OBJECTIVES: Cannabis-based formulations have been used in neurology. To report, based on real-world experience, the clinical results of CBD /CBG pharmaceutical-grade formulations (PGF) in a series of cases of PD and DLB patients.

METHODS: Review of electronic records of 14 PD and 5 DLB patients. Subjects were on prescription of 4 possible PGF: 1) CBD isolated, 2) CBD/CBG (2:1), 3) CBD/CBG (2:1) + THC0.3%, 4) CBD+THC0.3%. Demographic data, PD H/Y staging, disease duration, and doses were collected. Outcomes of each unmet need (UMN) were tabulated, and graded, including local cost-effectiveness comparisons.

RESULTS: Demographics: PD N =14(10 male). DLB: N=5(3 male). Mean age:PD:76.2yrs.(46-94), DLB:82.2yrs.(83-92). Disease duration: PD(6.57 yrs.),DLB(4.2 yrs.);PD H/Y stage(3); PD levodopa dose:400mg(150-900). PD on rasagiline(n=10); Ache-inhibitors: DBL (n=4 rivastigmine, n=1 donepezil) PD (n=2 rivastigmine, n=1galantamine).PD under 2 or more dopaminergic drugs:(n=13). Formulations: PD (CBD isolated n=5, CBD/CBG 2:1 n=3,CBD/CBG 2:1+THC 0.3% n=4, CBD/THC 0.3% n=2).DBL:(CBD isolated n=3, CBD/CBG 2:1 n=1, CBD/CBG 2:1+THC 0.3% n=1).Daily doses: PD CBD:65.17mg (8.33-125mg),CBG: 22,50 mg (4.16-50mg),THC: 2,32 mg (0,75-4,5mg).DLB CBD: 52 mg (5-100mg).CBG: 8,75mg (2,5-15mg),THC:0,225mg. Most frequent unmet needs: PD: disruptive RBD (N=10), anxiety(n=5), insomnia(n=9), MSK pain(5), hallucinations / cognitive decline (n = 5),motor fluctuations(n = 4), impulsive compulsive behaviors(n = 2). DLB: wandering(n=4), disruptive RBD(3), sleep fragmentation(n=5), night agitation(n=3),severe/complex hallucinations(n=4), and severe sensorium fluctuations (5). Response rates based on UMN: RBD (9/10), insomnia (9/9), anxiety (5/5), MSK pain(3/5). All pain responders were on formulations with CBG and/or THC. Hallucinations were attenuated on PD(4/5) and on DLB(4/5).

CONCLUSIONS: CBD/CBG PGF demonstrated efficacy in several non-motor symptoms in sleep disorders and anxiety. Data points benefits of pain control in formulations with full-spectrum of cannabinoids. CBD and CBD/CBG combinations appear to have antipsychotic effect as an add-on therapy. Safety and tolerability profiles were favorable. So, in our analysis there are a promising potential clinical and economical endpoints.