Andrew L. Avins, MD, MPH

JAMA. 2010;304(1):93-94.

Nonspecific chronic low back pain (LBP) remains one the most prevalent, expensive, and poorly treated conditions seen by primary care clinicians.¹ The etiology of most chronic LBP is unknown; therefore, treatment approaches are often empiric and usually based on a relatively thin foundation of evidence. Most interventions have not been rigorously tested and many back pain studies are limited by poor design and research practice, so little is known about what treatments are or are not effective for patients with chronic LBP. Because patient-specific diagnosis and treatment plans cannot be rationally formulated in most cases,² patients frequently experiment with a variety of interventions, often turning to complementary and alternative therapies.^3-4

Glucosamine is a precursor of the proteoglycans that make up articular cartilage, and it is widely used orally by patients for treating peripheral joint osteoarthritis based on the theory that degenerative cartilage lesions can be treated by taking high doses of a precursor molecule.⁵ However, the evidence regarding glucosamine for hip and knee osteoarthritis is inconsistent with great variation depending on the quality of the study design, the glucosamine preparation used, and the funding source.^6-7 Similar arthritic changes often occur in the synovial facet joints of the spine, and more than 25% of patients with chronic LBP have tried glucosamine supplements, seeking to gain relief for their back pain.⁸

In this issue of JAMA, Wilkens et al⁹ report the results of a randomized, double-blind clinical trial of oral glucosamine for the treatment of patients with chronic LBP and imaging evidence of facet joint osteoarthritis. The investigators randomized 250 participants to 6 months of treatment with 1.5 g of glucosamine sulfate daily or an identical-appearing placebo. Overall, this was a well-designed and well-conducted trial with clear eligibility criteria, adequate allocation concealment, good baseline comparability, acceptable medication adherence, few withdrawals, well-accepted outcome measures, adequate sample size specified a priori, and an appropriate intention-to-treat analysis. The use of the sulfate salt of glucosamine was also a wise choice given the issues surrounding the bioavailability of this dietary supplement and the role of sulfate in its potential efficacy.⁵

The results of the trial were negative: on no outcome measure was there a statistically significant benefit of glucosamine over placebo. The 95% confidence intervals generally excluded any effect considered clinically meaningful, suggesting the results were probably not due to insufficient statistical power. Given the high quality of the trial methods and execution, the most likely explanation for the outcome is simply that glucosamine probably offers little benefit for chronic LBP with osteoarthritis beyond whatever placebo effect it may provide. Importantly, there were few adverse effects associated with the use of glucosamine in this study, consistent with other literature, indicating that glucosamine is well tolerated and causes minimal toxicity, at least in the short term.⁶ Thus, the data presented by Wilkens et al⁹ provide no incentive for clinicians to recommend glucosamine for patients with chronic LBP.

It would be easy for clinicians and patients to become discouraged as increasing numbers of potential chronic LBP treatments fail to survive the test of clinical trials. However, the public health burden of chronic LBP cannot afford cynicism, and high-quality negative trials such as that reported by Wilkens et al⁹ should be viewed positively as important contributions. Indeed, some important progress has been made as patients with back pain are no longer advised to try prolonged, counterproductive bed rest and there is much greater appreciation for the complex interactions between the psychosocial and physical aspects of chronic LBP.¹⁰ Overall, however, care for patients with LBP remains insufficient for far too many patients. Why has such an enormous public health problem remained so stubbornly resistant to the identification of effective treatment?

Some challenges are unique to back pain. Unlike other common chronic illnesses, there is no dominant organization that represents the chronic LBP community, advocating for greater attention and funding for LBP research. It is ironic that in the United States orders of magnitude more resources are spent on treatments for chronic LBP of limited or unknown value than on research to study existing and promising new approaches that could provide more hope for patients. Moreover, the fragmented clinical silos in which chronic LBP treatments are often delivered (eg, primary care, physical therapy, surgery, interventional procedures, behavioral therapy, complementary and alternative medicine practice) rarely align to force an objective appraisal of efficacy and collaborate to identify optimal treatment approaches. In the competition for federal research dollars, back pain has not been allocated funding commensurate with its societal cost and quality-of-life burden. For example, as of June 2010, the National Institutes of Health’s clinical trials registry (http://clinicaltrials.gov) includes only 69 federally funded intervention studies in back pain, of which only 20 are currently recruiting patients. Fortunately, funding agencies are beginning to recognize the compelling public health imperative of chronic LBP as evidenced by the increasing numbers of federally funded studies related to back pain over the past 25 years.

The great need for more and more efficient clinical research in chronic LBP highlights an overall clinical research environment in the United States that operates well below its potential. Similar to other clinical conditions, LBP research is limited by insufficient funding, misguided regulations,¹¹ a heavy reliance on funding from for-profit entities,¹² and a lack of consensus about outcome measures and clinically meaningful goals of therapy.

Perhaps most important is that the clinical research community has failed to create the strong partnerships with the public that are required to build and sustain a robust clinical research agenda.¹³ Without a fundamental change in the relationship between the clinical research community and the public, clinical and translational research will continue to struggle with recruitment problems, inadequate financial and public support, and insufficient appreciation for its societal value.

The results of the high-quality clinical trial by Wilkens et al⁹ carefully evaluating a widely used treatment for chronic LBP were disappointing but should not be discouraging. Clearly, much more work remains before realizing the kinds of success in the treatment of chronic LBP that other conditions have experienced. With an objective and determined focus, sufficient support, greater collaboration, and a working partnership with patients, there is every reason for optimism, however cautious. The real test will be whether the environment for this success can be created and sustained.

AUTHOR INFORMATION

Corresponding Author: Andrew L. Avins, MD, MPH, Division of Research, Northern California Kaiser-Permanente, 2000 Broadway, Third Floor, Oakland, CA 94612 (andrew.avins@ucsf.edu).

Financial Disclosures: None reported.

Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.

Author Affiliation: Division of Research, Northern California Kaiser-Permanente, Oakland.
REFERENCES

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2. Deyo RA. Diagnostic evaluation of LBP: reaching a specific diagnosis is often impossible. Arch Intern Med. 2002;162(13):1444-1447. FREE FULL TEXT

3. Barnes PM, Bloom B, Nahin R. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. Hyattsville, MD: National Center for Health Statistics; 2008.

4. Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003;138(11):898-906. FREE FULL TEXT

5. Reginster JY, Bruyere O, Neuprez A. Current role of glucosamine in the treatment of osteoarthritis. Rheumatology (Oxford). 2007;46(5):731-735. FREE FULL TEXT

6. Towheed TE, Maxwell L, Anastassiades TP; et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev. 2005;2:CD002946. PUBMED

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8. Santaguida PL, Gross A, Busse J; et al. Evidence Report on Complementary and Alternative Medicine in Back Pain Utilization Report. Agency for Healthcare Research and Quality; 2009. AHRQ Publication No. 09-E006.

9. Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010;304(1):45-52. FREE FULL TEXT

10. Chou R, Qaseem A, Snow V; et al, Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147(7):478-491. FREE FULL TEXT

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12. Carragee EJ, Deyo RA, Kovacs FM; et al. Clinical research: is the spine field a mine field? Spine (Phila Pa 1976). 2009;34(5):423-430. FULL TEXT | WEB OF SCIENCE | PUBMED

13. Avins AL, Goldberg H. Creating a culture of research. Contemp Clin Trials. 2007;28(4):557-562. FULL TEXT | WEB OF SCIENCE | PUBMED

Restylane lump in the undereye area – can last for 4 years, but is easily dissolveable with hyaluronidase in 24 hours

I’ve read about people that are very happy with restylane to fill the tear troughs and I’ve read about people who have permanent lumps or asymetry from fillers.

the most important qualification for this procedure is lots of experience.
doctors will tout that they have been on TV and that they have triple board certifications, but none of that really matters if they have never done this particular, exact procedure.
always insist on knowing how many of these specific procedures the doctor has done and you should see his or her own before and after pictures.
by the way, restylane and juvederm are easily dissolveable (as are all hyaluronic acid based products), so nobody should have permanent lumps or asymmetries.

1-can we do the non surgical nose surgery and cheek enhancement in every 2 years(because it’ll absorbe after 2 years)

2-i desire to have a forme of the face and nose as 1 asian actress ,do u really can help me?(i’ll send u her photo and mine)

3-im 162 cm and 61 kg i want to lose weight until 48 kg,do u have any way for me lose weight?(wanna have a skinny legs and arms)

Thanks! well… become beautiful is 1 of my dream! ur answers will be help! hope u can reply me back. thanks again

Thanks! well… become beautiful is my dream ! hope u can reply back.

hi xxx,
improving how you look from the outside is ok to do.
however, i think there are much more important things in life.
the material (radiesse) lasts for about a year, actually.
i think i said 2 years somewhere on the website, and that is incorrect.
there is a permanent filler available that works very well.
it is called artefill and i have used it on several hundred patients.
when you are 18 you are considered an adult and you can get procedures done if you want.
i think that you should be careful not to let improving your appearance become too big of a goal.
at your age, working on your inside beauty – becoming a good person – is more important than trying to become beautiful.
you will see that this is what is going to make you happy, not cosmetic procedures.
i do not know of any good way to lose weight, except for a good diet and daily exercise.

Actually, it is great to see the continued attention that non surgical facial sculpting is receiving.These procedures have been adoopted faster than I even expected back in the day (6 years ago) when it was all getting started.

Fillers and Botox have redefined the relationship that the average person has with the aesthetic field.

The last six years have seen a non surgical revolution and I look forward to all the new stuff we have yet to discover!

you know, i normally would not chime in on a post condemning a procedure i do, but this thread started with a question to me, so i feel involved.
i understand that the writer had a unsuccessful perlane procedure. she experienced pain and swelling afterwards and the perlane was dissolved with an enzyme. while i am not challenging her account, pain and swelling for 4 months afterwards sounds like a very unusual reaction to a filler injection. i am very happy that her revision rhinoplasty went very well and she is satisfied with her nose now.
ok.
over more than a thousand procedures, i have seen this happen maybe five times. each time we dissolved or brought down the filler and there were no problems.
unfortunately, as with any medical procedure, if you do enough of them you will see a couple of unusual complications. that is no reason to discard the procedure entirely.
this procedure is an injection of filler under the skin. it carries no more risk than an injection of filler under the skin in any other area of the face. there have been reports of unusual reactions with pain or swelling to nasolabial fold injection, but we still do them every day because, for the vast majority of patients this is an easy, effective and safe procedure. same story with non surgical rhinoplasty.
i hear alot of propaganda from rhinoplasty surgeons about the risks of this procedure. i have not yet seen any studies or reports documenting any adverse reactions. what i have seen is a heck of alot of happy patients. i’m not saying its perfect – of course there are occasional problems. and that is to be expected. what i would love to see is a study comparing 1000 surgical and non surgical rhinoplasty patient results, complications and satisfaction. if the non surgical rhinoplasty patients had even one minor complication for every 15 on the surgical side, i would be surprised. in fact, i would not expect a single permanent complication from the non surgical rhinoplasty set of patients. according to emedicine:
“According to the literature, the complication rate for nasal surgery varies from 4-18.8%. In individual hands, this rate generally falls as surgical experience accumulates. Skin and associated soft tissue complications occur in up to 10% of cases. According to estimates, severe systemic or life-threatening complications occur in 1.7-5% of rhinoplasty cases. Intracranial complications are rare.”
that means that out of our 1000 patients, 40 to 188 patients will have complications. 20 to 50 will have life threatening complications!
again, i do not mean to minimize the experience of the person posting. she is just repeating the stuff her surgeons told her. but to even compare the safety of a filler injection to that of an invasive surgical procedure is absurd.

http://inyourface.freedomblogging.com/2010/05/05/heidi-montag-plans-more-surgery-stop-her/17227/

I hate to waste even more ink on this poor girl, but I am hoping that she will serve a purpose. The public is actually seeing something relatively unique – we get to watch the mind of a body dysmorphic disorder patient working in real time. And anyone out there who has doubts that this is a screaming example of body dysmorphic disorder, is delusional. I hope that watching her will scare some of the girls who think that a boob job is all that stands between them and popularity. I hope that watching her will shame those plastic surgeons who would ignore the signs of BDD and operate on these sick people to make a buck.

I am a bit pessimistic, however, after seeing a recent episode of EXTRA where Dr. Frank Ryan operated on a lady who sought him out because she thought that he did such a fine job on Ms. Montag. Really? Well, I guess it all worked out as expected. She got publicity, a reality show and, I’m sure, lots of money to appear on other shows. He got publicity and lots of new patients who are flying in because they admire his work.

I guess we will see, won’t we? Its only human to be fascinated by a train wreck in progress.

Hint: its not a close relationship

http://www.newyorker.com/reporting/2010/03/29/100329fa_fact_thurman – this is the abstract – i couldn’t find a way to view the full article without being a subscriber.