A Single-Blind, Randomized, Placebo Controlled Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C Sublingual +Drops in People with Post-Acute Coronavirus Disease 2019 Syndrome.
Young et al.·Cannabis and cannabinoid researchImpact 2.5
MixedGRADELow7 citations
Samplen = 31 Pat.
Duration28 days per treatment period…
ControlPlacebo sublingual
EndpointPROMIS score
Blindingeinfachblind
DesignRCT
Cannabinoidcbd
Routeoromukosal
”Key finding
Both groups showed improvements in PGIC and PROMIS scores at day 28, but the placebo control was compromised, as the placebo formulation unexpectedly contained high terpene concentrations and was not a true placebo.
Summary
n=31 Post-Acute COVID-19 Syndrome (PACS), CBD-rich full-spectrum preparation (Formula C) vs. placebo over 28 days, then crossover to open-label active treatment (further 28 days). n=24 completers, 8 discontinuations (not product-related). PROMIS and PGIC scores improved in both groups from day 28; post-hoc placebo analysis unexpectedly showed medicinal terpene concentrations (not a true placebo). Improvement persisted in the open-label phase. No safety events.
P
PopulationAdults with Post-Acute COVID-19 Syndrome (PACS), n=31 randomized (n=24 study completion)
I
InterventionEndourage Formula C: CBD-rich, whole-plant terpene-rich preparation, sublingual, 28 days (double-blind), then 28 days open-label
C
ControlPlacebo sublingual (28 days; retrospectively identified as an inauthentic placebo with terpenes)
O
OutcomePGIC and PROMIS scores improved in both groups after 28 days; improvements were maintained in the open-label phase; no true placebo comparison possible
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Introduction: Coronavirus Disease 2019 (COVID-19) causes a wide range of symptoms, including death. As persons recover, some continue to experience symptoms described as Post-Acute COVID-19 Syndrome (PACS). The objectives of this study were to measure the efficacy of Formula C, a cannabidiol (CBD)-rich, whole-flower terpene-rich preparation in managing PACS symptoms. Materials and Methods: This randomized, placebo-controlled, single-blind, open-label crossover study was conducted in 2021. Informed consent was obtained from participants, and they were randomized to two treatment groups. Group 1 (n=15) received blinded active product for 28 days, and Group 2 (n=16) received blinded placebo for 28 days (Treatment Period 1). Both groups crossed over to open-label active product for 28 days (Treatment Period 2) with a safety assessment at day 70. Patient-Reported Outcomes Measurement Information System (PROMIS((R))) scores and the Patient Global Impression of Change (PGIC) score were used to assess primary and secondary objectives. Safety assessments were also done at each visit. Results: Twenty-four participants completed study, with 8 withdrawals, none related to study product. PGIC and PROMIS scores improved across both groups at day 28. This raised questions about the placebo. A reanalysis of the placebo confirmed absence of CBD and unexpected medical concentration of terpenes. The study continued despite no longer having a true placebo. The improved scores on outcome measures were maintained across the open label treatment period. There were no safety events reported throughout the study. Discussion: For persons with PACS who are nonresponsive to conventional therapies, this study demonstrated symptom improvement for participants utilizing Formula C. In addition, the benefits seen in Group 2 suggest the possibility that non-CBD formulations rich in antioxidants, omega-3, and omega-6 fatty acids, gamma-linoleic acid, and terpenes may also have contributed to the overall improvement of the partial active group through the study. Conclusion: Given that both groups demonstrated improvement, both formulations may be contributing to these findings. Limitations include the small number of participants, the lack of a true placebo, and limited time on study products. Additional studies are warranted to explore both CBD-rich hemp products and hempseed oil as treatment options for PACS. Trial Registration ClinicalTrials.gov Identifier: NCT04828668.