significant.

According to two of the authors of the study, Dr. B. Anthony and Dr. R. Kizhakedath, the herbal combination of curcumin derived from turmeric and boswellia out-performed celecoxib in pain relief, walking distance and joint line tenderness scores. The herbal formula was equally effective as celecoxib in alleviating crepitus (a crunching sensation in arthritis-damaged knees), and range of joint movements. Overall the herbal combination showed superior efficacy and tolerability as compared with celecoxib for treating active osteoarthritis.

Osteoarthritis is the most common form of joint disorder, and is common among people over age 55. Caused by wear and tear of the joints, osteoarthritis is characterized by pain and stiffness in joints. Exercise and placing weight on joints generally increase the severity of discomfort. Overweight people have increased risk of osteoarthritis in hips, knees, ankles and foot joints. According the Centers for Disease Control in Atlanta, approximately 27 million Americans had osteoarthritis in 2005, and that number is climbing.

These health statistics mean that a lot of people experience regular pain. To relieve pain, most people turn to the NSAID’s, or non-steroidal anti-inflammatory drugs. Ibuprofen, naproxen, diclofenac and Celebrex belong to this class of drugs. These drugs are designed to inhibit activity of what is known as the COX2 enzyme, a major factor in pain. This natural enzyme is created in all of us, and is responsible for the production of some of the agents called prostaglandins, which trigger pain and inflammation.

The NSAID’s relieve pain, but can also cause liver and kidney damage, and are shown to increase the risk of heart attack and stroke. A recently published study reveals even greater risks to these drugs. In the study Danish researchers found that use of NSAID’s among heart attack survivors greatly increased their risk of a repeat heart attack. This risk persisted even six months after the heart attack, and even if the use of the drugs was brief. For those who have had a heart attack or stroke, the NSAID’s pose a real danger.

Commenting on the NSAID’s, co-author of the comparative study and orthopedic surgeon Kizhakkedath noted, “Long-term non-steroidal inflammatory drug (NSAIDs) use is associated with gastrointestinal, kidney, and cardiovascular risks. These drugs can be dangerous. Given the efficacy, safety and tolerability issues associated with NSAIDs, development of new agents to manage OA without adverse events is a major priority.”

In various health categories, a number of comparative studies between herbal remedies and pharmaceutical drugs have shown better efficacy and safety with herbs. Both turmeric root and boswellia enjoy long histories of safe traditional use for the treatment of pain. In toxicity studies, these herbs and their extracts show none of the health problems associated with the NSAID’s. Finding safer options to replace potentially harmful drugs is a major health priority, as both osteoarthritis and NSAID use are expected to increase. The Rhulief product, which is marketed in India, is sold in the U.S. under the name Healthy Knees and Joints, by Wisconsin-based EuroPharma.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

Tuesday, September 27, 2011

Exercises for back pain have long been recommended - Williams Flexion Exercises for when there is posterior joint compression (imbrication) or McKenzie Extension Exercises when there is disc inflammation. Here's a little primer on the two:

Williams' Flexion Versus McKenzie
Extension Exercises For
Low Back Pain

In general, extension exercises may cause further damage in people with spondylolysis, spondylolisthesis and facet joint dysfunction (Harvey 1991), not to mention the possibility of crushing the interspinous ligament (McGill 1998).  While flexion exercises should be avoided in persons with acute disc herniation (Harvey 1991). 
 
Brief History of Williams' Flexion Exercises
 
Dr. Paul Williams first published his exercise program in 1937 for patients with chronic low back pain in response to his clinical observation that the majority of patients who experienced low back pain had degenerative vertebrae secondary to degenerative disk disease (Williams 1937).

These exercises were developed for men under 50 and women under 40 years of age who had exaggerated lumbar lordosis, whose x-ray films showed decreased disc space between lumbar spine segments (L1-S1), and whose symptoms were chronic but low grade.  The goals of performing these exercises were to reduce pain and provide lower trunk stability by actively developing the "abdominal, gluteus maximus, and hamstring muscles as well as..." passively stretching the hip flexors and lower back (sacrospinalis) muscles.  Williams said: "The exercises outlined will accomplish a proper balance between the flexor and the extensor groups of postural muscles..." (Williams 1965, Williams 1937, Blackburn 1981, Ponte et al.). 
 
Williams’ flexion exercises have been a cornerstone in the management of lower back pain for many years for treating a wide variety of back problems, regardless of diagnosis or chief complaint.  In many cases they are used when the disorder’s cause or characteristics were not fully understood by the physician or physical therapist.  Also, physical therapists often teach these exercises with their own modifications.  Williams suggested that a posterior pelvic-tilt position was necessary to obtain best results (Williams 1937).
 
Examples of Williams' Flexion Exercises
 
1. Pelvic tilt.  Lie on your back with knees bent, feet flat on floor.  Flatten the small of your back against the floor, without pushing down with the legs.  Hold for 5 to 10 seconds.
2. Single Knee to chest.  Lie on your back with knees bent and feet flat on the floor.  Slowly pull your right knee toward your shoulder and hold 5 to 10 seconds.  Lower the knee and repeat with the other knee.
3. Double knee to chest.  Begin as in the previous exercise.  After pulling right knee to chest, pull left knee to chest and hold both knees for 5 to 10 seconds.  Slowly lower one leg at a time.
4. Partial sit-up.  Do the pelvic tilt (exercise 1) and, while holding this position, slowly curl your head and shoulders off the floor.  Hold briefly.  Return slowly to the starting position.
5. Hamstring stretch.  Start in long sitting with toes directed toward the ceiling and knees fully extended.  Slowly lower the trunk forward over the legs, keeping knees extended, arms outstretched over the legs, and eyes focus ahead.
6. Hip Flexor stretch.  Place one foot in front of the other with the left (front) knee flexed and the right (back) knee held rigidly straight.  Flex forward through the trunk until the left knee contacts the axillary fold (arm pit region).  Repeat with right leg forward and left leg back.
7. Squat.  Stand with both feet parallel, about shoulder’s width apart.  Attempting to maintain the trunk as perpendicular as possible to the floor, eyes focused ahead, and feet flat on the floor, the subject slowly lowers his body by flexing his knees.    
 

Brief History of McKenzie Back Exercises
 
The McKenzie back extension exercises have been order by physicians and prescribed by physical therapists for at least two decades (
McKenzie 1981).  Robin McKenzie noted that some of his patients reported lower back pain relief while in an extended position.  This went against the predominant thinking of Williams Flexion biased exercises at this period of time.

 
Physical therapists can become "McKenzie certified", but the vast majority of physical therapists who treat low back pain are not.  McKenzie has developed diagnostic categories that assign patient to specific treatments.  Patients evaluated by McKenzie certified therapists are most likely to be placed into an extension biased exercise program.  This is probably why most people think of extension when talking about McKenzie exercises, or because the original exercises were in opposition to Williams' flexion exercises.
 
The goal of McKenzie exercises is to centralized pain.  If a patient has pain in the lower back, right buttock, right posterior thigh, and right calf, then the goal would be to "centralize" the pain to the lower back, buttock, and posterior thigh.  Then, "centralize" the pain to the lower back and buttock, and finally just the lower back.
Typical McKenzie Back Extension Exercises
 
1.  Prone lying.  Lie on your stomach with arms along your sides and head turned to one side.  Maintain this position for 5 to 10 minutes.
2.  Prone lying on elbows.  Lie on your stomach with your weight on your elbows and forearms and your hips touching the floor or mat.  Relax your lower back.  Remain in this position 5 to 10 minutes.  If this causes pain, repeat exercise 1, then try again.
3.  Prone press-ups.  Lie on your stomach with palms near your shoulders, as if to do a standard push-up. Slowly push your shoulders up, keeping your hips on the surface and letting your back and stomach sag.  Slowly lower your shoulders.  Repeat 10 times.
4.  Progressive extension with pillows.  Lie on your stomach and place a pillow under your chest.  After several minutes, add a second pillow.  If this does not hurt, add a third pillow after a few more minutes.  Stay in this position up to 10 minutes.  Remove pillows one at a time over several minutes.
5.  Standing extension.  While standing, place your hands in the small of your back and lean backward.  Hold for 20 seconds and repeat. Use this exercise after normal activities during the day that place your back in a flexed position: lifting, forward bending, sitting, etc.
 
What Does Recent Research Suggest About William Flexion or McKenzie Back Exercises?
 
A.  Adams, et al. found that "extension can reduce stresses in the posterior annulus of those discs that are most protected by the neural arch.  This protection may be related to disc height loss, to the morphology of the neural arch, or both....
 
Discogenic pain is associated with stress concentrations in the posterior annulus.  That backward bending can reduce such stress peaks in some discs could explain pain relief in some back pain patients undergoing extension exercises...  Pain relief would be anticipated only in those patients whose painful discs can be stress shielded by the neural arch in extension, and this may depend on factors such as disc height, and the precise shape of the neural arch....  
 
Backward bending may also correct any posteriorly displaced intradiscal mass, which is presumably an embryonic stage of disc herniation.  This dynamic internal disc model may provide an explanation for the commonly noted phenomenon of "centralization", in which distal pain is abolished and symptoms move proximally, often in response to extension exercises (Adams 2000).
 
B.  When rehabilitating patients with back dysfunction, extension exercises that are presumably "passive" for the erector spinae muscles are frequently used.  The results of a study demonstrated that "passive" extension exercises were not truly passive for lumbar back extensor muscles.  From a clinical perspective, if the performance of passive back extension is important, extension in lying prone may not be the exercise of choice and having patients lying prone may be the most beneficial (Fiebert 1994 ). 
 
C.  In one of the more carefully conducted randomized trials of nonsurgical back pain treatments undertaken in recent years, researchers conclude that McKenzie back exercises provide slightly greater pain relief than a placebo--the control group received a patient education booklet on low back pain.  Neither chiropractic manipulation nor McKenzie back exercises provided a significant functional benefit.
 
One of the most important tests of a therapy's efficacy is how it affects back problems over the long term.  McKenzie proponents have argued that their protocol reduces recurrences of back pain and decreases utilization of services.  This study showed evidence that McKenzie back exercises do not reduce low back pain recurrence.
 
"This casts doubt on the ability of the self-care-oriented McKenzie (back exercises) to reduce the utilization of services," suggest the researchers.  "There was no evidence that the higher initial costs of the physical treatments were offset by later savings," they add (Cherkin 1998).
 
D.  Nachemson arguably discredited Williams flexion back exercises when his study showed that these exercises may significantly increased the pressure within intervertebral discs of the lumbar spine (Nachemson 1963).
 
E.  Two studies have shown that lower back stiffness may only be a symptom of lower back pain and not the cause of it. (Johannsen 1995, Mellin 1985)  Johannsen, et al. conclude that "...increased spinal mobility does not necessarily lead to LBP (low back pain) improvement, and mobilizing exercises alone cannot be recommended to LBP patients (Johannsen 1995).
 
F.  Is there another explanation for symptom relief resulting from McKenzie?  What about tight iliopsoas muscles?  Isn't it more likely that the effectiveness of McKenzie extension exercises is associated with the elongation of the iliopsoas muscles secondary to the stretch positions.  The truth is that there is no reproducible data that shows that the exercise effect has anything to do with the nucleus pulposis "moving"... (Jorgensson 1993, Ingber 1989).
 
References

Adams MA, May S, Freeman BJ, Morrison HP, Dolan P. Effects of backward bending on lumbar intervertebral discs. Relevance to physical therapy treatments for low back pain. Spine 2000 Feb 15;25(4):431-7.
 
Blackburn SE, Portney LG. Electromyographic activity of back musculature during Williams' flexion exercises. Phys Ther  1981;61:878-885.
 
Cherkin DC et al., A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain, New England Journal of Medicine, 1998; 339:1021-9.
 
Fiebert I, Keller CD. Are "passive" extension exercises really passive?  J Orthop Sports Phys Ther 1994 Feb;19(2):111-6.
 
Harvey J, Tanner S. Low back pain in young athletes: a practical approach. Sports Med 1991;12:394-406.
 
Ingber R. Iliopsoas myofascial dysfunction: A treatable cause of "failed" low back syndrome. Arch Phys Med Rehab (70): 382-386 (1989).
 
Johannsen F, et al. Exercises for chronic low back pain:  A clinical trial. J Ortop Sports Phys Ther. 1995;22:52-59.

Jorgensson A. The iliopsoas muscle and the lumbar spine. Australian Physiotherapy 39(2): 125-132 (1993).

McGill SM. Low back exercises: evidence for improving exercise regimens. Phys Ther. 1998;78:754-765.
 
Mellin G: Physical therapy for chronic low back pain:  Correlations between spinal mobility and treatment outcome. Scand J Rehabil Med 1985;17:163-166.
 
Nachemson AL. the influence of spinal movements on the lumbar intradiscal pressure and on the tensile stresses in the annulus fibrosus.  Acta Orthop Scand 1963;33:183-207
.
Ponte DJ, Jensen GJ, Kent BE. A preliminary report on the use of the McKenzie protocol versus Williams protocol in the treatment of low back pain.  J Orthop Sports Phys Ther 1984;6:130-9
.
Williams PC: Lesions of the lumbosacral spine:  chronic traumatic (postural) destruction of the intervertebral disc, J Bone Joint Surg 1937;29: 690-703.
 
Williams PC: The Lumbosacral Spine.  New York, NY, McGraw-Hill Book Co, 1965, pp 80-98.

- From THE BACKTRAINER.COM 

Saturday, September 24, 2011

Exercise in children is not only good to lose weight, it also help build stronger bones....and now a study has found that it also helps increase insulin sensitivity:

 

ASBMR: Exercise Builds Kids' Bones, Insulin Sensitivity

By Nancy Walsh, Staff Writer, MedPage Today
Published: September 23, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
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SAN DIEGO -- In obese children, 12 weeks of vigorous exercise decreased their body fat while increasing bone formation and insulin sensitivity, a researcher said here.

The aerobic exercise intervention resulted in significant dose-response benefits on total and visceral adiposity (P for trend = 0.001), according to Norman Pollock, PhD, of Georgia Health Sciences University in Augusta, and colleagues.

The exercise program did not appear to change fasting glucose, but on other measures of insulin sensitivity there were benefits, as shown by an upward trend on the Matsuda index (P=0.004) and a downward trend on fasting insulin (P<0.04), Pollock said at the annual meeting of the American Society for Bone and Mineral Research.

There also was an upward trend for the markers of bone formation osteocalcin and procollagen type 1 amino propeptide (P1NP) (P=0.04 and P<0.001, respectively).

"Animal studies have identified a novel 'bone-fat-pancreas' axis involved in the regulation of energy homeostasis, in the coordination of energy partitioning between adipose tissue and bone, and control of insulin sensitivity," Pollock explained.

To explore the possibility that similar relationships might exist -- and be modifiable -- in humans, he enrolled 222 children ages 7 to 11 whose body mass index was at or above the 95th percentile for age and sex.  A total of 58% were girls, and the same percentage were black.

The children were randomized to a low-exercise regimen, which consisted of 20 minutes of aerobic exercise per day five days a week, or to a high-exercise regimen of 40 minutes five days a week.  A control group had no structured exercise.

Each child was given a portable Holter monitor, and the goal was to keep their heart rate above 150 beats per minute during activities such as soccer, basketball, and jump rope.
Unlike markers of bone formation, there was no dose response effect of exercise for the marker of bone resorption carboxyterminal telopeptide region of type I collagen (ICTP) or carboxyterminal collagen crosslinks (CTX).

Multiple linear regression analyses adjusting for age, race, and sex showed that the changes in bone formation were positively associated with changes in insulin sensitivity and negatively correlated with changes in visceral adipose tissue (P<0.04 for both).

The researchers then looked at whether insulin sensitivity mediated the relationship between visceral fat and bone formation, and by how much.  For this analysis, they used a mediation model, with a z value greater than 0.97 indicating a statistically significant pathway at the 0.05 level of significance.

For visceral fat, Pollock's group determined that, with a z value of 1.47, 16% of the effect of visceral fat on osteocalcin was mediated through insulin sensitivity.

In addition, they found a z value of 1.99 for bone formation, showing that 27% of the effect of visceral fat on the bone formation marker PN1P was mediated through insulin sensitivity.
This observed relationship between bone formation and central adiposity should be further investigated to determine if the link can be explained by glucose homeostasis, Pollock concluded.

Pollock declared that he had no disclosures.


Primary source: American Society for Bone and Mineral Research
Source reference:
Pollock N, et al "Dose-response effect of vigorous aerobic exercise on bone turnover, insulin sensitivity, and adiposity in obese children: a randomized controlled trial" ASBMR 2011; Abstract 1177.

Saturday, September 17, 2011

Gee, can't we just learn to eat healthier? Alas, the search for the silver bullet continues:

Makers of Obesity Pills Again Try to Win FDA Approval

By John Gever, Senior Editor, MedPage Today
Published: September 16, 2011
Companies developing three different weight-loss pills that were rejected by the FDA still believe they can eventually bring the products to market, though the firms are taking different approaches to winning over the agency.

Vivus Inc., which is developing an oral combination of topiramate and phentermine called Qnexa, said Thursday that it planned to submit a revised application for the product this October, sooner than it had first expected, after discussions with FDA staff.

The developer of lorcaserin hydrochloride (Lorqess), Arena Pharmaceuticals, recently announced that it had obtained encouraging results from new studies intended to answer the FDA's concerns, which centered on cancer risk and unimpressive efficacy.

Meanwhile, the company that is pursuing a combination of bupropion and naltrexone (Contrave) is mounting more of a frontal assault on the FDA. Orexigen Therapeutics said it was appealing the agency's demand for a new clinical trial through its dispute resolution process, and would focus on gaining approvals elsewhere in the world if it fails to change the FDA's mind.

The emergence of serious post-marketing safety problems with previous weight-loss drugs -- notably the combination of fenfluamine and phentermine known popularly as Fen-Phen -- has led the FDA to take a harder line on new products, insisting on detailed data for evaluating the balance of risks and benefits.

Vivus, Arena, and Orexigen received so-called complete response letters on their products during a three-month span from October 2010 to January 2011.

Qnexa's Way Forward

For Qnexa, the FDA had identified increased risk of psychiatric problems, cardiovascular effects, and, in women taking the drug during pregnancy, birth defects. These issues are believed to result mainly from the topiramate half of the combination, although psychosis is a recognized risk of phentermine as well.

Vivus said its new development plan calls for an initial application that would list "child-bearing potential" as a contraindication for the drug in obese women. It is currently conducting a retrospective analysis of electronic health records for some 2,500 children of women who took topiramate during pregnancy.

If results of that study exonerate topiramate, Vivus would then seek broader approval in all obese women as well as men. The company also has conducted other retrospective analyses showing minimal risk of birth defects associated with topiramate.

The company has not indicated how it plans to address the FDA's concerns about psychiatric or cardiovascular risks associated with the product, although new clinical trials do not appear to be on its agenda.

No New Contrave Trial

The agency told Orexigen in late January that it needed to conduct "a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."

In June, the company said such a trial would be "unprecedented and would generate significantly more information than is necessary or feasible."

It also expressed frustration that the FDA refused to consider approving the product for a restricted population without the additional cardiovascular safety data.

Orexigen has since been mum on further progress, other than to say last month that it was continuing with the dispute resolution process.

New Look at Crucial Lorcaserin Rat Study

Arena's lorcaserin was tripped up by data showing an increase in rat mammary tumors coupled with clinical efficacy results showing a mean average weight loss of 5%, the poorest of the three products. The FDA indicated that the drug's tepid efficacy failed to offset the safety risks.

The company has now produced a reanalysis of the two-year rat study, commissioning a group of independent pathologists to take another look at the tumor diagnoses.

The result: "Adenocarcinomas were no longer numerically higher than the control group in the lorcaserin low- and mid-dose groups," Arena said in a statement.

Another potential cancer risk mentioned by the FDA was astrocytoma, also seen in rat studies, though not in the drug's clinical trials. Arena has addressed this problem indirectly, with pharmacokinetic data indicating that the drug penetrates into the human brain at far lower rates than in rats.

As a result, the company suggested, lorcaserin concentrations in the human brain are probably much lower than rats at equivalent doses.

On the other hand, recently reported efficacy data for lorcaserin have confirmed that it seldom produces large weight loss. For example, a meta-analysis of three phase III trials reported in June, based on intention to treat, found that more than one-third of patients failed to lose 5% of body weight after one year and only about one-fifth lost 10% or more.

Arena has not said when it plans to ask the FDA to reconsider approving the drug.

Friday, September 16, 2011

FDA: "Ignore that man [Dr. Oz] behind the curtain" with regard to Oz' claim that apple juice can be harmful to your health.

FDA Slams 'Dr. Oz' for Apple Juice Report

By Todd Neale, Senior Staff Writer, MedPage Today
Published: September 15, 2011
ABC News video
Mehmet Oz, MD, the Columbia University thoracic surgeon who gained fame first in books and more recently with his syndicated television show, has run afoul of the Food and Drug Administration with his report about levels of arsenic in popular brands of apple juice.

The FDA called the report "irresponsible and misleading" and another TV doc, ABC's Richard Besser, MD, accused Oz of fear-mongering.

In a recent episode of The Dr. Oz Show, Oz reported that five brands of apple juice -- Minute Maid, Apple & Eve, Mott's, Juicy Juice, and Gerber -- all contained some level of arsenic and suggested that this was a cause for concern.

The show used an independent laboratory, EMSL Analytical, to test dozens of samples from three U.S. cities to compare the level of arsenic in the juices to the Environmental Protection Agency's safe standard for drinking water, less than 10 parts per billion.

At least one sample for four of the five brands -- excluding Minute Maid -- came in above that threshold. The highest level measured was in Gerber apple juice, at 36 ppb.

The segment earned a stiff rebuke from representatives of government, industry, and academia for causing unnecessary alarm, even before it aired.

The criticism centered primarily on Oz's testing methods, which provided a level of total arsenic in the juices. The results do not provide a breakdown of the levels of the two forms of arsenic -- organic and inorganic.

In heated confrontation aired on ABC's Good Morning America, Besser not only blasted reporting of only the total arsenic numbers but also charged that relying on a single lab to test for arsenic fell far short of scientific standards. Oz, however, refused to back down and maintained that he acted responsibly.

According to the FDA, arsenic is found in the environment in both forms, either as a result of natural processes or the result of contamination from human activities. In the U.S., some pesticides used up until 1970 contained arsenic.

The organic form of arsenic is "essentially harmless," according to the FDA. The inorganic form can cause problems at high levels or with a long period of exposure.

In a letter sent to The Dr. Oz Show before the segment aired, Don Zink, PhD, senior science adviser in the FDA's Center for Food Safety and Applied Nutrition, wrote, "The FDA believes that it would be irresponsible and misleading for The Dr. Oz Show to suggest that apple juice contains unsafe amounts of arsenic based solely on tests for total arsenic."

The FDA said it has been testing for arsenic in apple juice for several years. The juice is first screened with a test for total arsenic because it is rapid, accurate, and cost-effective, according to Zink. Only when the total level of arsenic is greater than 23 ppb does the agency employ the more complex inorganic arsenic test.

"The vast majority of samples we have tested for total arsenic have less than 23 ppb," Zink noted.

In a second letter to the show, Zink informed the producers that the FDA had performed its own testing on samples of apple juice from the same lot that yielded the highest level of arsenic in Dr. Oz's investigation. All of the results ranged from 2 ppb to 6 ppb.

"In short," Zink wrote, "the results of the tests cited above do not indicate that apple juice contains unsafe amounts of arsenic."

In an email to ABC News and MedPage Today, Aaron Barchowsky, PhD, a professor in the department of environmental and occupational health at the University of Pittsburgh, said that he agrees with the FDA's conclusion.

"It is the inorganic form of arsenic in the environment that is toxic, and measuring total arsenic is not informative," he wrote. "I support the comments by the FDA and agree that the Oz show analysis is incomplete and probably misleading."

On its website, the FDA said that it has a standard for an unsafe level of arsenic in water but not in apple juice for two main reasons -- the consumption of water is much greater and most of the arsenic in water is the unsafe inorganic form, whereas in fruit juice, most of the arsenic is the organic form.

Henry Miller, MD, a fellow at the Hoover Institution at Stanford University and formerly the founding director of the FDA's Office of Biotechnology, criticized Oz for failing to provide evidence that the levels of arsenic found in the apple juice were dangerous.

"Unless there is evidence that a substance is present at sufficient exposures and levels to cause harm, warnings about its presence in food (or in our bodies, for that matter) is irresponsible alarmism," he wrote in an email. "This is the same sort of rubbish peddled by radical environmental activist organizations about pesticides."

This article was developed in collaboration with ABC News.


Tuesday, September 13, 2011

Nonaspirin NSAIDs may help your headache but now may cause pain elsewhere as their regular use is linked to higher risk of renal cancer...

Nonaspirin NSAID Use Linked to Risk for Renal Cell Cancer

Laurie Barclay, MD


September 12, 2011 — Long-term use of nonaspirin anti-inflammatory drugs (NSAIDs) is linked to a risk for renal cell cancer (RCC), according to an analysis of data from 2 prospective studies reported in the September 12 issue of the Archives of Internal Medicine.

"Epidemiologic data suggest that analgesic use increases the risk of ...RCC, but few prospective studies have been published," write Eunyoung Cho, ScD, from Harvard Medical School and Brigham and Women's Hospital in Boston, Massachusetts, and colleagues. "We investigated the association between analgesic use and RCC in 2 large prospective studies."

Use of aspirin, other NSAIDs, and acetaminophen was determined in 1990 in the Nurses' Health Study and in 1986 in the Health Professionals Follow-up Study, as well as every 2 years subsequently. In the Nurses' Health Study, 77,525 women were followed up for 16 years, and in the Health Professionals Follow-up Study, 49,403 men were followed up for 20 years.

Although use of aspirin and acetaminophen was not associated with the risk for RCC, regular use of nonaspirin NSAIDs was associated with an increased risk for RCC. At baseline, the pooled multivariate relative risk (RR) was 1.51 (95% confidence interval [CI], 1.12 - 2.04). For users vs nonusers of nonaspirin NSAIDs, the absolute risk differences were 9.15 per 100,000 person-years in women and 10.92 per 100,000 person-years in men.

Duration of nonaspirin NSAID use was linked to RCC risk in a dose-response relationship (P < .001 for trend). Compared with nonregular use, the pooled multivariate RRs were 0.81 (95% CI, 0.59 - 1.11) for less than 4 years' use, 1.36 (95% CI, 0.98 - 1.89) for 4 to less than 10 years' use, and 2.92 (95% CI, 1.71 - 5.01) for at least 10 years' use.

"Our prospective data suggest that longer duration of use of nonaspirin NSAIDs may increase the risk of RCC," the study authors write.

Limitations of this study include possible residual confounding, confounding by indication, confounding by past use of phenacetin, and incomplete information on NSAID dose.

"Risks and benefits should be considered in deciding whether to use analgesics; if our findings are confirmed, an increased risk of RCC should also be considered," the study authors conclude.

In an accompanying editor's note, Kirsten L. Johansen, MD, notes that approximately 60 million people in the United States use NSAIDs regularly.

"The study by Cho et al uses prospective data from 2 different cohorts to estimate the risk of renal cell carcinoma related to NSAID use and reports a pooled multivariate relative risk of 1.51 (95% confidence interval, 1.12-2.04) for nonaspirin NSAID use, with a dose-response relationship based on duration of use," Dr. Johansen writes. "Although the absolute risk differences between users and nonusers of NSAIDS were quite low, we find the results compelling in light of the widespread use of these drugs."

The National Institutes of Health, the Kidney Center Association, and the Dana-Farber/Harvard Cancer Center Kidney Cancer Specialized Programs of Research Excellence supported this study. The study authors have disclosed no relevant financial relationships.
 
Arch Intern Med. 2011;171:1487-1493, 1493.

Monday, September 12, 2011

Addressing the cause of complaints, rather then providing treatment for symptoms, in a preventive approach makes sense, saves money, and may well be healthier for patients.

 

Weight-Loss Program in Medicare Could Save Billions

By John Gever, Senior Editor, MedPage Today
Published: September 10, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston andDorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

The financial burden on Medicare could be cut by as much as $15 billion if it funded weight-loss programs for overweight and obese people, ages 60 to 64, with certain other risk factors, researchers said.

Assuming effectiveness like that seen in a recent community-based intervention trial, in which participants had average losses of 4.2% of body weight, enrolling 70% of the 60 to 64 age cohort with "prediabetes" or cardiovascular risk factors could reduce Medicare expenditures by a net $15.1 billion over the cohort's lifetime, according to Kenneth E. Thorpe, PhD, and Zhou Yang, PhD, both of Emory University in Atlanta.

Lifetime net savings with 55% participation would be $11.9 billion, they calculated.
Writing online in Health Affairs, Thorpe and Yang noted that Medicare's recently added "wellness benefit" -- part of the Affordable Care Act -- covers an annual visit, personalized care plan, and a referral if necessary. But the new benefit doesn't include payment for commercial or community-based diet-and-exercise programs that promote better health.

"Without payment for preventive programs, the wellness benefit remains incomplete," they wrote. "We propose that Medicare expand its new wellness benefit to include reimbursement for [the modeled program] and other qualifying behavior change programs."

The Centers for Medicare and Medicaid Services actually took a step in that direction earlier this month, proposing that Medicare cover "high-intensity" obesity counseling by primary care physicians.

But another recent study called the effectiveness of such programs into question when delivered in this way.

In a one-year trial conducted in the U.K., Germany, and Australia, much greater weight loss was seen among mainly obese participants randomized to the commercial Weight Watchers program than in those counseled in primary care.

Although weight losses in the study were not reported as percentages of initial body weight, the mean one-year loss of five pounds among patients in the primary care counseling group was almost certainly less than 4%.

For the current study's calculations, Thorpe and Yang relied on findings in the 2008 DEPLOY pilot trial of a diabetes prevention program delivered through YMCA centers.

Modeled after a program developed by the CDC, it involved group sessions delivered weekly for 16 weeks with additional follow-up meetings. It promoted intensive lifestyle modifications for both diet and physical activity.

The DEPLOY study randomized patients with elevated, but nondiabetic, fasting blood glucose levels and other risk factors to participate in the program, or to visit YMCA centers and use their regular services as participants wished.

At follow-up, those in the intervention group had a mean 6% weight loss after six months. This was 4.2 percentage points higher than in a control group receiving only standard weight loss advice, and the results were sustained for more than 12 to 14 months. These participants also lowered their total cholesterol by about 25 mg/dL.

Thorpe and Yang used other published data to estimate the effect on Medicare utilization from these improvements in risk factors if achieved broadly in the population at ages 60 to 64.
If only prediabetic individuals are targeted, the net savings with 70% participation over the cohort's lifetime would be $9.3 billion, the researchers calculated.

Focusing the program on individuals 60 to 64 with cardiovascular risk factors such as high cholesterol and family history, but with normal blood glucose, would create net lifetime savings of $5.8 billion with 70% participation.

Thorpe and Yang also calculated savings over a 10-year period starting in 2011, therefore assuming an immediate implementation.

Targeting everyone 60 to 64 with prediabetes or cardiovascular risks and achieving 70% participation, the net 10-year saving would be $3.7 billion.

The lifetime savings are four times greater because, as these individuals age, the medical costs associated with failing to prevent more serious disease accelerate.

"Our results show the potential savings to Medicare if a proven, community-based approach to reducing obesity and related chronic disease were to be made available, nationwide, to high-risk individuals soon to become Medicare beneficiaries," Thorpe and Yang wrote.

"They also present a potential business case for the federal government to partner with the private sector in order to encourage broad enrollment in effective weight loss programs," they said.

Thorpe and Yang noted that the YMCA program had been funded by the insurance company UnitedHealth, calling it "an important case in point."

If such an effort were to prove cost-effective in the 60 to 64 age group, the government should then consider extending it to both younger and older age groups, they suggested.

The study received support from the Peter G. Peterson Foundation.
Study authors reported no relevant financial interests.