The American opiate crisis and its resulting heroin/fentanyl addiction epidemic began in 1980 when the prestigious medical journal, The New England Journal of Medicine, indicated that “less than one percent” of patients given opiate drugs for pain became addicted (1). Sadly, this statistic was not based on valid scientific data. It was based on a short letter-to-the editor by physicians Jane Porter, MD, and Hershel Jick, MD, from Boston University Medical Center. This publication began the relentless marketing of opiate drugs for pain, supported by the concept that these drugs were not addictive.
Six years later, in 1986, prescribing opiates for chronic pain was further enhanced when physicians Russell Portenoy, MD, and Kathleen Foley, MD, published a small case series (38 subjects) that concluded that chronic opioid analgesics use was safe in patients with no history of drug abuse (2).
Yet, it is stunning to realize that until this year (2017), there were no published studies of opiate therapy for chronic pain that evaluated long-term (greater than one year) outcomes related to pain, function, or quality of life. Most of the placebo-controlled randomized clinical trials pertaining to opiate drugs were less than six weeks in duration (3).
The current issue of The Back Letter (July 2017) profiles the use of opiate drugs for chronic back pain with the headline (4):
Landmark Trial Punctures the Myth That Opioids Provide Powerful Relief of Chronic Pain
The opening comments from this article are:
“The deadly opioid overtreatment epidemic picked up steam in the late 1980s and early 1990s with the misguided notion that opioids are painkillers that can be used safely and effectively in the long-term treatment of chronic back pain—or other forms of non-cancer chronic pain.”
“The intervening years—and as many as 300,000 deaths in the related opioid overdose epidemic—have rebutted the idea that opioids can be used safely on a mass basis. More than 30,000 Americans will die in 2017 as the result of opioid overdoses. And the opioid overdose epidemic is still increasing in ferocity in many quarters.”
The landmark trial referenced is the first randomized controlled trial (RCT) with long-term follow-up comparing opioids with non-opioid medications. It is from the Minneapolis Veterans Health Care System (5). The authors found that opioids provided no better pain relief for patients with low back pain than other safer approaches. Comments pertaining to the study include (4):
“It is the first clinical trial comparing opioid and non-opioid medications with long-term follow-up. It provides strong evidence that opioids should not be the first line of treatment for chronic musculoskeletal pain, given that there were similar changes in pain and function with non-opioids.”
“A lot of people at the conference were impressed with this study, as it confirmed the clinical impressions of many physicians that opioids are not as effective as advertised.”
“Opioids are perceived as strong pain relievers, but our data showed no benefits of opioid therapy over non-opioid medication therapy for pain.”
“Opioids provided no advantage in terms of function at the 12-month follow-up mark, and patients in the opioid wing of the study actually reported marginally more pain at 12 months than those in the non-opioid group.”
“The data do not support opioids’ reputation as powerful painkillers.”
“Opioids are not achieving the benefits for which they are marketed. And everyone is now well aware of the adverse effects of opioids.”
A related article from the same issue of The Back Letter is titled (4):
What If the New Opioid Study Had Been Published In 1995?
How Many Lives Would Have Been Saved?
Comments from this article note that the opiate drug movement has been one of the most “destructive” and “among the most lethal in modern medical history.” The article notes:
“Had this study been conducted and published in 1995, it might have saved 300,000 lives or more—lives lost to opioid overdoses.”
“The opioid overtreatment epidemic and resulting heroin/fentanyl addiction epidemic continues to kill more than 30,000 US residents per year. And with an estimated eight million Americans on long-term opioid therapy, this issue may bedevil US society for decades.”
Opiate drugs continue their grip on America. As of this year (2017), four states (Missouri, Mississippi, Ohio, Illinois) have officially sued several of the drug company producers of opiates in an effort to recapture compensation for societal devastation caused by these drugs (6). Interestingly, these lawsuits against the drug companies are also being filed at the local level. Santa Clara County (Northern California) and Orange County (Southern California) have filed similar lawsuits in an effort to recapture some of the incredible local financial burdens associated with the opiate drug epidemic. American Indian reservations are taking a similar approach (6).
In spite of all of this, opiate drugs continue to be overly prescribed for patients with back pain (13). Yet, over the past decade, Clinical Practice Guidelines for the treatment of back pain have increasingly moved away from prescribing drugs, especially opiates, and have emphasized more on the non-drug approaches to the back pain problem:
Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
Clinical practice guidelines define the role of specific diagnostic and treatment modalities in the diagnosis and management of patients.
Clinical practice guideline recommendations are based on evidence from rigorous systematic reviews and synthesis of the published medical literature.
The October 2007 issue of the journal Annals of Internal Medicine published the comprehensive and authoritative (7, 8):
Clinical Guidelines for the Diagnosis and Treatment of Low Back Pain
An extensive panel of qualified experts constructed these clinical practice guidelines. These experts performed a review of the literature on the topic and then graded the validity of each study. The literature search for this guideline included studies from MEDLINE (1966 through November 2006), the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, and EMBASE. This project was commissioned as a joint effort of the American College of Physicians and the American Pain Society. The results of their efforts are summarized in two separate articles. The first article is (7):
Diagnosis and Treatment of Low Back Pain:
A Joint Clinical Practice Guideline from the
American College of Physicians and the American Pain Society
Recommendations from these guidelines include:
This publication notes that acceptable non-pharmacologic options for acute, subacute, and chronic low back pain include spinal manipulation. In fact, spinal manipulation is the only non-drug treatment recommendation for acute low back pain in this document. The article notes:
For acute low back pain (duration 4 weeks), spinal manipulation administered by providers with appropriate training is recommended.
“For chronic low back pain, moderately effective non-pharmacologic therapies include acupuncture, exercise therapy, massage therapy, yoga, cognitive-behavioral therapy or progressive relaxation, spinal manipulation, and intensive interdisciplinary rehabilitation.”
The second guideline article was also in the October 2007 issue of the journal Annals of Internal Medicine. At the time (a decade ago, 2007), it was the most comprehensive review of the literature concerning non-drug therapies used in the treatment of low back pain. It was titled (8):
Non-pharmacologic Therapies for Acute and Chronic Low Back Pain:
A Review of the Evidence for the American Pain Society and
the American College of Physicians Clinical Practice Guideline
This article defines spinal manipulation as:
“Manual therapy in which loads are applied to the spine using short- or long-lever methods. High-velocity thrusts are applied to a spinal joint beyond its restricted range of movement.”
Spinal mobilization was defined as:
“Low-velocity, passive movements within or at the limit of joint range.”
These authors note that there are many non-pharmacologic therapies available for treatment of low back pain. They therefore assessed the benefits and harms of acupuncture, back schools, psychological therapies, exercise therapy, functional restoration, interdisciplinary therapy, massage, physical therapies (interferential therapy, low-level laser therapy, lumbar supports, shortwave diathermy, superficial heat, traction, transcutaneous electrical nerve stimulation, and ultrasonography), spinal manipulation, and yoga for acute or chronic low back pain (with or without leg pain). These authors note:
There is “good evidence that cognitive-behavioral therapy, exercise, spinal manipulation, and interdisciplinary rehabilitation are all moderately effective for chronic or subacute (4 weeks’ duration) low back pain.”
“For acute low back pain (4 weeks’ duration), the only non-pharmacologic therapies with evidence of efficacy are superficial heat and spinal manipulation.”
In this review, the only non-drug treatment that has proven evidence to benefit acute, subacute, and chronic back pain is spinal manipulation.
The Council on Chiropractic Guidelines and Practice Parameters have been in continuous development since 1995. The most recent update appeared in the Journal of Manipulative and Physiological Therapeutics in 2006, and is titled (9):
Clinical Practice Guideline:
Chiropractic Care for Low Back Pain
This publication is the most recent update of the best practice recommendations for chiropractic management of low back pain; the update included 80 references. The participants continue to perform a systematic review of published articles on the topic, as well as to entertain input from multidisciplinary experts who represent a broad sampling of jurisdictions and practice experience related to low back pain management. The panel used the RAND-UCLA methodology to reach a formal, robust consensus position. The process and review is comprehensive and detailed. The conclusion of the process is:
“The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.”
In February 2017 the European Journal of Pain published a study titled (10):
Clinical Practice Guidelines for the
Noninvasive Management of Low Back Pain:
A Systematic Review by the Ontario Protocol for
Traffic Injury Management (OPTIMa) Collaboration
These authors performed an extensive search of published Low Back Pain Guidelines published between 2005 and 2014. Their conclusions include:
“Most high-quality guidelines target the noninvasive management of nonspecific low back pain and recommend education, staying active/exercise, manual therapy, … as first-line treatments.”
These Guidelines advocate manual therapy for low back pain. They define manual therapy as the application of either manipulation or mobilization. They state:
“Manual therapy, including spinal manipulation or mobilizations.”
The evolving nature of Low Back Evidence Based Practice Guidelines is best represented in another study published in April of 2017 in the journal Annals of Internal Medicine, and is titled (11):
Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain:
A Clinical Practice Guideline From the American College of Physicians
The American College of Physicians developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain. The committee based their recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and non-pharmacologic treatments for low back pain. Updated literature searches were performed through November 2016 and included in their review. The article included 182 references.
The authors note that the target audience for this guideline included all clinicians; the target patient population includes adults with acute, subacute, or chronic low back pain. These authors note:
“…clinicians and patients should select from superficial heat, massage, acupuncture, or spinal manipulation…”
“For patients with chronic low back pain, clinicians and patients should initially select non-pharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.”
“Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients.”
“Low-quality evidence showed no difference between acetaminophen and placebo for pain intensity or function through 4 weeks or between acetaminophen and NSAIDs for pain intensity or likelihood of experiencing global improvement at 3 weeks or earlier.”
This most recent Guideline for Low Back Pain clearly emphasized “non-pharmacologic treatment” which included spinal manipulation. Consistent with other recent Guidelines, there is a de-emphasis for the use of acetaminophen. In addition, there is a clear warning about the use of opiate drugs for these patients.
As noted above, Clinical Practice Guidelines are systematically developed based upon “evidence from rigorous systematic reviews and synthesis of the published medical literature.” As such, additions to the published medical literatu