A controlled trial found that sublingual cannabis extracts containing THC and CBD significantly improved pain and bladder control in patients with intractable neurological symptoms from MS and spinal cord injury.
Read this if you have neurological pain that has not responded to standard treatments and want to know about cannabis-based options.
Both THC and CBD extracts significantly superior to placebo for pain relief
What the researchers found
In 24 patients with neurological conditions (18 MS, 4 spinal cord injury, 2 other) whose symptoms had not responded to standard treatments, sublingual cannabis extracts produced significant pain relief. Both THC-containing and CBD-containing extracts improved pain significantly compared to placebo. Some patients also experienced improvements in bladder control, muscle spasms, and spasticity.
The extracts were self-administered by sublingual spray at doses patients titrated based on symptom relief, ranging from 2.5 to 120 mg per 24 hours. Three patients experienced transient hypotension and intoxication with rapid initial dosing, but unwanted effects were generally predictable and well tolerated.
Why it matters
This was one of the early clinical trials of what would become Sativex, testing sublingual delivery of standardized cannabis extracts. The finding that both THC and CBD provided significant pain relief in treatment-resistant neurological conditions helped build the evidence base for subsequent approval of Sativex.
The numbers in context
Twenty-four patients enrolled. Doses ranged from 2.5 to 120 mg per 24 hours via sublingual spray. Two-week treatment periods for each condition. Three patients experienced transient hypotension.
How the study worked
This was a series of double-blind, randomized, placebo-controlled, single-patient crossover trials with two-week treatment periods. Twenty-four patients received whole-plant extracts of THC, CBD, 1:1 CBD:THC, or placebo via sublingual spray. Patients recorded daily symptom, well-being, and intoxication scores using visual analogue scales.
What this study cannot tell us
The sample was small (24 patients) and heterogeneous in terms of underlying conditions. The single-patient crossover design, while appropriate for early-stage investigation, limits generalizability. The wide dose range (2.5-120 mg) suggests substantial individual variation that requires further characterization.
How to read the evidence
This is a randomized, double-blind, placebo-controlled crossover trial, though with a small sample of 24 patients.
When this study was published
Published in 2003. This trial contributed to the development of Sativex, which was subsequently approved in multiple countries.
The bigger picture
This study was part of GW Pharmaceuticals' clinical development program that led to the eventual approval of Sativex for MS spasticity. The sublingual spray delivery method tested here became the standard delivery for the approved product.
Questions still open
- How does the dose-response relationship for sublingual cannabis extracts compare to other delivery methods? Which specific symptoms are most responsive to THC versus CBD versus combination extracts?
Common questions
What is sublingual cannabis spray?
Did CBD help with pain in this study?
Read the original research
A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms.
Clinical rehabilitation, 17(1), 21-9
Citation
Wade, Derick T; Robson, Philip; House, Heather; Makela, Petra; Aram, Julia. (2003). A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms.. Clinical rehabilitation, 17(1), 21-9.
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