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Regenerative Medicine: Unproven or Unprovable

Discussion in 'PM&R' started by drusso, Aug 4, 2015.

?

Which of the following statements best describes your opinion about Regenerative Medicine?

Poll closed Jan 31, 2016.
  1. It is unproven: More evidence is needed to determine whether it works.

    18 vote(s)
    100.0%
  2. It is unprovable: There is no way to demonstrate by evidence or argument that it works.

    0 vote(s)
    0.0%
  1. drusso

    Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    Please select the response that BEST describes your opinion.
     
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  3. GH253

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    Provable: certain practices within regenerative medicine are already proven to work.
     
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  4. lobelsteve

    lobelsteve SDN Lifetime Donor
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    Only in your mind.
     
  5. GH253

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    Mine is the one that matters. And your signature is ******ed. There is no conflict between profits and ethics.
     
    #4 GH253, Aug 4, 2015
    Last edited: Aug 7, 2015
  6. ampaphb

    ampaphb Interventional Spine
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    Please post the studies that document your assertion.
     
  7. GH253

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    The following material pertains specifically to the use of intra-articular injection of MSCs to treat cartilage ailments. These are just the studies I've found on pubmed; they don't represent the entirety of what's out there.



    Reviews



    Studies

     
    #6 GH253, Aug 7, 2015
    Last edited: Sep 4, 2015
  8. Doctodd

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    expansion is not easy or pratical (or legal) for majority of MD's. Studies need to differentiate.
     
    #7 Doctodd, Aug 13, 2015
    Last edited: Aug 15, 2015
  9. GH253

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    Expansion would be legal if medicine was a respectable field whose members asserted their rights, in which case labs would quickly emerge to handle expansion.
     
    #8 GH253, Aug 30, 2015
    Last edited: Aug 30, 2015
  10. ampaphb

    ampaphb Interventional Spine
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    ⚠Do not feed the troll⚠
     
  11. RUOkie

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    Since this is a STUDENT doctor forum, I will explain to the students why I take all of those studies posted by @GH253 with a grain of salt. Every last one of them is a "preliminary" or "proof of concept" study. All that suggests is that it MIGHT work. I for one, will never change my practice for a study (or 10 studies for that matter) with a n=18.
    We need LARGE multicenter studies to prove effectiveness and long term improvement vs. controls. This reminds me so much of IDET when it was first introduced. People were jumping on that bandwagon too. But when the 5 and 7 yr results were published? No more IDET.

    I hope that these large multicenter studies are indeed published someday. I hope that this is the "miracle" cure for osteoarthritis. But I ain't holding my breath.
     
  12. j4pac

    j4pac PM&R resident
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    But you can make so much money...
     
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  13. GH253

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    If the view that money is evil wins out, the crusaders for socialized medicine will prevent you from making very much of it soon enough.
     
    #12 GH253, Aug 31, 2015
    Last edited: Aug 31, 2015
  14. sloh

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    I'd definitely appreciate some genuine input. Does the argument that regenerative medicine injections tend to confer benefits to select populations hold weight here? It seems from what I've read and been exposed to, if you were to take 2 hypothetical case scenarios...

    1) 45 year old smoker, obese, sedentary, multiple comorbid conditions, psychiatric issues (depression), likely has symptoms consistent with chronic pain

    2) 45 year old who eats a nutritious diet, healthy weight, regularly active and is in fact in your office because of overuse or minor strain/sprain from triathlon training or crossfit, minimal comorbid conditions

    Would stem cell/PRP treatments be a much more viable option to patient 2 while worthless for patient 1?
     
  15. RUOkie

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    @sloh that is the problem. We don't know. My gut instinct is that the second patient would be a better candidate, but that is exactly why we need big trials with lots of patients with different demographics.
     
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  16. GH253

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    So until that indeterminate "someday," which is at least decades away, you want members of the healthy, responsible group to suffer and die while waiting for the results of your big trials that can't even get under way for financial reasons?
     
  17. j4pac

    j4pac PM&R resident
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    I'm sorry...but there is absolutely no reason why a multi-center study couldn't be performed. All it would take is coordination. We have cars that can drive themselves and we can't get a group of Physiatrists and Sports Medicine physicians to collaborate a study that would revolutionize medicine? I have two words for that...lazy and embarrassing. Many physicians don't care about efficacy...and many may even be afraid of efficacy studies. They would rather continue to sell their snake oil to desperate patients that are more than willing to buy it up.

    Quit the BS. This isn't about finances nor government regulation...this is about physicians would care more about fattening their wallets than helping patients.
     
  18. GH253

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    It is very much about regulation and finances. The FDA has regulated cultured stem cells as drugs since 2012. You should be able to figure out what that means: an average time of 15 years and prices tag of $1 billion+ to get regulatory approval for a novel product. And it will likely have to be approved discretely for every individual joint in which it is to be used. Nobody is going to be able to come up with those kinds of resources unless it's for a patentable, off-the-shelf product whose sales can recoup the investment, which in turn means the product has to be inexpensive enough to produce that it can gain widespread insurance coverage. If it is cost prohibitive it will simply never happen. Now this desperately needed revolutionary technology is stillborn thanks to the view that anyone's will other than the patient's should prevail when it comes to his own medical decisions.

     
    #17 GH253, Aug 31, 2015
    Last edited: Sep 1, 2015
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  19. lobelsteve

    lobelsteve SDN Lifetime Donor
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    Your bias knows no bounds.
     
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  20. ampaphb

    ampaphb Interventional Spine
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    Scientists need to be unbiased. This technology is currently unproven. Patient's and physician's medical decision-making needs to be informed by all relevant information. The lack of data makes prp, amniotic tissue, and stem cells snake oil at present. Promising snake oil, but snake oil all the same.
     
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  21. GH253

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    [​IMG]
     
    #20 GH253, Sep 1, 2015
    Last edited: Sep 1, 2015
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  22. RUOkie

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    best way to win an argument.
    Post a meme.

    I fear for our society
     
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  23. GH253

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    The image I posted isn't a meme you insufferable ******. It's the right point of view as stated by someone a hell of a lot smarter and more qualified to opine on the subject than you. As for society, the time to fear for it was decades ago; now you deserve the one you're stuck with.
     
    #22 GH253, Sep 2, 2015
    Last edited: Sep 2, 2015
  24. RUOkie

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    I love the internet.
     
  25. ampaphb

    ampaphb Interventional Spine
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    Several issues: That isn't a picture of the Nobel prize winner. He isn't a physician. And he isn't American. So while he is undoubtedly smarter than I am, he isn't in a position to offer an informed opinion on US FDA policy.
     
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  26. GH253

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    What difference does it make whose face is in the picture or what his country of residence is? You are simply evading a point you can't refute.

    How about former FDA commissioner Andrew von Eschenbach? Is he informed enough? Here's what he wrote in a WSJ op-ed:

    Which logical fallacy will you put forth this time to evade the undeniable fact that the regulations you're defending will kill millions upon millions of people?
     
    #25 GH253, Sep 3, 2015
    Last edited: Sep 3, 2015
  27. RUOkie

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  28. ampaphb

    ampaphb Interventional Spine
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    A British bench researcher is qualified to dictate US FDA policy?
     
  29. jesspt

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  30. GH253

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  31. RUOkie

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    I just got back from the AAPMR meeting. Went to some lectures on regenerative medicine for DJD and DDD. Not one person presented any credible research that shows significant effectiveness. Only preliminary studies that show that further study is needed. But in the technical exhibits there were no less than 10 vendors trying to sell us ways to integrate this unproven technology into our practices. Money is driving this instead of patient care
     
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  32. GH253

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    I already provided you with a list representing only a fraction of the credible studies out there showing objective radiological and histological evidence of cartilage regeneration. The idea that placebo-controlled clinical trials are the only acceptable form of evidence comes from the FDA and makes no sense from a medical or safety standpoint.
     
    #31 GH253, Oct 5, 2015
    Last edited: Oct 5, 2015
  33. j4pac

    j4pac PM&R resident
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    Did you even read the articles you posted? I didn't...but eventually I'll get around to it. I just reviewed your first article by Dr. Gupta...here is his conclusion:

    "Carefully planned clinical trials using BMSCs obtained from patients (autologous) and from normal healthy volunteers (allogeneic) may shed valuable insight into the curative properties and long-term sustenance of these cells in the local microenvironment. Undoubtedly, a great deal of progress is required at both basic and clinical research fronts before these cells can be used routinely in the clinic for treating patients with OA."

    The article was like many others I have read on MSC/PRP. It was a rah-rah cheerleader piece fluffing up the "potential" of MSC/PRP based on basic science and pre-clinical studies. It was NOT a clinical trial. And at least Dr. Rupta was responsible enough to state that more research needs to be done before treating patient's like lab mice.

    You don't need FDA approval for a clinical trial. You need a well designed study with patient consent. Thus far...other than for tennis elbow...physicians haven't done that.
     
  34. RUOkie

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    http://jama.jamanetwork.com/article.aspx?articleid=185200

    Nah, this is a pretty well designed study with 54 people for achilles tendinopathy.

    and there was no benefit to saline injection.

    Of course ALL patients received Eccentric exercise
     
  35. j4pac

    j4pac PM&R resident
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    Correction...poorly worded. Physicians have tried...but have failed...in all studies besides tennis elbow.

    I believe in the basic science. I think that there is also some promise in pre-clinical trials...but the clinical trials are failing. Why? I honest to God think that it is an issue with our scaffolds and delivery mechanisms. Dentistry is lightyears ahead of medicine in regenerative medicine because of their "therapeutic scaffolds". You can't just squirt PRP/MSCs into a joint and expect it to 1) go to the right area and 2) act like normal tissue. We've got to improve our scaffolds, along with standardizing our study methods. Will that happen? We'll see.
     
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  36. Doctodd

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    There is a ton of research in the pipeline. And to analogize regenerative medicine with IDET is not apples to apples. Orthos have been doing regenerative techniques for years.....just not concentrated enough. I admire the passion on both sides.
     
  37. ampaphb

    ampaphb Interventional Spine
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    Well, when it emerges from the pipeline, do let us know. For now, it is still all smoke and mirrors, all hat, no cattle.
     
  38. Doctodd

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    You yourself admit adequate research has been done for epicondylitis.....how is it so much of a stretch to extend it to other body parts? Again....someone keeps harping IDET.....but it is not even close to being a similar comparison.
     
    #37 Doctodd, Oct 11, 2015
    Last edited: Oct 12, 2015
  39. ampaphb

    ampaphb Interventional Spine
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    I have not once mentioned IDET. . However, I believe Roukie's point is, IDET was touted and over utilized based on preliminary data. Once definitive RCTs were completed? No one who puts their patients' well being first continues to do the procedure.

    That u are willing to subject "hundreds" of your patients to unproven therapy says all I need to know.

    http://www.ncbi.nlm.nih.gov/pubmed/25881762

    http://www.ncbi.nlm.nih.gov/pubmed/24782334

    http://www.ncbi.nlm.nih.gov/pubmed/24563387

    http://www.ncbi.nlm.nih.gov/pubmed/24363098

    http://www.ncbi.nlm.nih.gov/pubmed/24169302
     
  40. Mad Jack

    Mad Jack Critically Caring
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    I've seen horrific and even fatal outcomes of stem cell therapy in my prior career. There is a reason we regulate stem cells like drugs- because we need expansive studies to prove they are safe, and if they are not safe, we need these studies to point us in the direction as to why so that we can improve things in the future. We also need them so that we can provide full disclosure to our patients that will allow them to provide proper consent with the full knowledge of risks and benefits of the treatment being offered, not some doctor's n=1, anecdotal opinion that is likely colored by confirmation bias.
     
    #39 Mad Jack, Oct 11, 2015
    Last edited: Oct 11, 2015
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  41. Crayola227

    Crayola227 The Oncoming Storm
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    Yeah I'm sorta naive enough to think you can inject me with stuff that came from me, that said, just being poked with a needle carries risk. And it comes from me but that doesn't mean I should eat my own **** or have it injected in me.

    Sigh, I guess maybe it could upset my body to jam a needle into my ovaries, try to suck out some eggs, or grab some bone marrow, and then inject try to that into my epidural space. Back to torturing lab rats I guess. At least until I have a miscarriage and can... OK, no more mad science.

    No, really, from an immunological standpoint working with autologous tissue is pretty much going to be better than any other source, but you can't just start rearranging the furniture.

    But yeah, I'd love it if we could just draw my blood and grow me a knee replacement, but it's going to take more than that.

    Question, I heard about some sort of magnet/electric device you wear next to a degenerated joint and it regenerates? Anyone know about this? I know a terribly disabled physician (non-quack) that did this for their non-replaceable joint and had miraculous results... they weren't trying to promote it, just something they did to salvage their own life and claimed it worked

    it's nice to have some of those "seemingly" harmless unproven therapies in mind to try when you become so desperate you're thinking "I wear this magnet bracelet or it's time to euthanize". In that way is the only way I sorta support the earlier poster saying sometimes the FDA should let people inject themselves with their own stuff, like some form of medicalized autosarcophagy harm reduction model, because that's better than total despair? then again helping a patient pursue potentially useless or harmless treatment because they aren't getting benefit from being counseled acceptance.... is bad. And it makes sense that's it bad. And we try to help patients see "reason." And it doesn't work.

    But then again given no proven benefit, why would MS patients refuse to stay in the US and accept their symptoms versus pay thousands of dollars to fly south of the country for some weird spine injections that they think work but stymies science. Why can't they do nothing for the same result?

    Our patients will demand treatment. We must offer them safe placebo if nothing else, and if not proven safe placebo or treatment, have no part of it. Which they will find cruel. We are holding out on them.

    I'm trying to find the various things I've read about how shamanism only works and has value if it comes at great cost

    So we may continue to sell snakeoil, magnetic bracelets, but only as a last resort when pressed, it can't be free, but at least shouldn't be prohibitive, but should not be doing crazy wild joint stem cell injections for thousands of dollars. There must be a middle ground. A magnetic bracelet for hundreds of dollars instead? and donate the money to researching the injections
     
  42. Doctodd

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    I read the first link......it was pretty vague and ambiguous.....but it didnt support your case. Your selfrighteous comment about my practice is "all u need to know" is noted. Let's leave it at this.....u keep injecting corticosteroids like water and prescribing statins and other drugs you have been lead to believe help.....Deal? Bye bye.
     
    #41 Doctodd, Oct 11, 2015
    Last edited: Oct 12, 2015
  43. Doctodd

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    Just read your other links......the 2nd and 4th are the same article. Dr Shiple authored the last one, which says their PRP doesnt work. What jumped out at me was they used 10-15cc of lidocaine to numb the epicondyle area which is ALOT. Seems self defeating.....i have a call out to someone who knows him.
     
  44. ampaphb

    ampaphb Interventional Spine
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    If it is proven, by all means, show us the literature.

    I realize u only skim the articles. Had u read all the way to the end, you would have found that #4 is an update of #2, and, in fact, they are not the same.

    Not sure why any pain guy would be writing for statins.

    I am only quoting the American Academy of Orthopedic Surgery, which withdrew its recommendation for the use of prp for lateral epicondylitis. So if that is "incorrect and disingenuous", you should probably take it up with them. Till then, I won't subject my patients to the risk of an intra/periarticular infection without evidence of efficacy.
     
  45. RUOkie

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    I'm the one who brought up IDET. And it was just used to elucidate how we in medicine tend to jump on the latest new treatment when preliminary studies are published. Then, when the long term data are published, these "Miracle cures" just fade away into obscurity. I'm old enough to have seen Chymopapain, IDET and laser annuloplasty all come and go for the treatment of discogenic pain. Now Centeno is injecting stem cells into the disc. Maybe it will work. Maybe not.

    But we as a profession, should not be using ANY novel treatment until large, multicenter RCTs are done. With long term follow up. That is piece that is missing with regenerative medicine.
     
    #44 RUOkie, Oct 11, 2015
    Last edited: Oct 12, 2015
  46. GH253

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    It took the mind of Kyriacos Athanasiou, one of the world's most renowned bioengineers:

    [​IMG]

    This technology has already been used successfully to resurface the joints of animals, but thanks to government paternalism, patient access will be delayed for decades. The FDA makes it so difficul and expensive to get approval for engineered biological tissues that at this time there is no investor funding toward getting this technology out there. So people will continue to suffer excruciating pain and loss of quality of life, lose their ability to work, commit suicide, and die of CV events caused by NSAIDs...but at least they'll be protected from their own tissues, and most importantly, no one will make any money.
     
    #45 GH253, Oct 11, 2015
    Last edited: Oct 11, 2015
  47. Doctodd

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    Again.....not apples to apples regarding PRP/stem cells being new and novel, and comparing autologous procedures to IDET or medications(with many studies being funded by drug companies and given yay or nay by advisory panels before FDA. Recall that bone marrow has been used for decades for cancer treatment, and btw NOT autologous. Some biotech companies have already successfully jumped through FDA hoops regarding stem cell treatments. I believe Provenge was approved by the FDA and had a variation of stem cells that were expanded and trained for medicare authorized treatment of prostate cancer. Sadly they went bankrupt. The innovation and new applications would not be proceeding without proven safety for basic applications. Fyi i do not perform intradiscal procedures.
     
    #46 Doctodd, Oct 11, 2015
    Last edited: Oct 11, 2015
  48. PMR2008

    PMR2008 PM&R
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    http://www.ncbi.nlm.nih.gov/pubmed/26432430
    Arthroscopy. 2015 Sep 29. pii: S0749-8063(15)00659-3. doi: 10.1016/j.arthro.2015.08.005. [Epub ahead of print]
    Efficacy of Intra-articular Platelet-Rich Plasma Injections in Knee Osteoarthritis: A Systematic Review.
    CONCLUSIONS:
    In patients with symptomatic knee OA, PRP injection results in significant clinical improvements up to 12 months postinjection. Clinical outcomes and WOMAC scores are significantly better after PRP versus HA at 3 to 12 months postinjection. There is limited evidence for comparing leukocyte-rich versus leukocyte-poor PRP or PRP versus steroids in this study.

    LEVEL OF EVIDENCE:
    Level I, systematic review of Level I studies.
     
  49. PMR2008

    PMR2008 PM&R
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    Clin Orthop Relat Res. 2010 Nov; 468(11): 3112–3120.
    Published online 2010 Aug 11. doi: 10.1007/s11999-010-1443-0
    PMCID: PMC2947661
    Increased Chondrocyte Death after Steroid and Local Anesthetic Combination
    Boglárka Farkas, MD,1,2 Krisztián Kvell, MD, PhD,3 Tamás Czömpöly, MD, PhD,3 Tamás Illés, MD, PhD,1 and Tamás Bárdos, MD, PhD[​IMG]1
    Results
    Glucocorticoids and local anesthetics induce apoptosis in chondrocytes at various rates. When used in combination, the percentage of dead chondrocytes was increased in in vitro chondrocyte cell cultures and osteochondral ex vivo specimens.

    Conclusions
    We observed a time-dependent decrease in chondrocyte viability after concurrent steroid and local anesthetic exposure.

    Clinical Relevance
    The combination of glucocorticoids and local anesthetics has an adverse effect on articular chondrocytes, and it raises a question regarding whether concomitant administration should be used in treating osteoarthritis.
     
  50. Disciple

    Disciple Senior Member
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    Those studies are unlikely to be done.

    Then again, how many of the standard treatments for outpatient spine/MSK/pain management are backed by large, multicenter RCTs?

    It all depends on where we want to set the bar for level of evidence before utilization.
     
  51. ampaphb

    ampaphb Interventional Spine
    10+ Year Member

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    http://www.ncbi.nlm.nih.gov/pubmed/25952818

    http://www.ncbi.nlm.nih.gov/pubmed/25687110
     
    #50 ampaphb, Oct 11, 2015
    Last edited: Oct 11, 2015
    lobelsteve likes this.

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