JP Sears goes Woke...over CBD

Awaken makes a lot of medical claims. Do they hold up?

JP Sears recently launched a new CBD company. In a marketing email for Awaken’s Daily Dose Gummies, he makes 10 medical claims.

While I’m all for beneficial therapeutics, CBD or cannabis-related products have only proven clinical efficacy for three products to date:

• Epidiolex, for seizure treatment

• Marinol and Syndros, which contains dronabinol, used to treat nausea and vomiting in chemotherapy and HIV patients

• Cesamet, which contains nabilone, used when dronabinol doesn't work

Supplements don’t have to be clinically tested to be marketed and sold. But the claims on the package should reflect reality in some manner.

Let’s take a look at Awaken’s claims against what we know.

A bottle of Daily Dose Gummies contains 30 gummies, and each one contains 25mg of CBD. One $64.99 bottle contains 750mg of CBD. Awaken suggests you take 1-2 gummies daily—25-50mg of CBD.

Claim: Reduced Stress and Anxiety: CBD gummies can help you relax, leading to a better mood and less stress throughout the day.

A number of SEO-driven websites try to sell you on CBD’s amazing therapeutic benefits, especially when it comes to stress.

Do the claims hold up?

Sort of.

Most anxiety-reducing claims are “truthy,” yet don’t live up to the hype. As Dan Nosowitz writes,

CBD has been riding the wave of the anxiety economy, in which all sorts of products, from fidget spinners to weighted blankets, are pitched as reducers of the mild panic of everyday life.

One study found that CBD worked as well as Klonopin for reducing anxiety, heart rate, and blood pressure—at a dose of 300mg, equivalent to 12 Awaken gummies.

Two other groups in the CBD cohort, each taking 100mg and 900mg doses, did not produce similar reductions.

Another small-scale study found anxiety reduction in 400mg doses, while most studies fall in the 10-20mg per kg of bodyweight dose.

To get the purported anxiety-reducing effects being marketed, a $65 bottle would be good for 2.5 doses.

Claim: Improved Sleep Quality: CBD’s natural calming effects can help you get a better night’s sleep.

Preliminary research on CBD’s effects on sleep have found that low dosages might actually be stimulating, while higher doses are sedating.

A 2017 review found that

Administration of CBD has been shown to have differential effects on sleep based on dose. Indeed, low-dose CBD has a stimulating effect, while high-dose CBD has a sedating effect. In a study among individuals with insomnia, results suggested that administration of 160 mg/day of CBD increased total sleep time and decreased the frequency of arousals during the night while low-dose CBD has been associated with increased wakefulness.

The low dose was 15 mg—less than one Awaken gummy. It’s important to note that similar research has found greater efficacy when CBD is combined with THC.

In fact, of the four groups studied, there were no effects on nocturnal sleep when just using THC or just using CBD. When the two were combined, there were measurable effects.

As this New York Times article notes,

When it comes to CBD helping with sleep…the research is sparse. ‘To this day, there’s no study that has used CBD on its own in any trial of insomnia,’ said Anastasia Suraev, a doctoral candidate and research fellow at the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney. There are studies that have found that CBD used in combination with THC holds promise as a treatment for sleep disorders like insomnia, sleep apnea, restless legs syndrome and nightmares related to post-traumatic stress disorder. But there are no large placebo-controlled clinical trials that have investigated how CBD alone might help with sleep problems.

Claim: Reduced Inflammation: CBD gummies can help reduce inflammation throughout your body, leading to fewer aches and pains.

While I’ll get into this in more depth with Awaken’s cardiovascular health claims, suffice to say that this sentiment is problematic for two reasons:

• CBD has shown efficacy at inflammation reduction in animals and in humans with specific conditions, like rheumatoid arthritis.

• There’s no evidence that low-dose CBD leads to “fewer aches and pains,” which is a completely ambiguous statement. Pain is relative to a specific condition or bodily insult; it can also be emotional, or cultural. 

Claim: Improved Digestive Health: CBD can help to improve digestion and reduce stomach issues.

This is a good time to remember these two facts about supplementation:

• it implies your body is lacking in something

• no vitamin or mineral is inert

The notion of taking something “extra” often results in expensive urine, because that’s how your body treats supplements it doesn’t need.

But there are also cases where supplements can be dangerous, especially when it comes to prolonged usage. 

And so a 2020 study found that regular high-dose CBD can negatively affect your gut microbiome.

In the general wellness space, leaky gut is a common trope, but in the medical literature it implies the creation of gaps in the intestinal walls that allow bacteria and toxins into the bloodstream and needs medical attention.

While you’ll find plenty of supplements hawkers stating CBD helps digestion, the claim is on shaky ground.

There’s evidence that CBD is successful in the gastroenterology office—as an adjuvant, when combined with THC.

Marijuana has been studied for years for helping with gut issues, with some real success.

That’s the problem: you can’t remove half of the equation and expect the same result.

As noted in a 2021 Time article,

There’s a tipping point with using cannabis for GI disorders. Cannabinoids reduce the tone of the lower esophageal sphincter, which can increase heartburn and reflux symptoms. They also decrease gut motility, causing the stomach to empty more slowly, which can increase nausea and be problematic for patients with gastroparesis, a disorder that delays the movement of food from the stomach to the small intestine.

Claim: Increased Focus and Concentration: CBD can help you stay focused on tasks and improve your memory.

A 2021 review of 17 studies seems to provide great news:

Neuroimaging studies have shown that acute CBD induces significant alterations in brain activity and connectivity patterns during resting state and performance of cognitive tasks in both healthy volunteers and patients with a psychiatric disorder. This included modulation of functional networks relevant for psychiatric disorders, possibly reflecting CBD’s therapeutic effects. Future studies should consider replication of findings and enlarge the inclusion of psychiatric patients, combining longer-term CBD treatment with neuroimaging assessments.

Then I go through the review.

While 115 healthy subjects were tested, 33 at high risk for clinical psychosis, 13 with a psychotic disorder, 10 with anxiety disorder, and 17 with autism spectrum disorder.

If CBD has a neuroprotective effect, great.

But the dosage used on healthy volunteers—Daily Dose Gummies are marketed to be used daily for general consumers—was 600mg of CBD combined with 10mg of oral THC.

That’s nearly a full bottle of Awaken CBD, which provides no THC.

When a 10mg dose of CBD was used both with and without THC, “no significant effects were found within the executive control network.”

The only subjective experience that did change their consciousness was when cannabis was administered, not CBD.

When given to volunteers with the varying conditions mentioned above, again efficacy occurs at 600mg.

You can spend nearly $65 a day to improve executive function—and you might need to source a little THC as well—but then you’d also be forced to eat 24 gummies.

At 30 calories each, that’s a gummy meal at 720 calories.

The first two ingredients are tapioca syrup and turbinado sugar, along with the ambiguous “natural flavor and color,” which could mean literally anything. 

Claim: Pain Management: CBD gummies can reduce inflammation which may provide relief.

As noted above, consider how expansive the term “pain” is—the first red flag.

According to Harvard,

Further human studies are needed to substantiate claims that CBD helps control pain. One animal study from the European Journal of Pain suggests CBD could help lower pain and inflammation due to arthritis when applied to skin. Other research identifies how CBD may inhibit inflammatory and neuropathic pain, which are difficult to treat.

A review published in the journal Antioxidants did find some success with CBD reducing inflammation, but as the authors note, recent troubles with CBD treatment “disqualifies it as a drug of choice.”

This predominantly had to do with CBD’s interaction with the enzymes ALT and AST, both of which are metabolized by the liver. 

A study in Cell Death & Disease found that CBD was useful as an adjuvant therapy in treating inflammatory rheumatoid arthritis.

This was in combination with an existing arthritic therapeutic—not in the form of a low-dose gummy. 

Claim: Reduced Blood Pressure: Regularly consuming CBD gummies can help reduce high blood pressure.

A 2017 study of nine men found that a single dose of CBD reduced blood pressure—at 600 mg.

Another 2017 study found efficacy reducing stress-induced blood pressure in rats.

Then a 2020 study in rats found the opposite.

Yet another 2020 study in rats found that CBD reduces stress-induced hypertension—sometimes.

Stress reduction is dependent on the amount of relaxation provided to the rat’s hyptothalamic-pituitary-adrenal axis.

They also note that the effects of CBD are species-specific, and while they’re hopeful this can translate to humans, they’re just not sure. 

Finally, a 2011 study on high blood pressure found that CBD combined with THC sometimes reduces blood pressure and sometimes increases blood pressure.

Given that CBD can have negative interactions with certain hypertension medications, it’s important to talk to your doctor before beginning any adjuvant.

Even in gummy form.

Claim: Better Immunity: CBD gummies can help boost your immune system and reduce your risk of getting sick.

Just as “pain” is a vague and wildly divergent term, so is immunity.

You hear “immune health” all the time, especially from supplements hawkers.

What does it mean in the context of Awaken’s marketing email? 

Well, one review on epilepsy notes that

Overall, the data overwhelmingly support the notion that CBD is immune suppressive and that the mechanisms involve direct suppression of activation of various immune cell types, induction of apoptosis, and promotion of regulatory cells, which, in turn, control other immune cell targets.

Whereas a supplements salesman will write that CBD will “boost” your immune system, the researchers are a little more measured when writing that it “alters immune function.”

They continue:

Immunity is maintained through various cell types acting together to provide protection against foreign invaders, and simultaneously avoid reactions against self-proteins. Thus, an appropriate immune response requires a regulated balance between robust reactions against non-self, but limited or no reactions against self.

Administered at the dose of 5mg per kilogram of weight, CBD showed efficacy in creating an appropriate response for treating inflammation associated with MS.

Consider this: I’m 195 pounds, requiring a single dose of 442 mg.

Oh, and I’d have to have MS. 

What I dug up regarding CBD as a “natural way to boost the immune system” came back pretty clear: “there’s no evidence for this.”

CBD doesn’t “strengthen” the immune system, but it does treat specific autoimmune issues through suppression.

Claim: Improved Cardiovascular Health: Regularly consuming CBD gummies can help improve your heart health and reduce your risk of heart disease.

We already touched upon CBD’s effects on hypertension, which is mostly shown to help rats.

Add to the mix that CBD is broken down and metabolized by the liver—which means it can be contraindicated to heart medications. 

Here’s where it gets even murkier.

Heart disease isn’t one thing.

We’ve noted blood pressure and inflammation, both of which are part of heart disease.

The anti-inflammatory effects could help relax arterial walls and thus lower the risk of excess cholesterol.

But that study was conducted on patients with type 2 diabetes, and the lowest CBD dose was 100 mg 2x daily for 13 weeks.

Of the five cohorts in this study, only one was CBD-only.

Even at 200mg per day it didn’t work.

CBD only showed efficacy in combination with THCV—another psychoactive phytocannabinoid.

Claim: Improved Mood: CBD gummies can improve your overall mood and reduce feelings of depression and anxiety.

This one is impossible to criticize because of its ambiguity.

While anecdotal research is important, “improved mood” is a subjective term dependent on numerous factors.

We’ve touched on anxiety and depression already, so this final claim is both repetitive and useless.

The same can be said for Awaken’s “science” claims.