Press release: Dutch researchers outline planned cannabinoid sleep study with Formula Swiss

Paziņojums presei: Nīderlandes pētnieki sadarbojas ar Šveices kaņepju uzņēmumu, lai pētītu drošas un dabiskas alternatīvas miega problēmu risināšanai

18/08/2023

This historical press release outlined a proposed Dutch study of cannabinoids and sleep, motivated by the health and economic burden of sleep disorders and insufficient sleep. It described research plans, rather than completed trial results.

A Dutch population study, published online in 2016, reported a general sleep disturbance prevalence of 32.1% in a questionnaire survey conducted in November 2012 among adults aged 18–70. This was a survey measure, not a 2016 count of diagnosed sleep disorders. Sleep complaints include poor sleep quality, non-restorative sleep, early awakenings, and difficulty initiating and maintaining sleep. Their effects on daytime functioning and health help explain the interest in sleep research.

The announcement raised concerns about diabetes, obesity, hypertension, coronary heart disease (CHD), stroke, anxiety, depression, dementia, immune function and deaths involving cancer, stroke and CHD. This list was part of its research rationale, not evidence that sleep loss directly causes every condition or that cannabinoids prevent them. NHLBI explains that sleep deficiency can affect health, immunity and daytime performance. The linked RAND study modelled economic effects in five countries, excluding the Netherlands. Its 2016 estimates included Germany at 1.56% of GDP (US$60 billion) and the United Kingdom at 1.86% (US$50.2 billion), in 2015 US dollars. These are modelled output losses, not healthcare bills or euro estimates for the Netherlands.

A proposed study of cannabinoids and sleep

The announcement described researchers attached to the University of Groningen in the Netherlands who proposed investigating full-spectrum cannabidiol (CBD) and cannabinol (CBN) products. They were interested in possible calming, neuroprotective and sedative effects on the central nervous system. These were hypotheses motivating the proposal; the announcement did not establish that these products were effective or safe alternatives for sleep problems.

The proposed design was a large double-blind, randomised, placebo-controlled crossover trial involving more than 300 people in the Netherlands, using cannabis products from the Swiss producer Formula Swiss AG. The intended participants were patients with irritable bowel syndrome (IBS) and patients with musculoskeletal pain due to rheumatoid arthritis (RA). The proposal itself does not establish trial completion, regulatory authorisation or the legal status of a particular product.

The proposed study aimed to investigate possible effects on sleep, underlying disease mechanisms, symptoms and quality of life, rather than assume an improvement. Separately, RAND’s analysis associated less than six hours of night-time sleep with 13 per cent higher all-cause mortality, and six to seven hours with seven per cent higher mortality, relative to seven to eight hours in estimates for studies with follow-up longer than ten years. These observational associations are not individual predictions or proof that a sleep intervention prevents those deaths.

Improving sleep duration and quality was the proposed research goal. Good sleep supports health and quality of life, but this does not establish that CBD or CBN improves either, or that an intervention will reduce the health problems discussed above.

In RAND’s scenario analysis, moving sleepers from under 6 hours to 6–7 hours produced estimated output gains of 1.11% of GDP (US$29.9 billion) for the UK and 0.88% (US$34.1 billion) for Germany. The figures use 2015 US dollars; they are hypothetical model results, not measured savings from a cannabinoid trial.

The economic findings explain the interest in sleep research, but they do not demonstrate that the proposed cannabis study would reduce health or work-related costs. Outcomes, adverse effects and economic consequences would require assessment rather than a guaranteed benefit.

Contact for more information:

Drs. I. Niedlich den Herder Pathologist, medical manager, researcher plantbasedera@gmail.com (+31) 646740912

Robin Roy Krigslund-Hansen CEO Formula Swiss AG,Chamerstrasse 176
6300 Zug, Switzerland www.formulaswiss.com (+41) 78 932 8584, robin@formulaswiss.com

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