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CBD Health Benefits
Jul, 2022 by Cannabiz Wholesaler
CBD is good for you in a variety of ways – and research continues to back that up. A pair of human safety studies on CBD have provided evidence that further addresses the Food and Drug Administration’s (FDA's) requests for liver safety data -- and the findings are encouraging.
Charlotte's Web Holdings, Inc., the science-driven CBD industry pioneer, recently shared the conclusions of the combined first and second cohorts of the industry-sponsored liver safety study. The investigation's preliminary findings mirror the first cohort's results, according to a press release:
• No association of increased prevalence of increased liver function test
• No clinical liver disease
• Zero product-related adverse events
• New data concluding no daytime drowsiness and no testosterone deficiency
Charlotte's Web Holdings, Inc. in Denver, CO, markets hemp extract wellness products under a family of brands which includes Charlotte's Web, CBD Medic, CBD Clinic, and Harmony Hemp.
"We were asked by Congressional leadership to understand and get answers to important safety questions posed by the FDA so they can confidently regulate these products. Together, we achieved our goal – with feedback from FDA and participation by 17 brands, we oversubscribed and operated a nationwide, decentralized clinical study in the midst of the COVID pandemic," said Rod Nuss, Chief Operating Officer of Validcare, the contract research organization that ran the study, gained FDA feedback on the IRB approved protocol, and augmented the protocol over time to collect additional lab results at the request of FDA, in the release.
The FDA's earlier requests for scientific data on liver safety
have been formally addressed through safety investigations of
1,061 adults who supplied blood lab samples and maintained
daily journals. Secondary outcomes from the study include:
• No increase in daytime drowsiness reported per the
Stanford Sleep Scale
• CBD use by male study participants does not increase
prevalence of low testosterone at any age
• Data suggests CBD use may be helpful in preventing low
testosterone in older individuals
"We are excited that these two cohorts will provide the FDA with
the scientific data the government agency had requested of the
CBD industry on liver safety for those who ingest CBD daily.
These results provide further evidence to support policymakers
in shaping a much-needed federal regulatory framework for
hemp CBD products," said Charlotte's Web co-founder and Chief
Operating Officer Jared Stanley in a statement. "Charlotte's Web
will continue to support and invest in hemp CBD studies as we
are a science-driven company."
"The execution of these two cohorts provides proof of the hemp CBD industry working cooperatively to support rigorous scientific research to inform regulators, the FDA, and the U.S. Congress," noted Charlotte's Web Senior Vice President and the President of its CW Labs Division Tim Orr. "The 17 leading hemp CBD industry brands have advanced the science for hemp CBD by providing real world, evidence-based outcomes in liver safety, drowsiness, and testosterone levels."
Cohort two added another 222 adults who daily consumed hemp
CBD tinctures orally for 60 days. The second cohort, combined
with the first study cohort, used 17 commercially available brands
and 39 hemp CBD products across a total of 1,061 participants,
increasing statistical certainty to 98%.
Reducing Pain
According to another group of researchers, an orally-absorbed
tablet containing CBD effectively reduced pain after shoulder
surgery with no safety concerns.
Led by researchers in the Department of Orthopedic Surgery at
NYU Grossman School of Medicine, the study found that the
tablet Oravexx safely managed pain after minimally invasive
rotator cuff surgery, according to a release from NYU Langone
Health. The findings were presented at the American Academy of
Orthopaedic Surgeons (AAOS) 2022 Annual Meeting in Chicago.
“There is an urgent need for viable alternatives for pain
management, and our study presents this form of CBD as
a promising tool after arthroscopic rotator cuff repair,” said
lead investigator Michael J. Alaia, MD, Associate Professor in
the Department of Orthopedic Surgery. “It could be a new,
inexpensive approach for delivering pain relief, and without
the side effects of anti-inflammatory drugs like NSAIDs (nonsteroidal anti-inflammatory drugs) and addiction risks linked to
opiates. Additionally, CBD has the benefit of pain relief without
the psychotropic effects associated with THC or marijuana.”
On the first day after surgery, Langone reported, patients
receiving CBD experienced on average 23% less pain as measured
by the visual analog scale (VAS) pain score compared to patients
receiving the placebo, highlighting that in patients with moderate
pain, CBD may render a significant benefit.
On both the first and second days after surgery, patients receiving
CBD reported 22% to 25% greater satisfaction with pain control
compared to those receiving placebo. Further analysis also
showed that patients receiving 50 mg. of CBD reported lower pain
and higher satisfaction with pain control compared to patients
receiving placebo. No major side effects were reported.