Can Herbal Supplements Effectively Relieve Pain?

Drs. Nial Wheate and Joanna Harnett, University of Sydney

In an era where chronic pain affects millions worldwide, the search for effective and safe pain relief has never been greater.

PanaNatra is a line of herbal products from Haleon, the makers of Panadol. Haleon claims the three PanaNatra’s products, made from plant extracts, help manage and provide relief from mild joint aches, mild muscle pain, and mild pain affecting sleep.

They contain different combinations of four plants:

• Boswellia serrata (contained in the joint and muscle products)

• Curcuma longa (in the joint and muscle products)

• Piper nigrum (just in the joint product)

• Withania somnifera (just in the sleep product).

These products are “listed medicines” in Australia. This means the ingredients are considered broadly low risk, have been used in traditional medicine, and are manufactured to a high standard. But the manufacturer has not provided evidence to the government regulator that they work.

So can herbal ingredients effectively and safely relieve different types of pain? Let’s consider the evidence for the four main ingredients.

Boswellia serrata

Indian Frankincense (Boswellia serrata) has been described in traditional Indian Ayurveda texts since the 1st century AD. Key active compounds derived from the gum resin of the tree called boswellic acids are thought to have anti-inflammatory effects.

The Boswellia serrata dry concentrate extract (Rhuleave K) used in the Muscle Pain product contains 50 mg of the herb per tablet, whereas the Joint Pain product includes 33.3 mg as a different formulation (Apresflex).

Boswellia serrata

A review of various human clinical trials using a range of formulations of this herb supports its ability to reduce some types of pain and improve function in osteoarthritis. But a key finding of the study was that improvement only begins when Boswellia serrata is used continuously for four weeks and at a dose of at least 100–250 mg per day.

In a clinical trial, 100 mg daily of a Boswellia serrata gum-based product was found to reduce pain and improve physical functions for people with osteoarthritis.

Curcuma longa

Turmeric (Curcuma longa) has been used in Chinese and Indian medicine for at least 2,000 years. It contains a well-known chemical called curcumin, a natural compound used for its anti-inflammatory properties, especially for osteoarthritis.

Turmeric compounds such as curcumin are often combined with Boswellia serrata compounds to improve their anti-inflammatory effects to reduce pain.

Curcuma longa

A review of 16 different clinical trials found turmeric extracts were effective for knee osteoarthritis.

A similar conclusion was drawn from a review of 11 clinical trials which examined the use of curcuminoids (of which curcumin is one) for one to four months. It found curcuminoids had similar pain-relieving qualities as non-steroidal anti-inflammatory based drugs.

Piper nigrum

Black pepper (Piper nigrum) contains the chemical piperine, which has anti-inflammatory properties.

Piper nigrum is often added to curcumin products to improve the absorption of curcumin, as is the case with the PanaNatra Joint Pain product.

Piper nigrum

For musculoskeletal pain, a preliminary human trial that examined the effects of a 1,000 mg daily dose of Rhuleave K (the extract used in PanaNatra) found it was as effective as paracetamol.

But the study was not placebo-controlled and the dose of paracetamol given (1,000 mg per day) was below the recommended daily intake for pain relief. 

Withania somnifera

Withania somnifera (also called Ashwagandha) has been used in traditional Indian Ayurvedic medicine for thousands of years to reduce stress and ease inflammation.

One of the key chemicals appears to be withaferin A, which interferes with the inflammatory signalling pathway.

Withania somnifera

PanaNatra’s Pain and Sleep product contains 300 mg per tablet of a Withania somnifera extract called KSM66.

A human trial found a daily 600 mg dose of Withania somnifera extract improved sleep quality and helped in managing insomnia.

In a separate trial, Withania somnifera was found to improve sleep quality, again when administered at a dose of 600 mg per day.

Does Herbal Medicine Work?

Whether, and how well, a herbal medicine works is largely dependent on the formulation (how it’s made and the extract used) and the dose provided. The same herb used in one formulation may result in a different outcome than a different formulation containing the same herb.

It’s also important to note that effectiveness for one type of pain does not mean a product will work for other types of pain.

Overall, similar herb extracts to those that have been included in the PanaNatra products do have some evidence that they work for pain and sleep. Whether they work for you will depend on a number of factors including the effectiveness of the PanaNatra formulation, how much you take, and the extent of your pain.

Is It Safe?

PanaNatra needs to be used carefully by some patients.

Overall, there is insufficient human data to recommend any of these herbal ingredients in pregnancy or lactation. In fact there is some evidence that Withania somnifera may be unsafe to use in pregnancy, and other than the amounts commonly found in food, turmeric and its compounds are not considered safe to use in pregnancy either.

The herbs may also impact the effectiveness and safety of other medicines. For example, the blood levels of the cancer drug tamoxifen may be reduced when taken concurrently with turmeric supplements.

Withania somnifera has been associated with drowsiness and cases of liver toxicity.

Curcuma longa products, including formulations containing curcumin and piperine, have also been associated with liver toxicity. As such, Australia’s Therapeutic Goods Administration has proposed adding warning labels to any products that contain those ingredients. But this discussion is ongoing and a decision won’t be made until next year.

While there is a long history of traditional use of the herbs in the PanaNatra products, there is limited high-quality scientific evidence for the effectiveness and safety for these specific products.

Pregnant and breastfeeding women should not take these products, and you should not exceed the daily dose recommended by the manufacturer.

If you have an underlying health condition, or are taking other medication, before you try them, consult your doctor or pharmacist to check if these products are suitable for you.

Nial Wheate, PhD, is an Associate Professor at the University of Sydney’s School of Pharmacy. He is a Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association.

Joanna Harnett, PhD, is a Senior Lecturer at University of Sydney’s Faculty of Medicine and Health Pharmacy School, where she teaches and conducts research in the field of traditional, complementary, and integrative medicine.

This article originally appeared in The Conversation and is republished with permission.

Herbal Pain Relief Tea Recalled for Having Undeclared Drugs

By Pat Anson, PNN Editor

“Alleviates Pain & Inflammation Within 10 Minutes”

“Drug-Free All Natural Herbal Pain Relief”

As the saying goes, if the ads sound too good to be true, they probably are. Especially the part about being “drug-free.”

An herbal tea being marketed as a pain reliever for arthritis, gout, fibromyalgia and migraine is being voluntarily recalled after the Food and Drug Administration found that it contained “undeclared drugs.”

WS Global, a New York-based distribution company, is recalling all packages of Himalayan Pain Relief Tea after being informed by the FDA that the tea contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone, a corticosteroid.

The company said it had not received any reports of adverse events involving the tea, but urged consumers to “immediately consult their health care professional” if they consumed it.

In a news release, the FDA said diclofenac may raise the risk of cardiovascular events, such as a heart attack or stroke, and could interact with other medications.

Dexamethasone can suppress the adrenal gland, impair a person’s ability to fight infections, and cause high blood sugar, muscle injuries and psychiatric problems. It may also have serious side effects when combined with other medications.

Neither diclofenac or dexamethasone are mentioned on the tea’s product label or advertising. The company claims the tea was “formulated by a traditional comprehensive recipe from the Himalayan monks.”

Himalayan Pain Relief Tea was being sold online, primarily through Amazon.

This is not the first time that an herbal or dietary supplement sold by Amazon was recalled due to undeclared drugs, contamination or other health concerns. In recent months, recalls were also ordered for a male sexual enhancement product, a glucose supplement, apple sauce, and an anti-cavity mouthwash for kids. All were being sold on Amazon.  

In a recent warning letter to Amazon’s CEO about selling several brands of unapproved eye drops, the FDA said the company should take more responsibility for the products it sells.

“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” said Jill Furman, Director of the FDA Office of Compliance, Center for Drug Evaluation and Research.

Amazon complied with that request by removing the eye drops from its online marketplace.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” the company said in a statement.

Amazon received a similar warning letter in 2022, for selling a “misbranded” dietary supplement for arthritis that was linked to liver toxicity and at least one death. That product also contained diclofenac and dexamethasone.

You can still find Himalayan Pain Relief Tea on Amazon, with a notation that it is “currently unavailable.”

“We don't know when or if this item will be back in stock,” Amazon cautions potential buyers.

Most Americans and Canadians Use OTC Drugs and Self-Care for Pain Relief

By Pat Anson, PNN Editor

Most Americans and Canadians who experience pain prefer over-the-counter drugs, exercise and bed rest over prescription pain medication, according to a large new survey. A surprising number of respondents said they do nothing or simply accept their pain.  

The online survey, led by a research team at Ontario’s Western University, asked over 4,100 adults in 2020 what types of treatment, medication or self-care methods they use to deal with or prevent pain. Respondents were given ten different pain management techniques to choose from.

The survey findings, published in the journal Innovation in Aging, show that most people use a combination of methods for pain relief, along with a healthy dose of stoicism. Over half said they use OTC pain relievers, often in combination with self-care techniques such as exercise, bed rest or physical therapy.

Over 41% selected “just live with pain” and 10% chose “do nothing” – which essentially amounts to pain acceptance.

Only one in four (24%) said they use prescription pain medication. Not surprisingly, respondents who said they had high pain levels were over four times as likely to use a prescription drug  

SOURCE: INNOVATION IN AGING

The responses from Americans and Canadians were similar, with one notable exception. Americans were twice as likely than Canadians to turn to alcohol to dull their pain, with just under 4% of Canadians using alcohol as a pain management strategy, compared to almost 8% in the U.S. Alcohol use jumped to 21% for those with the highest levels of pain in both countries.

"Our research shows that using alcohol to treat pain is somewhat common, unfortunately. Previous research has shown that is not only ineffective at treating pain, but it can actually be counterproductive," said lead author Anna Zajacova, PhD, a demographer and sociology professor at Western University. "Our study also indicates that there is likely a lot of unmet need for better treatment options for people to manage their pain."

Zajacova and her colleagues noted that high alcohol use in the U.S. may be a reflection of more limited access to healthcare than in Canada, which has a national health system.

"What we learned from this survey is that people aren't necessarily just visiting their doctor to manage their pain, and it's important to understand the non-medical and non-pharmacological strategies that people are using, for better or for worse," said Zajacova.

A major weakness of the study, which the authors acknowledge, is that they did not differentiate between acute, short-term pain and chronic pain. They also didn’t ask if the prescription pain medication used was an opioid or non-opioid.

Pharmacies Under ‘Extreme Pressure’ to Give Patient Records to Law Enforcement

By Pat Anson, PNN Editor

Three of the nation’s largest pharmacy chains -- CVS, Kroger and Rite Aid – allow staff in their pharmacy stores to routinely hand over prescription records to law enforcement without a warrant, according to congressional investigators. In most cases, pharmacy customers are never informed that their medical records have been provided to law enforcement or why they were being sought.   

The policies were revealed in a joint letter sent to Health and Human Services Secretary Xavier Becerra by Sen. Ron Wyden (D-OR) and Reps. Pramila Jayapal (D-WA) and Sara Jacobs (D-CA), who have been looking into the privacy practices of major pharmacy chains.

“Americans' prescription records are among the most private information the government can obtain about a person. They can reveal extremely personal and sensitive details about a person’s life, including prescriptions for birth control, depression or anxiety medications, or other private medical conditions,” Wyden, Jayapal and Jacobs wrote in their letter, which was first reported on by The Washington Post.

Congressional investigators asked eight major pharmacy chains about their policies for dealing with law enforcement requests for prescription records. Five of them — Amazon Pharmacy, Cigna, Optum Rx, Walmart and Walgreens —- said the requests are automatically reviewed by legal professionals before responding.

“The three remaining pharmacy chains — CVS Health, The Kroger Company, and Rite Aid Corporation — indicated that their pharmacy staff face extreme pressure to immediately respond to law enforcement demands and, as such, the companies instruct their staff to process those requests in the store,” the letter said.

“CVS Health and the Kroger Company both defended this practice, arguing that their pharmacy staff — who are not lawyers or paralegals — are trained to respond to such requests and can contact the legal department if they have questions.”

All eight pharmacy chains said they do not require a warrant to share pharmacy records, unless there is a state law that dictates otherwise. Only three states – Louisiana, Montana and Pennsylvania – have laws that require a warrant signed or reviewed by a judge before medical data is disclosed.

HIPAA Privacy Issues

Law enforcement agencies are not covered by the Health Insurance Portability and Accountability Act (HIPAA), which protects patient privacy. The pharmacy chains are covered by HIPAA, but say they are exempt under HHS regulations that allow healthcare providers to disclose patient records to law enforcement if it is obtained through a subpoena or a simple administrative request. Unlike warrants, subpoenas generally do not require a judge’s approval.

Congress began looking into the HIPAA policies of pharmacies after the U.S. Supreme Court overturned Roe v Wade, leaving it up to individual states to make their own laws about abortion. Some medications that induce abortions are now banned in certain states.

But the Drug Enforcement Administration and other law enforcement agencies were showing a keen interest in obtaining prescription records long before Roe v Wade was overturned. In 2020, the DEA solicited bids from contractors for a prescription drug surveillance program that would identify virtually every patient, prescriber and pharmacy that may be diverting or abusing opioids and other controlled substances.

Under the proposed surveillance program, DEA investigators would have “unlimited access” to prescription data, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment. The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to identify them.

No contract was awarded by DEA and it’s unclear if the surveillance program was ever initiated. State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA was seeking, but law enforcement access to the data usually requires an active investigation or warrant.

Regardless of the method used, some pain patients with a history of needing high-dose opioid prescriptions have suspected they are being tracked by the DEA as a way to gather evidence on their doctors.

“I have talked to many patients who described things that made them believe this was occurring,” says Anne Fuqua, a disabled nurse in Alabama who needs high-dose opioids for intractable pain. At least two of Fuqua’s out-of-state physicians have been raided by the DEA and driven from medical practice without criminal charges ever being filed against them.

She’s pleased that Congress is looking into HIPAA issues at the pharmacy level, but feels that law enforcement already has easy access to patient information.  

“I'm glad that the huge potential for intrusion into a person's medical care is finally attracting attention,” Fuqua told PNN. “There are many states like Alabama where state and local law enforcement can access PDMP by simply affirming there is an active investigation in process. As long as some states permit unfettered access to the PDMP by law enforcement, the police and DEA don't really even need to contact the actual pharmacy for records related to controlled substances.”

Of the eight pharmacy chains contacted by congressional investigators, only Amazon said it automatically notifies customers if a law enforcement agency asked for their medical records, unless there is a legal reason not to do so.

Under the HIPAA Act, every American has the right to ask a healthcare provider if their medical information has been disclosed. Few people do, however. CVS said it received only a “single-digit number” of consumer requests last year.  A CVS spokesman told The Washington Post that most law enforcement requests come with a directive that they be kept confidential.

Pharmacies already face enormous scrutiny over their dispensing of opioid pain medication. Under the national opioid settlement, drug wholesalers have to limit the amount of opioids supplied to each pharmacy and are required to collect from pharmacies a list of suspicious orders and red flags that may indicate drugs are being abused or diverted. Pharmacies that don’t comply risk being “terminated” by their suppliers.

Wyden, Jayapal and Jacobs say more privacy protections are needed for pharmacy customers.

“We urge HHS to consider further strengthening its HIPAA regulations to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles. Pharmacies can and should insist on a warrant, and invite law enforcement agencies that insist on demanding patient medical records with solely a subpoena to go to court to enforce that demand,” they wrote.

Can Antivirals Prevent Long Covid?

By The Conversation

Evidence is continuing to accumulate on the burden and frequency of chronic effects after a COVID infection, which fall under the umbrella term “long COVID”.

At least 5%–10% of people who contract COVID experience long COVID. This can include symptoms (for example, fatigue, brain fog and breathlessness) or conditions (for example, heart conditions, neurological conditions and diabetes) after the initial infection that may be persisting, new or relapsing.

Studies show the symptoms and increased risk of chronic conditions can persist for up to two years after infection. The individual impact of long COVID can range from temporary to severely disabling, and the societal cost – for example due to reduced workforce and increased health-care costs – is enormous

The lower risk of developing long COVID with up-to-date COVID vaccinations is substantially offset by the high levels of infections and re-infections globally. As a result, the cumulative burden of long COVID has increased, including in lower and middle income countries. A conservative estimate suggests 65 million people may be currently affected globally.

So where are we at with reducing the risk of, and treating, long COVID?

Reduced Risk of Severe Disease

COVID antiviral drugs, taken orally, continue to play an important role in reducing acute severe disease after infection. In Australia and the US, they’re available to those at highest risk from COVID.

Observational research has suggested taking antivirals during a COVID infection can reduce the risk of long COVID in people with at least one risk factor for acute severe COVID.

In one study, nirmatrelvir and ritonavir, known as Paxlovid, was associated with a 26% reduced risk of developing long COVID. It was also linked to a 47% reduced risk of death and a 24% reduced risk of hospitalisation after the acute infection phase.

A similar 14% reduction in long COVID risk has been reported for molnupiravir (Lagevrio).

Ensitrelvir – a COVID antiviral available in Japan – could also reduce the risk of long COVID, preliminary analyses suggest.

More research is needed, but this data indicates antiviral medications may be a key approach to lessening the risk of long COVID.

The population most at risk of long COVID (often working-age adults) differs from those most at risk of severe disease from a COVID infection (older adults or those with chronic medical conditions). Eligibility criteria to access antivirals do not currently include consideration of long COVID.

Meanwhile, one randomised trial found metformin, a commonly prescribed diabetes medication, could also reduce long COVID risk. The study offered people with symptomatic COVID who were overweight or obese metformin for two weeks (beginning within a week of symptoms starting). This group was 41% less likely to develop long COVID compared with a placebo group that didn’t take metformin.

The way this works might involve an effect on the powerhouses of our cells, mitochondria, or directly on the virus. Whatever the precise mechanism, further research should be priortised to fast-track this potential.

Still No Treatments for Long Covid

There are no effective or approved treatments for long COVID at present. Currently about 12 clinical trials are testing potential drugs. A number of candidate treatments exist for certain components of long COVID that may be useful in subgroups of patients.

However, recently we’ve seen major advances in understanding what’s actually driving long COVID in the body. This knowledge opens up approaches for both diagnosis and treatments or interventions.

An Australian parliamentary inquiry into long COVID stressed the best way to avoid the condition is to lower the risk of getting infected with COVID in the first place (through protective behaviours such as vaccination, mask wearing and cleaner indoor air).

While these are all important measures, we would benefit from having more tools at our disposal to prevent and treat long COVID. After all, COVID is still evolving rapidly and vast numbers of people are likely to be reinfected in the months and years ahead.

Overall, the quantity and speed of clinical trials into long COVID treatments has been insufficient. And most public health policy approaches are focused on preventing severe disease from a COVID infection, rather than the long-term effects.

That said, Australia recently announced an initial A$22 million of funding and a plan for research into long COVID through the Medical Research Future Fund.

In July 2023, the White House established the Office of Long COVID Research and Practice which will coordinate the US government’s response to long COVID, as well as two randomised trials of Paxlovid.

Given what we now know about long COVID, and the additional concern of what we don’t know (for example, could organ damage reveal itself many years down the track?), we desperately need diagnostic tools, clinical care pathways coupled with health worker training, and treatments to prevent and cure long COVID.

Unaddressed, long COVID may well lead to a new and substantial health and societal burden for many years to come. The response must involve prioritisation of research, such as that which led to the fast development of COVID vaccines and antivirals.

While there are some positive signs in the policy and research space, we need to see stronger recognition of long COVID and a greater sense of urgency around finding solutions.

Authors:

Suman Majumdar, Associate Professor and Chief Health Officer - COVID and Health Emergencies, Burnet Institute

Brendan Crabb, Director and CEO, Burnet Institute

Emma Pakula, Senior Research and Policy Officer, Burnet Institute

Michelle Scoullar, Senior Research Fellow, Burnet Institute

Ziyad Al-Aly, Director Clinical Epidemiology Center, VA St. Louis Health Care System, Washington University in St Louis

The Burnet Institute is a not-for-profit independent, unaligned organisation that combines medical research in the laboratory and the field with public health action to address major health issues affecting disadvantaged communities in Australia and internationally.

This article originally appeared in The Conversation and is republished with permission.

Why We Need to Study Suicides After Opioid Tapering

By Stefan G. Kertesz, MD

How can we understand and prevent the suicides of patients in the wake of nationwide reductions in opioid prescribing?

Answering that question is the passion and commitment of our research team at the University of Alabama at Birmingham School of Medicine. Our study’s name, “CSI: OPIOIDs,” stands for “Clinical Context of Suicide Following Opioid Transitions.” Let me tell you why we are doing this work, what we do, and how you can help.

Opioid prescribing in the US started falling in 2012, after a decade of steady increases. The original run-up in prescribing was far from careful and a judicious correction was needed. A judicious correction, however, is not what happened. Instead, opioid prescriptions fell, rapidly, to levels lower than those seen in 2000. It may require a book to understand how prescribers swung so easily from one extreme to another.

For the 5 to 9 million patients who were taking prescription opioids long-term, reductions and stoppages were often rapid, according studies in the US and Canada. In one Medicare study, 81% of long-term opioid discontinuations were abrupt, often leaving patients in withdrawal and uncontrolled pain.

Prescription opioid reductions are not always good, and not always bad. For some patients, modest reductions are achievable without evident harm, especially if a reduction is what the patient wants to achieve. For others, the outcomes appear to be harmful. Several who serve on our research team have witnessed friends, family, or patients deteriorate physically or emotionally following a reduction. Some attempted suicide and, tragically, others died by suicide.

Large database analyses tell a similar (and nuanced) story. In research derived from Kaiser Permanente, Veterans Health Administration, Oregon’s Medicaid program, and Canadian databases, patient outcomes were diverse. Some researchers found no safety problems after opioid reductions, but others describe suicides, mental health crises, medical deteriorations, and overdoses at frequencies that are too common to ignore. These are not acceptable outcomes. 

The shocking nature of patient suicides led some experts to jump to conclusions, arguing that acute withdrawal from opioids explains all the bad outcomes, and that slow reductions or tapers prevent harm. But that’s not true. In two studies, mental health crises or overdoses occurred at elevated rates a full year after modest dose reductions, such as a 39% reduction in one national study.

Jumping to conclusions about why something bad happens is another way of saying, “We don’t want to investigate.”

After a suicide, we think the right step – the respectful step – is to ask questions: What happened here? Why did it happen? What were all the factors in a person’s life that might have played a role in their death? And where does an opioid reduction fit, or not fit, into explaining what happened?

Asking those questions is crucial. The decision to end one’s life through suicide is rarely simple, but understanding the person’s history and reasoning will spur better approaches to care. Approaching these questions through in-depth rigorous research, rather than pretending we already know why suicides happen, could also induce leaders to take them more seriously than they have to date.

Just like investigators examining a plane crash, we intend to collect the full story of what happened, carrying out detailed interviews and, where possible, reviewing medical records. Studying just one case can tell us a great deal. But our goal is to study over 100 patient suicides.

This approach is called a “psychological autopsy interview.” That phrase can sound a bit daunting. In reality, it’s an interview where we ask about the person’s life, their health, their care, and what happened before they died.

How You Can Help

We seek people who have lost somebody, such as a close family member or good friend, to suicide after a prescription opioid reduction. We are studying deaths in the US among veterans and civilians, and hope to interview more than one person for each suicide.  

Interview topics range from health and social functioning, to care changes prior to death, to whether the person who died felt a sense of connection to others or perceived themselves to be a burden. To our knowledge, no other team is attempting to do this work.  

We face a singular challenge: recruitment. That’s why we need your help. For the last 60 years, studies of suicides involved collaboration with medical examiners in a state or county. That option is not available to us, because medical examiners usually don’t know about health care changes that took place prior to a person’s death.  

There is no master list of suicides that occurred following a reduction or stoppage in opioids. Yet those deaths are precisely the ones we need to learn about. The only way we can document those cases is to reach out to the public and ask if survivors are willing to come to us, either online or by phone (1-866-283-7223, select option #1). 

If enough survivors are willing to participate in this initiative, then we can begin to describe, understand, and prevent future devastating tragedies.  

For the people who are considering participation in the study and wondering what risks are involved, let me offer some reassurance. First, there is an online questionnaire housed on a very secure server. A person can start it and stop at any point if they choose, no questions asked.  

Also, this study is protected by two federal “Certificates of Confidentiality.” These federal orders prohibit release of identifiable data under any circumstances, even a court order.  We are aware that some families are pursuing legal action, and this was a major factor in our decision to take this extra step to protect participants. 

When a person completes the survey, we will evaluate their answers to see how confident they were that the death was likely a suicide, and whether the death occurred after a prescription opioid dose reduction. If they meet these criteria, then we will reach out to discuss further participation in the research study.  

What follows is a more detailed informed consent process. There is a modest incentive ($100) for being interviewed, and a smaller one if the person can work with our medical record team. It is not necessary for a survivor to have access to a loved one’s medical records.  

So far, the interviews we’ve conducted have been serious, warm and thought-provoking. At the outset, we were concerned that these interviews could be upsetting. We learned from reading the literature on this type of interview, that the individuals who agree to participate usually have a desire to share their feelings about their loved one’s death and tend to perceive the interview as a positive experience.  

In the long-run, we hope that after looking at 110 suicides, we can formulate recommendations and programs for care, without leaping to any conclusions. We want to help save lives.  

A study like this is clearly not the only answer to an ongoing tragedy. Research is almost never a “quick answer” to anything. That’s why many members of our team have already engaged in direct advocacy with federal agencies. It was 4 years ago that several of us urged the CDC to issue a clarification regarding its 2016 Guideline on Prescribing Opioids for Pain. A revised CDC guideline was released last year, but we’ve noticed that the health care situation faced by countless patients with pain remains traumatic and unsettled.

These events are hidden and need exploration. We need to take this next step and learn more to prevent further tragedies and lost lives.

If you would like to enter the screening survey for this research, please click here.

If you would like to learn more general information about our study, click here.

If you know a group of patients or clinicians who would like a flyer, presentation, or a link to our study, please let us know by email at csiopioids@uabmc.edu or stefan.kertesz@va.gov

Stefan G. Kertesz, MD, a Professor of Medicine and Public Health at the University of Alabama at Birmingham School of Medicine, and a physician-investigator at the Birmingham Alabama Veterans Healthcare System.  Stefan is Principal Investigator for the CSI: OPIOIDs study.

Views expressed in this column are those of Dr. Kertesz and do not represent official views of the United States Department of Veterans Affairs or any state agency.

For anyone thinking about suicide, please contact the 988 Suicide & Crisis Lifeline, available online, via chat, or by dialing “988.”  A comprehensive set of resources can also be found at this link.

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.  

Opioid Therapy Is Controversial, But Why?

By Barby Ingle, PNN Columnist

There are many factors that contribute to the controversy surrounding opioids, which have been used for thousands of years for pain relief.

Mainstream media often say that opioid medication is harmful and increase the risk of addiction, overdose and death. Many media outlets do not distinguish between FDA approved medications and street drugs, or show the life-giving side of opioid medication.

That is the root cause of the controversy. If people don't understand or are misinformed, they go with what they hear -- right or wrong.

Let’s explore these issues and, hopefully, set the record straight.

Rx Opioid Side Effects

All medications have side effects, including opioids. At least 50% of patients in clinical trials experience a side effect from opioid therapy, such as nausea, vomiting, constipation, dizziness, dry mouth or sedation. These side effects vary and can decrease or increase with long-term use.

Most side effects of opioids improve shortly after therapy begins or following a dose increase. However, itching and constipation can persist throughout treatment. Most of the chronic pain patients I have met on my journey are okay with these side effects and wish to continue with treatment. For others, opioid therapy is discontinued when the side effects are too severe.

A variety of respiratory issues can be caused by opioids, including inadequate breathing, erratic breathing, and impairment of the upper airways. That can lead to respiratory depression, a precursor to an overdose. Patients in acute pain management who are new to opioids are most at risk of respiratory depression because they have not developed tolerance to opioids.

To be clear, an overdose from prescription opioids is relatively rare. A recent study found the risk of a fatal overdose at 90 morphine milligram equivalents (MME) – a fairly high daily dose – is only 0.26%. The risk is even lower at 50 MME – just 0.16%.

Opioids have more respiratory effects during sleep. Several fatalities have been reported in patients with obstructive sleep apnea, who may be contraindicated to opioid therapy. Patients with sleep apnea who take other central respiratory depressants, such as benzodiazepines, should be cautious about this. If opioids are prescribed to patients with sleep apnea, a nocturnal respiratory assessment will be needed.

Patients may absorb more opioids from transdermal opioid formulations if they have a fever or other illnesses. This is also true if they are exposed to heat, such as a sauna.

Is Pain Inevitable?

The Japanese author Haruki Murakami once wrote, "Pain is inevitable. Suffering is optional." Murakami was writing about running a marathon, but it’s an apt description for someone with chronic pain. Does their suffering have to be inevitable?

I didn't understand that concept as a collegiate coach or as an athlete until I developed chronic intractable pain and needed treatment. It is difficult to understand chronic pain or intractable pain if you haven't lived with them.

So that we are all on the same page, chronic pain is defined as pain lasting over three months. Intractable pain is complex and can last a lifetime, causing immense suffering. Acute pain is pain that lasts for less than three months.

Acute pain is usually caused by an injury, trauma or medical condition. Left untreated, acute pain can progress to the chronic stage, causing long-term disability, depression, and impaired quality of life. Therefore, it is essential to identify and treat pain as soon as possible, preferably in the acute stage.

Different approaches, including medication, physical therapy, and lifestyle changes, can be used to manage pain. Finding the right approach for each patient is crucial, as something that worked for one patient may not work for another. It is essential to consider all options before selecting the most appropriate treatment.  

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Back Pain? Bum Knee? Be Prepared to Wait for Physical Therapy

By Mark Kreidler, KFF Health News

At no point along his three-year path to earning a degree in physical therapy has Matthew Lee worried about getting a job.

Being able to make a living off that degree? That’s a different question — and the answer is affecting the supply of physical therapists across the nation: The cost of getting trained is out of proportion to the pay.

“There’s definitely a shortage of PTs. The jobs are there,” said Lee, a student at California State University-Sacramento who is on track to receive his degree in May. “But you may be starting out at $80,000 while carrying up to $200,000 in student debt. It’s a lot to consider.”

As many patients seeking an appointment can attest, the nationwide shortage of PTs is real. According to survey data collected by the American Physical Therapy Association, the job vacancy rate for therapists in outpatient settings last year was 17%.

Wait times are generally long across the nation, as patients tell of waiting weeks or even months for appointments while dealing with ongoing pain or post-surgical rehab. But the crunch is particularly acute in rural areas and places with a high cost of living, like California, which has a lower ratio of therapists to residents — just 57 per 100,000, compared with the national ratio of 72 per 100,000, according to the association.

The reasons are multifold. The industry hasn’t recovered from the mass defection of physical therapists who fled as practices closed during the pandemic. In 2021 alone, more than 22,000 PTs — almost a tenth of the workforce — left their jobs, according to a report by the health data analytics firm Definitive Healthcare.

Growing Demand for PT

And just as baby boomers age into a period of heavy use of physical therapy, and covid-delayed procedures like knee and hip replacements are finally scheduled, the economics of physical therapy are shifting. Medicare, whose members make up a significant percentage of many PT practices’ clients, has cut reimbursement rates for four years straight, and the encroachment of private equity firms — with their bottom-line orientation — means many practices aren’t staffing adequately.

According to APTA, 10 companies, including publicly held and private equity-backed firms, now control 20% of the physical therapy market.

“What used to be small practices are often being bought up by larger corporate entities, and those corporate entities push productivity and become less satisfying places to work,” said James Gordon, chair of the Division of Biokinesiology and Physical Therapy at the University of Southern California.

There’s a shortage of physical therapists in all settings, including hospitals, clinics, and nursing homes, and it’s likely to continue for the foreseeable future, said Justin Moore, chief executive of the physical therapy association. “Not only do we have to catch up on those shortages, but there are great indicators of increasing demand for physical therapy,” he said.

The association is trying to reduce turnover among therapists, and is lobbying Congress to stop cutting Medicare reimbursement rates. The Centers for Medicare & Medicaid Services plans a 3.4% reduction for 2024 to a key metric that governs pay for physical therapy and other health care services. According to the association, that would bring the cuts to a total of 9% over four years.

Several universities, meanwhile, have ramped up their programs — some by offering virtual classes, a new approach for such a hands-on field — to boost the number of graduates in the coming years.

“But programs can’t just grow overnight,” said Sharon Gorman, interim chair of the physical therapy program at Oakland-based Samuel Merritt University, which focuses on training health care professionals. “Our doctoral accreditation process is very thorough. I have to prove I have the space, the equipment, the clinical sites, the faculty to show that I’m not just trying to take in more tuition dollars.”

Rising Cost of PT Education

All of this also comes at a time when the cost of obtaining a physical therapy doctorate, which typically takes three years of graduate work and is required to practice, is skyrocketing. Student debt has become a major issue, and salaries often aren’t enough to keep therapists in the field.

According to the APTA’s most recent published data, median annual wages range from $88,000 to $101,500. The association said wages either met or fell behind the rate of inflation between 2016 and 2021 in most regions.

A project underway at the University of Iowa aims to give PT students more transparency about tuition and other costs across programs. According to an association report from 2020, at least 80% of recent physical therapy graduates carried educational debt averaging roughly $142,000.

Gordon said USC, in Los Angeles’ urban core, has three PT clinics and 66 therapists on campus, several of whom graduated from the school’s program. “But even with that, it’s a challenge,” he said. “It’s not just hard to find people, but people don’t stay, and the most obvious reason is that they don’t get paid enough relative to the cost of living in this area.”

Fewer therapists plus growing demand equals long waits. When Susan Jones, a Davis, California, resident, experienced pain in her back and neck after slipping on a wet floor in early 2020, she went to her doctor and was referred for physical therapy. About two months later, she said, she finally got an appointment at an outpatient clinic.

“It was almost like the referral got lost. I was going back and forth, asking, ‘What’s going on?’” said Jones, 57. Once scheduled, her first appointment felt rushed, she said, with the therapist saying he could not identify an issue despite her ongoing pain. After one more session, Jones paid out-of-pocket to see a chiropractor. She said she’d be hesitant to try for a physical therapy referral in the future, in part because of the wait.

Universities and PT programs graduate about 12,000 therapists a year, Moore said, and representatives of several schools told KFF Health News they’re studying whether and how to expand. In 2018, USC added a hybrid model in which students learn mostly online, then travel to campus twice a semester for about a week at a time for hands-on instruction and practice.

That bumped USC’s capacity from 100 students a year to 150, and Gordon said many of the hybrid students’ professional skills are indistinguishable from those of students on campus full time.

Natalia Barajas received her PT doctorate from USC last year and was recently hired at a clinic in nearby Norwalk, with a salary of $95,000, a signing bonus, and the opportunity to earn more in incentives.

She’s also managing a lot of debt. Three years of tuition for the USC physical therapy program comes to more than $211,000, and Barajas said she owes $170,000 in student loans.

“If it were about money alone, I probably would have shifted to something else a while ago,” Barajas said. “I’m OK with my salary. I chose to do this. But it might not be the perfect situation for everybody.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

DEA Cuts in Opioid Supply ‘Completely Irresponsible’

By Pat Anson, PNN Editor

This is the final day for patients, providers and other interested parties to leave a public comment on the DEA’s plan to reduce the supply of opioid medication in 2024.

The DEA wants to cut production quotas for oxycodone, hydrocodone other opioids for the 8th straight year, and invited people to comment on its plan in the Federal Register. Over 3,400 have so far, most of them patients who already have problems getting prescription opioids due to shortages.

“This will do nothing but harm the chronic pain community,” one poster wrote. “The reduction of opioid production will only cause more overdoses, because when people can’t find medication and are suffering, often their only option is to turn to drug dealers.”

“I am a chronic pain patient that would have absolutely no quality of life if it wasn't for opiates. I don't understand why the DEA thinks that pain medication is not a good thing. I would not be able to function without it!” said Joanne Kurtz. “If the government puts more restrictions on the manufacturers, it will be impossible for anyone to get the medicine that is needed. It is nearly impossible now. Please stop decreasing the production!”

“The US population is only getting older, and as more bodies start to fail, the medical need for pain medications will only increase. I’ve noticed a marked decrease in the availability of medications for patients with painful conditions - spine problems, endometriosis, etc,” wrote another poster, who said they worked in the pharmaceutical industry.

“Having the government intervene to limit the supply when legitimate demand is only going to grow is completely irresponsible.”

Also weighing in is the R Street Institute, a non-partisan think tank based in Washington DC that supports free market policies and limited government. The DEA’s proposal, according to R Street, will do more harm than good.

“History teaches us that when the legal supply of prescription medication is reduced too quickly or by too much — whether through problems in the supply chain or restrictions on provider practices — it harms patients by cutting medication access, potentially sending them to the illicit market in an attempt to manage pain, withdrawal, mental health symptoms and more,” wrote Stacey McKenna, PhD, Senior Fellow of Integrated Harm Reduction at R Street. 

McKenna said supplies of opioid medication are “already stretched thin” from previous DEA cuts. And she noted that diversion rates for prescription opioids are quite low.

“The DEA extensively cites the need to minimize diversion as a justification for reducing the 2024 production quotas for opioid painkillers. However, the DEA’s own projected diversion rates are well below 1 percent. Furthermore, the current overdose crisis in the United States is driven not by diverted prescription painkillers, but by illicitly manufactured fentanyl and other synthetic opioids,” McKenna wrote.

“Given the harms associated with restricting medication availability and the extremely low rates of diversion cited by the DEA, we strongly encourage the reconsideration of proposed 2024 reductions on opioid painkiller manufacturing.”

The DEA relies on advice from the FDA on the projected medical need for controlled medications. For 2024, the FDA predicts a decline of 7.9% from 2023 on the medical use of Schedule II opioids.

Since the DEA started slashing opioid production quotas in 2016, the supply of oxycodone has been reduced by over 68% and hydrocodone by nearly 73%. Yet overdose deaths kept rising, fueled primarily by illicit fentanyl and other street drugs.

McKenna told PNN the DEA lacks good evidence to support further cuts in the opioid supply.

“I think the evidence clearly does not support reducing the production quota. I don't see any in the data that I looked at. I see no evidence-based justification to do it,” she said. “I think they're overstepping into decisions that should be between providers and their patients.” 

Is the DEA a Domestic Terrorist Organization?

By Carol Levy, PNN Columnist

Terrorism is very much in the news these days, given the Israeli-Hamas war and all the fallout from it around the world. But terrorism can also hit close to home and in unexpected ways.

The FBI defines domestic terrorism this way:

“Violent, criminal acts committed by individuals and/or groups to further ideological goals stemming from domestic influences, such as those of a political, religious, social, racial, or environmental nature.”

It may not be domestic violence in the literal meaning of the term, but I would posit the U.S. Drug Enforcement Administration is a domestic terrorist organization.

Why would I believe that? The answer lies in how terrorists work. Their goals and methods are simple: kill one person and scare thousands. In the DEA's case, it means arrest a doctor and allege that they overprescribe opioids without a legitimate medical reason. This has a chilling effect on thousands of other physicians, who then limit or even refuse to prescribe opioids.

If a doctor knows his patients well and has been prescribing opioids safely to them for years, with beneficial results, makes no difference. The doctor is essentially arrested on ideological, social and political grounds, which gives validation to the concept that they are being terrorized.

The DEA’s war on drugs has gone far beyond its original goal of going after street drugs and drug dealers. It has escalated into a war against prescription opioids and the doctors who prescribe them, essentially making patients hostages to the DEA's political persecution.

I know there are instances when the arrests are legitimate, but from what I can tell many of the doctors caught in the DEA snare have been unfairly targeted.

I have never been a victim of their terrorism. I did lose one of the best doctors I ever had when he lost his privileges to write scripts for opioids. Although this was not due to the DEA but his own inappropriate actions, it allows me to better understand the effect that DEA terrorism has on so many of us.

My experience is nothing compared to the stories of patients who can no longer work, play with their kids, or even get out of bed because the opioids that allowed them to do these things were tapered or discontinued. Or they can’t get their opioid prescriptions filled at a pharmacy.

It’s nothing compared to all the stories of patients killing themselves because they can no longer get the medication that was helping them. Or the patients who were abandoned by a doctor who fears the DEA, who then struggle to find another doctor with the courage to risk going to jail by prescribing opioids.

To the DEA, the fact that these medications are working and that doctors are legitimately prescribing them is irrelevant. Fear seems to be their primary goal. Is that not terrorism?

Until the DEA and politicians get out of the exam room, I fear that pain patients will remain their hostages.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

Migraine Sufferers Rank Triptans as Most Helpful Medication

By Pat Anson, PNN Editor

A large new study that compared the effectiveness of acute migraine medications found that triptans are two to five times more helpful than ibuprofen and acetaminophen in treating migraine attacks. Triptans were also found to be more effective than Excedrin migraine, opioids, and other non-steroidal anti-inflammatory drugs (NSAIDs).

The study used a unique methodology, gathering data on over 3 million migraine attacks reported by over 278,000 people in the US, UK and Canada who used a smartphone app during a six-year period. The Migraine Buddy app allows users to monitor the frequency of their migraine attacks, triggers and symptoms, and rate how “helpful” or “not helpful” their medications are.

“There are many treatment options available to those with migraine. However, there is a lack of head-to-head comparisons of the effectiveness of these treatment options,” said lead author Chia-Chun Chiang, MD, a neurologist who specializes in Headache Medicine and Vascular Neurology at the Mayo Clinic. “These results confirm that triptans should be considered earlier for treating migraine, rather than reserving their use for severe attacks.”

Chiang and his colleagues looked at a total of 25 medications among seven drug classes. Different dosages and medication combinations were combined in their analysis. Newer drugs that inhibit calcitonin gene-related peptides (CGRP) were excluded because they were not in wide enough use during the study period.

How Patients Rated Effectiveness of Acute Migraine Drugs

NEUROLOGY

The study findings, published in the journal Neurology, ranked several triptans (eletriptan, zolmitriptan, sumatriptan, rizatriptan, naratriptan, almotriptan and frovatriptan) as the most helpful medications, with about 75% effectiveness.

By comparison, acetaminophen (paracetamol) was helpful only 37% of the time.

“Our results strongly support the use of triptans, the first class of migraine-specific medication for the acute treatment of migraine,” researchers reported. “In practice, NSAIDs and acetaminophen are generally the first-line medications utilized for mild to moderate headache, and migraine-specific medications are often reserved for moderate to severe migraine attacks, which could potentially result in under-utilization of triptans or delayed treatment during migraine attacks.”

Participants found NSAID’s more effective than acetaminophen, with ketorolac helpful 62% of the time, indomethacin helpful 57% of the time, diclofenac helpful 56% of the time and ibuprofen helpful 42% of the time.

Excedrin migraine was effective only about half the time, about the same as tramadol and codeine. Opioids are usually not recommended for migraine because they’ve been associated with medication overuse headache.

“For people whose acute migraine medication is not working for them, our hope is that this study shows that there are many alternatives that work for migraine, and we encourage people to talk with their doctors about how to treat this painful and debilitating condition,” said Chiang.

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, according to the American Migraine Foundation.  

Another recent study that compared migraine prevention drugs found that two medications usually used to treat depression and high cholesterol are just as effective as the new CGRP inhibitors. Amitriptyline is a tricyclic antidepressant, while simvastatin is a statin. Both drugs are used off-label for migraine prevention and cost substantially less than CGRP drugs.

Autoimmune Disease Patients Struggle with Diagnosis and Costs

By Andy Miller, KFF Health News

After years of debilitating bouts of fatigue, Beth VanOrden finally thought she had an answer to her problems in 2016 when she was diagnosed with Hashimoto’s disease, an autoimmune disorder.

For her and millions of other Americans, that’s the most common cause of hypothyroidism, a condition in which the thyroid, a butterfly-shaped gland in the neck, doesn’t produce enough of the hormones needed for the body to regulate metabolism.

There’s no cure for Hashimoto’s or hypothyroidism. But VanOrden, who lives in Athens, Texas, started taking levothyroxine, a much-prescribed synthetic thyroid hormone used to treat common symptoms, like fatigue, weight gain, hair loss, and sensitivity to cold.

Most patients do well on levothyroxine and their symptoms resolve. Yet for others, like VanOrden, the drug is not as effective.

For her, that meant floating from doctor to doctor, test to test, and treatment to treatment, spending about $5,000 a year.

“I look and act like a pretty energetic person,” said VanOrden, 38, explaining that her symptoms are not visible. “But there is a hole in my gas tank,” she said. And “stress makes the hole bigger.”

Autoimmune diseases occur when the immune system mistakenly attacks and damages healthy cells and tissues. Other common examples include rheumatoid arthritis, lupus, celiac disease, and inflammatory bowel disease. There are more than 80 such diseases, affecting up to an estimated 50 million Americans, disproportionately women. Overall, the cost of treating autoimmune diseases is estimated at more than $100 billion annually in the U.S.

‘Patients Feel Dismissed’

Despite their frequency, finding help for many autoimmune diseases can prove frustrating and expensive. Getting diagnosed can be a major hurdle because the range of symptoms looks a lot like those of other medical conditions, and there are often no definitive identifying tests, said Sam Lim, clinical director of the Division of Rheumatology at Emory University School of Medicine in Atlanta. In addition, some patients feel they have to fight to be believed, even by a clinician. And after a diagnosis, many autoimmune patients rack up big bills as they explore treatment options.

“They’re often upset. Patients feel dismissed,” Elizabeth McAninch, an endocrinologist and thyroid expert at Stanford University, said of some patients who come to her for help.

Insufficient medical education and lack of investment in new research are two factors that hinder overall understanding of hypothyroidism, according to Antonio Bianco, a University of Chicago endocrinologist and leading expert on the condition.

Some patients become angry when their symptoms don’t respond to standard treatments, either levothyroxine or that drug in combination with another hormone, said Douglas Ross, an endocrinologist at Massachusetts General Hospital in Boston. “We will have to remain open to the possibility that we’re missing something here,” he said.

Jennifer Ryan, 42, said she has spent “thousands of dollars out-of-pocket” looking for answers. Doctors did not recommend thyroid hormone medication for the Huntsville, Alabama, resident — diagnosed with Hashimoto’s after years of fatigue and weight gain — because her levels appeared normal. She recently switched doctors and hopes for the best.

“You don’t walk around hurting all day long and have nothing wrong,” Ryan said.

And health insurers typically deny coverage of novel hypothyroidism treatments, said Brittany Henderson, an endocrinologist and founder of the Charleston Thyroid Center in South Carolina, which sees patients from all 50 states. “Insurance companies want you to use the generics even though many patients don’t do well with these treatments,” she said.

Meanwhile, the extent of Americans’ thyroid problems can be seen in drug sales. Levothyroxine is among the five most prescribed medications in the U.S. every year. Yet research points to some overprescribing of the drug for those with mild hypothyroidism.

A recent study, paid for by AbbVie — maker of Synthroid, a brand-name version of levothyroxine — said a medical and pharmacy claims database showed that the prevalence of hypothyroidism, including milder forms, rose from 9.5% of Americans in 2012 to 11.7% in 2019.

The number of people diagnosed will rise as the population ages, said McAninch. Endocrine disruptors — natural or synthetic chemicals that can affect hormones — could account for some of that increase, she said.

In their search for answers, patients sometimes connect on social media, where they ask questions and describe their thyroid hormone levels, drug regimens, and symptoms. Some online platforms offer information that’s dubious at best, but overall, social media outlets have increased patients’ understanding of hard-to-resolve symptoms, Bianco said.

They also offer one another encouragement.

VanOrden, who has been active on Reddit, has this advice for other patients: “Don’t give up. Continue to advocate for yourself. Somewhere out there is a doctor who will listen to you.” She has started an alternative treatment — desiccated thyroid medication, an option not approved by the FDA — plus a low dose of the addiction drug naltrexone, though the data is limited. She’s feeling better now.

Research of autoimmune thyroid disease gets little funding, so the underlying causes of immune dysfunction are not well studied, Henderson said. The medical establishment hasn’t fully recognized hard-to-treat hypothyroid patients, but increased acknowledgment of them and their symptoms would help fund research, Bianco said.

“I would like a very clear, solid acknowledgment that these patients exist,” he said. “These people are real.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues  

How to Recognize and Treat Intractable Pain

By Dr. Forest Tennant, PNN Columnist

The realization that a subgroup of chronic pain patients has intractable pain is finally spreading. Over half a dozen states now have laws protecting intractable pain (IP) patients and Wikipedia refers to IP as a disease that causes “a severe, constant, relentless, and debilitating pain.”

A major impediment to treatment of IP is simply that it is not commonly recognized by either patient or practitioner. Basically, the concept that pain alone can cause serious medical complications is not yet appreciated. This fact is evidenced in product advertising and lay person media articles about “chronic pain.” A close analysis implies that everyone has simple chronic pain and needs a “one size fits all” treatment.

The fact is that the IP subgroup of patients isn’t recognized by even the most sophisticated and prestigious medical institutions. For example, I hear almost daily about a person with IP who has severe hypertension, tachycardia, or even angina without any recognition that IP is the culprit.

Other examples are persons with IP who have hormonal deficiencies. Medical practitioners are treating their patients for such hormonal complications as osteoporosis, impotence, and depression, with no recognition that IP is the cause. Regrettably, some persons have had their pituitary or adrenal removed for a “tumor” when in reality the gland was over functioning and enlarged due to IP.

About half of the persons who develop IP have a genetic or inherited disorder. The most common high risk genetic conditions are Ehlers-Danlos Syndrome (EDS), ankylosing spondylitis, and scoliosis.  Other genetic, but less common, risk disorders include Marfan Syndrome, porphyria, and autoimmune diseases such as rheumatoid arthritis and ulcerative colitis. 

How IP Starts 

Thanks to research and studies in recent years, there is now an understanding of the pathologic sequences that lead to IP.  Basically, IP is the end product of multiple events and conditions that may affect a person.   

IP always has a starting or painful initiating event which is either traumatic or inflammatory. Typically, the initiating event takes place several months or years before IP symptoms develop. 

The most common traumatic events are falls, altercations or surgery. Trauma may be to the head, spinal cord, or a nerve in the arm or leg.  The most common initiating inflammatory disorders are fibromyalgia, severe respiratory infection or arthritis. 

The initiating event doesn’t usually cease but “smolders on” with pain that comes and goes.  A diagnosis of chronic pain is likely assigned, and a wide variety of medications and other measures are attempted.   

Interestingly, an initiating inflammatory event such as arthritis or fibromyalgia may seemingly spread. The person may develop additional inflammatory disorders such as thyroiditis, carpal tunnel syndrome, migraine, and irritable bowel. 

Trauma may be severe or minor and the sequelae quite variable. Neuropathies or intervertebral disc degeneration and herniation are the most common traumatic complications that lead to IP.  Pain after the initiating event is usually not constant, but at some point becomes constant. 

This constancy is associated with inflammation that develops in the brain and/or spinal cord of the central nervous system (CNS). Cells called glia or microglia promote CNS inflammation, which can damage the neurotransmitter-receptor systems that control pain.   

Exactly how injuries and inflammatory disorder activate glial cells to produce CNS is unclear. The two most discussed mechanisms are excess electromagnetic energy generated in the injury and inflammatory sites, and autoimmunity or viral invasion of CNS tissue.  The Epstein Barr virus is the most likely virus.

The first chapters of my new book, “Handbook for Intractable Pain,” are dedicated to how to recognize IP symptoms. The second section is a step-by-step treatment program of self-help.

IP doesn’t have to thrust a person into misery and a short life if a three-component protocol is followed:

1. Suppression of inflammation and autoimmunity

2. Restoration of damaged tissues

3. Pain control

To carry out this protocol, one has to become knowledgeable about IP and build, over time, an effective therapeutic program.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. To Tennant Foundation has launched a new website, IntractablePain.org, where you can learn more about the conditions that cause intractable pain and their many complications.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Neuroplasticity: How the Brain ‘Rewires’ Itself

By Hilary Diefenbach, University of Colorado School of Medicine

High-profile sports like football and soccer have brought greater attention in recent years to concussions – the mildest form of traumatic brain injury.

Yet people often do not realize how common concussions are in everyday life, and seldom does the public hear about what happens in the aftermath of concussions – how long the road to recovery can be and what supports healing. Concussions are important to understand, not only for recovery, but also for the insights that the science of recovery can bring to brain health.

I am a speech language pathologist and an instructor in physical medicine and rehabilitation. I specialize in brain injury rehabilitation, with experience ranging from coma recovery to concussion care.

Treating problems tied to head injuries is complex. This is, in part, because it is not possible to directly examine the brain of a living person and because every brain injury is unique. Many aspects of health, both pre- and post-injury, affect recovery. In treating brain injuries, I work to translate this specialized science for each patient and their unique situation.

Brain Injuries Take Many Forms

While people commonly think of athletes when it comes to concussions, sports-related concussions are just one type of mild brain injury seen in health care practice. Concussions can also result from abusive head trauma, blast exposure, car accidents and falls.

The severity of a brain injury is diagnosed based on symptoms, brain imaging and a neurologic exam. Concussions are characterized by a lack of clear tissue damage seen on brain images like an MRI and by the length of time that a person loses consciousness – defined as between zero to 30 minutes.

In addition, a significant portion of concussions may not be identified or formally diagnosed at all. Even if you do not lose consciousness at the time of an injury, you could still have a concussion. Confusion, sensitivity to noise and lights and even changes to sleep and mood are common symptoms. But often, these signs may be misunderstood as signs of stress or shock during traumatic events, such as a car accident. Some people mistakenly assume that if they don’t lose consciousness, they haven’t experienced a concussion.

People who don’t feel that they have returned to normal after a concussion may need further treatment. Many report chronic symptoms that linger beyond the typical three-month recovery – a condition known as post-concussive syndrome. Around 10% of those who suffer a concussion experience post-concussive syndrome, although differences in how this problem is defined and recorded leads to highly variable estimates across studies.

So how does having a concussion affect the brain over time?

The links between concussion and dementias such as chronic traumatic encephalopathy, or, more generally, the relationship between a brain injury early in life and later brain diseases, are not yet clear. This uncertainty should not stop people from finding a path forward and taking strides to support their own brain health.

Brain ‘Detours’

After recovering from a brain injury, patients want to understand how to minimize further risk to their brain, which is all the more important since prior injury puts the brain at greater risk for further injuries.

Researchers and medical providers have learned that after injury the brain can change and “rewire” itself at a cellular level over the life span – a process called neuroplasticity. Brain cells, called neurons, join to form electrical pathways that power activity within the brain.

In addition to other repair processes, neuroplasticity supports damaged brain areas to reconnect injured routes or find “detours” to restore brain function. This means that in recovery, the brain can literally find a new way – or make one – to regain critical abilities.

Neuroplasticity also offers insight into why each brain injury is unique. Following a concussion, therapists focus on detailed evaluations and patient interviews to identify affected areas and to design an intervention.

While the general map of brain regions and their associated functions is standard, individual variability is common. Brain injuries from the same cause of injury, via similar force and intensity of impact and affecting the same location of the brain, can lead to very different symptoms in different people.

While the brain is fully developed by the time people reach their early 20s, neuroplasticity continues well beyond this point. Researchers have seen neuroplastic change during the life span in both the white and gray matter that form brain tissue. The remapping of brain pathways that occurs in late-life injuries, such as a stroke, is one strong piece of evidence to suggest there may be no specific “end date” to the brain’s capacity to restore its internal connections.

Importantly, fuller density of brain cells is thought to create a buffer that is protective against damage due to injury and aging. This extra “bandwidth” is referred to as cognitive reserve. Broadly speaking, higher levels of baseline cognitive reserve have been linked to genetics, educational attainment and health factors.

Neuroplasticity is one process that research shows is critical to maintaining these reserves throughout life.

Building Brain Health

Cognitive reserve is crucial to brain health both before and after a concussion. Studies show that higher levels of cognitive reserve may lessen your risk for prolonged problems after a concussion.

In addition, injuries that occur during childhood and late life may present different challenges in recovery linked to the brain’s cognitive reserves and overall health. For this reason, screening tools for concussion often probe a person’s medical history prior to the event.

Keeping up cognitive reserves likely maintains healthy brain connections that can help us age better. Bilingualism, maintaining an active social life and even going to museums are linked with lower rates of dementia. These studies support that brain activity is good for brain health and it is triggered by many things, including thinking, learning and engaging with the world around us.

Just as there is no one-size-fits-all brain injury, there is also no single path toward brain health.

Advanced brain imaging to detect concussions is not available in standard clinical settings, so clinicians rarely have clear road maps for rehabilitation. But getting optimal sleep, avoiding excessive drinking or other toxic substances and leading a physically and mentally active life are core tenets of brain health.

Finally, the brain does not exist in isolation. Its health is connected to other parts of the body in many ways. Therefore, doctors recommend treating medical conditions that directly affect our brain health and that reduce brain aging, such as high blood pressure,sleep apnea,migraines and even hearing loss.

Brain health is unique to each person, and brain injury treatment depends on your individual lifestyle and health risks. Strategies to treat specific symptoms vary and should be designed with the help of medical specialists. But brain health and cognitive reserve provide a common direction for everyone. Living an active lifestyle – physically, mentally and socially – can drive neuroplasticity and maintain the brain.

Studies of healthy people offer insights into how individual brains are shaped through everyday activities. For instance, research finds that expert musicians have denser sound-processing regions in their brains. The brains of cab drivers have greater development of spatial memory areas. Even military fighter pilots have been shown to have denser tissue in regions connected to strategic thinking.

These startling discoveries teach us that what we do every day truly matters to brain health. For all of these reasons, brain researchers commonly use the phrase “neurons that fire together, wire together” to describe how the brain’s connections change shape associated with repeated patterns of the electrical firing of brain activity.

While many questions remain to be answered, it is well established that the brain can be shaped throughout life. With this knowledge in mind, we can tend to it with greater care.

Hilary Diefenbach, MA, is a licensed Speech Language Pathologist at the Marcus Institute for Brain Health and an Instructor at the University of Colorado School of Medicine. Hilary specializes in brain injury rehabilitation for adults.

This article originally appeared in The Conversation and is republished with permission.