In response to our nation's opioid crisis claiming more than 70,000 lives annually, the CDC released a 56-page draft guideline detailing 12 recommendations for Prescribing Opioids for Chronic Pain for public comment in 2015. The NCCAOM, ASA, Acupuncture Now Foundation, Integrative Health Policy Consortium (IHPC), and other stakeholders and individuals responded to the CDC's request for feedback.
The Original Guideline (2016): What Happened?
However, to the surprise and general disgust of our profession, the CDC stripped the entire reference to complementary and alternative therapies in their final guideline published in 2016, and didn't refer to acupuncture even once throughout the document. That decision was clearly based on politics, not science.
The acupuncture community wrote in the concluding paragraph of its response to the proposed 2016 draft: "Considering the magnitude of the opioid crisis, non-opioid alternative approaches to the management of chronic pain that are shown to be safer, while of equal or superior clinical effectiveness to opioids, should not merely be categorized as a 'possible option.'"
Some of the concerns voiced by the pain management community were that the upper limits recommended in the guidelines as a rule of thumb would be misconstrued and applied as hard and fast limits, hamstringing practitioners in the treatment of chronic pain patients. And that's exactly what happened. Hard limits were imposed in 36 states, as well as by pharmacies and third-party payers (including Medicare).
The 2019 Advisory: Too Little, Too Late
Recognizing the unintended consequences of the guideline, the CDC issued an advisory in 2019 attempting to clarify their intentions and counter the misapplication of their dosage recommendations. Too little, too late.
Critics called it a catastrophic failure, while others just considered it a misguided attempt to regulate handing out opioids like candy. (There were 214,881,622 prescriptions written in 2016.) And while opioid dispensing rates substantially dropped between 2006 and 2020, the deaths have not.
Pundits suggest those who were addicted to prescription opioids transitioned over to illegal opiates (some laced with Fentanyl). In typical government fashion, they tried to solve one problem and inadvertently created another, in stark contrast to the genius of drug companies, whose carefully developed business model produces two income streams: one by killing people and another (Naloxone, etc.) to "save lives." (The Sackler family and Purdue Pharma recently agreed to pay an additional $1 billion to the settlement proposed at $4.5 billion, plus up to $500 million more.)1
In the opening letter to "The President's Commission on Combating Drug Addiction and the Opioid Crisis"2 written in 2017, the commission wrote: "Our people are dying. More than 175 lives lost every day. If a terrorist organization was killing 175 Americans a day on American soil, what would we do to stop them?" However, seeing that these homicides were perpetrated by a major campaign contributor, our legislators turned a blind eye.
2022: A Better Guideline? In Some Respects, Yes
Since the first guideline turned out to be colossal failure, the CDC decided to gather the original team from the National Center for Injury Prevention and Control and the Division of Unintentional Injury Prevention to write a new and improved guideline for 2022, released for public comment in February 2022. More than four times the length of the original document, but still containing 12 recommendations and clocking in at a yawn-inducing 211 pages, the authors emphasized that the guideline is not:
- A replacement for clinical judgment of individualized, person-centered care
- Intended to be applied as inflexible standards of care across patients, and/or patient populations by health care professionals, health systems, pharmacies, third-party payers, or governmental jurisdictions or to lead to the rapid tapering or discontinuation of opioids for patients
- A law, regulation and/or policy that dictates clinical practice or substitute for FDA-approved labeling
- Applicable to the following types of pain treatment: sickle cell disease-related pain;cancer pain, palliative care or end-of-life care
Shockingly, the authors included some of the suggestions made by the acupuncture community, IHPC and the Alliance to Advance Comprehensive Integrative Pain Management in their draft 2022 guideline.
They expanded their scope from chronic pain to the management of acute and chronic pain, and included recommendations to clinicians to discuss the known risks and benefits of opioid therapy; as well as establishing treatment goals for pain and function and considering how opioid therapy will be discontinued if the benefits don't outweigh the risks.
Additionally, under "implementation considerations," they addressed lack of access to our services, stating "[H]ealth insurers and health systems should increase access to noninvasive, nonpharmacologic therapies with evidence for effectiveness," recognizing that these therapies are "not always or fully covered by insurance." Thankfully, the CDC also stated, "Opioids should not be considered first-line or routine therapy for subacute or chronic pain."
The updated guideline refers to acupuncture approximately 30 times (not including the reference section), although it doesn't mention practitioner type or licensure, nor does it list acupuncturists under the definitions of "primary care provider" or "clinician." It recognizes the demand for our services by referring to a 2008 Gallup poll3 that found 78 percent of Americans preferred nonpharmacological therapies to address pain over prescribed pain medication; and a 2018 survey4 that indicated frequent use of complementary and integrative therapies for chronic pain.
The primary conditions for which the CDC evaluated effectiveness and comparative effectiveness for various therapies included chronic low back pain, hip pain, osteoarthritis of the knee, hip and hand, fibromyalgia and chronic tension headaches.
Again, to the credit of the CDC, they recommend that practitioners review the patient's history and context beyond the presenting pain syndrome and to focus on the root cause, such as improving glucose control in diabetic patients suffering from neuropathy. They also promote nonpharmacologic approaches such as exercise, cognitive behavioral therapy, mindfulness-based stress reduction, spinal manipulation, low-level laser therapy, massage, tai chi, qigong, myofascial techniques, yoga and massage.
I'm impressed that they follow Taoist philosophy in recommending active approaches (as opposed to passive ones like massage), to engage the patient to reduce pain and improve function.
What Still Needs Fixing
Unfortunately, they didn't address the strength of acupuncture in addressing the addiction aspect of opioid use, which is pretty myopic. Additionally, they based their "supporting rationale" on the Agency for Healthcare Research and Quality systematic reviews that cherry-picked (low quality) studies related to acupuncture and blatantly ignored studies that actually pitted acupuncture directly against opioids.
(Spoiler alert – a 2016 prospective, randomized trial titled "Acupuncture vs. Intravenous Morphine in the Management of Acute Pain in the ED" found that IV morphine had a 78 percent success rate compared with a 92 percent success rate for acupuncture, and the percentage of adverse effects between the two interventions was 56.6 percent in the morphine group and only 2.6 percent in the acupuncture group.)5
Another major failure in the new guideline (which we will point out in the IHPC response letter) is its complete lack of outcome measures of success. In 2016, there were approximately 70,000 deaths attributed to opioid overdoses, and more than 75,000 in 2021, although the pandemic certainly compounded issues related to the emotional component of pain.
The opioid crisis is certainly a multi-dimensional public health conundrum; however, in the research community, there's an unwritten rule to not pose a question to which you don't want to know the answer. Clearly this is not a casual oversight.
Again, as the authors emphasized, the guideline is not a law, regulation, or policy and therefore has no "teeth," compared with the 2018 Joint Commission pain assessment and management standards requiring accredited hospitals to provide "some nonpharmacologic treatment options relevant to their patient population" with examples that included acupuncture therapy.6
There's no question that our government, hospitals, physicians and allied health professionals are becoming aware of the value of acupuncture in the management of acute and chronic pain. However, the American health care system is quite rigid in its standard operating practices and resistant to change. The future is bright in that medical students and the Biden Administration are very open and interested in integrative approaches to pain, as well as health promotion and disease prevention.
"As rates of addiction and deaths from prescription and illicit opioids continue to rise as evidenced by the CDC National Center for Health Statistics, awareness and incorporation of effective, non-pharmacological, non-invasive therapies like acupuncture is more crucial than ever," said Mina Larson, chief executive officer of the NCCAOM.
"It is hopeful that the CDC draft 2022 Opioid Prescription guideline now references acupuncture, thanks to comments submitted by NCCAOM, ASA, IHPC and other organizations, but we have more work to do to ensure that CDC and all federal agencies acknowledge and recognize the value of acupuncture's effectiveness for treatment of acute and chronic pain.".
References
- Hoffman J. "Sacklers and Purdue Pharma Reach New Deal with States over Opioids." The New York Times, March 3, 2022. Click here to read
- The President's Commission on Combating Drug Addiction and the Opioid Crisis. Final Draft Report, Nov. 15, 2017. Click here to read
- Rosenberg EI, Genao I, Chen I, et al. Complementary and alternative medicine use by primary care patients with chronic pain. Pain Med, 2008;9(8):1065-1072.
- Grissa MH, Baccouche H, Boubaker H, et al. Acupuncture vs intravenous morphine in the management of acute pain in the ED. Am J Emerg Med, Nov 2016;34(11):2112-2116.
- Francois SJ, Lanier VM, Marich AV, et al. A cross-sectional study assessing treatment preference of people with chronic low back pain. Arch Phys Med Rehab, 2018;99(12):2496-2503.
- "Pain Assessment and Management Standards for Hospitals," effective Jan. 1, 2018. R3 Report (a publication of the Joint Commission), Aug. 29, 2017. Click here to read
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