A preliminary controlled study to determine whether whole….pdfVIP

Clinical Rehabilitation 2003; 1 7: 21–29 A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms Derick T Wade Oxford Centre for Enablement, Philip Robson Oxford University Department of Psychiatry, Warneford Hospital, Heather House, Petra Makela and Julia Aram Oxford Centre for Enablement, Windmill Road, Oxford, UK Received 23rd August 2002; manuscript accepted 15th September 2002. Objectives: To determine whether plant-derived cannabis medicinal extracts (CME) can alleviate neurogenic symptoms unresponsive to standard treatment, and to quantify adverse effects. Design: A consecutive series of double-blind, randomized, placebo-controlled single-patient cross-over trials with two-week treatment periods. Setting: Patients attended as outpatients, but took the CME at home. Subjects: Twenty-four patients with multiple sclerosis (18), spinal cord injury (4), brachial plexus damage (1), and limb amputation due to neurofibromatosis (1). Intervention: Whole-plant extracts of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), 1:1 CBD:THC, or matched placebo were self-administered by sublingual spray at doses determined by titration against symptom relief or unwanted effects within the range of 2.5– 120 mg/24 hours. Measures used: Patients recorded symptom, well-being and intoxication scores on a daily basis using visual analogue scales. At the end of each two-week period an observer rated severity and frequency of symptoms on numerical rating scales, administered standard measures of disability (Barthel Index), mood and cognition, and recorded adverse events. Results: Pain relief associated with both THC and CBD was significantly superior to placebo. Impaired bladder control, muscle spasms and spasticity were improved by CME in some patients with these symptoms. Three patients had transient hypotension and intoxication with rapid initial dosing of THC-containing CME. C