A study supporting the reputation of CBD as having anxiolytic effects has been released. The study, published by Medscape, was a Phase IV trial conducted as an open-label, randomized controlled trial. It included 2,704 participants aged 21 years or older with anxiety, sleep disorders, or chronic pain. Intermediate results were encouraging, with 63% of participants reporting a decrease in anxiety.
CBD, or cannabidiol, is a substance derived from cannabis. It has been on sale for a short time in France in specialized stores. The motivations of consumers are diverse. A new study would support its reputation as an anxiolytic substance.
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There’s More to Study in CBD
Cannabis contains many cannabinoid substances, the two best known being cannabidiol (CBD) and tetrahydrocannabinol (THC). While THC has psychoactive properties and generates a dependence for the consumer, it is not the case with CBD. Recently, it is sold freely in France in specialized stores that are flourishing everywhere. CBD is available in the form of cartridges for electronic cigarettes, oils, herbal teas, cakes…
CBD has the reputation of having anxiolytic, anti-inflammatory, and analgesic properties, however further study is still required. Even if elements from basic research support these hypotheses, there is no or very little clinical data to confirm or deny them. This is the objective of the Advancing CBD Education and Science (ACES) trial.
A New Kind of Study
The study, published by Medscape, was conducted in real life, as a Phase IV trial. It is a 100% virtual, open-label, randomized controlled trial. It included 2,704 participants, aged 21 years or older, with anxiety, sleep disorders or chronic pain. Fourteen groups were formed: 13 groups of 208 individuals each received one of the 13 oral CBD extracts available for sale and the 14th group was a control group (n=296).
The primary endpoint in the study was “a distinct and palpable improvement in quality of life.”
The Study Results Are Promising
The secondary endpoints were:
- an improvement in sleep assessed from the Promis Sleep Short Form,
- a decrease in anxiety as assessed by the Promise Anxiety Scale and the General Anxiety Disorder-7 (GAD-7).
Intermediate study results were encouraging:
- consumers reported an average 71% improvement in well-being,
- 63% reported a decrease in anxiety,
- 61% had an improvement in sleep.
- Regarding pain, less than half of the participants experienced an improvement related to CBD use (47%).
Does CBD Have a Placebo Effect?
In a double-blind study, neither the patient nor the doctor knows which drug the patient has received. This allows for a maximum level of evidence. This is not the case here where the patients know the content of the treatment. Moreover, the craze for CBD is currently very important. It has an excellent reputation among consumers, which may distort people’s feelings. Nevertheless, in view of these data, this substance deserves to be tested in an additional study following the recommendations of good practice.
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