K

ratom, an herbal supplement that was once a quiet member among the legion of botanical products sold in the United States, exploded onto the national scene in August 2016 when the Drug Enforcement Administration announced plans to classify it as a Schedule 1 controlled substance. As such, it would join heroin, LSD, ecstasy, marijuana, and other so-called recreational drugs as a substance with “a high potential for abuse and the potential to create severe psychological and/or physical dependence.”

The DEA withdrew its call to ban kratom, and instead asked for public comments on the product. The comment period closed Dec. 1.

We believe that a move to make kratom a Schedule 1 controlled substance is premature and shortsighted, from both the scientific and clinical perspective. It would make it nearly impossible for researchers to fully examine its safety and clinical uses.

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Walter C. Prozialeck: Kratom is the popular name for the leaves of Mitragyna speciosa, a tree native to Southeast Asia. Kratom leaves have been used for centuries as a mild stimulant, a painkiller, and a treatment for opioid addiction. Its leaves can be eaten raw, but more often they’re crushed and brewed as tea or turned into capsules, tablets, and liquids.

I recently published a review on the pharmacology of kratom in the Journal of the American Osteopathic Association. There is substantial evidence from animal and biochemical studies that kratom and its active constituents, such as mitragynine and 7-hydroxymitragynine, have beneficial pharmacologic effects. Primarily, researchers suspect it might provide pain relief similar to opioids, but with significantly less potential for addiction and for severe toxicities from overdose.

As might be expected with almost any botanical product, as the use of kratom in the US has grown, there have been increasing numbers of reports of adverse effects resulting from the use of purported “kratom” products.

The DEA based its decision to classify kratom as a Schedule 1 drug based largely on reports of adverse effects. According to the CDC, about 42 percent of kratom-related adverse events reported between 2010 and 2015 involved non-life-threatening symptoms that required some treatment. About 7 percent were classified as major and life-threatening. The DEA claims that kratom can lead to psychotic symptoms and psychological addiction, and reports that there have been 15 kratom-related deaths between 2014 and 2016.

In those fatal incidents, however, the kratom products were almost always either concentrated extracts or fortified with various substances or drugs, including mitragynines, opioids, or stimulants. Many of the users had confounding conditions, such as a history of drug addiction or the use of multiple drugs such as alcohol, opioids, or marijuana, aside from kratom or along with kratom. The bottom line: It is not at all clear that kratom itself was the cause of the problems.

In evaluating the effects of kratom, it is important to note that most information is based on personal reports by kratom users. Scientists who have systematically analyzed those reports have concluded that even though kratom can be addictive, the potential therapeutic benefits of kratom outweigh its risks.

After carefully evaluating the literature on kratom, I have concluded that when it is taken in pure herbal form at moderate doses (no more than 5 to 10 grams), pure leaf kratom is relatively benign in the vast majority of users. In addition, even though kratom itself is clearly addictive, it appears to be much safer than opioids.

That said, I don’t think it is appropriate for physicians to recommend kratom to their patients at this time. There are clearly issues regarding quality control and standardization of kratom products that need to be addressed. Questions about kratom can be addressed only through well-controlled clinical trials in humans.

My concern is that a move to Schedule 1 status would stifle this important research. It is my sincere hope that some sort of compromise can be developed so that quality standards for the production of kratom can be established without banning this product.

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Anita Gupta: I specialize in helping patients manage pain. More and more of my patients are asking me about alternatives to opioids, which are highly addictive and only about 30 percent effective at treating chronic pain.

After kratom was featured so prominently in the media, a number of my patients asked me about it. I believe in evidence-based medicine, so I did some research on kratom. The “evidence” was all over the place, and I had trouble finding solid, reliable information. At the same time, I know there is some value in anecdotal reports, of which there are many. Given what I had learned about kratom, I couldn’t in good conscience recommend it to my patients.

But quite a few of them started taking it on their own. Their results have been all over the place. Some tell me that they feel better, have less pain, and don’t need to use opioids for pain control as much. Some say they feel a little bit different, but aren’t sure if kratom it is making much of a difference. Others say it didn’t do anything for them. That assessment is hard for me to decipher — it can be a genuine statement that kratom didn’t work or it can be a veiled way to obtain prescription opioids, which carry well-established benefits and risks.

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Does kratom actually ease pain is a question that must be answered. But we also need to know what risks are related to using it, and whether it interacts with medications and other supplements.

The supplement field is largely unregulated. There have been reports of so-called herbal supplements for erectile dysfunction that were spiked with sildenafil, the active ingredient in Viagra. When you don’t know the provenance of kratom, there’s no way of knowing whether it eases pain because it is laced with opioids.

As an osteopathic physician, my primary focus is on wellness and prevention. If kratom has the potential to manage pain without causing a secondary disease like opioid addiction, I believe we should give it a chance — but not before rigorously studying it to fully understand its benefits and its risks.

Walter C. Prozialeck, PhD, is professor and chairman of the department of pharmacology at the Chicago College of Osteopathic Medicine at Midwestern University. Anita Gupta, DO, is an anesthesiologist and professor of pain medicine at Drexel University College of Medicine and currently co-chairs the Committee of Prescription Opioid Abuse of the American Society of Anesthesiologists.

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