Scientific American is the essential guide to the most awe-inspiring advances in science and technology, explaining how they change our understanding of the world and shape our lives. A new study shows that an FDA-approved, pharmaceutical-grade formulation of CBD has an antiviral effect in human lung cells and mice, and shows a significant negative association with COVID infection in human patients. Cannabidiol in Anxiety and Sleep: A Large Case Series Cannabidiol (CBD) is one of many cannabinoid compounds found in cannabis. It does not appear to alter consciousness or trigger a “high.” A
Can CBD Cure What Ails You?
When a shop selling cannabidiol (CBD), a compound found in marijuana, opened near the place where I get coffee in my Southern California neighborhood, I was of two minds. Actually, for several weeks I was of one mind, which was to wish for the speedy demise of the business. As a physician, I just know too much about some of the deleterious consequences associated with marijuana use: memory issues, altered judgment, addiction, longer-term cognitive issues, chronic bronchitis symptoms, and so on.
But as the days passed, I began to glimpse the other side of the conversation. In the end, I spent quality time with the supervisors of three CBD stores in my area, and each had inspiring stories to share of customers who alleviated their aches, overcame chronic pain, reduced stress, had a good night’s sleep or got a semblance of their lives back. They told me stories like that of Lorraine, who had been bucked off a horse, broke some vertebrae, was ridden with chronic pain, yet experienced such dramatic improvement with CBD that after a month, she rode her horse 400 miles through the south of Spain.
That’s certainly storybook enough. So, is CBD a miracle cure? Despite its promise, if you’re someone who hopes to read that science proves CBD is a wonder product, I’m afraid this isn’t the place to look.
The truth is unforgiving. The studies around pure CBD—that is, CBD without THC—are limited due to the fact that some are small and inconsistently designed. Jason White, who chairs the World Health Organization Expert Committee on Drug Dependence, told me in an interview that he believes the number of randomized control trials (RCTS) specific to pure CBD is small, likely fewer than 10. Outside of one prescription drug created to treat two rare pediatric seizure disorders, the Food and Drug Administration (FDA) has not evaluated or approved pure CBD for any therapeutic use. This is a thicket of often conflicting claims.
Before we go any deeper, let’s cover the basics. I mentioned marijuana above, and that plant does have more than 100 different compounds within it called cannabinoids. Its primary component is THC, which has the psychotropic properties that give users the feeling of being “high.” CBD is the second-most prevalent component, and does not have this same effect.
Perhaps more significant, THC and CBD are also found in hemp, but the THC concentrations are very low. In the U.S., hemp plants by definition have no more than 0.3 percent THC, while marijuana plants are bred to have much higher levels. And where marijuana is primarily used as a drug, hemp is found in all sorts of products, including fabrics and textiles, paper, food, animal feed and supplements.
CBD’s popularity has skyrocketed because of its purported therapeutic benefits, along with a low potential for abuse. There’s also plenty of it, and it’s profitable. According to Julian Wright, Founder of Science and Recreation, farmers can make $60,000 per acre to produce hemp high in CBD, versus $750 per acre in hemp sold for fiber. The commercial market for CBD, meanwhile, is projected to rise from an estimated $500 million in 2018 to $1.8 billion by 2022.
Why so popular? Well, CBD is being marketed as a health supplement and a medicine, with the ability to reduce inflammation, lessen pain and reduce anxiety as well as to potentially help alleviate other conditions like post-traumatic stress disorder, some of the side effects of chemotherapy, and even spasticity associated with multiple sclerosis. The Hemp Farming Act of 2018 reclassified hemp from a highly controlled Schedule 1 substance, like marijuana, to an agricultural product that could now be grown and distributed legally.
Though CBD is legal to sell, the FDA has made it clear that unapproved CBD products cannot be in food, beverages, cosmetics or sold as a dietary supplement; neither can they be marketed with unsubstantiated health claims. CBD can be purchased as oils, tinctures, sprays, creams, capsules, lollipops, chocolates, energy bars, trail mix and gummies, among other things. It can even be vaped. (According to Pam Miles, past president of the Association of Food and Drug Officials, one restaurant chain offered sandwiches infused with CBD as part of a promotion, so you know we’re already there in terms of availability.)
I visited three stores in the San Diego area. At the Golden State Greens shop, the supervisor, Jake C. told me his customers use CBD primarily for stress, anxiety, insomnia and pain, including several cancer patients who found that the product helped them sleep and perhaps regain some weight they’d lost while undergoing treatments. Shawn McManigal, owner of the Injoi CBD store in La Jolla, said a 92-year-old customer of his stopped taking his constipating pain medications after realizing that CBD gummies relieved the pain and allowed him to rest. “I’m not saying this is a miracle cure,” McManigal told me, “but there is science behind it and it really proves what it does.”
Does it, though? The question of what pure CBD (without THC) has been proven to treat is genuinely difficult to answer. Much of the peer-reviewed research looks at CBD as a medicinal drug or includes cannabis in the study. In a review of 79 randomized clinical trials (RCTS) of cannabinoids for the below indications, the authors found moderate-quality evidence for cannabinoid use for the treatment of chronic pain and spasticity, and only low quality evidence for improvements in vomiting resulting from chemotherapy, weight gain in HIV infection, sleep disorders and Tourette syndrome. But the study was limited because it included multiple cannabinoids that were evaluated at different doses by different routes, with many products containing THC.
Jason White, who chairs the World Health Organization Expert Committee on Drug Dependence, told me he believes CBD will prove efficacious for a broader range of seizure types, that it likely has some anti-psychotic efficacy, and that it may help improve the quality of life among those who suffer from Parkinson’s disease. In studies, CBD has been found to treat certain types of seizures, has benefited schizophrenia patients with psychotic symptoms in two of three RCTS, and has improved activities of daily life and sleep in Parkinson’s patients in early trials.
On the other hand, a review that included 83 studies (40 of them RCTs) involving over 3,000 people with various mental health conditions found that there was “scarce evidence” to show that cannabinoids improved depression or anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder or psychosis.
One of the most comprehensive reports, produced by the National Academies of Sciences, Engineering, and Medicine, examined over 10,000 scientific abstracts and concluded that substantial evidence existed for cannabis and cannabinoid treatment of three conditions: chronic pain, chemotherapy-induced vomiting and muscle spasms. “There was little or no evidence for any therapeutic effects of CBD,” according to oncologist Donald Abrams, one of the study’s committee members. The active components of cannabis have been shown to modulate the immune system and inflammation, yet a WHO report concluded that CBD’s effect on the immune system is unclear, with evidence showing suppression at higher doses but stimulation at lower doses.*
You can see the limits of existing CBD research: multiple small trials that yield conflicting results, along with RCTs and meta-analyses that too often include marijuana and mixed THC/CBD compounds rather than just pure CBD products—many of them in varying amounts. These certainly influence the results, and they also leave consumers rightly wondering what the proper dose for them might be.
“You don’t know the dose, you don’t know the formulation and therefore [you don’t know] the absorption,” White told me. “In a lot of places, it’s essentially a backyard pharmacy where people just sort of make it up…. When you get in a situation where people are kind of doing it themselves then that is really out of control.”
As for potential users, “low and slow” was the refrain from the CBD store managers with whom I spoke. With CBD tincture, for example, McManigal recommended placing a half of vial of oil under the tongue—the equivalent of 17 milligrams in his formulation—and waiting 45 minutes to an hour. “If you don’t feel the effect of being more relaxed, use more,” he said.
According to a WHO report, CBD is generally well-tolerated with a good safety profile, and in humans it exhibits no effects that would indicate potential for abuse or dependence. The side effects are generally mild and may include sleepiness, diarrhea, mood changes, etc., but concerns exist of potential liver injury, medication interactions, and male fertility issues. White said there is little known about the effects of sustained and/or cumulative use of CBD, or its use in special populations like adolescents, the elderly and pregnant women.
The FDA is investigating reports of CBD containing such dangerous contaminants as unhealthy levels of heavy metals (including lead), pesticides, bacteria and fungi. Law enforcement agencies found that 128 samples out of more than 350 tested by government labs in nine states had synthetic marijuana in products being sold as CBD.
At Golden State Greens shop, Jake C. told me that CBD containing THC is highly regulated by the state of California, and he believes the products to be safe and labeled appropriately. However, he said over-the-counter hemp-derived CBD (depending on state regulations) or black-market cannabis product, could have wildly varying amounts of THC and CBD, to say nothing of potential contaminants.
The lack of high-quality studies reflects the hoops one has to jump though to conduct marijuana research. Regulatory barriers need to be streamlined and funding sources need to be identified so that large, well-designed RCTs can be conducted to explore the beneficial and harmful health effects of CBD use, which ultimately would better inform states, the FDA and the public. Currently, there are “This industry is not going to go away. Our sales are up,” one shop owner told me. All the more reason for us to do the research, prove CBD’s efficacy, standardize dosing and ensure quality, among other things. I no longer growl when I pass my local store; the people there genuinely believe they’re doing a good thing. Let’s find out if they’re right.
*Editor’s Note (10/5/20): This paragraph was edited after posting to correct the description of the report by the National Academies of Sciences, Engineering, and Medicine.
ABOUT THE AUTHOR(S)
Carolyn Barber has been an emergency department physician for 25 years. She is co-founder of the homeless work program Wheels of Change and author of many articles and the book Runaway Medicine: What You Don’t Know May Kill You, which was recently Amazon’s number-one Hot New Release in Health Care Administration. She received her M.D. at the Johns Hopkins University School of Medicine.
Researchers recommend clinical trials for CBD to prevent COVID-19 based on promising animal data
An interdisciplinary team of researchers from the University of Chicago has found evidence that cannabidiol (CBD), a product of the cannabis plant, can inhibit infection by SARS-CoV-2 in human cells and in mice.
The study, published on January 20, 2022, in Science Advances, found CBD showed a significant negative association with SARS-CoV-2 positive tests in a national sample of medical records of patients taking the FDA-approved drug for treating epilepsy. The researchers now say that clinical trials should be done to determine whether CBD could eventually be used as a preventative or early treatment for COVID-19. They caution, however, that the COVID-blocking effects of CBD come only from a high purity, specially formulated dose taken in specific situations. The study’s findings do not suggest that consuming commercially available products with CBD additives that vary in potency and quality can prevent COVID-19.
Scientists have been looking for new therapies for people infected by the coronavirus and emerging variants, especially those who lack access to vaccines, as the pandemic continues across the country and world and as breakthrough infections become more common.
CBD: An unexpected avenue for fighting COVID-19
The idea to test CBD as a potential COVID-19 therapeutic was serendipitous. “CBD has anti-inflammatory effects, so we thought that maybe it would stop the second phase of COVID infection involving the immune system, the so-called ‘cytokine storm.’ Surprisingly, it directly inhibited viral replication in lung cells,” said Marsha Rosner, PhD, Charles B. Huggins Professor in the Ben May Department of Cancer Research and a senior author of the study.
To see this effect, the researchers first treated human lung cells with a non-toxic dose of CBD for two hours before exposing the cells to SARS-CoV-2 and monitoring them for the virus and the viral spike protein. They found that, above a certain threshold concentration, CBD inhibited the virus’ ability to replicate. Further investigation found that CBD had the same effect in two other types of cells and for three variants of SARS-CoV-2 in addition to the original strain.
CBD did not affect the ability of SARS-CoV-2 to enter the cell. Instead, CBD was effective at blocking replication early in the infection cycle and six hours after the virus had already infected the cell.
Like all viruses, SARS-CoV-2 affects the host cell by hijacking its gene expression machinery to produce more copies of itself and its viral proteins. This effect can be observed by tracking virus-induced changes in cellular RNAs. High concentrations of CBD almost completely eradicated the expression of viral RNAs. It was a completely unexpected result.
“We just wanted to know if CBD would affect the immune system,” Rosner said. “No one in their right mind would have ever thought that it blocked viral replication, but that’s what it did.”
The researchers showed that the mechanism by which CBD blocks SARS-CoV-2 replication involves CBD activation of one of the host cell stress responses and generation of interferons, an antiviral cell protein.
Real world data: Patients taking CBD test positive for COVID-19 at lower rates
The researchers wanted scientific data to show that CBD prevents viral replication in live animals. The team showed pretreatment with CBD for one week prior to infection with SARS-CoV-2 suppressed infection both in the lung and the nasal passages of mice. “These results provide major support for a clinical trial of CBD in humans,” said Rosner.
And the success of CBD wasn’t limited to the laboratory: An analysis of 1,212 patients from the National COVID Cohort Collaborative revealed that patients taking a medically prescribed oral solution of CBD for the treatment of epilepsy tested positive for COVID-19 at significantly lower rates than a sample of matched patients from similar demographic backgrounds who were not taking CBD.
The potential for CBD to treat patients recently exposed to or infected by SARS-CoV-2 does not precede the first lines of defense against COVID-19, which are to get vaccinated and follow existing public health guidelines for masking in indoor spaces and social distancing. But the published results offer a potential new therapeutic, something still needed as the pandemic rages on.
“A clinical trial is necessary to determine whether CBD is really effective at preventing or suppressing SARS-CoV-2 infection, but we think this may have potential as a prophylactic treatment,” said Rosner. “Maybe you’re in a hot spot or you think you might have been exposed or you’ve just tested positive — that’s where we think CBD might have an effect.”
Not your dispensary’s CBD
The research team emphasized that the COVID-blocking effects of CBD were confined strictly to high purity, high concentrations of CBD. Closely related cannabinoids such as CBDA, CBDV and THC, the psychoactive element enriched in marijuana plants, did not have the same power. In fact, combining CBD with equal amounts of THC actually reduced the efficacy of CBD.
“Going to your corner bakery and buying some CBD muffins or gummy bears probably won’t do anything,” said Rosner. “The commercially available CBD powder we looked at, which was off the shelf and something you could order online, was sometimes surprisingly of high purity but also of inconsistent quality. It is also hard to get into an oral solution that can be absorbed without the special, FDA-approved formulation,” Rosner said.
Furthermore, CBD use is not without potential risks. It appears to be extremely safe when consumed in food or drink, but methods of use such as vaping can have negative side effects, including potential damage to the heart and lungs. It’s also not well studied in certain populations, such as pregnant people, and so should be used only under the supervision of a physician and with caution.
While the study’s results are exciting, additional study is needed to determine the precise dosing of CBD that is effective at preventing SARS-CoV-2 infection in humans as well as its safety profile and any potential side effects.
“We are very eager to see some clinical trials on this subject get off the ground,” Rosner said. “Especially as we are seeing that the pandemic is still nowhere near the end — determining whether this generally safe, well-tolerated, and non-psychoactive cannabinoid might have anti-viral effects against COVID-19 is of critical importance.”
Rosner was also pleased that this research project was a case study in the power of scientific collaboration by bringing together a highly interdisciplinary group of researchers. Senior authors listed on the paper came from three different research universities and from departments as diverse as microbiology, molecular engineering, cancer biology and chemistry.
“This was truly a team-science effort, and that’s something that really excites me,” said Rosner. “From clinicians to David Meltzer’s group who did the patient analysis to virologists like Glenn Randall, and it goes on and on. This is the way science should be carried out.”
The study, “Cannabidiol Inhibits SARS-CoV-2 Replication through Induction of the Host ER Stress and Innate Immune Responses,” was supported by a BIG Vision grant from the University of Chicago, the National Institutes of Health (R01 GM121735, R01 CA184494, R01 AI137514, R01 AI127518, R01 AI134980, R01 CA219815, R35 GM119840, P30 CA014599), and the Harry B. and Leona M Helmsley Charitable Trust. Additional authors include Long Chi Nguyen, Dongbo Yang, Thomas J. Best, Nir Drayman, Adil Mohamed, Christopher Dann, Diane Silva, Lydia Robinson-Mailman, Andrea Valdespino, Letícia Stock, Eva Suárez, Krysten A. Jones, Saara-Anne Azizi, James Michael Millis, Bryan C. Dickinson, Savaş Tay, Scott A. Oakes, and David O. Meltzer of the University of Chicago; Vlad Nicolaescu, Haley Gula, and Glenn Randall of UChicago and Argonne National Laboratory; Divayasha Saxena, Jon D. Gabbard, Jennifer K. Demarco, William E. Severson, Charles D. Anderson, and Kenneth E. Palmer of the University of Louisville; Shao-Nong Chen, Takashi Ohtsuki, John Brent Friesen, and Guido F. Pauli of the University of Illinois at Chicago; and the National COVID Cohort Collaborative Consortium.
Cannabidiol in Anxiety and Sleep: A Large Case Series
Cannabidiol (CBD) is one of many cannabinoid compounds found in cannabis. It does not appear to alter consciousness or trigger a “high.” A recent surge in scientific publications has found preclinical and clinical evidence documenting value for CBD in some neuropsychiatric disorders, including epilepsy, anxiety, and schizophrenia. Evidence points toward a calming effect for CBD in the central nervous system. Interest in CBD as a treatment of a wide range of disorders has exploded, yet few clinical studies of CBD exist in the psychiatric literature.
To determine whether CBD helps improve sleep and/or anxiety in a clinical population.
A large retrospective case series at a psychiatric clinic involving clinical application of CBD for anxiety and sleep complaints as an adjunct to usual treatment. The retrospective chart review included monthly documentation of anxiety and sleep quality in 103 adult patients.
Main Outcome Measures
Sleep and anxiety scores, using validated instruments, at baseline and after CBD treatment.
The final sample consisted of 72 adults presenting with primary concerns of anxiety (n = 47) or poor sleep (n = 25). Anxiety scores decreased within the first month in 57 patients (79.2%) and remained decreased during the study duration. Sleep scores improved within the first month in 48 patients (66.7%) but fluctuated over time. In this chart review, CBD was well tolerated in all but 3 patients.
Cannabidiol may hold benefit for anxiety-related disorders. Controlled clinical studies are needed.
The Cannabis plant has been cultivated and used for its medicinal and industrial benefits dating back to ancient times. Cannabis sativa and Cannabis indica are the 2 main species.1 The Cannabis plant contains more than 80 different chemicals known as cannabinoids. The most abundant cannabinoid, tetrahydrocannabinol (THC), is well known for its psychoactive properties, whereas cannabidiol (CBD) is the second-most abundant and is nonpsychoactive. Different strains of the plant are grown containing varying amounts of THC and CBD. Hemp plants are grown for their fibers and high levels of CBD that can be extracted to make oil, but marijuana plants grown for recreational use have higher concentrations of THC compared with CBD.2 Industrial hemp must contain less than 0.3% THC to be considered legal, and it is from this plant that CBD oil is extracted.3
Many different cultures have used the Cannabis plant to treat a plethora of ailments. Practitioners in ancient China targeted malaria, menstrual symptoms, gout, and constipation. During medieval times, cannabis was used for pain, epilepsy, nausea, and vomiting, and in Western medicine it was commonly used as an analgesic.4,5 In the US, physicians prescribed Cannabis sativa for a multitude of illnesses until restrictions were put in place in the 1930s and then finally stopped using it in 1970 when the federal government listed marijuana as a Schedule I substance, claiming it an illegal substance with no medical value. California was the first state to go against the federal ban and legalize medical marijuana in 1996.6 As of June 2018, 9 states and Washington, DC, have legalized recreational marijuana, and 30 states and Washington, DC, allow for use of medical marijuana.7 The purpose of the present study is to describe the effects of CBD on anxiety and sleep among patients in a clinic presenting with anxiety or sleep as a primary concern.
CBD has demonstrated preliminary efficacy for a range of physical and mental health care problems. In the decade before 2012, there were only 9 published studies on the use of cannabinoids for medicinal treatment of pain; since then, 30 articles have been published on this topic, according to a PubMed search conducted in December 2017. Most notable was a study conducted at the University of California, San Diego’s Center for Medicinal Cannabis Research that showed cannabis cigarettes reduced pain by 34% to 40% compared with placebo (17% to 20% decrease in pain).8 In particular, CBD appears to hold benefits for a wide range of neurologic disorders, including decreasing major seizures. A recent large, well-controlled study of pediatric epilepsy documented a beneficial effect of CBD in reducing seizure frequency by more than 50%.9 In addition to endorphin release, the “runner’s high” experience after exercise has been shown to be induced in part by anandamide acting on CB1 receptors, eliciting anxiolytic effects on the body.10 The activity of CBD at 5-HT1A receptors may drive its neuroprotective, antidepressive, and anxiolytic benefits, although the mechanism of action by which CBD decreases anxiety is still unclear.11 CBD was shown to be helpful for decreasing anxiety through a simulated public speaking test at doses of 300 mg to 600 mg in single-dose studies.12–14 Other studies suggest lower doses of 10 mg/kg having a more anxiolytic effect than higher doses of 100 mg/kg in rats.15 A crossover study comparing CBD with nitrazepam found that high-dose CBD at 160 mg increased the duration of sleep.16 Another crossover study showed that plasma cortisol levels decreased more significantly when given oral CBD, 300 to 600 mg, but these patients experienced a sedative effect.17 The higher doses of CBD that studies suggest are therapeutic for anxiety, insomnia, and epilepsy may also increase mental sedation.16 Administration of CBD via different routes and long-term use of 10 mg/d to 400 mg/d did not create a toxic effect on patients. Doses up to 1500 mg/d have been well tolerated in the literature.18 Most of the research done has been in animal models and has shown potential benefit, but clinical data from randomized controlled experiments remain limited.
Finally, the most notable benefit of cannabis as a form of treatment is safety. There have been no reports of lethal overdose with either of the cannabinoids and, outside of concerns over abuse, major complications are very limited.19 Current research indicates that cannabis has a low overall risk with short-term use, but more research is needed to clarify possible long-term risks and harms.
Given the promising biochemical, physiologic, and preclinical data on CBD, a remarkable lack of randomized clinical trials and other formal clinical studies exist in the psychiatric arena. The present study describes a series of patients using CBD for treatment of anxiety or sleep disturbances in a clinical practice setting. Given the paucity of data in this area, clinical observations can be quite useful to advance the knowledge base and to offer questions for further investigation. This study aimed to determine whether CBD is helpful for improving sleep and/or anxiety in a clinical population. Given the novel nature of this treatment, our study also focused on tolerability and safety concerns. As a part of the evolving legal status of cannabis, our investigation also looked at patient acceptance.
Design and Procedures
A retrospective chart review was conducted of adult psychiatric patients treated with CBD for anxiety or sleep as an adjunct to treatment as usual at a large psychiatric outpatient clinic. Any current psychiatric patient with a diagnosis by a mental health professional (psychiatrist, psychiatric nurse practitioner, or physician assistant) of a sleep or anxiety disorder was considered. Diagnosis was made by clinical evaluation followed by baseline psychologic measures. These measures were repeated monthly. Comorbid psychiatric illnesses were not a basis for exclusion. Accordingly, other psychiatric medications were administered as per routine patient care. Selection for the case series was contingent on informed consent to be treated with CBD for 1 of these 2 disorders and at least 1 month of active treatment with CBD. Patients treated with CBD were provided with psychiatric care and medications as usual. Most patients continued to receive their psychiatric medications. The patient population mirrored the clinic population at large with the exception that it was younger.
Nearly all patients were given CBD 25 mg/d in capsule form. If anxiety complaints predominated, the dosing was every morning, after breakfast. If sleep complaints predominated, the dosing was every evening, after dinner. A handful of patients were given CBD 50 mg/d or 75 mg/d. One patient with a trauma history and schizoaffective disorder received a CBD dosage that was gradually increased to 175 mg/d.
Often CBD was employed as a method to avoid or to reduce psychiatric medications. The CBD selection and dosing reflected the individual practitioner’s clinical preference. Informed consent was obtained for each patient who was treated and considered for this study. Monthly visits included clinical evaluation and documentation of patients’ anxiety and sleep status using validated measures. CBD was added to care, dropped from care, or refused as per individual patient and practitioner preference. The Western Institutional Review Board, Puyallup, WA, approved this retrospective chart review.
Setting and Sample
Wholeness Center is a large mental health clinic in Fort Collins, CO, that focuses on integrative medicine and psychiatry. Practitioners from a range of disciplines (psychiatry, naturopathy, acupuncture, neurofeedback, yoga, etc) work together in a collaborative and cross-disciplinary environment. CBD had been widely incorporated into clinical care at Wholeness Center a few years before this study, on the basis of existing research and patient experience.
The sampling frame consisted of 103 adult patients who were consecutively treated with CBD at our psychiatric outpatient clinic. Eighty-two (79.6%) of the 103 adult patients had a documented anxiety or sleep disorder diagnosis. Patients with sole or primary diagnoses of schizophrenia, posttraumatic stress disorder, and agitated depression were excluded. Ten patients were further excluded because they had only 1 documented visit, with no follow-up assessment. The final sample consisted of 72 adult patients presenting with primary concerns of anxiety (65.3%; n = 47) or poor sleep (34.7%; n = 25) and who had at least 1 follow-up visit after CBD was prescribed.
Main Outcome Measures
Sleep and anxiety were the targets of this descriptive report. Sleep concerns were tracked at monthly visits using the Pittsburg Sleep Quality Index. Anxiety levels were monitored at monthly visits using the Hamilton Anxiety Rating Scale. Both scales are nonproprietary. The Hamilton Anxiety Rating Scale is a widely used and validated anxiety measure with 14 individual questions. It was first used in 1959 and covers a wide range of anxiety-related concerns. The score ranges from 0 to 56. A score under 17 indicates mild anxiety, and a score above 25 indicates severe anxiety. The Pittsburg Sleep Quality Index is a self-report measure that assesses the quality of sleep during a 1-month period. It consists of 19 items that have been found to be reliable and valid in the assessment of a range of sleep-related problems. Each item is rated 0 to 3 and yields a total score from 0 to 21. A higher number indicates more sleep-related concerns. A score of 5 or greater indicates a “poor sleeper.”
Side effects and tolerability of CBD treatment were assessed through spontaneous patient self-reports and were documented in case records. Any other spontaneous comments or complaints of patients were also documented in case records and included in this analysis.
Deidentified patient data were evaluated using descriptive statistics and plotted graphically for visual analysis and interpretation of trends.
The average age for patients with anxiety was 34 years (range = 18–70 years) and age 36.5 years for patients with sleep disorders (range = 18–72 years). Most patients with an anxiety diagnosis were men (59.6%, 28/47), whereas more sleep-disordered patients were women (64.0%, 16/25). All 72 patients completed sleep and anxiety assessments at the onset of CBD treatment and at the first monthly follow-up. By the second monthly follow-up, 41 patients (56.9%) remained on CBD treatment and completed assessments; 27 patients (37.5%) remained on CBD treatment at the third monthly assessment.
Table 1 provides means and standard deviations for sleep and anxiety scores at baseline and during the follow-up period for adults taking CBD. Figure 1 graphically displays the trend in anxiety and sleep scores over the study period. On average, anxiety and sleep improved for most patients, and these improvements were sustained over time. At the first monthly assessment after the start of CBD treatment, 79.2% (57/72) and 66.7% (48/72) of all patients experienced an improvement in anxiety and sleep, respectively; 15.3% (11/72) and 25.0% (18/72) experienced worsening symptoms in anxiety and sleep, respectively. Two months after the start of CBD treatment, 78.1% (32/41) and 56.1% (23/41) of patients reported improvement in anxiety and sleep, respectively, compared with the prior monthly visit; again, 19.5% (8/41) and 26.8% (11/41), respectively, reported worsening problems as compared with the prior month.