Jerusalem — Medical cannabis, also known as medical marijuana, is being prescribed more often these days, but safety concerns regarding prescriptions to people over 65 with chronic pain problems haven’t received much attention.
Now a team of researchers at Ben-Gurion University of the Negev (BGU) and the Cannabis Clinical Research Institute at Soroka University Medical Center are creating a treatment protocol that addresses these issues.
“A treatment protocol says how to start treating the patient,” said Dr. Ran Abuhasira of the BGU Faculty of Health Sciences and Soroka’s Cannabis Clinical Research Institute. “What’s the initial dosage, how do you increase that dosage safely, if necessary? The goal isn’t to say we enrolled X number of patients. It’s to share our experience to improve the quality of care.”
In their study, “Medical Cannabis for Older Patients—Treatment Protocol and Initial Results,” which was published in the Journal of Clinical Medicine, 184 patients whose median age was 82 began cannabis treatment at a geriatric clinic in Bnai Brak, a suburb of Tel Aviv. Six months later, 58.1 percent of the patients were still using cannabis.
Of these, 84.8 percent reported moderate to significant improvement in their general condition. But a third also reported adverse events like dizziness, sleepiness and fatigue.
Part of the study’s funding came from NiaMedic, a medical data company that provides researched-based medical protocols integrating conventional medicine with treatments that involve proprietary strains of cannabis. (The company, which owns the Bnai Brak clinic, “had no influence on the data collection, analysis or manuscript preparation,” according to the research paper.)
The research focused on older adults “because we think this is a group of patients that has the potential to gain from cannabis, but there is very little data,” said Abuhasira. “Very few studies have focused on the elderly population, but that’s true of medicine in general.”
That omission is troubling considering that anywhere from 10 to 40 percent of cannabis users are 65 and older, Abuhasira said, citing statistics from the U.S. and Europe.
The majority of the study’s patients suffered from chronic pain. Others had Parkinson’s disease, sleep disorders, anorexia, post-traumatic stress disorder or spasticity. The patients were treated with THC oil, CBD oil or a combination of the two.
The researchers said cannabis was “well tolerated” by most patients, with a relatively low number of adverse events.
“Most of the patients were satisfied with the treatment and believed it was beneficial to their general health,” the study said.
These findings were in keeping with results of a previous study performed by the researchers, and other studies performed in the United States, the researchers said.
However, due to its side effects, cannabis “is not suitable for all patients,” the study emphasized, and its use should be considered after evidence-based treatments have failed to address the problem.
The study called on cannabis researchers to carefully monitor older adults via clinical trials and registry studies.
“Once treatment is initiated and the therapeutic dose is achieved, we recommend at least monthly follow-up at first to assess adverse events and treatment efficacy,” Abuhasira said.
Of the patients who dropped out of the study, several cited dizziness, fatigue, dry mouth, sleepiness, gait instability or feeling “high.” Some of the patients who remained in the study reported the same.
“Most of these adverse events were not defined as severe,” Abuhasira noted.
Still, dizziness and gait instability should be of concern to patients and physicians because falls are a leading cause of injury and death in the elderly.
In addition to treatment ineffectiveness and adverse events, other patients were removed from the study either because they chose not to participate or could not be reached.
The BGU-Soroka protocol advises special caution when treating older adults due to potential negative medication interactions. Cannabis might also impair the nervous system and cardiac function.
The differences in absorption, distribution, metabolism and elimination of drugs in the elderly affect the way they react to cannabis, said Dr. Victor Novack, who heads the Clinical Research Center and Research Authority and directs an internal medicine department at Soroka.
“They’re already on medications so there are many potential interactions you need to think about,” he said. “This isn’t aspirin. You can’t give the same dose to every patient. This is cannabis.”
The risk of negative drug interactions is higher in the over-65 population because older patients typically take more medications than younger patients.
A recent New York Times article by Jane Brody noted that people aged 65 to 69 take an average of 15 prescriptions a year, and those aged 80 to 84 take 18 prescriptions a year, according to the American Society of Consultant Pharmacists.
These figures did not include vitamins and over-the-counter medications.
“The elderly are particularly vulnerable to polypharmacy and a too-frequent consequence known as a ‘prescribing cascade’ — in which still further medications are prescribed to treat drug-related side effects that are mistaken for a new medical condition,” the Times article said.
Abuhasira emphasized that the BGU-Soroka study — which is part of a larger study — was conducted in order to create a protocol to safely test cannabis on the elderly, not to prove cannabis’ efficacy.
“Currently we don’t have good evidence that cannabis can treat most of the diseases we’re giving it for. That doesn’t mean it won’t help. It means we need to collect more data.”
Abuhasira said the cannabis patients he saw in the study were “generally satisfied” with their treatment.
“When we speak about the elder and quality of life, these are important issues, even if some of it is attributed to the placebo effect. That’s not enough for FDA approval and shouldn’t be. As a scientist I agree.
“But when patients are saying they are experiencing less pain and sleep better, it’s not for me as a doctor to argue.”
The researchers will publish another part of the study sometime later this year on a larger group of patients. It will focus on the effects of cannabis in older adults on sleep, pain, activities of daily living, quality of life and more.