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Posts Tagged ‘arthritis’

Wrist Splints Work For Thumb Arthritis

Posted by medconsumers on June 1, 2009

People with osteoarthritis at the base of the thumb are often told to wear a thumb splint to ease symptoms. The first study to test this advice found it to be effective for many people. It was published recently in Annals of Internal Medicine by a French team of researchers led by Francois Rannou, MD.

The 112 participants were mostly women, who were randomly assigned to wear custom-made splints at night or to continue with their usual care, which could include anti-inflammatory drugs and steroid injections but no splints. Dr. Rannou and colleagues found that nighttime splinting had no effect at one month, when all the participants were asked about their pain levels and hand function.

At 12 months, however, larger improvements in pain scores and hand function were reported for a greater proportion of the people wearing nighttime splints, compared to those who continued their usual care. At 12 months, 86% of the people assigned to wear a splint reported wearing it more than 5 nights a week.


Maryann Napoli, Center for Medical Consumers(c) June2009

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Arthroscopic Surgery for Knee Arthritis

Posted by medconsumers on October 1, 2008

Arthroscopic surgery is no better than conservative treatment for people with knee osteoarthritis. This was shown in a 2002 clinical trial, and now a new trial has produced the same result. Will it change anything? Will people be told that surgery provides no advantage over drug treatment and physical therapy? Are there any exceptions?

These are just a few of the questions raised by two studies published in The New England Journal of Medicine. The backstory for their findings are the advances in fiberoptics and instrumentation that have made knee procedures much easier and safer to perform than an open-incision operation. And advances in imaging, specifically MRI scans, can mislead doctors into seeing a tear in the knee cartilage as reason enough to perform surgery for someone with knee pain. Add the lack of any requirement for scientific proof that an operation is effective before it becomes widespread. And what Americans get as a result is a lot of unnecessary knee surgery.

Sometimes referred to as “keyhole surgery,” arthroscopic surgery involves a small incision in the knee, which is inflated with fluid under pressure with a pump. This allows the surgeon to work through an arthroscope, flushing out material (lavage), such as cartilage fragments, and scraping the rough surfaces of the arthritic knee joint to remove debris (debridement).

The new trial randomly assigned 178 men and women to receive the operation or conservative treatment alone. All were treated at a sport medicine clinic at the University of Western Ontario, Canada; all had moderate-to-severe osteoarthritis of the knee. All, including those assigned to surgery, received 12 weeks of physical therapy, drug therapy advice, and were free to try any other non-surgical treatments, such as lubricant or steroid injections.

At two years of follow-up, the Canadian researchers concluded, “The people assigned to arthroscopic surgery were no more likely to improve with respect to physical function, pain, or health-related quality of life than were those assigned to the control group [no surgery].” The Canadian Institutes of Health Research funded this trial.

Its findings should settle a controversy that followed a 2002 American trial that also found knee surgery offered no advantage over the usual non-surgical care. Although many people experienced symptom relief after knee surgery, some orthopedic surgeons had long suspected that the operation did not work. In one of a few clinical trials to show that surgery can have a placebo effect, researchers at the Veterans Affairs Medical Center, Houston, TX, randomly assigned 165 men with knee arthritis to receive either knee surgery or a sham procedure.

Those assigned to the sham procedure were taken to the operating room, lightly sedated and given an incision similar to the one made during arthroscopic surgery. This allowed all participants to remain unaware of their actual treatment until two years later—after they had had their symptoms and knee function regularly assessed. Those given the sham procedure had the same level of pain relief and physical function as those given surgery. Whether this study led to a decline in knee surgery is unknown because there is no national system for keeping track.

Predictably, many orthopedic surgeons rejected the 2002 findings, charging that the trial was flawed. For example, only one surgeon had performed all the operations and the participants were all men who were older than the typical knee surgery patient. The Canadian trial was designed specifically to overcome these and other criticisms.

MRI of the Knee

Another study published in the same issue of The New England Journal of Medicine found that a tear in the knee cartilage is present on a MRI scan of most middle-aged and elderly people who have no knee symptoms. This finding has major implications because doctors often order magnetic resonance imaging for people with knee pain of unknown cause. And when a tear in the knee cartilage (meniscus) is found, it is often assumed to be the cause, especially in people with knee osteoarthritis. Repair of the meniscus, which is the small portion of the cartilage that helps stabilize the knee, is a common reason for arthroscopic knee surgery. (About 80% of the people in the Canadian trial had degenerative meniscal tears.)

The MRI study participants were living in Framingham, Massachusetts, when they were randomly selected from census data and random-digit telephone dialing. MRI scans were performed on the right knee of 991 male and female participants. All were asked to fill out questionnaires about possible knee symptoms. Of the participants who reported “knee pain, aching or stiffness on most days,” 63% had meniscal tears on the MRI. Of those who reported no knee problems, 60% showed meniscal tears on the MRI.

In an editorial that accompanied this MRI study and the Canadian trial, Robert G. Marx, MD, observed that the latter had excluded people with large meniscal tears from participation because there still is a role for knee surgery for this injury. In a telephone interview, Dr. Marx, an orthopedic surgeon at New York City’s Hospital for Special Surgery, was asked how a “large” meniscal tear is determined and how the consumer would know whether it is large enough to warrant surgery. “It’s not so simple,” he responded. “It is determined by the surgeon who takes all variables into consideration, such as the patient’s history, the physical exam, the x-ray and the MRI before recommending surgery.”

A co-author of the Canadian trial, Brian G. Feagan, MD, University of Western Ontario, strongly disagreed with Dr. Marx’s diagnostic advice but was in total agreement that large meniscal tears require surgery. “Large meniscal tears are not difficult to diagnose with a physical examination because the patient will have substantial locking of the knee,” said Dr. Feagan in a telephone interview. “It is usually seen in younger people with sports injuries and you you don’t need an MRI scan. No one would deny that surgery is effective for people with locking of the knee due to a large meniscal tear, but the vast majority of people do not have large tears, they get meniscal tearing, which is actually meniscal degeneration.”

Referring to the MRI study, which was published along with his arthroscopic surgery trial, Dr. Feagan emphasized, “That study showed that there is no correlation between those small tears seen on an MRI scan and clinical symptoms, so it doesn’t make sense to repair them because they don’t cause any symptoms in the first place.”

Asked for the take-home message of his study, Dr. Feagan replied, “The majority of the patients with mild to moderate osteoarthritis of the knee will do reasonably well with drug therapy and physiotherapy. And total knee joint replacement is excellent for people with severe disease.”

Maryann Napoli, Center for Medical Consumers ©

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Hip and Knee Replacement: Low Rate of Repeat Surgery

Posted by medconsumers on October 1, 2008

Hip & Knee-Replacement Surgery: Need for Reoperation within Three Years is Extremely Low

People facing hip- or knee-replacement surgery might want to know whether there’s a success rate that can be checked beforehand. The National Joint Registry for England and Wales has provided just such information. It differs from the type of information generated by clinical trials, most of which take place in academic medical centers. The latter represents surgery performed under the best of circumstances, whereas registries provide information about surgery as it is performed in the real world.

In this case, the real world is England’s National Health Service between 2003 and 2006 when more than 150,000 people underwent hip or knee replacement. Nokuthaba Sibanda and colleagues of the London School of Hygiene and Tropical Medicine used the National Joint Registry to determine the rates of revision, or reoperation, within the first three years after surgery. Their findings were reassuring because the need for revision was low for both procedures. Overall, one in 75 people required revisions within three years of surgery.

Partial Replacement

When the researchers broke things down according to age, gender and different types of operative techniques, they found that those who underwent a newer technique called hip resurfacing were more likely to need another operation than people whose hips were fully replaced and cemented (3% vs. 0.9%).

Similarly, people who underwent unicondylar knee replacement, which replaces only half of the knee joint, also did not fare as well as the people whose knee joints were fully replaced. (For both unicondylar knee replacement and hip resurfacing, only the diseased parts of the joint are replaced, if the damage is limited to one component of the joint.) The revision rates were slightly higher for women who underwent unicondylar or hip resurfacing procedures. Additionally, the need for revision after knee replacement “strongly decreased with age.”

Sibanda and colleagues concluded that hip resurfacing should be performed only in men and unicondylar knee replacement only in elderly people. This conclusion was challenged soon after the study was published in the Public Library of Science Medicine, a peer-reviewed open-access online medical journal.

Conclusion Challenged

The conclusion that people fare worse after hip resurfacing and unicondylar knee replacement was called “misleading” and “erroneous” by Justin P. Cobb, professor of orthopaedic surgery, Imperial College, London. In a letter to the editor of the British Medical Journal, which had published a short report about the registry data analysis, Professor Cobb cites two studies to support his contention that partial replacement procedures provide better results.

The lower rate of complications after unicondylar knee replacement was established nearly 10 years ago with data from the Swedish registry, wrote Professor Cobb, “Total replacement is not more successful, just harder to revise.” There is a substantial group of people who not entirely happy with their total knee replacement result, he explained, “yet they choose not to undergo reoperation because revision of a total knee is a huge undertaking, while revising a partial knee [unicondylar] is a relatively simple affair.”

In response to an e-mail request for more explanations, Professor Cobb wrote that the registry analysis implies that any reoperation is equivalent to failure. “Of course any reoperation is an event best avoided, but the type of reoperation and the function following it are essential pieces of information,” he wrote. “Given the choice of lumpectomy or mastectomy, most women would accept a risk of one in 30 of having a second operation, if that meant a 29 out of 30 chance of saving a breast. So it is with partial knee replacement. If there’s a one in 30 chance of having your entire knee cut out and replaced, but a 29 in 30 chance of saving two-thirds of the joint and all the ligaments, then most would choose the conservative option.”

And what about hip resurfacing? “There does appear to be a higher failure rate for resurfacing among women,” responded Professor Cobb, “but the causes of that failure are still far from certain, and function following the more conservative operation of hip resurfacing does appear to be superior to that experienced when the entire hip is excised.”

Maryann Napoli, Center for Medical Consumers ©

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Comparison of Arthritis Drugs

Posted by medconsumers on August 1, 2007

A Comparison of Drugs for Osteoarthritis

People with osteoarthritis are often in chronic pain and that usually means long-term use of non-steroidal anti-inflammatory drugs, or NSAIDs*. To help them weigh the risks and benefits of these drugs, the U.S. Agency for Healthcare Research and Quality has issued a report on its Web site. It concluded that all NSAIDs—both over-the-counter and prescription—“present similar, increased risks of heart attacks while offering about the same level of pain relief.” There is, however, a notable exception: Naproxen (Aleve, Naprosyn) does not increase the chance of a heart attack. Conversely, Celebrex is associated with a higher risk of heart attack than the other NSAIDs.

The report drew upon the best research findings for both prescription and non-prescription NSAIDs, but did not include information about prescription opiate medications like morphine, Tylenol-3, and Vicodin.

*All the oral drugs mentioned in this article are NSAIDs. The exception is acetaminophen (Tylenol) which is a pain reliever with no anti-inflammatory effects.

Here are the highlights:

Mild Pain:

  • Acetaminophen (Tylenol) works on mild pain and has fewer risks than other pain pills.
  • There were mixed results for topical drugs. Skin creams, like Theragen or Zostrix, can help with mild pain, but half the people using this product, which has fewer risks than NSAIDs, experience a burning sensation that diminishes over time. Salicylate skin cream, such as Aspercreme and Bengay Arthritis, does not work for osteoarthritis pain.

Moderate to Severe Pain:

  • The popular dietary supplements glucosamine hydrochloride (1500 mg a day) plus chondroitin sulfate (1200 mg a day) can reduce moderate to severe pain without serious side effects, but this combination has no effect on mild pain. Keep in mind, though, that the FDA does not regulate these or any other supplements, so the quality will vary.
  • Celebrex relieves pain just as well as the other NSAIDs, but this drug also comes with a higher risk of heart attacks. All NSAIDs, like ibuprofen (Motrin, Advil), naproxen (Aleve) or aspirin, will reduce pain but can also cause stomach bleeding. Lower your risk by taking the lowest dose for the shortest time possible. But even at low doses, aspirin can cause stomach bleeding.

High Doses

  • Ibuprofen (Motrin) in high doses (800 mg three times a day) and diclofenac (Voltaren) in high doses (75 mg twice a day), respectively, can increase the risk of heart attack. For other oral NSAIDs, there are no comparative studies regarding heart risks to make reliable judgments.
  • Naproxen, even at high doses (500 mg twice a day), does not increase the risk of heart attack.

The Most Common Serious Risk

All NSAIDs, including aspirin, block enzymes that protect the stomach. This can cause stomach bleeding.

There are no studies to help you determine how long you can take NSAIDs without bleeding. Generally speaking, stomach bleeding is more likely for people taking NSAIDs who are older, especially more than 75 years old; take higher doses; use NSAIDs for a longer time; or also take medicine to help prevent blood clots, like aspirin or warfarin (Coumadin).

Celebrex has a lower risk of bleeding than other NSAIDs only if taken short term (unfortunately this report does not define short term). However, adding daily aspirin therapy (even at a low dose) to chronic use of Celebrex will either reduce or negate any protective benefit.


Risk of Stomach Bleeding Rises with Age

For people age 16-44:

5 out of 10,000 people taking NSAIDs will have a serious bleed

1 out of 10,000 people taking NSAIDs will die from a bleed

For people age 45-64:

15 out of 10,000 people taking NSAIDs will have a serious bleed

2 out of 10,000 people taking NSAIDs will die from a bleed

For people age 65-74:

17 out of 10,000 people taking NSAIDs will have a serious bleed

3 out of 10,000 people taking NSAIDs will die from a bleed

For people age 75 or older:

91 out of 10,000 people taking NSAIDs will have a serious bleed

15 out of 10,000 people taking NSAIDs will die from a bleed

For More Information

Go to Agency for Healthcare Research and Quality (http://effectivehealthcare.ahrq.gov/reports). Scroll down to “Muscle, Bone and Joint Conditions” and click into “Choosing Pain Medicine for Osteoarthritis”. The physicians’ version of the same report is also available. Both have an excellent section listing the comparative prices of a one-month supply of brand and generic versions of all the drugs mentioned in the report. For free print copies call (800) 358-9295 and ask for AHRQ Publication Number: 06(07)-EHC009-2A.

, and colleagues at two European medical centers. They found nine trials had produced enough information to pool results and come to a conclusion about the effectiveness of acupuncture for arthritic knee pain.

All nine trials had some sort of comparison group against which the effects of acupuncture could be measured. The comparator was either a sham procedure (i.e., needles placed away from the traditional points), or usual care (e.g., anti-inflammatory drugs), or time spent on a waiting list for acupuncture treatment. All trials had randomly assigned participants to receive one of these treatments or acupuncture for at least six weeks. Randomly assigned means that the participants cannot choose their treatment.

Acupuncture showed moderate to large benefits in the trials that compared it with usual care or waiting list, and small benefits in the trials that compared it with a sham procedure. Significantly, acupuncture showed little to no benefit in the two trials that compared it with a sham acupuncture procedure that was clearly indistinguishable to the participants from the true acupuncture.

The analysis of all nine trials suggested that the more likely participants knew or suspected they were getting real acupuncture, the more likely they were to report a benefit. This led Manheimer and colleagues to conclude that placebo effects are mostly responsible for the benefits of acupuncture.

In a telephone interview, Eric Manheimer mentioned the importance of trials that not only had sham acupuncture as a comparator but had also tested the credibility of the sham procedure. This means that after the trial is over, the investigators asked the participants if they knew whether were getting the real or the sham acupuncture, explained Manheimer, and the participants could not distinguish between the two procedures.

But things are even more complicated because the sham acupuncture can involve intensive needling, Manheimer continued, “and this insertion of needles, even if they are not in the right place and even if it’s just superficial, may have some physiological or biological effects.” He suspects that this could partly explain why there was no difference between the effect of sham and real acupuncture in the two trials that used a particularly intensive version of fake needling.

Despite the finding that much of the benefit of acupuncture appears to be due to patients’ expectations, Manheimer and colleagues concluded that acupuncture “seems to have a genuine biological effect suggested by the small short-term improvements in pain and function shown in the trials compared with sham.” In addition, no adverse effects were reported in the trials, which is more than can be said about the painkillers.

“Like acupuncture, many prescription painkillers have benefits that are too small to be meaningful to patients,” said Manheimer. “Given the limited treatment options available for patients with arthritis and the possibility of a slight short-term benefit of acupuncture, some might consider acupuncture as one treatment option in a multidisciplinary approach to treating knee osteoarthritis.

Maryann Napoli, Center for Medical Consumers ©
August 2007

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Acupuncture for Knee Pain

Posted by medconsumers on August 1, 2007

Strong Placebo Effect

How good is acupuncture at alleviating the pain of knee osteoarthritis? Studies have attempted to answer this question, but results are mixed. One solution is an analysis of all the highest quality trials on the topic. The results, published recently in Annals of Internal Medicine, say more about the power of the placebo than any substantial painkilling effect of acupuncture and may be disappointing to anyone looking for a safe alternative to drugs.

The new analysis was conducted by Eric Manheimer, University of Maryland School of Medicine, Baltimore, and colleagues at two European medical centers. They found nine trials had produced enough information to pool results and came to a conclusion about the effectiveness of acupuncture for arthritic knee pain.

All nine trials had some sort of comparison group against which the effects of acupuncture could be measured. The comparator was either a sham procedure (i.e., needles placed away from the traditional acupuncture points), or usual care (e.g., education and anti-inflammatory drugs), or time spent on a waiting list for acupuncture treatment. All trials had randomly assigned participants to receive one of these treatments or acupuncture for at least six weeks. The phrase randomly assigned means that the participants cannot choose their treatment.

Acupuncture showed moderate to large benefits in the trials that compared it with usual care or waiting list, and small benefits in the trials that compared it with a sham procedure. Yet acupuncture showed little to no benefit in the two trials that compared it with a sham acupuncture procedure that was clearly indistinguishable to the participants from the true acupuncture. The analysis of all nine trials suggested that the more likely participants knew or suspected they were getting real acupuncture, the more likely they were to report a benefit. This led Manheimer and colleagues to conclude that placebo effects are perhaps mostly responsible for the benefits of acupuncture. In a telephone interview, Eric Manheimer mentioned the importance of trials that not only had sham acupuncture as a comparator but had also tested the credibility of the sham procedure. This means that after the trial is over, the investigators asked the participants if they knew whether they were getting the real or the sham acupuncture, explained Manheimer, and they could not distinguish between the two procedures.

But things are even more complicated because the sham acupuncture can involve intensive needling, Manheimer continued, “and this insertion of needles, even if they are not in the right place and even if it’s just superficial, may have some physiological or biological effects.” He suspects that this could partly explain why there was no difference between the effect of sham and real acupuncture in the combined results of the two trials that used a particularly intensive version of fake needling.

Despite the finding that much of the benefit of acupuncture appears to be due to patients’ expectations, the researchers were not closing the door on it. Manheimer and colleagues concluded that acupuncture “seems to have a genuine biological effect suggested by the small short-term improvements in pain and function shown in the trials compared with sham.” In addition, no adverse effects were reported in the trials, which is more than can be said about arthritis drugs.

“Like acupuncture, many prescription painkillers have benefits that are also probably too small to be meaningful to patients,” said Manheimer. “Given the limited treatment options available for patients with arthritis and the possibility of a slight short-term benefit of acupuncture, some might consider acupuncture as one treatment option in a multidisciplinary approach to treating knee osteoarthritis.”

Maryann Napoli, Center for Medical Consumers ©
August 2007

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Our View of the FDA Hearings on Vioxx, Bextra and Celebrex Safety

Posted by medconsumers on April 1, 2005

A Consumer Advocate at the FDA

February saw an unprecedented three-day FDA advisory committee meeting of outside experts called to consider the fate of the blockbuster arthritis drugs, Vioxx, Celebrex and Bextra. Vioxx was suddenly withdrawn by its maker Merck last September because it was found to increase the risk of heart attack and stroke. Although similar concerns about Celebrex and Bextra were confirmed in studies published early in 2005, their maker, Pfizer, decided not to withdraw the drugs.

Despite the growing evidence of life-threatening adverse reactions, a majority of the combined Arthritis Drug and Drug Safety and Risk Management Advisory Committees (I am a member of the latter) advised the FDA that all three brands were safe enough to remain on the market. Perhaps the most unexpected outcome was the committee’s vote (17 to 15) for the return of Vioxx. The group voted to keep Bextra on the market by almost as slim a margin. But Celebrex received a resounding 31 votes in favor of continued availability. I cast the lone vote against that drug remaining on the market.

My vote against Celebrex (as well as Bextra and Vioxx) was based on my conclusion from the available evidence that the increased risk of heart attack and stroke was probably a class effect* – meaning that any drug whose action is similar to Vioxx was likely to present similar risks. This was confirmed, by the way, in our discussions by many of my fellow panel members. I thought the committee’s vote bordered on the irrational given the general agreement that serious cardiovascular risks could be expected with all three drugs.

The committee members were obviously impressed by the emotional power of the patient anecdotes– more than 40 patients testified that one or another of the three drugs were the only treatment that brought relief. And, the rheumatologists on the committee for the most part argued (using anecdotal experience as well) that these drugs should remain available because they worked in some patients when all else failed. But, in fact, there is no scientific evidence that Vioxx, Celebrex or Bextra are any more effective in relieving pain than the older drugs taken for arthritis pain.

Perhaps more ominous than the fact that the anecdotes apparently trumped science in the voting, was the revelation after the meeting that a third of the advisory committee members had troubling conflicts of interest. This raised the specter that financial ties to industry, especially Merck and Pfizer, might have influenced the committee’s votes on Bextra and Vioxx.

Prior to the meeting, the newly appointed Secretary of Health & Human Services, Michael Leavitt , and the FDA Commissioner-nominee, Dr. Lester Crawford, assured the public that the agency would be more transparent in the future. Yet the FDA knowingly included scientists and physicians with direct conflicts of interest in the February advisory committee process. And, adding insult to injury, the FDA chose to forgo publically identifying the conflicted committee members. Normally the agency presents a conflict of interest statement at the start of each advisory committee session which identifies conflicted members. The statement also specifies the nature of their conflict, including the dollars involved, and declares whether the member has been granted a waiver to participate or has been recused . For this meeting, the agency inexplicably concluded that, because the discussion was not about a drug approval, such transparency was unnecessary.

Congress continues to draft legislation to deal with FDA’s shortcomings. What is needed is real reform – not marginal changes that are more scenic than substantive. The Center for Medical Consumers, working with other national consumer and patient advocacy organizations, is trying to make sure that whatever legislation is passed will meaningfully improve the ability of the FDA to protect the public from harm. To be effective, Congress must provide more money and grant more legal authority for the FDA to monitor and enforce drug safety. Congress should also insist that the agency’s decision-making be completely transparent to the public it serves.

* Older arthritis drugs, such as ibuprofen and naproxen, are not included in this class because they have a somewhat different action.

Arthur A. Levin, MPH, Center for Medical Consumers ©, April 2005.

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Osteoarthritis Treatments

Posted by medconsumers on May 1, 2003

By Maryann Napoli

There is no effective treatment for osteoarthritis (OA), a chronic degenerative joint disease that afflicts most people to some degree by the time they reach the age of 70. A wide range of options, however, are available to people looking for symptom relief. Most of the OA studies have concentrated on the hip and knee, the weight-bearing joints most likely to cause pain and disability.

Exercise:
People with knee OA can benefit from exercise, in terms of pain relief and improved function, according to a review of 17 studies conducted by the Cochrane Collaboration (see below). Of the combined total of 1,492 people who participated in the studies, those doing some form of exercise, be it walking or muscle-strengthening exercises, were better off than those who did not. However, the effect of exercise overall was found to be quite small. The reviewers did not find enough good quality studies to determine a benefit to people with hip OA.

After this Cochrane Review was completed, a newly published study called into question the standard thigh-muscle strengthening advice given to people with knee OA ( Annals of Internal Medicine , 4/15/03). It found that quadriceps muscle strengthening might actually be counterproductive to people whose knees are misaligned or unusually loose. Leena Sharma , MD, and colleagues at Northwestern University, Chicago, followed 230 people with knee arthritis who experienced difficulty with knee-related activities After 18 months the x-rays showed that OA progressed in the people with greater quadriceps muscle strength. Worsening of arthritis was defined as more joint space narrowing on knee x-rays. These results do not mean that exercise is bad for people with knee OA, only that the muscle-strengthening regimen for those with misaligned or loose knee joints might be reconsidered. This study did not assess the participants’ symptoms.

Drugs:
In the March 2003 issue of Current Opinion in Rheumatology, Bischoff and Roos noted that exercise will provide a “small to moderate benefit” in terms of pain and improved function to people with hip and/or knee arthritis. And the “small to moderate benefit,” they wrote, also applies to the non-steroidal anti-inflammatory drugs (NSAIDs) commonly prescribed for osteoarthritis. NSAIDs encompass a wide range of popular over-the-counter and prescription drugs, including aspirin, Ibuprofen, Motrin, Naprosyn, Mobic, Celebrex, and Vioxx.

Acetaminophen (Tylenol) used to be singled out as the most effective OA drug, but a recent review found NSAIDs to be superior to acetaminophen in reducing pain and overall disease activity. The review conducted by the Cochrane Collaboration involved six randomized controlled trials; it also found NSAIDs were not better than acetaminophen in improving joint function. And there is no consistent evidence to show that any one NSAID stands out among the rest. A survey, published in 2000, found that most people take many different drugs for OA. The majority found a NSAID to be more “helpful” than acetaminophen, though many reported taking a NSAID and acetaminophen.

All NSAIDs and acetaminophen (in high doses) are associated with gastrointestinal bleeding which accounts for an estimated 70,000 hospitalizations and 10-15,000 deaths each year in the U.S. Only one in five people who develop this adverse reaction will have symptoms in advance. Gastrointestinal bleeding occurs in 1% of everyone who takes NSAIDs for three to six months, and in 2-4% of those taking NSAIDs for one year. The risk increases accordingly in those who take the drugs for longer periods of time.

The newest, most expensive NSAIDs—Celebrex, Vioxx, Bextra, which are from a drug class called COX-2 inhibitors—are no more effective as painkillers than other NSAIDs, though they may lower the risk of gastrointestinal reactions. The Food and Drug Administration (FDA) ruled that uncertainties remain about this advantage because many of the study participants in the pre-approval trials were not representative of the people who typically take NSAIDs. For example, 40% of the participants in the Celebrex studies had an endoscopic examination that ruled out the presence of ulcers prior to participation. Also, many of the study participants taking COX-2 inhibitors were also taking low doses of aspirin to prevent heart attacks, thereby reducing any stomach-protective benefit. Elderly people, particularly those who are debilitated, and those with ulcers should not take these drugs for OA, nor should anyone with heart disease.

Most NSAID studies pit a drug against a placebo and follow people only about 12 weeks. Some have compared a COX-2 inhibitor with another NSAID and have found their pain-relief benefit to be equivalent. In one Vioxx study, however, the people taking COX-2 inhibitors had twice the rate of heart attacks as those taking Naproxen.

Glucosamine:
Glucosamine is a natural substance classified by the FDA as a dietary supplement, which means that it is available over-the-counter without the safety and efficacy testing required of drugs. Furthermore, there is no quality control so consumers cannot count on the supplement containing the ingredients or the amount listed on the label. Studies conducted with glucosamine in standardized doses show that it is safer than OA drugs and just as effective in alleviating pain. Most intriguing, glucosamine appears to slow the progression of OA.

The Cochrane Collaboration reviewed 16 randomized, controlled trials ( RCTs ) and evaluated the effectiveness and safety of glucosamine for people with OA. In 13 RCTs in which glucosamine is compared to a placebo, glucosamine was found to be superior in all but one trial. In the four RCTs in which glucosamine was compared to a NSAID, glucosamine was found to be superior in two and equivalent in two. This review concluded that further research is needed to confirm the long-term effectiveness and safety of glucosamine. Few of the RCTs lasted more than six weeks. Glucosamine appears to be far safer than NSAIDs and acetaminophen—based on the mostly short-term results of these RCTs .

One RCT in this review found that the people taking a placebo showed a progressive joint-space narrowing that did not occur among those taking glucosamine. Symptoms worsened slightly in the placebo group, but the significant lessening of pain and disability was sustained for three years among those taking glucosamine.

Ultrasound, Electromagnetic Fields, etc.:
Electrical stimulation therapy had a small to moderate effect on knee OA, according to three studies with a total of 259 people who had been randomly assigned to this treatment or a placebo. Transcutaneous electrical nerve stimulation, also known as TENS, was shown in seven trials to provide significant improvement in knee stiffness and pain relief. Ultrasound therapy had no benefit over placebo or short wave diathermy in three clinical trials.

Herbal Medicine:
The Cochrane Collaboration conducted a review of the evidence for herbs and plant substances and found two studies that showed avocado/soybean oil extract had beneficial effects on joint function, pain, and reduced need for NSAIDs, and general well-being. The symptomatic relief persisted even after discontinuation. Results were better with hips than knees. The former involves more chronic and continuous inflammation and pain, whereas the latter is more likely to consist of flare-ups. Avocado/soybean extract is sold as a dietary supplement in the U.S. under the brand name of AvoFlex .

Rub-on Creams:
Rubbing liniment, such as capsaicin cream, into the skin around the joint will stimulate blood flow and create warmth, which may temporarily reduce pain and improve function.

What is the Cochrane Collaboration?
The Cochrane Collaboration is an international network of over 6,000 researchers, epidemiologists, physicians, consumer advocates, scientists, and statisticians in over 60 countries. Most are based at universities and medical centers. Their work is divided into review groups, according to topic (e.g., breast cancer, pregnancy and childbirth, complementary medicine).

Each review group conducts systematic reviews of all available research on a specific treatment, such as “Glucosamine Therapy for Treating Osteoarthritis.” The goal is to help doctors and consumers make informed decisions by answering the question: Is there high-quality evidence to show that this treatment is effective and safe?

Most of the information in this article came from the Musculoskeletal Review Group whose Web site (www.cochranemsk.org) offers free access to summaries (abstracts) of existing reviews intended for health professionals. For more consumer friendly summaries, go to www.cochraneconsumer.com to read Cochrane abstracts on a range of medical topics.

Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
May 2003

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