Advocates, regulators and scientists weigh in on the controversial herbal supplement.
By Lisa Esposito, Staff Writer April 6, 2018, at 11:23 a.m
To its proponents, the herbal medicine kratom represents a safe and natural plant-based supplement that enhances mood and offers mild pain relief. Government agencies warn that the botanical substance, used for several centuries in Southeast Asia, can be harmful and possibly addictive. However, some U.S. scientists and doctors aren’t so sure.
The X-factor is whether kratom might have a role to play in treating opioid addiction or withdrawal, or serve as a safer alternative to drugs such as heroin, fentanyl and oxycodone now fueling the opioid epidemic. But for now, kratom is unregulated, under-researched and unproven.
Salmonella contamination is another concern. On April 3, the Food and Drug Administration issued a mandatory recall of kratom products from a Las Vegas-based company because they were tainted with the bacteria. Previously, other brands of kratom supplements have been tied to salmonella cases.
Kratom is native to Thailand, Indonesia, Malaysia, Myanmar, the Philippines and New Guinea. It’s pronounced several ways (KRAY-tum, crate-UHM or KRAY-tom). Traditionally, kratom’s fresh or dried leaves have been chopped and either chewed or made into tea as a workday pick-me-up for manual laborers, according to a historical summary in BioMed Research International. It’s also been used as a folk remedy to relieve pain, ease withdrawal from morphine or opium and sometimes act as a replacement for the drugs.
Today, people can find kratom in many tobacco or vape shops, gas station convenience stores or simply by going online. It comes in a variety of forms including crushed leaves, capsules, tablets, powers and even gum. Users describe it as having a bitter taste.
Price ranges for kratom appear similar to other supplements. On one online site, a bottle of 50 capsules costs about $25. Consumers are on their own when choosing a dose for the desired effect.
Based on various surveys, an estimated 3 to 5 million people use kratom throughout the U.S., says Dave Herman, chairman of the American Kratom Association. As head of the advocacy group, Herman is determined to maintain public access to kratom. “You’ve got a grassroots feeling from consumers that they should have the right to make their choices for their health and well-being, as long as it doesn’t harm them,” Herman says. “They want access. Why shouldn’t they?”
Dr. Alicia Lydecker, a medical toxicologist and emergency physician at Albany Medical Center, sees kratom from her dual professional perspectives. “At low doses, kratom acts like a stimulant – like coffee – but at high doses it has opioid-like effects,” she says. “This explains why the same drug historically has been used for things like work productivity, but on the other hand is also used to self-medicate anxiety, opioid addiction and restlessness.”
Nausea, itching, sweating and dry mouth are some side effects of kratom. Users may also have symptoms such as anxiety, irritability, dry mouth, increased urination, constipation and loss of appetite. Several cases of seizure associated with kratom have been reported, along with at least one case report of liver injury.
The vast majority of people who call poison control centers or come to the emergency department with kratom-associated issues have mild to moderate symptoms, Lydecker says. In contrast, patients admitted with heroin overdoses, for example, can arrive blue and not breathing at all. They require immediate treatment to reverse the drug’s action.
Kratom products sold online could be dangerous, Lydecker emphasizes. Some may be adulterated or contaminated with certain components of the kratom plant that might have a much stronger effect. The lack of regulation is troubling, she adds: “Anybody could be adding things to those capsules or powders.”
“People think kratom is safe because it’s from a plant, and it’s natural,” Lydecker says. “But you have to understand that heroin and morphine are also derived from plants.
To date, kratom is legal to use or purchase under federal law. However, a handful of states, including Alabama, Arkansas, Indiana, Rhode Island, Tennessee, Wisconsin and Vermont and the District of Columbia, have laws banning kratom. Some individual counties and cities have also imposed restrictions.
As of February, the FDA has received 44 reports of kratom-related deaths. These reports are complicated, however. Other factors are involved in many cases, such as victims also having illegal drugs, prescription opioids, benzodiazepines, alcohol or overdose-associated over-the-counter medications in their systems.
One new report of an overdose death was of particular concern, according to an FDA advisory, which noted: “This individual had no known historical or toxicologic evidence of opioid use, except for kratom.”
The FDA does not recommend kratom in any form or for any purpose. “The agency also remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms,” according to a statement. “Neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.”
The Drug Enforcement Agency, which has included kratom on its list of drugs of concern since 2011, continues to consider it harmful and dangerous, says DEA spokesperson Melvin Patterson. Mitragynine and related chemicals in kratom “are substances with opioid effects whose use may result in serious negative outcomes,” Patterson says. “Accordingly, DEA would advise against anyone using this substance for its psychoactive properties.”
In 2016, the DEA announced a plan to classify kratom as a Schedule I substance – the most restrictive category. Schedule I drugs are deemed to have a high potential for abuse and to create severe psychological or physical dependence.
However, the plan was withdrawn, at least temporarily. “There was a giant backlash,” says Marc Swogger, an associate professor in the department of psychiatry at University of Rochester Medical Center. “As a result the DEA backed off, which was surprising – probably unprecedented.” The agency then opened the issue to public commentary and announced it would gather more scientific information.
In the midst of the opioid epidemic, better evidence is needed before dismissing kratom’s potential and banning its use, Swogger believes. “We have no data to indicate that kratom causes psychosis, violence or criminality,” he says. “People who use it regularly – who may even be dependent on it – seem to function pretty well. They show up for their jobs; they have relationships.”
Most of the human research on kratom comes from case studies, individual testimonials and anecdotal reports. “We’re still not very far along in terms of kratom science,” Swogger says. “What we really need are longitudinal studies and randomized clinical trials to be able to understand the effects of kratom in much more nuanced ways.”
An analysis, commissioned by the American Kratom Association, was published in the February 2018 issue of the journal Psychopharmacology. It found no documented threat to public health that would warrant placing kratom as a Schedule I drug. “Kratom has some opioid effects but low respiratory depression and abuse potential compared to opioids of abuse,” the authors concluded.
Swogger is one of nine scientists who collaborated on a Feb. 8 science letter to the Trump administration addressed to White House advisor Kellyanne Conway and DEA acting administrator Robert W. Patterson. They outlined their concerns about potential placement of kratom as a Schedule 1 controlled substance and the resulting loss of public access.
Whether kratom will eventually be deemed a controlled substance is uncertain. “DEA’s independent evaluation is ongoing,” Patterson says. “We do not have a timetable to share on when a scheduling decision will be made.”
Original Article https://health.usnews.com/health-care/patient-advice/articles/2018-04-06/whats-the-deal-with-kratom
