The supermarket of care for spinal disorders just got more confusing with the release of an RCT by WC Peul et al. (Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two-year results of a randomized controlled trial, BMJ, 2008.).
In the June edition of The BACK LETTER, the lead article, “Balancing Costs and Benefits: Is Disc Surgery Cost-Effective?” (vol. 23, no. 6, 2008) Peul and his associates clouded the treatment of sciatica with a study that is filled with dumbfounding opinion, omissions, and bias. Sadly, this flawed study may be used against conservative care, including the chiropractic profession and manual medicine, despite its obvious shortcomings that only a professional versed in conservative care and manual medicine would notice.
Peul’s study suggests discectomies for sciatica are preferable/cost effective over conservative care in the short term (6 weeks), but admitted not in the long term (6 months). “The advantage was discernible six weeks after surgery but vanished by six months. And there were no significant differences between treatment groups in pain or disability beyond that follow-up point.”
A study in JAMA (Weinstein et al. Nov. 2006) also showed that patients with low back and leg pain who underwent spinal surgery fared no better two years later than those who used non-invasive therapy. So the obvious question remains: why are they doing expensive, risky surgery when the long term results are no better?
First of all, there are many concerns about this Peul study, most prominently, the definition of “conservative care.”
From the Peul study:
“Treatment methods were straightforward. Those allocated to disc surgery underwent microdiscectomy and removal of loose degenerated disc material from the disc space. General practitioners supervised conservative care. There are no proven nonoperative treatments for sciatica, so the treatment approach was empirical. It included information, reassurance, pain control, and encouragement to return to normal activity. Those who were fearful of movement were referred for physical therapy. Both groups had access to research nurses for advice and encouragement.”
It seems Peul’s definition of conservative care doomed a true comparison before it started in that he failed to offer the most effective treatments such as spinal manipulative therapy, flexion-distraction, and non-surgical spinal decompression. Instead, they offered cheap advice and drugs by non-MSD general practitioners—the typical medical management of back pain. This is ridiculous as well as ineffective, and it is certainly unethical to suggest this represents the best of conservative care.
As a practicing chiropractor, I found it mind boggling that Peul failed to offer patients seeking conservative care the most effective treatments—spinal manipulative therapy, flexion-distraction, non-surgical spinal decompression along with active rehab. Until someone does a RCT between the medical approach (drugs, shots, surgery) and the best in conservative care as I mentioned, a true evaluation cannot be made. I challenge Peul or any of his contemporaries to stop fooling around with non-effective so-called conservative methods and let’s go toe-to-toe.
Considering the avoidance of these best treatments of conservative care that I mention, I did find it compelling that using inferior conservative treatments still proved comparable in the long run than any kind of spine surgery.
Secondly, I find it odd that the author states “There are no proven nonoperative treatments for sciatica.” As a practicing DC who’s treated hundreds if not a few thousand sciatica cases, I find his opinion bizarre, perhaps indicating his professional bias. Should I tell all my sciatica patients that Dr. Peul says there is no proof I’ve helped them?
This begs the question: is Peul totally unfamiliar with manual medicine or what?
Indeed, most studies (BEAM, SPORT, Meade, Norway Spine Study, Swedish Lumbar Spine Study) have come to the same conclusion that there is ample evidence for manual medicine as noted by the AHCPR guideline on acute low back pain or the Decade of Bone and Joint Disorders study on chronic back pain to suggest that a course of spinal manipulation should be completed before surgical consult is considered. Apparently Peul ignored these landmark studies or feels there is no extrapolation to leg pain?
One quick scan of Medline for sciatica/herniated discs/manual medicine would reveal the plethora of studies on showing the effectiveness of spinal manipulative therapy, flexion-distraction, and non-surgical spinal decompression for leg pain.
Here is a short sampling of research supporting manual therapy (SMT, Flexion/distraction/non-surgical spinal decompression) for LBP/leg pain:
- Henderson RS (1952) The treatment of lumbar intervertebral disk protrusion: an assessment of conservative measures, Br. Med J 2:597-598.
- Mensor MD (1955) Non-operative treatment, including manipulation, for lumbar intervertebral disc syndrome, J Bone Joint Surg 37A:926-935.
- Kuo PP, Loh Z (1987) Treatment of lumbar intervertebral disc protrusions by manipulation, Clin Orthop 215:47-55.
- Cassidy JD, Thiel HW, Kirkaldy-Willis WH.Side posture manipulation for lumbar intervertebral disk herniation. J Manipulative Physiol Ther. 1993 Feb;16(2):96-103.
- Troyanovich SJ, Harrison DD, Harrison DE. Low back pain and the lumbar intervertebral disk: clinical considerations for the doctor of chiropractic. J Manipulative Physiol Ther. 1999 Feb;22(2):96-104.
- Quon JA, Cassidy JD, O’Connor SM, Kirkaldy-Willis WH. Lumbar intervertebral disc herniation: treatment by rotational manipulation. J Manipulative Physiol Ther. 1989 Jun;12(3):220-7.
- Cox JM, Hazen LJ, Mungovan M. Distraction manipulation reduction of an L5-S1 disk herniation. J Manipulative Physiol Ther. 1993 Jun;16(5):342-6.
- Schneider MJ, Distraction manipulation reduction of an L5-S1 disk herniation. J Manipulative Physiol Ther. 1993 Nov-Dec;16(9):618-20
- Slosberg M. Side posture manipulation for lumbar intervertebral disk herniation reconsidered. J Manipulative Physiol Ther. 1994 May;17(4):258-62.
- Bergmann TF, Jongeward BV. Manipulative therapy in lower back pain with leg pain and neurological deficit. J Manipulative Physiol Ther. 1998 May;21(4):288-94.
- Shealy, CN, MD, PhD, and Borgmeyer, V RN, MA, Emerging Technologies: Preliminary Findings, Decompression, reduction, and stabilization of the lumbar spine: a cost-effective treatment for lumbosacral pain; AJPM Vol. 7 No. 2 April 1997.
- Gose EE, Naguszewski WK, Naguszewski RK.Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Department of Bioengineering, University of Illinois at Chicago, USA. Neurol Res. 1998 Apr;20(3):186-90.
As I mentioned, this list is just a quick scan, so apparently Peul failed to do his homework when he stated “there are no proven nonoperative treatments for sciatica” and seems to have designed his comparison with the intention of using rather ineffective methods. Is it any wonder conservative care didn’t score better in his RCTs when you consider he avoided using the best of proven conservative treatments? Is this simply a case of ignorance or intellectual dishonesty?
The recent studies done by the researchers on chronic LBP (Haldeman et al. Decade of Bone and Joint Disorders; Evidence-Informed Management of Chronic Low Back Pain Without Surgery; The Spine Journal, January/Feb 2008,Volume 8, Number 1) gave meager endorsements of Peul’s choices of conservative care. If he were fair in his comparison, why didn’t Peul use the most effective forms of non-invasive conservative care rather than the old medical model of cheap advice and pain pills? Obviously his is a sham comparison of apples to rotten oranges
Thirdly, the fact that Peul had GPs manage the conservative care group also was strange considering most GPs know very little about MSDs. This is unconscionable considering many studies have shown the incompetence of GPs for diagnosing and treatment of MSDs. In 1998, Freedman and Bernstein published a landmark study in the Journal of Bone and Joint Surgery, wherein they administered a validated musculoskeletal competency examination to 85 recent medical graduates who had begun their hospital residency. Of these medical doctors, 82 percent failed to demonstrate basic competency on the examination, leading the authors to conclude, “We therefore believe that medical school preparation in musculoskeletal medicine is inadequate.”
In their 2004 review published in Physician and Sportsmedicine, Joy and Van Hala describe the musculoskeletal training of allopathic physicians as “woefully inadequate,” and noted that among a sample of 85 recent medical graduates, “the average time spent in rotations or courses devoted to orthopedics during medical school was only 2.1 weeks. One third of these examinees graduated without any formal training in orthopedics.”
If Peul wanted an accurate portrayal of care using conservative methods, why didn’t he use DCs (or even PTs or DOs) instead of GPs since most health professionals would agree that DCs, if good for anything, are the most prominent managers of conservative care for spinal treatments? Again, perhaps his bias wouldn’t allow using the best conservative care doctors for fear of not reaching his skewed conclusion that “disc surgery is cost-effective. It earns money for society.”
Okay, stop laughing, certainly it’s true for spine surgeons and hospitals, but I seriously question how anyone can suggest spine surgery is a better buy than conservative care considering the average total cost of spine surgery and hospitalization (not withstanding disability, rehab, and the reoperation) reaches $50,000 to over $100,000 for disc replacements and is shown to be no better in long-term results.
Even Rick Deyo, renowned spine researcher, admits:
”People say, ‘I’m not going to put up with it,’ and we in the medical profession have turned to ever more aggressive medication, narcotic medication, surgery, more invasive surgery.” (“With Costs Rising, Treating Back Pain Often Seems Futile” by Gina Kolata, NY Times, February 9, 2004)
Fourthly, Peul never questions the validity of the suspect disc theory itself as the underlying cause of LBP/leg pain, which may explain why the long-term benefits of spine surgery are so poor.
Many other researchers have questioned the disc theory as the prominent cause of spine disorders, such as Rick Deyo and JN Weinstein:
“Early or frequent use of these tests [CT and MRI] is discouraged because disc and other abnormalities are common among asymptomatic adults.
Degenerated, bulging, and herniated disks are frequently incidental findings…Detecting a herniated disk on an imaging test therefore proves only one thing conclusively: the patient has a herniated disk.” (Deyo RA, Weinstein JN. Low back pain. N Eng J Med 2001 Feb 1;344(5):363-70.)
NM Hadler, MD, author of “The Last Well Person” also criticizes the disc theory for LBP:
“‘Ruptured discs and ‘bad back’ are terms that deserve to be relegated to the historical archives…Whatever we see on the MRI is likely to have been present when the person heals. The discal hypothesis—the idea promulgated seventy years ago that the ‘ruptured disc’ is the culprit—has not withstood scientific scrutiny well. It is largely untenable for axial pain, and marginal for radicular pain.
“Magnetic resonance imaging cannot be used to predict back pain. Magnetic resonance imaging is not even sensitive to anatomical changes that might correlate with new symptoms.” (JAMA, Need for less imaging, better understanding June 4, 2003 vol. 289 no. 21)
The authors on www.spine-health.com also admit the fallacy of using MRIs as a selling point for spine surgery:
“You may have a bulging disc that shows up on an MRI scan, but that may not be the cause of your leg pain. You can have disc degeneration or other anatomical lesions that show up on the scan, but are not causing pain. Studies have shown that many people with no pain or other symptoms often have some sort of disc problem show up on an MRI scan.”
Fifthly, the long-term outcomes were negligible despite the fact that Peul avoided using the best types of conservative care. Indeed, even when using the nonsensical treatments like cheap advice and pain pills, the outcomes with surgery were comparable later on, which begs the question: why are we subjecting patients to the high costs and risk of surgery when even inappropriate conservative care is just as effective in the long run?
“There were no significant differences between treatment groups beyond six months. Results of the two groups were identical at one-year follow-up in terms of pain, disability, and global outcome. Over the course of the first year, 95% of both groups reported complete recovery.”
Sixthly, Peul’s focus on disc issue completely ignores the fact that many back pain problems may stem from joint problems and inflammation that are resolved by manual medicine and anti-inflammatory treatments like simple cold packs.
JL Shaw, MD, mentioned years ago:
“Joint dysfunctions are the major cause of LBP as well as the primary factor causing disc space degeneration and ultimate herniation of disc material.”
(Shaw JL, “The role of the sacroiliac joints as a cause of low back pain and dysfunction,” speech before the World Congress on Low Back Pain, University of California, San Diego, Nov. 5-6, 1992 )
Other orthopedists agree with Shaw.
“The sacroiliac joint appears to be the single greatest cause of back pain…when the normal joint play is lost, agonizing pain can be precipitated.”
(Bourdillon JF, Day EA (1987) Spinal manipulation, 4th edition, William Heineman medical books, London, 216-217.)
John McMillan Mennell, MD, testified at the Wilk et al. v. AMA et al. antitrust trial also spoke of the role of joint function in LBP:
“When you are dealing with manipulative therapy in the spine…your objective is to try to restore the proper motion joint play, which is prerequisite to the normal function in the spine…If you don’t manipulate to relieve the symptoms from this condition of joint dysfunction, then you are depriving the patient of the one thing that is likely to relieve them of their suffering.”
Regrettably, despite the many studies supporting the use of manual medicine in the treatment of LBP/leg pain, Peul’s ill-begotten study will be used to dash the role of manual medicine in these cases. Peul’s omission of the best conservative care is reminiscent of the Tim Carey cost-comparison study comparing SMT by DCs, drugs by GPs, and modality treatments by PTs, but excluded back surgery by spine surgeons. (Carey TS, et al. The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons. NEJM 1995; 333:913-7.)
The recent guidelines for LBP issued by the American Pain Society also mentions grave concerns about back surgery:
“Some studies have shown no benefit of surgery compared with intensive interdisciplinary rehabilitation, with a significant proportion of patients experiencing suboptimal outcomes, including persistent pain or functional deficits after surgery. On the basis of the evidence, Dr. Chou said, they were unable to give strong recommendations for surgery, “but we think there may be some patients for whom surgery, fusion specifically, might be helpful, but it’s really important for doctors to discuss the fact that surgery doesn’t tend to lead to huge improvements on average,” he said. You’re talking about a 10- to 20-point improvement in function on a 100-point scale, so that’s pretty small, and a significant proportion of patients still need to take pain medication and don’t return to full function.” (Low Back Pain Guidelines Expanded to Include Interventional Procedures, American Pain Society 27th Annual Scientific Meeting: Symposium 312. Presented May 8, 2008.)
Rick Deyo suggests:
“I think we need to be more careful about using our treatments in unproven circumstances. Our data, showing increasing costs without apparent benefit, may be a consequence of ‘promiscuous prescribing’ in the broad sense,” he said. Offering poorly documented treatments may simply be counterproductive… Though some would say in the absence of proof we should do what seems reasonable, I would argue that we may be subjecting patients to side effects and costs without knowing if there’s a benefit.” (The BackLetter® 33 Volume 23, Number 3, 2008)
Dr. Tim Johnson, ABC World News medical spokesman, asks the appropriate question: “So why are so many back surgeries performed in this country?
“It could be a combination of too many surgeons who are too eager to operate and the impatience of many patients who want results quickly. The truth is that 90 percent of back pain can be resolved without surgery if both doctors and patients are willing to try other treatments that basically help the back to heal itself.” (Back Surgery Not Always the Cure for Pain; U.S. Leads the World in Procedures That Some Experts Say Could Be Avoided, by Dr. Timothy Johnson , ABC World News, May 23, 2006)
Perhaps Dr. Jerry Groopman answered Johnson’s question when he admitted:
“If I don’t do them, they’ll go around the corner and the other surgeon will.”
(The New Yorker magazine by Dr. Jerry Groopman, “Knife in the Back,“ (April 8, 2002)
Sadly, Peul’s skewed study and conclusion that disc surgery is cost-effective over so-called conservative methods is a disservice to the millions of back/leg pain patients seeking relief. Dr. Scott Haldeman of the BJD research study admits there are over 200 treatments now used for chronic LBP, which makes a formidable choice for consumers, but skewed studies like Peul’s only throws more confusion into this mess.
And the question of relapse has obvious implications in the clinical management of disc herniations. “Physicians guiding patients with sciatica should remember that the long-term prognosis may be less favorable than is suggested by the first impression after successful treatment,” Peul suggests.
Not only is the long term outcome for surgery no better than for conservative care, another factor is omitted to patients—the fact that most will still be living on pain pills, another point conveniently omitted by Peul.
“The definition of success did not consider pain relief or opioid medication use. Even among the patients classified as having a successful result, most were still using narcotic medications at the 2-year follow-up, including 64% of the successful-result patients in the disc replacement group and 84% in the fusion group.” (Mirza, Sohail K. MD, MPH, Point of View: Commentary on the Research Reports that Led to Food and Drug Administration Approval of an Artificial Disc, Spine: 30(14) 15 July 2005 pp 1561-1564.)
The fact is the drugs/shots/surgery approach to spinal pain has not proven effective, albeit very profitable. Peul’s misleading RCT did nothing to improve patient outcomes as much as it perpetuate mistaken beliefs and disparaged the benefits of “real” conservative care with his sham treatments.
“The world of spinal medicine, unfortunately, is producing patients with failed back surgery syndrome at an alarming rate…Despite a steady stream of technological innovations over the past 15 years—from pedical screws to fusion cages to artificial discs—there is little evidence that patient outcomes have improved.” (The BackLetter, vol.12, no. 7, pp.79 July, 2004. The BackPage editorial, The BackLetter, pp. 84, vol. 20, No. 7, 2005.)
The bias in Peul’s study is obvious to astute practitioners in this field. For too long practitioners of manual medicine have been ignored, marginalized, their methods have been deemed “experimental and unproven” despite the obvious good clinical results. Even when recent RCTs and international guidelines recommend manual medicine for spinal disorders, it is given short shrift by those who suffer from a professional prejudice.
Dr. Paul Goodley, orthopedic physician, author of Release from Pain, and long-time promoter of manual medicine, coined a term, Fundamental Flaw, concerning the antipathy of mainstream medicine to manual medicine that he contends as led to a pandemic of pain. I might add it has also led to a pandemic of unnecessary drugs, shots, spine surgery and skewed research.
“Eventually, the prejudice against manipulation self-perpetuated and evidence was always available to justify this attitude. There have always been [chiropractic] charlatans. So, instead of the manipulative fundamental dynamically developing as a cohesive, trustworthy guide within traditional medicine, it was discredited as the synonymous derelict symbol of its most despised competitor – chiropractic.”
Fairbank J, Prolapsed intervertebral disc, BMJ. 2008; epub ahead of print; 0:bmj. 3 9583.438773.80v1-bmj.39583.4387 73.80;
Peul WC et al., Surgery vs. prolonged conservative treatment for sciatica, New England Journal of Medicine, 2007; 356: 2245–56.
Peul WC et al. (a), Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two-year results of a randomized
controlled trial, BMJ, 2008; published online May 23, 2008; doi: 10.1136/bmj.a143; www.bmj.com/cgi/content/full/bmj.a143v1.
Peul WC et al. (b), Influence of gender and other prognostic factors on outcome of sciatica, Pain, 2008; epub ahead of print; www.ncbi.nlm.nih.gov/pubmed/