WHO Releases First Guideline for Chronic Low Back Pain

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released its first-ever guideline for managing chronic low back pain, recommending treatments such as exercise, physical therapy, chiropractic care and non-steroidal anti-inflammatory drugs (NSAIDs).

Chronic low back pain — also known as “non-specific low back pain” — is defined as pain that persists longer than three months, with symptoms that cannot be accounted for by a structural spinal problem or disease process such as arthritis.

Although lower back pain (LBP) is the leading cause of disability worldwide – affecting about 619 million people – there has been little certainty about how to treat it. Almost all of the clinical trial evidence reviewed by WHO’s guideline development group was considered low or very low quality, a persistent problem.in many medical guidelines dealing with pain.

The lengthy 274-page guideline takes a dim view of some commonly used therapies for LBP, such as muscle relaxants, anticonvulsants, steroids, opioids, transcutaneous electrical nerve stimulation (TENS), and injectable anesthetics – treatments that are primarily used in high-income countries. WHO recommends a more holistic approach to LBP, using therapies that are affordable and accessible to more people.

"Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person's unique situation and the factors that might influence their pain experience," Dr. Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing, said in a press release. "We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care."

WHO recommends that adults with chronic LBP start with treatments that are the least invasive and least potentially harmful. The values and preferences of patients should also be considered, as they are more likely to adhere to therapies they consider helpful.  

Recommended Treatments for Chronic LBP

• Patient education and counseling

• Exercise or physical therapy

• Acupuncture or dry needling

• Spinal manipulation (chiropractic care)

• Massage

• Cognitive behavioral therapy or mindfulness

• NSAIDs

• Topical cayenne pepper

The guideline states that opioid analgesics “should never be used as a stand-alone treatment” for chronic LBP. When opioids are used alongside other therapies, the lowest dose should be prescribed and only for a short duration, according to WHO.

Recommendations against routine use are also made about many other pharmaceuticals, including antidepressants, anticonvulsants, muscle relaxers, glucocorticoids (steroids), weight loss drugs, and injectable anesthetics such as lidocaine or bupivacaine.  

No recommendations are made about benzodiazepines, cannabis or acetaminophen (paracetamol), primarily due to lack of evidence, but also because of potentially harmful side effects. Cayenne pepper is the only herbal remedy recommended by WHO.

The guideline does not address surgical procedures such as spinal fusions and spinal cord stimulators, or invasive procedures such as epidural injections.

WHO’s 25-member guideline development group included a broad range of clinical experts from around the world. Among them is Roger Chou, MD, a researcher and longtime critic of opioid prescribing who heads the Pacific Northwest Evidence-based Practice Center. Chou is a co-author of the 2016 and 2022 CDC opioid guidelines, and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group. Chou let his Oregon medical license lapse in 2022.

One of the clinical trials reviewed by WHO’s guideline group is a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with short-term back and neck pain. The OPAL study has been panned by critics because the treatment period only lasted six weeks and used a formulation of oxycodone that would not normally be used in clinical practice. Nevertheless, it’s been cited as evidence that “prolonged opioid use” is ineffective.

In 2021, WHO updated its guideline on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill. An earlier WHO guideline that recommended more pediatric use of opioids was withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  

Millions of People Worldwide Are ‘Left Behind in Pain’

By Pat Anson, PNN Editor

A new report by the World Health Organization (WHO) warns that limited access to morphine and other opioids is leaving millions of people in many parts of the world suffering in preventable pain.

The report, “Left Behind in Pain,” calls morphine a low cost, essential medicine for relieving moderate to severe pain. But access to morphine and other opioids is inadequate in many low and middle-income countries, with consumption patterns in wealthier nations that don’t correspond to medical need. Over 95% of the world’s supply of opioids is distributed in wealthy countries, with only 0.03% distributed in low-income ones.

“Leaving people in pain when effective medicines are available for pain management, especially in the context of end-of-life care, should be a cause of serious concern for policy-makers,” says Yukiko Nakatani, MD, WHO Assistant Director-General for Medicines and Health Products. “We must urgently advocate for safe and timely access to morphine for those in medical need through balanced policy, everywhere.”

The report calls for expanded access to morphine through local and regional distribution centers, changes in restrictive laws and guidelines, and reduced stigma surrounding opioid use.

“Some historical events, cultural beliefs, misinformation and disinformation about pain, and social stigma related to opioid use are known to have caused mistrust of opioids and contributed to fear of using them,” the report found.

Lawsuits and regulatory controls on the pharmaceutical industry are so strong in some countries that drug makers have stopped manufacturing morphine because the profit is low and risk of liability is high.

That may have played a role in Mundipharma’s recent decision to discontinue supplying Ordine, a liquid formulation of morphine, to Australia. Mundipharma is owned by the Sackler family, which has been enmeshed in opioid litigation over its role in the opioid crisis in the U.S. through its operation of Purdue Pharma.

A Mundipharma spokesperson told the Australia Broadcasting Corporation that the company’s third-party manufacturer decided to stop producing Ordine and that "sourcing another manufacturer would not be commercially viable."

Evolving Stance on Opioids

WHO’s position on opioids has evolved over the years. WHO’s guidelines for treating chronic pain, for example, used to say that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

That changed in 2019, after two U.S. congressmen – without any real evidence -- accused WHO of being “corruptly influenced” by opioid manufactures. WHO withdrew the guidelines a month later, citing “new scientific evidence” – although critics said caved in to political pressure and threats to withdraw U.S. funding of WHO.

In 2021, WHO backpedaled further, recommending that morphine only be given to sick children when they are dying. Physical therapy and “biopsychosocial” treatments such as cognitive behavioral therapy were suggested as alternatives for children who are in pain, but expected to live.

WHO’s latest report recognizes the potential harms of opioids, couched in language about the world facing two opioid crises.

“The world is facing two crises related to the use of opioids. In the first, inappropriate use and over-prescription combined with the wide availability of illicit unregulated opioids, such as fentanyl, in some countries is causing significant harm and loss of life. In the second, a lack of access to opioids such as morphine in many parts of the world means that millions of people continue to suffer preventable pain,” said Nakatani.

About 80% of the world’s morphine supply was consumed in North America in 2021, primarily in the United States, although the rest of the developed world is catching up. Opioid consumption in the U.S. has fallen so sharply in recent years that Canada, Australia and several European countries have become the highest consumers of opioid analgesics, according to a 2022 study that ranked the U.S. as being 8th in per capita opioid sales.

WHO Panel Finds Insufficient Evidence to Review Kratom

By Pat Anson, PNN Editor

An advisory committee of the World Health Organization (WHO) has concluded there is insufficient evidence to recommend a “critical review” of kratom, which potentially could have lead to international controls on the herbal supplement used by millions to treat pain and other medical conditions.

WHO’s Expert Committee on Drug Dependence (ECDD) recommended that kratom and its two active ingredients, mitragynine and 7-hydroxymitragynine, be kept under WHO surveillance. Under international treaties, WHO is required to give an annual assessment of psychoactive substances and advise the United Nations on whether they pose a public health risk.

The ECDD’s report said regular use of kratom can lead to dependence and mild withdrawal symptoms, but that serious adverse effects were rare. Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

“Kratom is used for self-medication for a variety of disorders but there is limited evidence of abuse liability in humans,” the ECDD said. “Kratom can produce serious toxicity in people who use high-doses, but the number of cases is probably low as a proportion of the total number of people who use kratom. Although mitragynine has been analytically confirmed in a number of deaths, almost all involve use of other substances, so the degree to which kratom use has been a contributory factor to fatalities is unclear.”

‘Great Victory for Kratom Consumers’

In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction. Kratom is legal in most states, although some states and communities have banned it. The Food and Drug Administration has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

The ECDD report was cheered by kratom advocates, including some who believe the FDA asked WHO to review kratom.

“It is a great victory for kratom consumers, for science and for the truth,” said Mac Haddow, a lobbyist for the American Kratom Association, a group of kratom vendors and consumers. "There can be no doubt that kratom should not be scheduled and that it should be responsibly regulated to protect against dangerously adulterated kratom products."

In a notice published in the Federal Register in July, the FDA called kratom “an increasingly popular drug of abuse” and said it was being “misused to self-treat chronic pain and opioid withdrawal symptoms.” Over 8,500 people responded to the FDA notice, most of them critical of the agency’s stance on kratom.

“When the FDA proposes that a natural substance like kratom be banned it is not because it’s dangerous to the public, it’s because it poses a threat to the pharmaceutical industries profits. These people have a financial interest in stopping a safe and natural substance from competing with high priced drugs,” wrote one anonymous poster.

“I suffer from chronic pain from an illness that no medication was able to help except for opioids. I became addicted, I lost my home and my job, and I was homeless for years dealing with an opioid addiction,” wrote Stewart Abe. “Kratom not only helps me get over that addiction, but it also helps me deal with the pain so I can be a functioning member of society. Without this plant in my life, the pain would be so horrific that it would not be worth living.”

“Kratom has helped countless people get away from addictive opioids and alcohol. It has all but saved my life from alcoholism and I haven’t drank in 8 years now,” wrote Davis Matthew. “Kratom has completely turned my life around and without it who knows how my life would have turned out.”

The legal status of kratom in Southeast Asia is mixed. In August, Thailand decriminalized kratom, dropped thousands of pending criminal cases involving the drug, and freed 121 inmates convicted of kratom crimes.

Hong Kong authorities recently banned kratom and seized a shipment of 2.5 tons of kratom powder that were enroute to Florida from Indonesia. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

WHO Guideline Only Recommends Opioids for Children Who Are Dying

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released new guidelines on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill and not expected to recover.

The 56-page guideline calls access to pain management a “fundamental human right,” while at the same time warning that “evidence of the effectiveness and safety of opioids is completely lacking in children.”

The guideline emphasizes the use of physical and psychological pain therapies, while taking a cautious approach to opioids. Morphine is only recommended for children in palliative care and those with “life-limiting” conditions for which there is no cure and “an early death is expected.”

“Children who are appropriately prescribed morphine for chronic pain in the context of end-of-life care or in children with life-limiting conditions, may require morphine for the management of intercurrent, acute or breakthrough severe pain,” the guideline states.

“Time-limited use of morphine in these contexts should be at the lowest appropriate dose and duration possible and must be regularly reviewed in order to ensure the fewest possible adverse events. Healthcare providers and caregivers need to perform frequent and repeated reassessments of pain and other symptoms, and the principles and relevant guidelines for acute pain management should be followed, including having an opioid stopping plan.”

The new recommendations for children between 0 and 19 years of age are a marked departure from previous WHO guidelines for chronic pain, which said that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Those guidelines were withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  A coalition of palliative care organizations objected, saying WHO caved-in to political pressure.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement. “Lack of availability and limited access to these medications for legitimate medical treatment is a human rights violation.”

‘Very Low Certainty’ of Evidence

Most of the recommendations made by a WHO advisory panel – the Guideline Development Group (GDG) — are vague, conditional and based on “very low certainty” of evidence. One of GDG’s members was Andrew Kolodny, MD, a psychiatrist and addiction specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Despite an admitted “paucity of high-quality research” on how to treat pain in children, the GDG recommended that children be treated from a “biopsychosocial perspective” that incorporates physical therapy and psychological interventions such as cognitive behavioral therapy.  

“Children with chronic pain and their families and caregivers must be cared for from a biopsychosocial perspective; pain should not be treated simply as a biomedical problem,” the GDG said.

There is surprisingly little discussion in the guideline about the risks and benefits of non-opioid drugs such as acetaminophen. Some of the recommendations border on platitudes, such as treatment being “child and family-centered” and “tailored to the family’s values, cultures, preferences and resources.”

One area where the GDG is adamant is the importance of treating childhood pain to prevent it from becoming a lifetime problem.

“Exposure to chronic pain in early life may have implications for the incidence, severity and duration of chronic pain, and may be associated with long-term, maladaptive neurological changes,” the guideline warns.

“Chronic pain in childhood is associated with progression of pain into adulthood and potentially predisposes these children to other chronic health problems in later life. The negative impacts of chronic pain also extend to family members who report a higher burden of care and a detrimental effect on family function. As such, chronic pain during childhood has a very significant negative impact on the child over their life course as well as their wider family unit, making appropriate diagnosis and management essential.”  

The GDG said large, multi-center trials are needed to examine the safety and efficacy of virtually all pain management therapies. Additional research is also needed for children suffering from cancer pain and those with developmental and intellectual disabilities.

Former President Trump withdrew the United States from WHO last year in a dispute over its handling of the COVID-19 pandemic. President Biden reversed that decision on his first day in office.  

WHO Criticized for Withdrawing Opioid Guidelines

By Pat Anson, PNN Editor

A coalition of international palliative care organizations is protesting a decision by the World Health Organization (WHO) to withdraw two guidelines for treating pain with opioid pain medication.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement released this week.

The guidelines were withdrawn after two U.S. congressmen released a report that accused WHO of being “corruptly influenced” by Purdue Pharma and other opioid manufactures when it developed the guidelines in 2011 and 2012. The guidelines for treating pain in adults and children state that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY) said the WHO guidelines served as “marketing materials” for Purdue, the maker of OxyContin.

“We are highly troubled that, after igniting the opioid epidemic that cost the United States 50,000 lives in 2017 alone… Purdue is deliberately using the same playbook on an international scale,” the report said. “If the recommendations in these WHO guidelines are followed, there is significant risk of sparking a worldwide public health crisis.”

WHO withdrew the guidelines a month after the report was released, citing “new scientific evidence” that emerged since their publication.

WHO’s decision to withdraw the guidelines gave credibility to a congressional report based largely on innuendo, according to the statement released by over a hundred palliative care organizations, including the American Academy of Hospice and Palliative Medicine and the UK-based International Observatory on End of Life Care.

“The report contains serious factual inaccuracies and draws inaccurate and unfair conclusions. It includes misleading information, and by making false accusations of existing collaborations and alliances to advance pain relief and palliative care, concludes that there was corruption within WHO,” the coalition said. “No staff member of the offices of the U.S. representatives contacted any of the organizations or individuals mentioned in the document to seek our responses to the allegations made in the report.”

According to the coalition, the withdrawal of the guidelines could further impede the availability of pain medication in third world countries, where less than 2% of palliative care patients have access to opioids.

“Under-treatment of severe pain is reported in more than 150 countries,” the coalition said. “At least 5 billion people live in countries affected by the crisis of under-consumption, and more than 18 million annually die with untreated, excruciating pain.”

The coalition cited the case of a cancer patient in New Delhi, India, who wanted to die until she was able to obtain opioids through a CanSupport palliative care program.  

“I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take.”

— Cancer patient in New Delhi, India

“I was a human wreck. My family was at their wits end as to how to help me. Because of my excruciating pain, I could not sit, sleep, eat or drink, let alone speak or think. When the team first met me my first request to them was for an injection that would put me out of my misery,” the patient said.

“Today, I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take on a regular basis.”

The palliative care coalition said it was unfair to deny opioids to patients in third world countries because of abuse and addiction problems in the U.S. and other developed nations.  The coalition called on WHO to update and revise the guidelines “with all deliberate speed” and to reinstate them until the revisions are made.

WHO Recognizes Chronic Pain as Disease With New Coding System

By Pat Anson, PNN Editor

The World Health Organization has adopted a new classification system for chronic pain, assigning it the code ICD-11 in a revision of the International Classification of Diseases (ICD). It’s the first time the ICD will include a specific diagnostic code for chronic pain, along with sub-codes for several common chronic pain conditions. 

The new classification system is important because it treats chronic pain as a distinct health condition and as a symptom to an underlying disease. It also takes into account the intensity of pain, pain-related disability, and psychosocial factors that contribute to pain.

“The inclusion of the new classification system for chronic pain in ICD-11 is an important milestone for the pain field,” says Lars Arendt-Nielsen, MD, President of the International Association for the Study of Pain (IASP), which headed a task force that developed ICD-11.

The new coding system will make it easier for physicians to diagnose, classify and get treatment for chronic pain patients. Insurers will use the new codes to authorize payments and researchers can use them to more easily track and measure the effectiveness of therapies. That’s the good news. 

The bad news is that the ICD changes won’t formally take effect until January 1, 2022. 

Under the current system, chronic pain conditions are poorly categorized under the code ICD-10, which makes it difficult for complex conditions such as fibromyalgia and Complex Regional Pain Syndrome (CRPS) to be classified. That led some physicians to diagnose patients with unexplained pain as having a somatic symptom disorder. 

“A diagnosis of somatic symptom disorder implies that the pain is caused by a behavioral, that is, mental condition. However, it is not appropriate to diagnose individuals with a mental disorder solely because an alternative medical cause cannot be established,” Jaochim Scholtz, MD, an IASP task force member, explained in Practical Pain Management.  

Under the new coding system, patients with fibromyalgia or CRPS could be classified as having a “primary pain” disorder, one of seven new sub-codes for chronic pain conditions:

1. Chronic primary pain

2. Chronic cancer-related pain

3. Chronic post-surgical or post-traumatic pain

4. Chronic neuropathic pain

5. Chronic secondary headache or orofacial pain

6. Chronic secondary visceral pain

7. Chronic secondary musculoskeletal pain.

There is some overlap between the different diagnostic codes. For example, neuropathic pain can be a symptom of cancer or chemotherapy, while trigeminal neuralgia could fall under neuropathic or orofacial pain. The idea is to give physicians a range of codes to choose from instead of the limited choices they have today.

“The integration of chronic pain in ICD-11 sends a strong signal that pain will achieve appropriate representation in this international standard for reporting diseases and health conditions,” said Scholtz. “The coding system also provides fundamental information for the identification of health trends and healthcare planning. It is widely hoped that the new systematic classification of chronic pain in the ICD-11 will support epidemiological, and other research that is essential for the development of future health policies.”

The classification system was outlined in a free online article published in the January 2019 issue of PAIN.