The FDA is considering making changes in how it regulates the supplement industry. In an interesting article offering one MD's opinion versus the position of the supplement industry, the pros and cons are discussed. Whether you take or sell supplements, whether you're pro or con on the issue of stricter FDA regulation, one thing is certain.....public safety should come first.

FDA Supplement Guidance Not Strict Enough, MD Says

By Emily P. Walker, Washington Correspondent, MedPage Today Published: January 26, 2012

An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine. More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance.  But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece. By law, ingredients that were used and sold in supplements prior to 1994 can be marketed without any proof that they are safe or effective. But under a law called the Dietary Supplement Health and Education Act (DSHEA), manufacturers of any ingredient introduced after 1994 must provide the FDA with evidence supporting "a reasonable expectation of safety." Cohen said that part of the law "has thus far not been enforced." Since DSHEA became law more than 15 years ago, the number of supplements on the market has gone from 4,000 to more than 55,000. Since 1994, the FDA has received proper notification for 170 new supplement ingredients, "undoubtedly a small fraction of the ingredients for which safety data should have been submitted," Cohen said. The FDA has mounted a new effort to discourage the sale and use of nutritional supplements that contain ingredients that are regulated as drugs. Last year, the agency issued draft guidance meant to inform supplement manufacturers about what information they must submit to the FDA, including spelling out when an ingredient is considered old and when it's considered new. (A synthetically produced replica of a botanical product, for instance, would be considered new). In addition, the FDA is proposing that the guidance call for in vitro, animal, and long-term tolerability testing for supplements that would be marketed at higher doses than those historically ingested. "The FDA's guidance provides a thoughtful framework for evaluating the safety of new ingredients and if implemented it would lead to substantial improvement in safety," Cohen wrote, but he said he didn't think the FDA goes far enough. He said under the guidance, companies can use historical data (instead of clinical trials) to prove that a supplement is safe, and Cohen said that the FDA can't assess the safety of new products scientifically without experimental data. Cohen also said that under the guidance, manufacturers would not be required to submit both favorable and unfavorable data to the FDA, so they could cherry-pick only positive data to submit. The dietary supplement industry largely opposes the draft regulation. One opponent is the Natural Products Association, whose 1,900 members include small health food stores and large supplement manufacturers. The group submitted its official response to the FDA's proposal in November and said the agency is "overstepping" and that the rules would have a "chilling effect" on the dietary supplement industry. "The draft guidance as currently written sets up inappropriate barriers to market entry, imposes food additive criteria, and requires multiple ... notifications beyond those required by law," the group wrote. Cohen said it's true that the proposed requirements would impose similar standards on supplements and food additives. "Industry advocates are correct insofar as DSHEA does not hold established (pre-1994) supplement ingredients to the same safety standards as food additives: a chemical preservative sprayed inside a can of tomato soup or the purple dye in Jell-O requires much more evidence of safety than ingredients used in supplements," Cohen wrote. Cohen urged the FDA to not change its proposal because of protests from industry. "If the FDA succumbs to industry pressure, the public health consequences will be significant, as hundreds of thousands of Americans continue to turn to new supplements to sustain their health and treat their ailments," he said. The FDA is accepting comments on the draft guidance until Feb. 1. Cohen reported no financial conflicts of interest, other than having his travel paid for to be a guest on an episode of the Dr. Oz Show that dealt with supplements.

If you, or someone you know, takes aspirin on a daily basis, a new study indicates that doing so can increase your risk for developing "wet" macular degeneration in advanced age.

Could Daily Aspirin Harm Seniors' Eyes?

Study found possible association between drug and age-related macular degeneration

Thursday, January 5, 2012

THURSDAY, Jan. 5 (HealthDay News) -- Daily aspirin use among seniors may double their risk of developing a particularly advanced form of age-related macular degeneration, a debilitating eye disease, a large new European study suggests.

 

The possible link involves the so-called "wet" type of age-related macular degeneration (AMD), a significant cause of blindness in seniors.

Aspirin use was not, however, found to be associated with an increased risk for developing the more common, and usually less advanced, "dry" form of AMD, according to the report published in the January issue of Ophthalmology.

Although the study team stressed that further research is needed, the findings could cause concern for the millions of older people who routinely take over-the-counter aspirin for pain, inflammation and blood-clot management, and to reduce their risk of heart disease.

"People should be aware that aspirin, often just bought over the counter without prescription, may have adverse effects -- apart from major gastrointestinal and other bleeding -- also for AMD," said lead author Dr. Paulus de Jong.

De Jong is an emeritus professor of ophthalmic epidemiology at the Netherlands Institute for Neuroscience of the Royal Academy of Arts and Sciences, as well as the Academic Medical Center, both in Amsterdam.
Age-related macular degeneration affects the critical central vision required for reading, driving and general mobility. The damage occurs when the retinal core of the eye (the macula) becomes exposed to leaking or bleeding due to abnormal growth of blood vessels.

To examine whether aspirin use might trigger this process, the authors focused on nearly 4,700 men and women over age 65 living in Norway, Estonia, the United Kingdom, France, Italy, Greece and Spain.

In the study, conducted between 2000 and 2003, the researchers looked at blood samples, frequency of aspirin use (though not doses), smoking and drinking history, stroke and heart attack records, blood pressure levels and sociodemographic data.

The team also analyzed detailed images of each participant's eyes, looking for indications of age-related macular degeneration and severity.

Daily aspirin use was associated with the onset of late-stage "wet" age-related macular degeneration, and to a lesser degree, the onset of early "dry" AMD -- even after the researchers took into account age and a history of heart disease, which in itself is a risk factor for AMD.

For late-stage wet AMD only, the association was stronger the more frequently an individual took aspirin.
Early AMD was found in more than more than one-third of participants (36 percent), while late-stage AMD was found in roughly 3 percent, or 157 patients.

Of those with late AMD, more than two-thirds (108) had wet AMD, while about one-third (49) had dry AMD, the researchers found.

More than 17 percent of participants said they took aspirin daily, while 7 percent took it at least once a week and 41 percent did so at least once a month.

About one-third of those with wet AMD consumed aspirin on a daily basis, compared with 16 percent of those with no AMD.

The study authors cautioned that further research is needed on aspirin's possible effects on eye health. Meanwhile, they suggested that doctors generally should not alter their current advice for aspirin use among older patients coping with heart disease risk.

"[But] I would advise persons who [already] have early or late AMD not to take aspirin as a painkiller," de Jong said. "[And] I would advise people with AMD who take small amounts of aspirin for primary prevention -- this means having no past history of cardiac or vascular problems like stroke, and no elevated risk factors for these diseases -- to discuss with their doctor if it is wise to continue doing so. For secondary prevention -- this means after having these elevated risks or disorders -- the benefits of daily aspirin outweigh the risks."

While the study uncovered an association between aspirin use and AMD, it did not prove a cause-and-effect relationship.

This point was also made by Dr. Alfred Sommer, a professor of ophthalmology and dean emeritus at the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. He noted that while the study was "well executed," it should not be seen as definitive proof that aspirin use and AMD are linked.

An observational study of this type "merely calls attention to the fact that such an association may exist, and that it may be causal, but only randomized clinical trials can prove the matter one way or the other," he said.
"Hence, this might or might not be real," Sommer added, "and we will only know that when and if a randomized trial is done."

In the interim, he said the findings should not guide patient behavior.

"It is well known that aspirin [and other NSAIDs] can increase the risk of gastric distress and gastric ulcers," Sommer said. "Like any medicine, it should only be taken if needed. But those taking aspirin to prevent heart disease, particularly those at increased risk of heart disease, definitely do benefit and should not change what they do."

SOURCES: Paulus de Jong, M.D., Ph.D., emeritus professor of ophthalmic epidemiology, Netherlands Institute for Neuroscience of the Royal Netherlands Academy of Arts and Sciences, and Academic Medical Center, Amsterdam, the Netherlands; Alfred Sommer, M.D., professor, ophthalmology, and dean emeritus, Bloomberg School of Public Health, Johns Hopkins University, Baltimore; January 2012, Ophthalmology

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Copyright (c) 2012 HealthDay. All rights reserved.

Cybercycling. A new study shows it may help reduce the onset of dementia and might be the best reason to buy your parents (or perhaps yourself) a new Wii Fit.

Cybercycling Gives Seniors a Brain Boost

By Crystal Phend, Senior Staff Writer, MedPage Today Published: January 16, 2012 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Virtual reality exercise games, like the Wii Fit, may help older adults fight cognitive decline, researchers found. Seniors who played a racing game by pedaling a stationary bike saw a significant boost in overall executive function on cognitive testing compared with stationary bike use alone (P=0.002), in a clinical trial by Cay Anderson-Hanley, PhD, of Union College in Schenectady, N.Y., and colleagues. "Cybercycling" for three months in the trial reduced risk of clinical progression to mild cognitive impairment by a relative 23%, the group reported in the February issue of the American Journal of Preventive Medicine. "Our findings give us hope that there can be an impact on improved brain health for older adults by this kind of synergistic mental and physical exercise," Anderson-Hanley told MedPage Today. "The other thing is it's a lot of fun." Participants in the trial often said they enjoyed exercise when playing the virtual reality game, she noted in an interview, which she suggested could help seniors start up and stick to a regimen. "If more people in later life were to embrace regular physical exercise, such as this 'exergaming' type of exercise, that there would be a significant benefit across the community," Anderson-Hanley said. Delaying the onset of dementia by even one year could cut the projected U.S. prevalence from 8 million down to 7 million in 2050, she explained. While virtual reality exercise games have proliferated for Nintendo's Wii and other consoles for the gym and home, not all may provide the same benefits, Anderson-Hanley cautioned. "It's hard to know yet whether we can generalize our findings to other forms of exergaming that have more intermittent activity, like tennis or golf," she told MedPage Today. Her study used cycling because it continuously elevates heart rate. It included 102 older adults at eight independent-living retirement facilities who were randomized to stationary recumbent bike use an average three times a week for three months with the virtual reality game monitor either turned on or off. Playing the game while cycling had a large effect on change in cognitive scores on the Color Trails Difference, Stroop C, and Digits Backwards tests (P=0.002 for time by treatment interaction together). Cybercyclists improved their performance on the Color Trails Difference (P=0.01) and Stroop C (P=0.05) tests over baseline, whereas traditional cyclists showed no change. The intervention group also maintained their Digits Backwards test performance over the three-month period, whereas the controls' performance declined (P=0.01). The average improvement in cognitive performance with cybercycling was one-half a standard deviation over and above traditional exercise, the researchers noted. During the study, three of the game participants and nine of those doing cycling alone developed mild cognitive impairment diagnosed clinically, for a 23% reduced risk with the intervention. The groups didn't differ in frequency, duration, or intensity of exercise, with both expending about 100 calories on average during a session. The only difference between groups was the virtual reality experience, Anderson-Hanley's group pointed out. "Navigating a 3D landscape, anticipating turns, and competing with others requires additional focus, expanded divided attention, and enhanced decision making," they wrote in the paper. "These are activities that depend in part on executive function, which was significantly affected." The group noted the relatively high level of education and low diversity of their study population, making further study necessary to determine generalizability, though the intervention should be widely applicable. Other limitations included unequal education and age between the groups, though controlled for in the results. The study was funded by a grant from the Robert Wood Johnson Foundation, through the Health Games Research national program, and by faculty and student grants from Union and Skidmore Colleges. The researchers reported having no conflicts of interest to disclose.

Primary source: American Journal of Preventive Medicine Source reference: Anderson-Hanley C, et al "Exergaming and older adult cognition: A cluster randomized clinical trial" Am J Prev Med 2012; DOI: 10.1016/j.amepre.2011.10.016.

Considering spinal surgery? According to a study published in The Spine Journal, 87% of spinal surgeries have at least one complication with 37% of them requiring prolonged hospital stay. However, most of those complications were postoperative.

 

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients

John T Street, MD, PhD; Brian J. Lenehand, MD; Christian P DiPaola, MD; Michael D Boyd, MD; Brian K Kwon, MD, PhD; Scott J Paquette, MD; Marcel FS Dvorak, MD; Y Raja Rampersaud, MD; Charles G Fisher, MD

Received 25 January 2011; received in revised form 17 November 2011; accepted 1 December 2011. published online 03 January 2012.

Abstract 

Background context

To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center.

Purpose

To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool.

Study design

Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study.

Patient sample

All adult patients admitted to the spine service of a quaternary referral center for a 12-month period.

Outcome measures

A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS).

Methods

Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded.

Results

One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission. The average LOS was 13.5 days (range, 1–221 days). Eight hundred twenty-two (87%) patients had at least one documented complication. Thirty-nine percent of these adversely affected hospital LOS. There were 14 mortalities during the study period. The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition requiring revision and 2.2% blood loss >2 L). The incidence of postoperative complication was 73.5% (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological deterioration, 3%).

Conclusions

Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect LOS. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

New study claims that if your child has ADHD, the best alternative to drug therapy is a healthy diet. Diets high in fiber, fruits and vegetables, and one free of sugars and processed foods, demonstrate benefits.

Pediatric Study: 'Healthy' Diet Best for ADHD Kids

By John Gever, Senior Editor, MedPage Today Published: January 09, 2012 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 Fast foods, sodas, and ice cream may be American kids' favorite menu items, but they're also probably the worst for those with attention deficit-hyperactivity disorder (ADHD), a new literature review suggests. According to two researchers from Children's Memorial Hospital in Chicago, a relatively simple diet low in fats and high in whole grains, fruits, and vegetables is one of the best alternatives to drug therapy for ADHD. Omega-3 and omega-6 fatty acid supplements have also been shown to help in some controlled studies, they noted. Writing online in Pediatrics, J. Gordon Millichap, MD, and Michelle M. Yee, CPNP, reviewed nearly 70 publications on diet-based interventions in ADHD, emphasizing recent research and controlled trials. Activate MedPage Today's CME feature and receive free CME credit on medical stories like this one They noted that diet is one established contributor to ADHD that parents can modify. One of the most provocative findings in recent years came from the Australian Raine study, which was a prospective cohort study that followed children from birth to age 14, Millichap and Yee indicated. It found that development of ADHD was significantly associated with so-called Western diets rich in saturated fats and sugar, compared with a "healthy" diet of proteins derived from low-fat fish and dairy products and with a high proportion of vegetables (including tomatoes), fruits, and whole grains. However, their review indicated that controlled trials had failed to show significant benefits for such intensive modifications as oligoantigenic, elimination, or additive-free Feingold-type diets except in small subgroups. Such diets also "are complicated, disruptive to the household, and often impractical," they wrote. The Feingold diet and others are based on the idea that artificial colors and salicylates contribute to ADHD, which became popular in the 1970s. Federally funded trials showed that most ADHD children did not improve significantly on such diets, although some children with genuine sensitivities to additives and preservatives have been identified. Such children, the researchers suggested, "might benefit from their elimination." More recent research has also indicated that atopic children with ADHD responded to a highly restrictive diet lacking colorings, preservatives, and certain food types. Millichap and Yee reached similar conclusions for so-called elimination diets that avoid common allergens such as nuts, dairy, and chocolate, as well as citrus fruits. "Studies have provided mixed opinions of efficacy," they noted. For both types of diet, the researchers pointed out, "a parent wishing to follow [them] needs patience, perseverance, and frequent evaluation by an understanding physician and dietitian." In another finding likely to raise eyebrows, if not hackles, Millichap and Yee concluded that only weak evidence supports the widespread belief that refined sugar promotes hyperactivity. Some effects on brain electrical activity have been documented, and reactive hypoglycemia following big jolts of sugary foods may account for behavioral changes seen in some ADHD children. But studies linking sugar consumption to ADHD have also been compromised by methodological problems. For example, one trial gave children sugar or placebo at breakfast with a high-carbohydrate cereal, which may have contributed to subsequent reactions to the sugar. Millichap and Yee cited a separate study that demonstrated when children ate a protein meal before or simultaneously with sugar, no hyperactivity reaction occurred. Still, the researchers conceded, the notion that sugar exacerbates ADHD has become so entrenched it may not matter whether it's true or not. "No controlled study or physician counsel is likely to change this perception. Parents will continue to restrict the allowance of candy for their hyperactive child at Halloween in the belief that this will curb the level of exuberant activity, an example of the Hawthorne effect. The specific type of therapy or discipline may be less important than the attention provided by the treatment," Millichap and Yee wrote. They also reviewed studies exploring the potential roles of zinc and iron deficiency in ADHD. The upshot is that there is currently little indication that such deficiencies explain more than a small minority of ADHD cases. Children with confirmed deficiencies should receive supplements or appropriate dietary adjustments regardless of their ADHD status. They were more impressed with the literature on polyunsaturated fatty acid supplements, especially the 2005 Oxford-Durham study. In that trial, several ADHD symptoms were significantly improved in children receiving omega-3 and omega-6 fatty acid supplements, "an effect duplicated in other...supplement trials," Millichap and Yee wrote. They acknowledged that not all studies have confirmed the result, and recent studies have used too many different methodologies to yield firm conclusions. Nevertheless, they indicated that they now recommend it to parents of their patients, though not as the sole treatment approach. "In almost all cases, for treatment to be managed effectively, medication is also required," they wrote. "The beneficial effects of omega-3 and omega-6 supplements are not clearly demonstrated." "Supplemental diet therapy is simple, relatively inexpensive, and more acceptable to patient and parent," Millichap and Yee concluded. "Public education regarding a healthy diet pattern and lifestyle to prevent or control ADHD may have greater long-term success." They suggested that diet-based interventions in ADHD are most appropriate when any of the following apply: Children suffer medication reactions or treatment failure. Parents or children want to try dietary modifications. Mineral deficiencies are evident. No external funding for the review was reported. The authors declared they had no relevant financial interests. Primary source: Pediatrics Source reference: Millichap J, et al. "The diet factor in attention-deficit/hyperactivity disorder" Pediatrics 2012; DOI: 10.1542/peds.2011-2199.

Unless you have a red flag indicating a specific risk, PSA testing for prostate cancer seems of little benefit and some new way of testing for the cancer in healthy populations will need to be devised.

No Mortality Benefit Seen from PSA Screening

By Charles Bankhead, Staff Writer, MedPage Today Published: January 06, 2012 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco. Prostate cancer screening with prostate-specific antigen (PSA) afforded no obvious prostate cancer mortality benefit during 13 years of follow-up in a large randomized trial. In fact, screened patients had a slightly higher prostate cancer mortality: 3.7 per 10,000 person-years, versus 3.4 for unscreened men. The results emphasize the need to find some means to identify patients who are most likely to benefit from PSA screening, said the first author of a report in the January issue of the Journal of the National Cancer Institute. "Routine mass screening of the population, purely on the basis of a man's age, is not going to be an effective way of reducing his chance of dying of prostate cancer," Gerald Andriole, MD, of Washington University in St. Louis, told MedPage Today.    "Having said that, that's not to say that no man should get PSA testing," he continued. "There are subsets of men in the population at large who do seem to stand a good chance of benefiting from PSA testing. "Those are men who are young, with no comorbidities, and generally very healthy. These are men with the longest life expectancy overall. They are men who, even if they harbor a nonaggressive, slow-growing cancer, are nonetheless expected to live long enough to die of prostate cancer in the absence of it being identified and treated." Screening also is reasonable for men who have an above-average risk of prostate cancer, such as African Americans and men with a strong family history of the disease, Andriole added. The data 0ffered nothing to change the conclusions of an earlier analysis of data from the same study, the National Institutes of Health-sponsored Prostate, Lung, Colorectal, and Ovarian (PLCO) screening program. After a median follow-up of seven years (up to as long as 10 years) the screened and unscreened groups had a similar prostate cancer mortality. The prostate cancer portion of PLCO involved 76,685 men who were ages 55 to 74 and cancer-free at enrollment. Study participants were randomized to annual PSA screening for six years or to usual care, which sometimes included "opportunistic" PSA screening. The initial report from the study showed a prostate cancer rate of 116 per 10,000 in the screened group compared with 95 per 10,000 in the control group. Prostate cancer mortality was 2 per 10,000 with screening and 1.7 per 10,000 in the control group. The current report showed that after a median follow-up of 13 years, cancer incidence was 108.4 and 97.1 per 10,000 in the screened and unscreened groups, respectively. The difference represented a statistically significant 12% increase in cancer incidence in the screened group (RR 1.12, 95% CI 1.07 to 1.17). Mortality was 3.7 and 3.4 per 10,000 with and without screening, respectively, a nonsignificant difference. "This article updates with more person-years of follow-up our previously reported finding of no reduction in mortality from prostate cancer in the intervention arm compared with the control arm to 10 years, with no indication of a reduction in prostate cancer mortality to 13 years," the authors wrote of their findings. Responding to the study, Otis W. Brawley, MD, chief medical officer of the American Cancer Society, acknowledged that the results are consistent with other studies that have pointed to a potential harm from overscreening and unnecessary treatment of indolent prostate cancer. "This trial does suggest that if there is truly an advantage to mass [PSA] screening it is small," Brawley said in a statement. Even so, the results do not rule out the possibility of a benefit in some high-risk men or the value of PSA screening in men who want the test, he added. "I truly believe that a man who is concerned about prostate cancer and understands that experts are not certain that screening saves lives, but it definitely causes anxiety and needless treatment, can reasonably choose to be screened," said Brawley. "A man who is more concerned with unnecessary diagnosis and treatment might reasonably choose not to be screened. It is an area that needs to be left to an informed patient." The PLCO trial is sponsored by the National Institutes of Health. Andriole disclosed relationships with Amgen, Augmenix, Bayer, Cambridge Endo, Caris, France Foundation, GenProbe, GlaxoSmithKline, Myriad Genetics, Steba Biotech, Ortho Clinical Diagnostics, and Viking Medical. Co-authors disclosed relationships with GlaxoSmithKline and Human Genome Sciences. Primary source: Journal of the National Cancer Institute Source reference: Andriole GL, et al "Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial: Mortality results after 13 years of follow-up" J Natl Cancer Inst. 2012; 104: 125-132.

Backing up claims often made by doctors of chiropractic, this latest study shows that manipulation and exercise are more effective in treating neck pain than is medication.

 

Spinal Manipulation, Home Exercise May Ease Neck Pain

Medication appeared least effective treatment in small study

By Serena Gordon HealthDay Reporter




MONDAY, Jan. 2 (HealthDay News) -- Spinal manipulation and home exercise are more effective at relieving neck pain in the long term than medications, according to new research.

People undergoing spinal manipulation therapy for neck pain also reported greater satisfaction than people receiving medication or doing home exercises.

"We found that there are some viable treatment options for neck pain," said Gert Bronfort, vice president of research at the Wolfe-Harris Center for Clinical Studies at Northwestern Health Sciences University in Bloomington, Minn.

"What we don't really know yet is how to individualize these treatments for each particular patient. All are probably still viable treatment options, but what we don't know is what each particular patient will need," Bronfort said, adding that it's possible a combination of treatments might be helpful, too.

Results of the study are published in the Jan. 3 issue of the Annals of Internal Medicine. Funding for the study was provided by the U.S. National Center for Complementary and Alternative Medicine.

Neck pain is an extremely common problem. About three-quarters of adults report having neck pain at some point in their lives, according to background information in the study. Neck pain is responsible for millions of health care visits each year, and it can have a negative impact on quality of life.

Spinal manipulation is one type of treatment that's offered for neck pain, and it can be administered by chiropractors, physical therapists, osteopaths and other health care providers, according to the study.

But, there isn't much evidence for treating neck pain with spinal manipulation. There also isn't a great deal of information on how effective medications or home exercise programs are for treating neck pain, the researchers noted.

Bronfort and colleagues thought that spinal manipulation might prove to be more effective than medications or home exercise therapy. To test their hypothesis, they recruited 272 people between the ages of 18 and 65 who had neck pain. Their neck pain had no known cause, such as a trauma or pinched nerve, and the patients been experiencing the pain for between two and 12 weeks when the study began.

The study volunteers were randomly selected for one of three treatment groups. One group received spinal manipulations over a 12-week period. Each individual was allowed to choose the number of spinal manipulations they felt they needed.

The second group received medications, both over the counter and prescription, depending on their needs. First-line medications included nonsteroidal anti-inflammatory medications or acetaminophen (Tylenol). If people didn't get relief from these drugs, narcotic pain medications and muscle relaxants were offered.

The third group was assigned two one-hour sessions of home exercise. The goal of the home-exercise program was to improve movement in the neck area. Participants were instructed to do the exercises six to eight times per day.

At the 12th week, 82 percent of people receiving spinal manipulation reported at least a 50 percent reduction in pain, compared with 69 percent of those on medication and 77 percent doing home exercises. Also at week 12, of people receiving spinal manipulation, 32 percent reported feeling a 100 percent reduction in pain, compared with 13 percent on medications and 30 percent doing home exercises.

At one year, 27 percent of those receiving spinal manipulation said they felt a 100 percent reduction in pain versus 17 percent of those on medications and 37 percent of those doing home exercises.

"For me, as an ER doctor, this study offers an interesting perspective," said Dr. Robert Glatter, an attending physician in emergency medicine at Lenox Hill Hospital in New York City. "It's a small study, but it found that home exercises and spinal manipulation were effective. So, should we be referring to physical therapists, osteopaths or chiropractors from the ER?"

"This study shows that basically neck pain will get better on its own," said Dr. Victor Khabie, chief of the departments of surgery and sports medicine at Northern Westchester Hospital in Mount Kisco, N.Y. "It would've been good if they had a no-treatment group, too," he added.

"Everyone heals differently. There are different pathways to healing, and whether you feel you're better off with chiropractic, home exercises or medications, this study shows that all three are basically just as effective. Whatever your pathway to healing, in about six to eight weeks, you should start to feel better," said Khabie.

He also noted that it's important for anyone receiving spinal manipulation to know that there are rare, but serious risks that can occur with neck manipulations.

All three experts said anyone experiencing neck pain needs to have it evaluated to make sure there isn't a serious or correctable cause of the pain. This is especially true if you've been in a car accident, or if you have any neurological symptoms, such as repeatedly dropping things, or if you have pain radiating down your arm.

More information
Learn more about neck pain, its causes and treatment from the U.S. National Library of Medicine.
SOURCES: Gert Bronfort, D.C., Ph.D., vice president and professor, research, Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn.; Robert Glatter, M.D., attending physician, emergency medicine, Lenox Hill Hospital, New York City; Victor Khabie, M.D., co-director, Orthopedic and Spine Institute, and chief, surgery, and chief, sports medicine, Northern Westchester Hospital, Mt. Kisco, N.Y.; Jan. 3, 2012, Annals of Internal Medicine
Last Updated: Jan. 03, 2012

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