The largest clinical trial in history compared melatonin to cannabis Sleep aids have found significant improvements in sleep quality and duration as well as less than one of the most common and stressful side effects of melatonin: ataxia
It has been well proven that getting good sleep regularly is critical to our physical and mental health. Despite this scientifically proven and universally accepted fact, it seems that sticking to an ideal sleep schedule may be out of reach. This is amid various reports suggesting how our collective sleep deficit is, with one revealing that “the average person sleeps less than seven hours each night and that 50 to 70 million adults in the United States are affected by a sleep disorder.” This is a lot of anxiety caused by alertness.
Given the scale of the problem, consumers continue to search for effective sleep aids. One such supplement, melatonin, is one of the most widely used over-the-counter sleep aids despite grogginess and other side effects that are often reported. Now, melatonin may have met its proverbial match amidst new groundbreaking results.”A sleep study to discover the roots Which could have significant implications, given the size of the melatonin market It said It is expected to reach $3 billion by 2027.
rhizomes, an AI-powered health tech company that offers the first easy path for health and wellness products to prove their true effects, has just announced the results of the first clinical trial in history comparing cannabis with melatonin for sleep outcomes. Study of 1,800 participants across the United States, Medical Research Corporation A sleep study to discover the roots It was the largest clinical trial in history looking at cannabinoids for sleep outcomes – and the largest trial of products containing CBN. The study was conducted exclusively with Open book excerpt (OBX), an NSF and ISO 9001 certified manufacturer and distributor known for the industry’s most innovative and highest quality cannabis ingredients and health and self-care products.
Study results concluded, “All products examined in the study demonstrated significant improvements in sleep quality and duration. Four of the five products demonstrated sleep improvement (ie, no statistically significant difference) compared to the melatonin control arm. No significant differences A statistic in the frequency of side effects of all types among any of the studied products.
For this clinical trial methodology, the company provides that A sleep study to discover the roots The Institutional Review Board (IRB) was a certified, darkened, randomized, controlled clinical trial evaluating the effects of various cannabis products in relation to melatonin. Five hemp products all containing CBD were compared, with some containing additional rare hemp substances like cannabinol (CBN) and cannabichromene (CBC) – and one containing an additional 5mg of melatonin, compared to a control product containing only 5mg of melatonin. Melatonin is one of the most widely researched and used over-the-counter sleep aids.
One thousand eight hundred (1,800) participants (56% female and 44% male) across the United States were enrolled and then randomly assigned to take a cannabis or melatonin product daily for just four weeks. Participants regularly reported their use, side effects, sleep quality, and other health outcomes, including pain and anxiety.
The results of the study were certainly favorable. Participants in all study groups experienced significant improvements in sleep quality, well-being, anxiety, and pain. The onset of effects from all of the cannabis products was similar to that of the control melatonin product, with most participants noticing an effect within one hour of taking their product.
During the study, the increased amount of sleep participants experienced from each different product ranged from an additional 34 to 76 minutes each night, although there was no statistically significant difference between the products.
The majority (>60%) of participants in all study groups experienced significant improvements (defined by ‘clinically significant difference’ thresholds) in their sleep. Seventy-one percent (71%) of participants who took either melatonin alone or melatonin in combination with CBD and CBN in a specified proportion experienced significant improvement and 69% of participants who took a combination of CBD, CBN, and CBC in a specified proportion experienced significant improvement. improved as well.
All study products demonstrated favorable safety profiles. Side effects were mostly mild in nature, and there were no significant differences in the frequency (~10%) of side effects reported among all six study groups. However, participants who received cannabis-containing products (including the cannabis-containing product + melatonin) reported lower incidences of ataxia than those who received melatonin alone.
Among those who also reported pain and anxiety as well as disturbed sleep at the start of the study, the largest proportion of participants who experienced significant improvement in pain and anxiety were those who took a combination of CBD, CBN, and CBC. This was greater than any other study product (including the melatonin control), although not with a statistically significant difference.
The takeaway is that the first IRB-certified randomized controlled trial comparing hemp products with melatonin found meaningful improvements in sleep across all products tested. The results revealed no significant differences in sleep improvement between melatonin compared to all cannabis-containing products (including those containing only cannabinoids and no melatonin) except for one that performed significantly worse than melatonin.
Study results suggest that the combination of some cannabinoids and melatonin may confer a greater improvement in sleep duration than melatonin alone, which warrants further research into these combinations—particularly animal studies that suggest an interaction between the endocannabinoid system and the melatonin-producing pineal gland. .
While the cannabinoid study products had the same incidence of overall side effects related to melatonin, participants who received products with cannabinoids (including cannabis with melatonin) reported lower incidences of ataxia relative to only melatonin. Therefore, hemp products require more attention and research as effective alternatives or supplements to melatonin that may avoid or reduce one of the more common and stressful side effects.
Furthermore, the combination of CBD, CBN, and CBC in a specific ratio may be a particularly promising alternative to melatonin, especially in those with concurrent pain or anxiety in addition to their sleep disturbance, which warrants further exploration.
“This is fantastic data and it’s a first of its kind,” said Dave Nondorfer, CEO of OBX. “We have always been committed to industry-leading research and development, and this historical data underpins our endeavors to create the most effective formulas that promote well-being. What is particularly interesting is that cannabis formulations for sleep can also help people who also experience pain or anxiety. Rather than having to If they take so many products to treat their ailments, they may be able to eat just one.”
“With sleep issues affecting between 50 and 70 million Americans, there is more need than ever for scientifically proven research on how to help improve rest,” said Dr. Jeff Chen, CEO and co-founder of Radicle Science. Sleep is one of the most common therapeutic uses of cannabis, and we are excited to begin this pioneering work in researching formulations and dosages to discover those with the greatest impact.”
Radicle Science and OBX’s next study will be a randomized, blinded controlled trial of formulations containing the cannabinoid THCV to explore the effects on energy, focus, and appetite.
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Merilee Kern, MBA is an internationally respected brand analyst and strategist who reports on cultural shifts and trends as well as prominent industry change-makers, movers, shakers and innovators in all categories, both B2C and B2B. This includes field experts, thought leaders, brands, products, services, destinations, and events. Merilee is founder, executive editor, and producer of “The Luxe List” as well as host of “The Luxe List”Savvy living“ A lifestyle TV show broadcast in New York, Los Angeles, San Francisco, Miami, Atlanta, and other major markets on CBS, FOX, and other major networks; In addition to “Savvy Ventures“A business TV show that airs locally on FOX Business TV and Bloomberg TV. As a prolific lifestyle, travel, dining, and entertainment industry, the voice of authority and taste maker, Merilee keeps her finger on the pulse of the market for new, innovative essentials and perfect experiences at all price points. From affordable prices to the max, her business reaches several million worldwide via broadcast television (her own shows and many other shows on which she appears) as well as countless print and online publications. www.TheLuxeList.com And the www.SavvyLiving.tv / Instagram www.Instagram.com/MerileeKern / Twitter www.twitter.com/MerileeKern / Facebook www.Facebook.com/MerileeKernOfficial / LinkedIN www.LinkedIn.com/in/MerileeKern.
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