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Does viscosupplementation for knee osteoarthritis in seniors really do the job?

Viscosupplementation Recommended For Appropriate Patients with Knee Osteoarthritis

Our Review Summary

knee painThis news release from the American Medical Society for Sports Medicine (AMSSM) describes a therapy called viscosupplementation that involves injecting hyaluronic acid, a gel-like fluid, that acts as a lubricant to alleviate pain in people with knee osteoarthritis. In this case the target audience is senior citizens.

Because the subhead of the release describes it as a “New Scientific Statement” the ASSM might be forgiven for the medical jargon used throughout the release. This clearly wasn’t written for the general public. For example, the release doesn’t explain the term “viscosupplementation,” which is what this release is promoting. We hope health journalists take care when re-interpreting the language for the older Americans considering their many options for treating a common ailment like painful knees.

The release offers no discussion on costs of viscosupplementation or insurance coverage restrictions. The benefit data is limited and there are no mention of harms. The article upon which this recommendation is based won’t be published until January 2016 which makes these limitations much more critical.

 

Why This Matters

Osteoarthritis of the knee is the most common form of arthritis and can be seen as a normal part of aging and of “wear and tear” of the body. It occurs most often in people over age 50 and more often in women than in men. It’s degenerative, getting worse over time.

With the aging of the US population, especially considering the crush of baby boomers, the subject of how best to manage the pain and disability seen with osteoarthritis of the knee becomes important. While viscosupplementation has been available for many years, the majority of randomized clinical trials have not demonstrated a consistent or important benefit to either pain level or functionality from this therapy. A terse, vaguely worded and incomplete release does little to inform either the general public or the clinical community.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Given the statistics on the incidence of osteoarthritis of the knee provided in the release, the cost of viscosupplementation is important. The costs of the material (technically, hyaluronic acid derivatives are medical devices) varies depending on which is chosen but costs range between $300 to $500 per injection.  Since osteoarthritis of the knee is a chronic condition, the durability of the injection is an important aspect of costs. Clinical trials suggest that when it is effective, the duration is varied ranging from weeks to up to six months.

According to the American Academy of Orthopedic Surgeons web page, an organization that does not specifically endorse viscosupplementation, “If the injections are effective they may be repeated after a period of time, usually 6 months.”

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release is nearly silent on the quantification of benefits of viscosupplementation. It does state, “AMSSM RECOMMENDS viscosupplementation injections for Kellgren and Lawrence (KL) grade II-III knee osteoarthritis in those patients above the age of 60 based on HIGH quality evidence demonstrating benefit using OMERACT-OARSI Responder Rating but the evidence should be downgraded due to indirectness for those under 60 years of age.”

What exactly is the high quality evidence? How is it determined? Does it include functional as well and pain levels in the assessment? The reader is simply advised this is high quality evidence.

There is also no mention of the longevity of any benefits from viscosupplementation. Does the lubrication, if it has a positive effect, last months or years? How many? There is also little in the way of qualification. Who best qualifies for this treatment?

To its credit the release does note that this recommendation appears to fly in the face of all of the evidence from clinical trials. This fact is underscored by a statement from the first author, “We do not treat groups of people we treat individuals,” said Dr. Thomas Trojian, Lead Author and Past AMSSM Board of Director.”

Randomized clinical trials are the recognized gold standard for medical interventions. Trials are designed to look at populations and not at individuals per se. All of these clinical trials are likely to have a group of responders to the intervention. In the case of failed trials, the group represents a subset. Since some people received a benefit, but the majority did not, this doesn’t seem like sound ground to stand on.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

It seems intuitive that injection of a solution into the joint space of the knee should have some downsides. Indeed, a 2012 meta-analysis of 89 clinical trials involving over 12,000 subjects published in Annals of Internal Medicine concluded, “In patients with knee osteoarthritis, viscosupplementation is associated with a small and clinically irrelevant benefit and an increased risk for serious adverse events.”

Common side effects of short duration following viscosupplementation include swelling, and feelings of pain and warmth at the injection site. Serious but rare complications include infection, allergic reaction and bleeding.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The quality of the evidence is limited to the few comments related to the “network meta-analysis.” We are not provided with any details on the methods, number of patients followed, what metrics were used to determine efficacy (other than the acronym) or how long people were followed. We’re not told why this is deemed a higher quality therapy for older people, just that it is. We’ll have to wait until the actual article is published in January 2016 to find out.

Does the news release commit disease-mongering?

Satisfactory

The statistics provided are fairly consistent to what is given out by the NIH and Centers for Disease Control and Prevention so we see no disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The information is being provided by the American Society for Sports Medicine, a multidisciplinary group of clinicians who specialize in sports medicine. There is a potential for an inherent bias. In case that needs spelling out the potential bias is that the association may be seeking new patients beyond its athlete patient base, and expanding into the aging population of “baby boomers” who have the greatest incidence of knee osteoarthritis.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release states that “people are more likely to show clinical improvement with viscosupplementation over placebo (saline) and intra-articular steroids. This is different than studies recently published that say the average response differs.” Unfortunately, the release doesn’t provide any data supporting that claim.

Reviewers agreed that most every credible source of information on the management of osteoarthritis of the knee suggest a step-wise progression of treatments including weight reduction, braces, analgesics, and the like.  While the release does mention steroid injections it does so dismissively.

Weight loss and strengthening exercises are also mentioned as initial management recommendations, but are quickly glazed over because of “controversial” treatment aspects. What is controversial about current OA treatment?

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The viscosupplementation procedure may be available at many clinics nationwide. We don’t know so we are rating this Not Satisfactory. To be complete the release could have also noted that insurers place some important restrictions for payment and that  Medicare coverage may vary among states.

Does the news release establish the true novelty of the approach?

Satisfactory

Suggesting that viscosupplementation, which is not a new treatment, should be a mainstay of treatment based on the argument that some may benefit is certainly a novel (and a controversial) idea. That recommendation puts it at odds with what the American Academy of Orthopaedic Surgeons says. Here’s what the AAOS has to say about viscosupplementation, “We cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA of the knee,” with a “Strong” rating, based on supporting evidence from 3 high-quality and 11 moderate-quality research studies that met the inclusion criteria.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

We think the phrase “high quality evidence” was unjustified language in this release because there was no evidence provided. It’s nearly unheard of for a medical association to offer practice “guidance” or a specific treatment recommendation that changes practice without providing copious data to back up that recommendation.

Total Score: 3 of 10 Satisfactory

Comments (2)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Steve Taggart

November 22, 2015 at 2:20 pm

I have read this review and many others in your archive, and have noted that almost all have extremely low scores. Many comments reflect missing information which seems to me to be very disingenuous since press releases are designed to be short and attention getting (http://www.huffingtonpost.com/zach-cutler/press-release-tips_b_2120630.html). It seems that you are doing a lot of Monday morning quarterbacking…how do these PR writers know what your criteria are before they write, and further, what makes your organization the judge and jury? No surprise that your reviews are mostly all negative. Unfortunately your disses of the PR releases suggest that the writers are attempting to hide or mislead, adding to the confusion that you purport to reduce. Perhaps you should re-examine your mission and focus on full feature articles as opposed to simple press releases. Thank you for the opportunity to comment.
Steve Taggart – Independent Consultant

Reply

    Kevin Lomangino

    November 22, 2015 at 10:39 pm

    Steve,

    Thanks very much for your comments. I would direct you to some of our blog posts that discuss our rationale for reviewing health care news releases.

    https://www.healthnewsreview.org/2015/04/news-releases-can-lead-media-like-sheep/

    https://www.healthnewsreview.org/2015/04/what-weve-learned-from-3-months-of-reviewing-health-care-news-releases/

    Perhaps in some other fields it’s ok for news releases to be merely “short and attention-getting,” but our position has always been that health care messages need to be balanced and provide a minimum core of information that allows consumers to make informed decisions. That’s hardly “disingenuous.” News releases can be “short and attention-getting” and still provide meaningful information to readers. But all too often we’ve found that news releases distort and mischaracterize health care information in ways that can cause real harm. That’s what’s disingenuous.

    We’ve only been reviewing news releases for 9 months, and it’s likely that many news release writers aren’t familiar with our criteria. That’s why we do the reviews and distribute them as widely as possible. We always inform the news release writer immediately when a review has been posted. As word spreads, we’re hopeful that more writers will be aware of our criteria and take them into consideration. We’ve certainly received lots of positive feedback from many writers and investigators who’ve been open to our constructive criticism. Here are some examples:

    “Your review was spot on. But I’m biased, because the story is a reprint of my news release. So, unfortunately, the story earns one more red “x” in the “relies on news releases” category. Keep up the good work. You are the voices of integrity and reason in science writing, and I use your criteria as my own checklist to avoid communications fatalities.”

    “Seeking permission to use your criteria for patient education talk. I’m going to use your review of a news release as an example – I am one of the co-investigators (of the research that was the subject of the news release). It may get me fired or severely chastised.”

    “I knew this research would get some headlines that were over the top and flat wrong. Indeed that happened. I wanted to make sure that we communicated a responsible message and in fact, consulted your website for a “check list” of points I needed to make. So thank you for being a strong resource. I’m glad the release received a positive review and I gladly accept the criticism.”

    I’m not sure what “disses” you are referring to or how pointing out the lack of crucial information in news releases would make anyone more confused. Our team of nearly 50 reviewers is composed of experienced journalists, PR professional, clinicians, and patient advocates who are eminently qualified to evaluate the quality of news releases. If not us, who else is going to do this work?

    And while we appreciate the suggestion that we re-examine our mission to focus on feature articles as opposed to news releases, you must have missed the fact that we’ve been reviewing such stories for 10 years and have more than 2,000 such reviews in our archive. What we’ve found is that these stories are often influenced by misinformation that originates in news releases. That’s why we’ve expanded the scope of our effort to include reviews of news releases. We hope to shine a light on excellence and point out areas where there is room for improvement. We are always constructive in our criticism and respectful in our tone.

    Kevin Lomangino
    Managing Editor

    Reply