By Pat Anson, Editor
A threatened ban on kratom would stifle scientific understanding of the herb and its value in treating pain, addiction and other medical problems, according to a commentary published in the Journal of the American Osteopathic Association.
"There's no question kratom compounds have complex and potential useful pharmacologic activities and they produce chemically different actions from opioids," said Walter Prozialeck, PhD, chairman of the Department of Pharmacology at Midwestern University Chicago College of Osteopathic Medicine.
“In my opinion, the therapeutic potential of kratom is too large to be ignored. Well-controlled clinical trials on kratom or the many active compounds in kratom are needed to address this issue.”
In August, the U.S. Drug Enforcement Administration issued an emergency order saying it would classify two of kratom’s active ingredients -- mitragynine and 7-hydroxymitragynine -- as Schedule I controlled substances.
Such an order would have effectively banned the sale and possession of an herbal supplement that millions of people use to treat pain, anxiety, depression and addiction. It would also make it harder for researchers to conduct clinical trials of kratom.
The DEA postponed its decision only after a backlash from kratom supporters and some members of Congress. The agency said it would seek new guidance from the FDA and allow public comment on the proposed ban until December 1. Over 7,000 people have commented so far at Regulations.gov.
In its emergency order, the DEA said kratom posed an “imminent hazard to public safety” and referred to its chemical compounds as “opioid substances.” But Prozialeck says kratom behaves differently than opioids, because it doesn't produce euphoria or depress respiration.
“At the molecular level, mitragynines are structurally quite different from traditional opioids such as morphine. Moreover, recent studies indicate that even though the mitragynines can interact with opioid receptors, their molecular actions are different from those of opioids,” he wrote. “Based on all of the evidence, it is clear that kratom and its mitragynine constituents are not opioids and that they should not be classified as such.”
Prozialeck also disputes the notion that kratom is linked to several deaths, saying other drugs or health problems could have been involved. While he thinks banning the herb would be a mistake, Prozialeck believes some regulation is needed to prevent kratom products from being adulterated or contaminated with other substances.
"After evaluating the literature, I can reach no other conclusion than, in pure herbal form, when taken at moderate doses of less than 10 to 15 g (grams), pure leaf kratom appears to be relatively benign in the vast majority of users. Without reported evidence, however, it would not be appropriate for physicians to recommend kratom for their patients,” he concludes.
That’s a sentiment that Dr. Anita Gupta agrees with. She says several of her patients have successfully used kratom for pain relief, but until more research is conducted on the herb’s safety and efficacy, Gupta won’t recommend it to other patients.
“What I hear from patients is that they’re getting good benefit from it. But we have to wonder if kratom itself has pharmacological benefit or if it’s a placebo effect,” said Gupta, an osteopathic anesthesiologist and pharmacist who also serves on an FDA advisory board.
“I would encourage more oversight of kratom. There should be more regulation of kratom substances. That could come from the FDA or DEA, to make sure patients are safe and there’s no harmful interaction. To say that it’s only a dietary supplement, I don’t know if that’s the right classification, because we’re using it for clinical conditions and diseases. I think we need more oversight and more research should be conducted,” Gupta told PNN.
It’s a Catch-22 for kratom supporters. If research confirms its therapeutic value, that could result in kratom being classified as a Schedule II or III controlled substance, on the same level as other medications that have a potential for abuse. Kratom would still be legal to obtain, but only with a prescription.
In a survey of over 6,000 kratom users by Pain News Network and the American Kratom Association, over 98 percent said they wanted kratom to remain available as a dietary supplement without a prescription. Seven out of 10 also said pharmaceutical companies should not be allowed to produce and market kratom products.