Most Chronic Pain Conditions Never Get Better

By Crystal Lindell

Most chronic pain conditions remain stable over time, with few patients getting worse and even fewer getting better. 

That’s according to a new study in JAMA Network Open that tracked over 1,477 patients with long-term non-cancer pain. The patients were being treated at specialized pain clinics in France.

The researchers used a cell phone app to track patients’ self-reported bodily comfort, sleep, and mood every week for six months. They excluded “pain intensity” from the list of things they tracked because it is "increasingly recognized as an incomplete proxy for the chronic pain experience.”

Most of the participants were middle-aged, overweight, professional women. About a fifth were on sick leave due to pain. 

Most had been dealing with pain for over five years, mainly from conditions like fibromyalgia and musculoskeletal pain. A large majority had a history of other medical conditions, including anxiety, depression and substance use disorders.

The primary medications that patients took were antidepressants, paracetamol (acetaminophen) and antiepileptic drugs; while the main nonpharmacological treatments were neuromodulation and physical therapy. 

The study authors were trying to find ways to predict which patients would improve and which ones may get worse. They hoped to use responses to basic questions at the start of the study, such as age, sex, pain severity and medical history, to help develop models that would predict how patients would fare.

Unexpectedly, most of the patients remained the same throughout the course of the study, with bodily comfort, sleep and mood remaining unchanged. Only 4.1% of patients improved, and just 10.2% got worse.

Researchers concluded that the most realistic outcome for the remaining 85% is to keep them stable. 

"These findings suggest that chronic pain… is better conceptualized as a stable digital state with rare transitions,” the researchers said. “In tertiary care, where patients are referred precisely because prior treatments have failed, preventing further deterioration over 6 months represents a meaningful therapeutic achievement.” 

Ideally, this type of research could be used to help doctors more realistically assess and treat chronic pain. For example, if their chronic pain is stable, patients shouldn’t have to see a pain specialist every four weeks to get their prescriptions renewed. And treatments should focus on keeping patients comfortable.

Sadly though, the results also suggest that most chronic pain conditions are never really cured or get better, even when treated at a specialized pain clinic.

My hope is that we will continue to find treatments and therapies that meaningfully improve chronic pain. After all, in an ideal world, chronic pain would not remain stable – it would go away.

Study Finds 85% of Kratom-Derived Products Mislabeled

By Pat Anson

A new study at the University of Florida is likely to increase the growing scrutiny of kratom, 7-OH and other kratom alkaloid products.

Researchers found that the vast majority of kratom-derived tablets, edibles and extracts contain alkaloid and chemical compounds that differ substantially from their product labels, potentially putting consumers at risk.

Some have been altered so significantly during the manufacturing process that researchers concluded “these products are definitively not kratom.”

Kratom comes from the leaves of the Mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant. In recent years, demand for kratom products has risen sharply in the United States, reaching an estimated market size of $2.56 billion in 2025.

As the kratom market has grown, so has the variety of products available, including concentrated formulations of 7-hydroxymitragynine (7-OH) and other kratom alkaloids that have “opioid-like” effects and are far more potent than natural leaf kratom.     

Researchers at the University of Florida College of Pharmacy conducted a laboratory analysis of 44 commercially available kratom-derived products purchased online and in stores in several U.S. states.

The study findings, published in the journal of Drug Testing and Analysis, show that 85% of the kratom products had ingredients and concentrations that did not match their labels. In some cases, products were labeled as having a single alkaloid, but multiple alkaloids were detected. Other products contained compounds that were not disclosed on their labels or were listed but not detected.

“The findings are of strong relevance to public health and underscore regulatory actions needed for proper labeling requirements by manufacturers for consumers to know what they are purchasing,” said co-author Christopher McCurdy, PhD, a Professor and Associate Dean for Faculty Development in the UF College of Pharmacy. 

“Right now, consumers are part of a large experiment in which they are taking products that they believe are properly labeled as to the composition of ingredients, yet they are being deceived intentionally or unintentionally by the manufacturers, putting the public at risk.”

McCurdy and his colleagues have spearheaded much of the U.S. research into kratom, with McCurdy serving as an expert witness in kratom litigation cases on both the plaintiff and defendant sides. 

Their research has grown more complicated in recent years, as the kratom market has been flooded by new semi-synthetic products that are often marketed as “natural kratom.” The DEA is currently planning to classify 7-OH and other concentrated kratom products as illegal Schedule One controlled substances, while keeping natural leaf kratom largely unregulated as a dietary supplement..

“Products containing semisynthetic, kratom-derived compounds should be clearly distinguished from natural kratom products,” says lead author Abhisheak Sharma, PhD, an Assistant Professor of Pharmaceutics in the UF College of Pharmacy. “Stronger manufacturing standards, comprehensive testing and transparent labeling are needed to help people make informed decisions and reduce potential safety risks.”

Kratom Litigation

Advocacy organizations for both natural leaf kratom and 7-OH products support stronger labeling, age restrictions and transparent marketing, but there is little effort to enforce those standards at the federal level. That has left most kratom regulation to individual states and local governments.

In a move reminiscent of the opioid litigation cases that cost the pharmaceutical industry over $50 billion dollars, the city of Baltimore recently filed a complaint against several manufacturers and distributors of kratom products, accusing them of “engaging in unfair, abusive, or deceptive trade practices.” 

Maryland has banned the sale of all synthetic or artificially altered kratom products under the state’s Kratom Consumer Protection Act, which also requires product labels to be accurate.

The Baltimore case focuses on several kratom entrepreneurs behind Optimized Plant Mediated Solutions (OPMS), a kratom brand that sells a potent kratom extract called Black Liquid Kratom that’s been linked to several deaths.

“Defendants have employed a web of shell companies and alter egos, and use multiple business names, assumed names, and trade names to hide the scope of their operation and to avoid liability for their actions… while falsely stating or implying in their labeling, packaging, advertising, and marketing of the Kratom Products that the Kratom Products are safe for consumption or offer therapeutic and health benefits that they do not have,” the complaint alleges.

In 2024, the FDA warned consumers not to use Black Liquid Kratom after it was linked to several adverse events. But the OPMS extracts are still available in smoke shops, vape shops and online, where they are often marketed as “all natural” kratom products.

OPMS is one of the “qualified vendors” registered with the American Kratom Association’s good manufacturing standards program, which requires vendors to have labeling that “provides all the information required for consumers to make an informed purchasing decision.”

In their analysis of Black Liquid Kratom, University of Florida researchers found the OPMS extracts “showed variability in their chemical composition, with measured content different from the values stated on the product labels.”  A laboratory analysis found more alkaloids in Black Liquid Kratom than what was indicated on the product label.

‘Enormous Confusion’ as Deadline Nears for 7-OH Kratom Ban

By Pat Anson

Supporters of a DEA plan to classify 7-OH and other concentrated kratom alkaloids as illegal Schedule One controlled substances are worried an impending ban may affect kratom itself. 

The American Kratom Association (AKA), a group of natural leaf kratom vendors, led the effort to ban what it calls synthetic kratom alkaloids, claiming they are dangerous “opioid products.”  

But now the AKA is worried the DEA scheduling may backfire, saying there is “enormous confusion among some members of Congress and even staff at the DEA” about the differences between natural leaf kratom, 7-OH, and other kratom alkaloids.

At issue is mitragynine pseudoindoxyl, one of many naturally occurring kratom alkaloids. A proposed DEA order would ban all pseudoindoxyl products, which are potent analgesics sold as dietary supplements. 

But because there is no current way to measure pseudoindoxyl levels, the AKA is worried that natural levels of pseudoindoxyl will be banned too – in effect a ban on natural leaf kratom. 

“That’s part of the problem, the confusion,” explained Mac Haddow, an AKA lobbyist who says a “zero tolerance” approach to pseudoindoxyl could theoretically lead to bans on kratom. He wants a “carveout” for pseudoindoxyl and natural leaf kratom, exempting them from any DEA bans.     

“That’s why we made the recommendation to the DEA that they should clarify the distinction. The same kind of carveout for pseudoindoxyl would be appropriate, even though it might not be quantifiable at normal testing levels,” he said.

Haddow blames much of the confusion on 7-OH manufacturers, who say their products are just as natural as kratom. 

“The 7-OH that the body metabolizes from a whole leaf product is really indistinguishable from 7-OH that is in a 7-OH product,” says Jeff Smith, Executive Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.     

“I frankly don't understand why the traditional kratom people have pushed so hard (for a 7-OH ban) when their products have to be considered a precursor.” 

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. In recent years, natural leaf kratom, 7-OH and other kratom alkaloid products have become popular in the United States, where they are used by millions of people to self-treat their pain, anxiety, depression, and substance use problems.  

Fearing they may also lead to addiction and overdoses, several states and dozens of cities and counties have banned 7-OH, and some have included kratom. 

The latest example is North Dakota, where the governor today declared a 30-day public health emergency banning all kratom products. Gov. Kelly Armstrong called for a special session of the legislature next month to make the ban permanent under state law.

“Doing nothing is not an option,” said Armstrong. “Right now, it's the Wild West when it comes to kratom and 7-OH sales in North Dakota: no regulations, no age limits, no accountability.  

“We’re taking emergency action to press pause and get these products off the shelves until the Legislature can address the issue.”   

A nationwide ban on 7-OH may be imminent. The DEA announced last month that it planned an emergency scheduling of 7-OH products as Schedule One controlled substances, the same classification as heroin and LSD. 

The scheduling order could take effect as soon as Wednesday, August 5. That has led to a run on 7-OH products in recent weeks, with 7-OH vendors slashing prices to dispose of as much inventory as possible before the ban takes effect. 

New Non-Opioid Analgesic Works Better Than Vicodin

By Crystal Lindell

An experimental non-opioid pain medication appears to outperform a low dose of Vicodin for patients who just had tummy-tuck surgery.

Latigo Biotherapeutics recently published results from its Phase 2 clinical trial in The New England Journal of Medicine, looking at the effectiveness of their new analgesic, which goes by the name LTG-001.

Like other new non-opioid analgesics, LTG-001 works differently than opioids because it blocks pain signals in the body’s peripheral nervous system before they reach the brain. Opioids act on nerve receptors in the brain, where they can slow down breathing and have a “euphoric” effect at high doses.    

In the clinical trial, 343 patients with moderate-to-severe post-operative pain after abdominoplasty surgery were randomly assigned to four groups. One group received low-dose LTG-001; another took high-dose LTG-001; a third took tablets of 5 mg hydrocodone and 325 mg acetaminophen (Vicodin); and the fourth group received a placebo. 

The LTG-001 doses were given orally every 12 hours, while the Vicodin tablets were taken every six hours, for a daily dose of 20 MMEs (morphine milligram equivalents). Patients also had the option to request oxycodone if their pain was getting too severe.  

When researchers asked patients about their pain levels, they found that the high-dose LTG-001 had a 50% greater analgesic effect than Vicodin. “Meaningful pain relief” was also achieved faster with high-dose LTG-001 than with Vicodin (52 minutes vs. 83 minutes).

But many in the high dose LTG-001 group were not able to stay “opioid free.” In a press release, Latigo highlighted the fact that over half (52%) of the patients taking LTG-001 didn’t need the oxycodone “rescue” medication.

Another way to look at that statistic is that the other 48% of patients did not have pain that was well controlled and wound up using opioids anyway. On average, patients in the high dose LTG-001 group still needed 11 MME of oxycodone for pain relief.

Despite the lackluster results, company officials said the clinical trial was “an important milestone for Latigo.”

“The publication of these findings adds to the growing scientific understanding of non-opioid approaches to pain management and comes at a time when there is broad recognition of the need for additional treatment options in the context of the ongoing opioid crisis,” Neil Singla, MD, Chief Medical Officer of Latigo, said in a statement.

Based on discussions with the FDA, Latigo believes the study may serve as one of the well-controlled trials needed to demonstrate the efficacy of LTG-001 to support its approval as a treatment of moderate to severe acute pain, including postoperative pain. 

The company’s next step is to initiate a placebo-controlled Phase 3 trial in participants undergoing bunionectomy and an open-label Phase 3 safety trial. Latigo is also investigating LTG-001 as a pain reliever after wisdom tooth removal.

Last year the FDA approved a similar non-opioid analgesic, Journavx. Although it is only approved for moderate to severe acute pain, it didn’t take long for Jourvanx  to be used off label for chronic pain.  A recent analysis of prescription data found that Jourvanx is prescribed about 33% of the time for chronic pain. In fact, it’s prescribed more often for chronic pain than opioids are.  

THC and CBD Edibles More Effective at Pain Relief Than CBD Alone

By Pat Anson

Yet another study has found that cannabis products containing both THC and CBD are more effective in treating chronic pain than products made with CBD alone.  

Researchers at the University of Colorado Boulder enrolled 243 people with chronic low back pain to evaluate the pain relieving effects of marijuana edibles over a 14-day period. Participants visited a dispensary of their choice and selected a THC-dominant edible, a CBD-dominant edible, or an edible that contained both CBD and THC.

Of the 243 participants, 97 selected CBD-dominant products, 112 chose THC/CBD products, and only 36 selected a THC-dominant product. They were told to take the edibles as often as they wanted for two weeks.

The study findings, published in the journal Biomedicines, show that pain levels were modestly lower for participants who selected THC-dominant products or edibles containing both THC and CBD. No comparable reduction was reported among those using CBD-dominant products.

After 14 days, the most significant reduction in pain intensity was -14.4% for those who took THC/CBD edibles, followed by THC-dominant edibles (-7.9%), and CBD-dominant edibles (-1.9%).

Because there was no uniformity in the frequency or doses of THC and CBD that participants took, researchers say their findings should be viewed with caution. 

But overall, there was a greater benefit from using products with both THC and CBD, suggesting there is a synergistic effect between the two substances in reducing inflammation, one of the primary causes of chronic pain.

“These findings indicate a complex interrelationship between THC and CBD, with THC-associated reductions in daily pain intensity attenuated by increasing doses of CBD, and products containing both THC and CBD associated with longitudinal reductions in pain intensity,” researchers said. 

“Statistically, the use of CBD-dominant products was not associated with any reductions in pain intensity at the daily or longitudinal levels, and these associations did not change regardless of how often participants used their products.” 

THC (tetrahydrocannabinol) is the psychoactive ingredient in cannabis, while CBD (cannabidiol) is a non-psychoactive compound believed to have health benefits. About 3 times as many participants in the study chose CBD-dominant edibles over THC-dominant ones, suggesting they wanted to avoid sensations of getting “high.”

“Many individuals see CBD as an attractive alternative therapy for mitigating chronic pain compared to THC. This may be the result of CBD not producing the intoxicating effects that are associated with THC. Yet, the use of CBD-dominant products and increasing doses of CBD were not associated with reductions in pain intensity in the present study,” researchers concluded.   

Previous studies of cannabis products have shown that the pain-relieving benefits of CBD alone are minimal, at best. 

A recent review of studies found that cannabis products with relatively high levels of THC provide small improvements in chronic pain, while those with high levels of CBD have minimal or no effect on pain.         

In a 2019 study of self-reported data from over 3,300 cannabis users, researchers said THC was more effective than CBD alone in treating chronic pain, insomnia and other medical conditions. Cannabis products containing higher doses of THC provided the most relief.

Another small study conducted in Israel found that microdosing small amounts of THC significantly reduced pain levels in patients suffering from neuropathy.

New Pain Reliever Combines Tylenol and Naproxen

By Crystal Lindell

Pain sufferers will soon be able to buy a new over-the-counter medication that combines acetaminophen with naproxen. 

That’s thanks to the FDA approving new “Tylenol with Naproxen.” A two-tablet dose contains 650 mg of acetaminophen and 220 mg of naproxen sodium. Many consumers know acetaminophen as the brand name Tylenol, while naproxen is known by the brand name Aleve. 

The non-prescription pain reliever is approved for minor aches and pains such as headaches, backaches, sore muscles, toothaches, menstrual cramps, and arthritis pain in adults and children 12 years and older. 

The new tablets start working within about 30 minutes because of the acetaminophen, while the non-steroidal anti-inflammatory drug (NSAID) naproxen provides 12 hours of extended pain relief.

Acetaminophen is believed to work more quickly to reduce pain signals, while naproxen provides longer-lasting relief by targeting pain caused by inflammation.

The FDA granted Kenvue, which makes the Tylenol brand, a three-year period of exclusivity for this new OTC formulation. That means there will be no generic alternative available in that time.

In a press release, Kenvue cited a recent company survey showing that 75% of pain sufferers report dissatisfaction with their current options.

“Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options,” said Rajesh Mishra, MD, Chief Medical Officer of Kenvue. “Tylenol with Naproxen simplifies that choice, offering fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose.”

The company said its research showed that Tylenol with Naproxen demonstrated superior pain relief versus using either medication alone. It didn’t provide a price or date for when the tablets will be available, only that they are “coming soon to major U.S. retailers nationwide.”

Company Touts ‘Opioid-Free’ Label

The press release touts the fact that the medication is "opioid-free" multiple times and claims "up to 1 in 4 patients prescribed opioids are at risk of addiction."

"Tylenol with Naproxen addresses this gap by combining two well-established non-opioid pain relievers into a single, clinically proven OTC therapeutic solution that requires no prescription and carries no opioid risk," the company said.

Most studies show the risk of opioid addiction is very low. Neither Kenvue or the FDA shared any research on whether the new medication was comparable to pain relief from opioids.

And just because there is no opioid-related risk, that doesn't mean there is zero risk. The FDA warned consumers not to use Tylenol with Naproxen with other drugs containing acetaminophen, as doing so may cause liver damage.

And, as with all NSAID-containing products, the labeling includes warnings for stomach bleeding and for increased risk of heart attack, heart failure, and stroke — risks that are higher when NSAIDs are used more than directed or for longer than directed.

While this is the first OTC combination of Tylenol with Naproxen, it is not the first time acetaminophen has been combined with an NSAID in an OTC medication. In 2020, the FDA approved the first over-the-counter pain reliever that combines acetaminophen with ibuprofen, Advil Dual Action.

Researchers Find Genetic Variants That Increase Risk of Fibromyalgia

By Pat Anson

The origins and causes of fibromyalgia have long baffled patients, doctors and researchers. Over the years, fibromylagia has been blamed on everything from gut bacteria and childhood trauma to a brain disorder and weakened immune system.

Through it all, fibromyalgia remains a poorly understood disorder characterized by deep tissue pain, headaches, fatigue, anxiety, depression and insomnia. Nearly 3% of the world’s population has fibromyalgia, with females making up 75% of cases 

An international team of researchers has now identified over two dozen genetic variants that play a role in the development of fibromyalgia. Their findings, published in Nature Medicine, suggest the nervous system plays an important causal role.

The team analyzed genetic data from more than 2.5 million adults around the world, including 55,000 who had been diagnosed with fibromyalgia. Researchers looked for genetic differences in people with and without fibromyalgia to find the genes that were most common in those with the condition.

This helped them identify genetic variants in 26 regions of the DNA genome that appear to play a role in fibromyalgia’s development. Many of the genes implicated in these regions are involved in brain and nerve function, and are associated with fibromyalgia’s physical and psychiatric traits.

"This work changes how we think about fibromyalgia at a fundamental level. For decades, patients have been dismissed or told their pain is simply psychological. Our findings confirm the condition has a clear biological basis," said co-senior author Michael Wainberg, PhD, an investigator at the Lunenfeld-Tanenbaum Research Institute and Assistant Professor of Psychiatry at the University of Toronto.

Of the 26 genetic variants identified, the one most strongly linked to fibromyalgia risk was within the gene HTT. Different mutations in the HTT gene cause Huntington's disease, a severe, progressive and fatal neurodegenerative disorder.

Further genetic analysis revealed moderate-to-strong positive associations between fibromyalgia and several psychiatric disorders, namely depression, suicidality, ADHD and PTSD. These correlations help explain the high comorbidity between fibromyalgia and these emotional states.

The study also revealed substantial genetic overlap between fibromyalgia and a range of painful conditions, including low back pain, migraine and irritable bowel syndrome. The researchers think shared biological mechanisms within the nervous system may make people susceptible to several of these conditions, explaining why they often appear together.

"We know that chronic pain syndromes cluster together in individuals and families and are genetically similar. Targeting the shared mechanisms underlying them could potentially benefit a whole cluster of disorders," said co-senior author Frances Williams, PhD, Professor of Genomic Epidemiology at King's College London.

"The findings also help us better understand why fibromyalgia so often occurs alongside conditions such as anxiety and depression, bringing us closer to understanding the condition as a whole."

Genetics alone do not determine whether someone develops fibromyalgia. Researchers suspect that even people who carry many of fibromyalgia’s genetic variants require other risk factors, such as arthritis, to trigger fibromyalgia.

"This study provides important new insights into why some people develop fibromyalgia syndrome and identifies biological pathways that could lead to new treatment approaches. One of these pathways is already the focus of drug trials for Huntington's disease, raising the possibility that existing pharmaceutical research could eventually benefit people with fibromyalgia,” said Williams.

Williams and her colleagues have founded the Chronic Pain Genomics Consortium to investigate other chronic pain syndromes, starting with pelvic pain. The consortium sees fibromyalgia as only the beginning of a broader exploration of the landscape of chronic pain conditions.

7-OH Retailers Slash Prices as DEA Deadline Looms

By Pat Anson

Online sellers of 7-OH products are offering major discounts on tablets, gummies and shots as a potential August 5 deadline nears for concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) become illegal Schedule One controlled substances.

“Once they are gone, they are gone for good,” is how Payless Kratom is promoting its 7-OH clearance sale. Other online 7-OH promotions include multi-buy discounts and steep price breaks on bulk purchases.

“This is really the last chance to stock up,” said another 7-OH retailer.

KURES APOTHECARY

The DEA announced on July 6 in the Federal Register that it planned an emergency scheduling of all concentrated forms of 7-OH as illegal Schedule One controlled substances, the same classification as heroin and LSD.  

The scheduling order “will not be issued before August 5,” according to the DEA, and will remain in effect for at least two years, with a possible extension of an additional year.

Stockpiling 7-OH

With the August deadline fast approaching, retailers are getting rid of 7-OH products they will soon be prohibited from selling, and 7-OH consumers are stockpiling products while they can.  

“There is a fire sale going on at the website I get my 7 from,” said one Reddit poster. “They even have a countdown timer that's got the days, hours and seconds until they will no longer be taking orders if/when this goes into effect…. I just placed a massive order a few days ago and it's already on the way. It is probably my last order ever.”

“Prohibition is about to happen and I don’t know that it’s happened with something this popular in a while. We’re gonna see how addictive it is when it becomes a street drug. Turns a lot of otherwise law-abiding citizens into felons,” wrote another Reddit poster. “They’ll be arresting normal folks and destroying their families with drug court for something that was legal to purchase in a gas station 6 months ago.”

“With 7-OH becoming Schedule I in the coming days, I think we're approaching an inflection point. Healthcare workers should be prepared for a spike in both withdrawal presentations and ODs (overdoses),” warned a medical student. “Keep an eye out for both extremes over the next few weeks. Those that stockpiled and unintentionally OD or suddenly lose access and present in severe withdrawal that can resemble heroin or fentanyl withdrawal.”

Whether concentrated 7-OH is an “opioid” like fentanyl is disputed, but most 7-OH consumers acknowledge that it has opioid-like effects and is a good pain reliever.

“The effects of 7-OH on a person's body bear no resemblance to those of heroin or fentanyl,” says Jeff Smith, National Policy Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.    

Smith has chronic pain from two significant back injuries. The pain was so severe he couldn’t sleep more than 20 minutes at a time, until he started using 7-OH.  

“I've been using it for over a year, and it's helped me immensely with chronic pain and helps me sleep through the pain,” Smith told PNN. “So it has been transformative for me, and I know for tons of other people who I've met when I've gone and testified in different state capitals.  

“No other painkillers have helped. No other sleep medication has helped. I've tried 15 different things probably over the course of a decade or more, and this has really been the first thing that's helped meaningfully.”

HART has produced a documentary to counter what it calls false and misleading narratives about 7-OH. It features 7-OH consumers sharing personal stories of how 7-OH helped them overcome pain, anxiety and PTSD.

Local Bans Already in Effect

In some states, cities and counties, sales of 7-OH and kratom itself are already banned.

In recent months, California has seized nearly 7,000 kratom and 7-OH products, achieving what the state’s Alcoholic Beverage Control (ABC) agency calls a “98% compliance rate.”  

Ironically, many California retailers agreed to stop selling 7-OH and kratom products rather than run the risk of losing their licenses to sell alcohol – a substance that causes substantially more public health and safety problems. 

“After five months of targeted kratom and 7-OH enforcement efforts, nearly 98 percent of ABC-licensed locations are in compliance,” ABC Director Paul Tupy said in a statement. “This is possible through the collaboration of our licensees, who are making sure these harmful products aren’t available on store shelves.” 

Jeff Smith is unsure what will happen after August 5, a date when a window opens 30 days after the DEA’s scheduling order was published.

“The whole process has been so bizarre and herky-jerky that it's difficult to predict,” Smith said. “There is no outer time bound to this process, so 30 days is a minimum, but it's not a maximum. So they could take 60 days, or 90 days, or 180 days, or 365 days. I mean, they could take as long as they want to to address this. We just don't know what they'll do.”

A Non-Corticosteroid Treatment for Arachnoiditis

By Dr. Forest Tennant

Methylprednisolone and other corticosteroids have been the mainstay of adhesive arachnoiditis (AA) treatment for many years.  AA is a progressive inflammatory spinal disease that causes severe intractable pain, neurologic impairment, and profound functional decline.

Understandably, there has been great resistance by AA patients and physicians to use corticosteroids due to their notorious complications. Corticosteroids are known to cause osteoporosis, hyperglycemia, weight gain, and adrenal suppression. 

Arachnoiditis Hope has been pursuing an alternative treatment for years and we are pleased to report we have discovered one.  Patients and physicians now have a choice. 

The New Alternative

1. Pregnenolone, 200 mg twice a day

2. Dehydroepiandrosterone, 200 mg twice a day

3. Palmitoylethanolamide, 600 to 1200 mg twice a day

Origin of the Treatment

Pregnenolone is a natural hormone made from cholesterol, primarily in the adrenal glands and the brain. Interestingly, pregnenolone was used as the main treatment for rheumatoid arthritis and lupus before corticosteroids were invented.

Pregnenolone and dehydroepiandrosterone (DHEA) are in the same class of natural hormones. They are called “neurosteroids” since they have a similar chemical structure to corticosteroids. However, they do not have the complications of corticosteroids. 

These neurosteroids are naturally produced in the central nervous system (CNS) to suppress inflammation, promote tissue restoration, and relieve pain. 

Palmitoylethanolamide (PEA) is another natural biochemical produced by the body to control inflammation, restore tissue, and provide pain relief. 

This new AA treatment can be initiated at any time. When taken together, these 3 medicinals have a potent anti-inflammatory, healing, and pain relieving effect. They can be used separately, but the three together are much more effective.

DHEA may cause hair loss or bleeding irregularities in pre-menopausal women. Reduce the dosage in these cases. Overall, there are far fewer side effects than corticosteroids.

New Handbook

To learn more about neurosteroids, please see my new handbook, “Primer on Neurosteroids and Chronic Pain Care.”

Neurosteroids are beneficial not just for AA patients, but for anyone with chronic pain, as they help heal damaged tissues, protect and regenerate nerves, and provide pain relief. 

There is a plethora of laboratory and human studies that pave the way to use neurosteroids in chronic pain care.

Their use in pain care improves pain control and lessens the need for opioids. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its bulletins here. 

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

Public Comments Show How 7-OH Ban Would Harm Pain Patients

By Crystal Lindell

Leigh Ann Matthews is a 51 year old woman with chronic pain. She lives alone, makes less than $2,000 per month, and can’t afford health insurance.

She relies on 7-OH for pain relief, and doesn’t know how she’ll be able to work if it’s banned.   

“Please don’t make me suffer with chronic pain by taking away the ONLY thing that has helped me tremendously,” she wrote. “I have no family or friends to lean on or help me. I don’t abuse 7-OH. I’m so afraid.”

Matthews is one of the thousands of people who have shared their stories in the Federal Register in response to the DEA announcing plans to make concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) an illegal Schedule 1 controlled substance.

As of July 24, more than 20,000 comments had been submitted to the Department of Health and Human Services (HHS).  Reading through them makes some common themes jump out. There are thousands of personal, individual stories that are clearly coming from real people with real fears. 

Many are chronic pain patients, who say that 7-OH has given them their lives back. In fact, a search for the phrase "my life back" turns up 290 comments. A search for "chronic pain" returns 2,608 results.

"I'm a 50-year-old male with multiple sclerosis. I live my life with chronic pain,” wrote Gabriel Duley. “It is so hard to get out of bed to even take a shower. Doctors do not prescribe pain medications. Please do not take 7-OH away. It's the only thing that has given my life back to me."

Tyler Bartone is 30 years old and lives in Ohio. He wrote that he has suffered from chronic pain since he was 22, after a motorcycle accident broke both of his legs.

"Oxycodone, hydrocodone, Suboxone, and tramadol all got tried over those years, and none of them let me function the way I needed to,” Bartone wrote. “When I found 7-OH, that changed. I can walk my dogs now. I can play with my kids. I stopped relying on opioid pain medication because this actually worked for my pain in a way [that] those didn't."

He shared that he takes 30 to 60 mg of 7-OH spread across 4 to 5 doses a day, and that amount has stayed steady for the 1 to 2 years he has used it. 

"What scares me is what happens after a ban like this. People in my situation, and others I know who rely on 7-OH daily just to function, would be left with two options: go back to opioid prescriptions that didn't work as well, or turn to street drugs,” Bartone explained. “I know people would die from that second option. That is the real hazard here, not the milligrams in a tested tablet.”

Bartone said he would support rules that “keep this market honest.” Rules like a 21 and up age requirement, mandatory lab testing with published results, child-resistant packaging, and clear dosage labeling. 

Unrealistic Threshold

The DEA’s scheduling order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 0.5 mg 7-OH per tablet. Virtually all 7-OH products currently on the market have much higher dosages. Bartone thinks it’s an unrealistic threshold.

“I'm asking HHS to set any threshold based on how people actually take this, not a number that erases the product entirely,” Bartone said. 

Katherine Loperena, a 33 year old who works in sales and suffers from chronic pain, also shared her story. She said for the past 1 to 2 years she has used more than 60 mg of 7-OH a day, split across 2 to 3 doses. 

"What scares me most is going back to the days when chronic pain decided whether I could work or not," she wrote. "I lost jobs because the pain became too much to push through, and I spent years choosing between showing up in agony or protecting my income. Before 7-OH, I had tried oxycodone, alcohol, cannabis, and over the counter pain relievers, and none of [them] gave me a real way to manage day to day life."

Lindsay Huffman also shared how 7-OH has helped her manage the chronic pain she’s had for five years.

“Without it, I would have no way to treat my pain,” she writes. “It has been massively beneficial to my quality of life. Banning it would affect thousands of people who just want to be able to function and have finally found some hope."

Kyle Whitman wrote just one sentence: "Please don’t do this."

Lane Reeves said simply, "This (7-OH) should be available for chronic pain patients with no insurance!"

Rolando Smith shared how he uses 25 to 50 mg of 7-OH daily, which he says “has made my life so much more enjoyable through the ability to no longer feel immense pain all day long.”

“I take 7-OH not to feel anything such as a high, but rather to just eliminate the feeling of pain that usually lasts hours each day,” Smith explained. “7-OH is a perfect substance for my pain compared to other painkillers I have received as I am not a fan of overly euphoric or ‘high’ feeling drugs.”

Smith said he’s had no issues with withdrawal or dependence from using 7-OH.

“I've been an on and off user for about a year now, and find it easy to quit when I want to lower my tolerance or run out of supply and feel too lazy to get more. Personally I have not felt negative effects physically or mentally with using this substance and I never feel the need to take any more than what makes my pain disappear,” he wrote.

Patricia Metz shared how she takes 7-OH a few times a week to help with chronic pain from a serious injury. Without it, she doesn’t think she’d be able to work and provide for her child.

"This product has given me back a quality of life I couldn't otherwise have," Metz writes. "I have had six surgeries, countless hours of physical therapy, and spent years working with pain management with no meaningful result. 7-hydroxymitragynine is far safer than prescription pain management and far more accessible.

“There are thousands of people with a similar story who rely on 7-OH, many of whom are scared to death right now because they feel the rug being pulled from under their feet and see a future of pain ahead. I fear that removing access to this valuable resource will drive a good number of those people to dangerous and deadly street drugs."

The American Kratom Association (AKA), which represents natural leaf kratom vendors who have lost market share to 7-OH, is in favor of banning 7-OH products. It recently sent a letter to HHS, claiming many of the public comments in support of 7-OH are ”Coordinated, Duplicate, Fictitious, and Financially Incentivized.”

According to the AKA, many of the comments are anecdotal personal stories that should not be considered as part of the scientific analysis of an appropriate 7-OH threshold. The letter also said some 7-OH vendors are offering discounts to consumers who show that they have left a comment.  

In 2016, the DEA dropped another effort to ban kratom after a public outcry. At the time, the DEA received over 22,000 public comments in the Federal Register, a record number on any issue. It seems likely that record will be broken again.

Swimming Reduces Disability From Chronic Low Back Pain

By Mark Hancock and Deborah Wareham

As we age, low back pain becomes more common. Between the ages 20 and 59, persistent low back pain (lasting more than three months) affects nearly one in five.

While you may be tempted to reach for heat packs, medication or a massage, new evidence suggests that the common advice to go for a swim is much more effective.

Until recently, there was no research to back up this advice. Our new trial shows for the first time that swimming can improve low back pain.

What We Did

We recruited 76 adults aged 26 to 74 who experienced persistent and bothersome low back pain for more than three months. They needed to be able to swim 25 meters (82 feet) independently, but didn’t swim regularly.

The participants were randomly allocated to receive either a swimming and education program (the intervention group) or education only (the control group).

The intervention involved an eight-week individualised swimming program, supported by four telehealth sessions with a physiotherapist, and free access to a local indoor or outdoor swimming pool.

The amount of swimming was tailored to each participant’s ability and fitness level, with the goal of completing three 30–45 minute swimming sessions per week by the end of the program. Participants were encouraged to continue swimming after the program completed.

The education, provided by a physiotherapist, aimed to help them better understand their pain, reduce the fear associated with movement and exercise, and increase confidence to manage their back pain.

While many people with back pain believe they should avoid activity to protect their back, a large body of evidence shows remaining active is better.

Participants in the education-only (control) group had one to two sessions with a physiotherapist to cover the same key messages about back pain, but otherwise continued their usual treatment and activity.

What Did We Find?

Participants in the swimming group reported improved function, less pain and more confidence to manage future back pain.

Their disability reduced by more than 50% at the end of the eight-week program. This could mean that a person improved their ability to do daily activities such as standing from a chair, walking or sleeping.

The swimming group’s improvements were 30% greater than those who received education only (control) group.

Participants told us swimming appealed to them because it was low-impact, it reduced weight-bearing and strain, and it enabled them to exercise more confidently and with less pain. They also reported additional health benefits, including better mood.

Swimming can be used as a way for people with back pain to start exercising and break the cycle of pain and limited activity.

At the end of the eight-week program, some people kept swimming, others swapped to another form of exercise and some stopped exercising.

Although most participants reported enjoyed swimming, some found accessing a pool and the time required a barrier to keep going in the longer term.

Twelve months after starting the program, there were still benefits for the swimming group for disability, function and confidence. But the difference between groups became smaller over time.

Our study’s sample size was relatively small, so these findings need to be confirmed in future, larger studies.

Further trials are also needed to test whether the results still hold for people with more severe or disabling back pain.

Finally, the volunteers in our study knew we were investigating swimming and had positive expectations of swimming before starting. This is a limitation that could affect the findings.

Swimming vs Other Exercises

A range of different exercises – including Pilates, functional exercises (a type of strength training that helps you perform daily activities) and structured walking – have been shown to be beneficial for treating disability and preventing low back pain recurrences.

While we didn’t compare swimming to another type of exercise, the benefits we identified were as large or larger than previously reported for other exercises.

People with chronic low back pain can now consider swimming as an evidence-based exercise option and be more confident in choosing it as part of their long-term management.

But if you find it a hassle to get to a pool, or don’t like swimming, it may help get your back pain under control before moving to a type of exercise you prefer or can more easily access.

Mark Hancock, PhD, is a Professor of Physiotherapy, Faculty of Medicine and Health Science, at Macquarie University in Australia. 

Deborah Wareham, PhD, is a Research Fellow at the Spinal Pain Research Centre at Macquarie University.

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

There’s Still Time to Fight the 7-OH Ban

By Crystal Lindell

It’s a bizarre experience to know that something you take on a daily basis is probably about to become an illegal Schedule 1 controlled substance.

If I take a tablet of the concentrated kratom alkaloid 7-OH on July 31, I’ll just be taking an OTC supplement. 

But assuming the proposed ban goes through, simply possessing the same tablet in August will technically mean I am committing a felony. 

The Drug Enforcement Administration says the 7-OH that I take to manage my chronic pain is so dangerous and medically worthless that it belongs in the same category as LSD and heroin. But they also think it’s fine to leave it legal for one last month.

None of it makes any sense.

Don’t get me wrong, I’m eternally grateful that 7-OH was not instantly made illegal. It gives tens of thousands of people like me time to taper off it.  

But nothing will change about 7-OH in August to suddenly make it more dangerous, other than the way the Trump administration has decided to classify it.

It’s difficult to manage life during such an abrupt transition. I will have to basically teach my brain that one of my supplements is now the kind of thing that could trigger a police raid on my home and get me fired from my job. 

Yes, I have been tapering myself off 7-OH. Of course I have been tapering. Anything less would be irresponsible.

I have successfully tapered from about 80 mg a day down to 25 mg a day. It was not very difficult to drop down my dose that much. I did a little more each day and had almost no withdrawal symptoms. There were a couple days when I was a little more anxious, but that was it.

When I was still living under the impression that 7-OH would remain widely available and legal, I took it whenever I had pain. But now, since I know that it will likely be illegal soon, I only take it when the pain is so severe that I cannot function without it.

Unfortunately, that presents a pretty big problem: What am I going to do when it’s illegal and my pain is so severe that I cannot function without it?

Despite the fact that I have lowered my dose so much – it’s the next 10 days that I’m really scared of. Because that’s when I have to figure out how to live with zero 7-OH. 

I still need it to get through a shift at work, even when using it in combination with opioid medication and  OTC pain relievers. In fact, I still need 7-OH to get through the physical strain of taking a shower.

One thing I love most about 7-OH is that it works immediately whenever I take it. And it’s a chewable tablet, which means I don’t even need a drink of water to swallow a pill.

That makes it an amazing pain reliever for when I’m working. And it makes it super helpful for when I’m on a strict time schedule. Needing to wait 30-40 minutes for a medication to kick in steals so much time out of my day.

There just is no alternative that helps me as much as 7-OH. As such, writing this column genuinely saddens me.

It’s not just grief for myself and what I will have to endure when I can no longer take the most effective pain reliever I’ve ever had. It’s the fact that tens of thousands of other people will also be losing the same thing at the same time. 

Advocacy groups think the total number of Americans who have used 7-OH is as high as one million. That’s a lot of potential felons. Some of them are my loved ones. 

I have seen firsthand how 7-OH has relieved their pain and given them their lives back – in ways I never could have dreamed just two years ago.

I don’t want people to get a false hope that the DEA could backtrack on this, like they did with the kratom ban in 2016. But I also know that doesn’t mean we should just give up.

We have to keep fighting, not just for ourselves, but for all the people who could be helped by this soon-to-be illegal substance.

If you support legal 7-OH, please go leave a public comment on the Federal Registrar. Here are links to the public comment page and the comment portal. Over 17-thousand people have commented already. The deadline is July 31.

Personal comments will have more of an impact. It’s important to remember that they are only asking for a threshold amount of 7-OH that should remain legal. So you should share what dosage you safely take on a daily basis.

We have not lost yet. As such, we can’t stop fighting for this either. 

Palmitoylethanolamide (PEA): A Natural Treatment for Intractable Pain

By Dr. Forest Tennant and Ingrid Hollis 

Palmitoylethanolamide (PEA) is a naturally occurring biochemical produced by the body for pain and inflammation control. It is also available as an over-the-counter dietary supplement. 

This article is presented with our belief that essentially every person with intractable pain should try a PEA supplement in a therapeutic trial.  Several companies market PEA supplements and researchers have determined effective dosages. 

PEA is the only medicinal that simultaneously fights inflammation at the site of an injury, as well as neuroinflammation in the central nervous system (CNS).  It helps heal damaged glial cells that are responsible for intractable or constant pain. 

About two dozen double-blind clinical studies have shown that PEA is more than just a placebo. German researchers say PEA is an effective and well-tolerated treatment for hundreds of patients with chronic pain.    

Our experience is not as extensive, but we have found that about 80% of patients experience good results if PEA is used for four to six weeks, providing relief for both chronic and intractable pain.  In most patients, PEA progressively wears down baseline pain. 

Starting dosage is 600 to 1200 mg twice a day.  This dosage can be increased if needed.  

Some PEA products contain luteolin, a polyphenol found in many fruits, vegetables and herbs that has anti-oxidant and anti-inflammatory properties. This is excellent as luteolin boosts the effectiveness of PEA, and also helps prevent the reactivation of the Epstein-Barr virus. 

One can simply add PEA to their current pain relief program.  Opioids and other pain medications need not be stopped. 

No serious side effects have been reported from taking PEA. As a natural biochemical, it is quite safe to take.  

If you have chronic or intractable pain, try a 1-to-2-month therapeutic trial of PEA. You have much to gain and nothing to lose. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its bulletins here.

Ingrid Hollis is a person in pain, patient advocate, and advisor to the Tennant Foundation.

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

Hydrocodone Is Better Than Oxycodone for Post-Operative Pain

By Pat Anson

When it comes to treating post-operative pain, hydrocodone works better than oxycodone in relieving pain and does it with smaller doses, according to a new study that compared the effectiveness of the two opioids.

A team of researchers evaluated health data for 663 patients who had elective joint arthroplasty on their hips or knees, a major surgical procedure where a damaged or arthritic joint is removed and replaced with an artificial one. About a third of the patients took oxycodone for post-operative pain, while the rest received hydrocodone. 

Nearly 1.25 million joint arthroplasty procedures are performed annually in the US, and many patients experience significant pain during recovery. Oxycodone is generally considered more potent than hydrocodone, and is typically prescribed more often for post-operative pain.

The study findings, published in JAMA Network Open, show that patients on hydrocodone had slightly lower pain scores 10 days after surgery than those who took oxycodone. 

They also needed significantly less morphine milligram equivalents (MMEs) over the course of their post-op recovery (93.2 MME for hydrocodone vs 134.8 MME for oxycodone).  

“We observed that patients prescribed hydrocodone had lower composite pain scores over the 10-day postoperative period, and their total opioid consumption (in MME) was significantly lower, compared with patients prescribed oxycodone. Therefore, we rejected our initial hypothesis that oxycodone provides better pain control than hydrocodone,” wrote lead author Julie Johnson, PharmD, Director of the Clinical and Translational Science Institute at The Ohio State University. 

It’s important to note that all of the participants in this study had the CYP2D6 gene, which makes them normal metabolizers (NMs) of opioids. Had they had a variation of the gene, oxycodone may have performed better, according to researchers. About 10% to 15% of individuals have those variants.

“Our findings have practical implications for postoperative pain management, especially in the context of personalized medicine and opioid-sparing strategies. For patients who are CYP2D6 NMs, a multimodal approach with hydrocodone appears to be a safe and effective option for managing acute post–total joint arthroplasty pain, achieving pain relief that was comparable to or better than oxycodone, with a lower MME,” Johnson wrote.

The hydrocodone and oxycodone formulations used in the study contained acetaminophen. Both groups also utilized other pain relievers, such as NSAIDs, nerve blocks and tramadol during their recovery. There were no significant differences in mobility, anxiety, and depression between the hydrocodone and oxycodone groups.

First Successful Treatment of Arachnoditis Published

By Dr. Forest Tennant

For the first time since arachnoiditis was identified and defined in medical dictionaries in 1873, patients and physicians now have a successful peer-reviewed treatment for chronic adhesive arachnoiditis (AA). 

I and my associates, Dr. Martin J. Porcelli, and Jennifer Sands, RN, have just published the results of a small study, “Low Dose Methylprednisolone and Ketorolac Treatment for Adhesive Arachnoiditis” in the International Journal of Emergency Medicine & Pain Management.

AA is a progressive inflammatory spinal disease in which cauda equina nerve roots become bound by adhesions to the arachnoid membrane, often resulting in severe intractable pain, neurologic impairment, loss of mobility, bowel and bladder dysfunction, and profound functional decline.

In our study, 20 patients with AA achieved symptomatic pain relief with low, intermittent dosages of the corticosteroid methylpredisolone and ketorolac, a non-steroidal anti-inflammatory drug (NSAID). The key goal in using these two drugs is to suppress inflammation. 

Low doses of methylpredisolone 4mg and oral ketorolac 10mg (or injectable ketorolac 15-30mg) were given to patients 1 to 3 days a week. Participants took the combination for 30 to 180 days.  

Seventeen of the 20 patients reported improved pain control, 13 reported improved physical activity, and 9 reported fewer bedbound days. Most patients also reported fewer pain flares and a decreased intensity of their flares. 

It is fitting that the first published treatment for AA is ketorolac and methylprednisolone. These two drugs have been the most reliable and consistent medicinals for AA. 

The absence of a published treatment for AA for 153 years has left patients in a dangerous vacuum. Into that vacuum came dismissal, therapeutic nihilism, medical abandonment, and the repeated phrase so many patients have heard: "There is nothing that can be done." This publication changes that conversation.

This does not mean the search for AA treatment is complete. It means the era of saying that nothing has ever been published must end, and a new treatment-development era has begun.   

Going forward, we believe the new treatment can be combined with neurosteroids, biologic pain relievers, neurohormones, and peptides for even better results. Let’s hope that this first study is just the beginning.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its bulletins here.

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