Studies: Popular back treatment for elderly with osteoporosis no better than fake one
Back treatment for elderly no better than fake one
NEW YORK — A common treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure reveal.
Pain and disability were virtually the same up to six months later, whether patients had a real treatment or a fake one.
Tens of thousands of Americans each year are treated with bone cement, especially older women with osteoporosis, some of them stooped and unable to stand up straight. The treatment is so widely believed to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing.
“All of us who do the procedure have seen apparently miraculous cures,” said Dr. David F. Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also “miraculous cures” among those who got the fake treatments.
The researchers said it is yet another example of a medical procedure coming into wide use before good studies are done to show that it is safe and effective. Medicare pays $1,500 to $2,100 for the outpatient procedure.
Bone cement has long been approved for many medical uses, but this particular use had not been tested against a placebo procedure until now.
The findings, published in Thursday’s New England Journal of Medicine, mean patients and doctors need to review the options together, wrote Dr. James N. Weinstein of Dartmouth Medical School in an accompanying editorial. “When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential,” he said.
About 750,000 Americans suffer painful compression fractures in the bones of the spine each year. Bone-thinning osteoporosis is the most common cause. The weakened bone collapses or cracks, sometimes causing debilitating pain, limiting mobility and resulting in a loss of height or a stooped posture.
Doctors usually try bed rest, painkillers and back braces before turning to vertebroplasty (pronounced vur-TEE-broh-plas-tee). During the procedure, hot bone cement is injected into the collapsed or cracked vertebra. The cement is thought to shore up or stabilize the compressed bone. There can be complications, including infection and leakage of the cement.
Bone cement was first used for spinal fractures in the U.S. in the 1990s, and Kallmes said it quickly became routine because there were few good options. The rate of Medicare-paid procedures nearly doubled from 2001 to 2005. Now there are about 80,000 procedures done in the United States each year, Kallmes said.
The Mayo-led study involved 131 patients at medical centers in the U.S., Britain and Australia. The second study enrolled 78 patients in Australia. The patients, mostly women with fractures from osteoporosis, were randomly assigned to get the cement injection or a fake treatment. On average, they were in their mid-70s.
Neither the patient nor the person who evaluated them knew which treatment they got.
All participants first got local anesthesia to numb their backs. For the fake treatment, doctors simulated the cement injection by pressing the back, tapping instruments and having the strong-smelling cement on hand.
The patients were questioned periodically afterward about their pain, mobility and other measures — up to six months in the Australian study and one month for the Mayo-led study. The results were similar in both tests.
“Both treatment groups improved, it’s just that they improved by about the same amount,” said study leader Dr. Rachelle Buchbinder of Cabrini Hospital in Melbourne, Australia.
The researchers do not know why people felt better, but suggest it could be due to the anesthesia, the placebo effect or that the fractures healed on their own over time. Kallmes said the procedure may work in a few patients, and that more research is needed to figure out who might benefit.
Kallmes, who’s been doing the procedure for 15 years, said he has revamped his practice so that most patients are enrolled in new studies of the procedure. Buchbinder, who treats patients with back pain, said she no longer recommends it.
The Mayo-led study was funded by the National Institutes of Health; some of the researchers have received fees or grants from drug makers and medical equipment companies. The Australian study was also mostly government funded; a medical cement maker provided the cement and some funding.
On the Net:
New England Journal: www.nejm.org
Filed under Government, Health, Human Welfare, Politics, Society | Tags: Australia, Australia And Oceania, Diseases And Conditions, Government Programs, Government-funded Health Insurance, New York, North America, Seniors' Health, United States | 3 Comments
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August 6th, 2009 at 5:56 am
The ‘innovative’ idea of a ‘pay for value / outcome’ pack came after the CBO had previously pointed out this health care reform wouldn’t work without ‘fundamental’ change in the out of date system. It is said that as much as 30 percent of all health-care spending in the U.S. -some $700 billion a year- may be wasted on tests and treatments that do not improve the health of the recipients, and this 700 billion dollars a year can cover a lot of uninsured people.
The expected Benefits of this ‘innovative idea’ are as follows ;
1. Meet the objective of revenue-neutral.
Supporters of the agreement say it could save the Medicare System more than $100 billion a year and ‘improve’
care, that means more than $1trillian over next decade, and virtually needs no other resources including tax on the
wealthiest. Supposedly even the ‘conservative’ number of such savings might be able to meet the objective of
revenue-neutral.
2. Quality and affordability.
If you are a physician, and your pay is dependant upon your patient’s outcome, you will most likely strive to
prescribe the best medicine earlier in the process, let alone skipping the wasteful, unnecessary treatments.
3. No intervention in decision-making.
The innovative idea of ‘a pay for outcome’ will more likely prompt team approach and decision, as at Myo clinic.
Under the ‘pay for outcome’ pack, for good reason, best practices as ‘recommendations’ would simply help them
make a better decision, and the government won’t still have to meddle in the final, actual decision-making
process as a non-expert.
4. Speed up the introduction of IT SYSTEM.
The pay for ‘Outcome’ pack is most likely to expedite the introduction of Health Care IT SYSTEM.
The synergy effect of the combined Health Care IT & a pay for ‘outcome’ system may allow the clinicians to
‘correctly’ diagnose and effectively treat a patient earlier in the process so that it can measurably scale back the
crushing lawsuits and deter the excuse for unnecessary cares to make fortunes.
5. Accelerate the progress in medical science, in return, it saves more cash.
6. Settle the regional disparity.
7. Reduce the emergency room visits & save immense costs.
Public health insurance plans such as Medicare and Medicaid paid for more than 40 percent of U.S. emergency
room visits in 2006, according to government figures released recently. Many experts say reducing these hospital
visits would be an important way to lower the enormous, and growing, expense of U.S. health care.
I share the opinion that unlike the insurer-friendly senate plan by ’some’ members, only a strong public option will be capable of getting the premium inflation under control and saving the U.S in turbulence.
To my knowledge, a dual system tends to deliver better results than a pure single payer system. Supposedly, to be or not to be might be up to the innovations like a pay for value program, otherwise, the forthcoming start-ups may fill the void with competitive deals. The competition based on ‘fair’ market value would be a beauty of true capitalism, not monopoly, an objective for anti-trust.
Thank You !
August 6th, 2009 at 11:25 pm
I injured my back helping carry a heavy machine down a fire escape 1n 1998. (It took me 10 minutes to get off a chair for a fortnight afterwards). It left me with Sciatica. I was 50 years old. The best relief exercise I found was laying belly on floor and arching back up to look at the ceiling (a classic Sciatica exercise). I couldn’t afford to stop working.
August 6th, 2009 at 11:34 pm
(continued) I could not afford to stop working. I humped 56lb bags of potatoes in a supermarket, I thought this would kill my back, instead it helped it get better. The Sciatica subsidded. (I always lifted the sacks the correct way, legs bent, etc.)
Now I work as an axiliary nurse shifting heavy patients up beds etc. I find that the vigorous work exercise has got rid of the back pain.Good luck!