The 0-10 NRS and responder PP analyses demonstrated that Sativex treatment resulted in a significant reduction in treatment-resistant spasticity, in subjects with advanced MS and severe spasticity. The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status.
These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified.
Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.
Summary:Aim: The purpose of this study was to develop a revised version of the Brief Bedside Dysphagia Screening Test for determining penetration/aspiration risk in patients prone to dysphagia. The priority was to achieve high sensitivity and negative predictive value. Methods: The study screeners conducted bedside assessment of the swallowing function in 157 patients with a neurological (mainly stroke) or an ear, nose, and throat diagnosis (mainly head and neck cancer). The results were compared with a gold standard, flexible endoscopic examination of swallowing. Results: For the neurological subgroup (N = 106), eight statistically significant bedside assessment items were combined into the Brief Bedside Dysphagia Screening Test-Revised (BBDST-R). Cut-off score 1 produced the highest sensitivity (95.5%; 95% confidence interval CI [CI]: 84.9-98.7%) and negative predictive value (88.9%; 95% CI 67.2-96.9%). Conclusion: The BBDST-R is suitable for dysphagia screening in departments caring for patients with neurological conditions.
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