Truth Seeker
New Member
Abstract
The primary aim of this open label pilot study is to evaluate the safety, tolerability and efficacy of 2 sublingual preparations of cannabis based medicinal extract (CBME) in patients with advanced multiple sclerosis (MS; Kurtzke > 6.5) and refractory lower urinary tract symptoms (LUTS) in whom indwelling catheterisation is being considered.
Inclusion criteria are troublesome LUTS and detrusor hyperreflexia demonstrated by cystometry. Patients with an indwelling catheter or mini-mental state examination score <27 are excluded. Data are collected using cystometry, frequency volume charts and pad testing. For the first 8 weeks of treatment patients receive CBME containing equal amounts of cannabidiol (CBD) and tetrahydrocannabinol (THC), whereas THC-only is prescribed for weeks 9-16. At the first treatment visit patients take up to 4 sprays of CBME as tolerated, under supervision (equivalent to 10mgs of THC and 10mgs of CBD).
17 patients have so far been recruited. We present the early results of 10 evaluable patients (2M:8F, 31-63yr), 8 of whom have now completed 16 weeks of CBME. Mean maximum cystometric capacity (MCC) was 278mls at baseline. After 8 weeks of treatment this increased to 344mls (without CBME use for the previous 24 hrs) and to 435mls following administration of the maximum tolerated dose of THC:CBD:1 :1. This suggests both a chronic and acute effect. At the 16-week visit the MCC decreased from a mean of 405mls before, to 392mls after, the maximum tolerated dose of THC-only extract.
These early results indicate that CBME may have a role in the management of patients with advanced MS and refractory LUTS.
Source: Clinical Studies and Case Reports
The primary aim of this open label pilot study is to evaluate the safety, tolerability and efficacy of 2 sublingual preparations of cannabis based medicinal extract (CBME) in patients with advanced multiple sclerosis (MS; Kurtzke > 6.5) and refractory lower urinary tract symptoms (LUTS) in whom indwelling catheterisation is being considered.
Inclusion criteria are troublesome LUTS and detrusor hyperreflexia demonstrated by cystometry. Patients with an indwelling catheter or mini-mental state examination score <27 are excluded. Data are collected using cystometry, frequency volume charts and pad testing. For the first 8 weeks of treatment patients receive CBME containing equal amounts of cannabidiol (CBD) and tetrahydrocannabinol (THC), whereas THC-only is prescribed for weeks 9-16. At the first treatment visit patients take up to 4 sprays of CBME as tolerated, under supervision (equivalent to 10mgs of THC and 10mgs of CBD).
17 patients have so far been recruited. We present the early results of 10 evaluable patients (2M:8F, 31-63yr), 8 of whom have now completed 16 weeks of CBME. Mean maximum cystometric capacity (MCC) was 278mls at baseline. After 8 weeks of treatment this increased to 344mls (without CBME use for the previous 24 hrs) and to 435mls following administration of the maximum tolerated dose of THC:CBD:1 :1. This suggests both a chronic and acute effect. At the 16-week visit the MCC decreased from a mean of 405mls before, to 392mls after, the maximum tolerated dose of THC-only extract.
These early results indicate that CBME may have a role in the management of patients with advanced MS and refractory LUTS.
Source: Clinical Studies and Case Reports
