title: Clinical experience with THC:CBD oromucosal spray in patients with multiple sclerosis-related spasticity.
abstract: This detailed medical charts' data collection study conducted at a multiple sclerosis (MS) clinic in Germany evaluated the effectiveness of tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray in patients with resistant MS spasticity. Over a 15-month timeframe, THC:CBD spray was initiated in 166 patients. Mean follow-up was 9 months. In all, 120 patients remained on treatment for a response rate of 72%. THC:CBD spray was used as add-on therapy in 95 patients and as monotherapy in 25 patients to achieve best-possible therapeutic results. Among responders, the mean spasticity 0-10 numerical rating scale (NRS) score decreased by 57%, from 7.0 before treatment to 3.0 within 10 days of starting THC:CBD spray. The mean dosage was 4 sprays/day. Most patients who withdrew from treatment (40/46) had been receiving THC:CBD spray for less than 60 days. Main reasons for treatment discontinuation were: adverse drug reactions, mainly dizziness, fatigue and oral discomfort (23 patients; 13.9%); lack of efficacy (14 patients; 8.4%); or need for a baclofen pump (9 patients; 5.4%). No new safety signals were noted with THC:CBD spray during the evaluation period. In this routine clinical practice setting at an MS clinic in Germany, THC:CBD spray was effective and well tolerated as add-on therapy or as monotherapy in a relevant proportion of patients with resistant MS spasticity.
authors.affiliation: Marianne Strauss Klinik , Berg , Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Koehler
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Feneberg
authors.forename: Martin
authors.initials: M
authors.lastname: Meier
authors.forename: Walter
authors.initials: W
authors.lastname: Pöllmann
mesh_terms: D000328:Adult; D002185:Cannabidiol / Q000627:therapeutic use*; D004185:Disability Evaluation; D013759:Dronabinol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009128:Muscle Spasticity / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D002185:Cannabidiol; D013759:Dronabinol
keywords: Germany; THC:CBD oromucosal spray; add-on therapy; monotherapy; multiple sclerosis; spasticity